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Electronic Code of Federal Regulations

e-CFR Data is current as of April 16, 2014

Title 21: Food and Drugs


PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS


Contents

Subpart A—General Provisions

§558.3   Definitions and general considerations applicable to this part.
§558.4   Requirement of a medicated feed mill license.
§558.5   Requirements for liquid medicated feed.
§558.6   Veterinary feed directive drugs.
§558.15   Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

Subpart B—Specific New Animal Drugs for Use in Animal Feeds

§558.55   Amprolium.
§558.58   Amprolium and ethopabate.
§558.59   Apramycin.
§558.76   Bacitracin methylene disalicylate.
§558.78   Bacitracin zinc.
§558.95   Bambermycins.
§558.105   [Reserved]
§558.115   Carbadox.
§558.128   Chlortetracycline.
§558.140   Chlortetracycline and sulfamethazine.
§558.145   Chlortetracycline, procaine penicillin, and sulfamethazine.
§558.175   Clopidol.
§558.185   Coumaphos.
§558.195   Decoquinate.
§558.198   Diclazuril.
§558.205   Dichlorvos.
§558.235   Efrotomycin.
§558.248   Erythromycin.
§558.254   Famphur.
§558.258   Fenbendazole.
§558.261   Florfenicol.
§558.265   Halofuginone.
§558.274   Hygromycin B.
§558.295   Iodinated casein.
§558.300   Ivermectin.
§558.305   Laidlomycin.
§558.311   Lasalocid.
§558.325   Lincomycin.
§558.340   Maduramicin.
§558.342   Melengestrol.
§558.348   Mibolerone.
§558.355   Monensin.
§558.360   Morantel tartrate.
§558.363   Narasin.
§558.364   Neomycin sulfate.
§558.365   Nequinate.
§558.366   Nicarbazin.
§558.369   Nitarsone.
§558.415   Novobiocin.
§558.430   Nystatin.
§558.435   Oleandomycin.
§558.450   Oxytetracycline.
§558.455   Oxytetracycline and neomycin.
§558.460   Penicillin.
§558.464   Poloxalene.
§558.465   Poloxalene free-choice liquid Type C feed.
§558.485   Pyrantel.
§558.500   Ractopamine.
§558.515   Robenidine.
§558.550   Salinomycin.
§558.555   Semduramicin.
§558.575   Sulfadimethoxine, ormetoprim.
§558.582   Sulfamerazine.
§558.586   Sulfaquinoxaline.
§558.600   Tiamulin.
§558.615   Thiabendazole.
§558.618   Tilmicosin.
§558.625   Tylosin.
§558.630   Tylosin and sulfamethazine.
§558.635   Virginiamycin.
§558.665   Zilpaterol.
§558.680   Zoalene.

Authority: 21 U.S.C. 360b, 371.

Source: 40 FR 13959, Mar. 27, 1975, unless otherwise noted.

Subpart A—General Provisions

§558.3   Definitions and general considerations applicable to this part.

(a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is not approved.

(b) The following definitions apply to terms used in this part:

(1) New animal drugs approved for use in animal feed are placed in two categories as follows:

(i) Category I—These drugs require no withdrawal period at the lowest use level in each species for which they are approved.

(ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required, or are a veterinary feed directive drug.

(2) A “Type A medicated article” is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. It consists of a new animal drug(s), with or without carrier (e.g., calcium carbonate, rice hull, corn, gluten) with or without inactive ingredients. The manufacture of a Type A medicated article requires an application approved under §514.105 of this chapter or an index listing granted under §516.151 of this chapter.

(3) A “Type B medicated feed” is intended solely for the manufacture of other medicated feeds (Type B or Type C). It contains a substantial quantity of nutrients including vitamins and/or minerals and/or other nutritional ingredients in an amount not less than 25 percent of the weight. It is manufactured by diluting a Type A medicated article or another Type B medicated feed. The maximum concentration of animal drug(s) in a Type B medicated feed is 200 times the highest continuous use level for Category I drugs and 100 times the highest continuous use level for Category II drugs. The term “highest continuous use level” means the highest dosage at which the drug is approved for continuous use (14 days or more), or, if the drug is not approved for continuous use, it means the highest level used for disease prevention or control. If the drug is approved for multiple species at different use levels, the highest approved level of use would govern under this definition. The manufacture of a Type B medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under §515.20 of this chapter.

(4) A “Type C medicated feed” is intended as the complete feed for the animal or may be fed “top dressed” (added on top of usual ration) on or offered “free-choice” (e.g., supplement) in conjunction with other animal feed. It contains a substantial quantity of nutrients including vitamins, minerals, and/or other nutritional ingredients. It is manufactured by diluting a Type A medicated article or a Type B medicated feed. A Type C medicated feed may be further diluted to produce another Type C medicated feed. The manufacture of a Type C medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under §515.20 of this chapter.

(5) A Type B or Type C medicated feed manufactured from a drug component (bulk or “drum-run” (dried crude fermentation product)) requires an application approved under §514.105 of this chapter or an index listing granted under §516.151 of this chapter.

(6) A “veterinary feed directive (VFD) drug” is a new animal drug approved under section 512(b) of the Federal Food, Drug, and Cosmetic Act (the act) or listed in the index under section 572 of the act for use in or on animal feed. Use of a VFD drug must be under the professional supervision of a licensed veterinarian.

(7) A “veterinary feed directive” is a written statement issued by a licensed veterinarian in the course of the veterinarian's professional practice that orders the use of a VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use the VFD drug in or on an animal feed to treat the client's animals only in accordance with the directions for use approved or indexed by the Food and Drug Administration (FDA). A veterinarian may issue a VFD only if a valid veterinarian-client-patient relationship exists, as defined in §530.3(i) of this chapter.

(8) A “medicated feed” means a Type B medicated feed as defined in paragraph (b)(3) of this section or a Type C medicated feed as defined in paragraph (b)(4) of this section.

(9) For the purposes of this part, a “distributor” means any person who distributes a medicated feed containing a VFD drug to another distributor or to the client-recipient of the VFD.

(10) An “animal production facility” is a location where animals are raised for any purpose, but does not include the specific location where medicated feed is made.

(11) An “acknowledgment letter” is a written communication provided to a distributor by a consignee who is not the ultimate user of medicated feed containing a VFD drug. An acknowledgment letter affirms that the consignee will not ship such medicated animal feed to an animal production facility that does not have a VFD, and will not ship such feed to another distributor without receiving a similar written acknowledgment letter.

[51 FR 7392, Mar. 3, 1986, as amended at 52 FR 2682, Jan. 26, 1987; 54 FR 51386, Dec. 15, 1989; 56 FR 19268, Apr. 26, 1991; 64 FR 63206, Nov. 19, 1999; 65 FR 76929, Dec. 8, 2000; 72 FR 69130, Dec. 6, 2007]

§558.4   Requirement of a medicated feed mill license.

(a) A feed manufacturing facility must possess a medicated feed mill license in order to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.

(b) The manufacture of the following types of feed are exempt from the required license, unless otherwise specified:

(1) Type B or Type C medicated feed using Category I, Type A medicated articles or Category I, Type B or Type C medicated feeds; and

(2) Type B or Type C medicated feed using Category II, Type B or Type C medicated feeds.

(c) The use of Type B and Type C medicated feeds shall also conform to the conditions of use provided for in subpart B of this part and in §558.15 of this chapter.

(d) This paragraph identifies each drug by category, the maximum level of drug in Type B medicated feeds, and the assay limits for the drug in Type A medicated articles and Type B and Type C medicated feeds, as follows:

Category I

Drug Assay limits percent1 type A Type B maximum (200x) Assay limits percent1 type B/C2
Amprolium with Ethopabate94-11422.75 g/lb (5.0%)80-120.
Bacitracin methylene disalicylate85-11525.0 g/lb (5.5%)70-130.
Bacitracin zinc84-1155.0 g/lb (1.1%)70-130.
Bambermycins90-110800 g/ton (0.09%)80-120/70-130.
Chlortetracycline85-11540.0 g/lb (8.8%)80-115/70-130.
Coumaphos95-1156.0 g/lb (1.3%)80-120.
Decoquinate90-1052.72 g/lb (0.6%)80-120.
Dichlorvos100-11533.0 g/lb (7.3%)90-120/80-130.
Diclazuril90-110182 g/t (0.02%)85-115/70-120.
Efrotomycin94-1131.45 g/lb (0.32%)80-120.
Erythromycin (thiocyanate salt)85-1159.25 g/lb (2.04%)<20g/ton 70-115/150-50:>20g/ton 75-125.
Iodinated casein85-11520.0 g/lb (4.4%)75-125.
Laidlomycin propionate potassium90-1101 g/lb (0.22%)90-115/85-115.
Lasalocid95-11540.0 g/lb (8.8%)Type B (cattle and sheep): 80-120; Type C (all): 75-125.
Lincomycin90-11520.0 g/lb (4.4%)80-130.
Melengestrol acetate90-11010.0 g/ton (0.0011%)70-120.
Monensin85-11540.0 g/lb (8.8%)Chickens, turkeys, and quail: 75-125; Cattle: 5-10 g/ton 80-120; Cattle: 10-30 g/ton 85-115; Goats: 20 g/ton 85-115; Liq. feed: 80-120.
Narasin90-1107.2 g/lb (1.6%)85-115/75-125.
Nequinate95-1121.83 g/lb (0.4%)80-120.
Niclosamide85-120225g/lb (49.5%)80-120.
Nystatin85-1255.0 g/lb (1.1%)75-125.
Oleandomycin85-1201.125 g/lb (0.25%)<11.25 g/ton 70-130; >11.25 g/ton 75-125.
Oxytetracycline90-12020.0 g/lb (4.4%)75-125/65-135.
Penicillin80-12010.0 g/lb (2.2%)65-135.
Poloxalene90-11054.48 g/lb (12.0%)Liq. feed: 85-115.
Ractopamine85-1052.46 g/lb (0.54%)80-110/75-125.
Salinomycin95-1156.0 g/lb (1.3%)80-120.
Semduramicin (as semduramicin sodium)90-1102.27 g/lb (0.50%)80-110
Semduramicin (as semduramicin sodium biomass)90-1102.27 g/lb (0.50%)80-120
Tylosin80-12010.0 g/lb (2.2%)75-125.
Virginiamycin85-11510.0 g/lb (2.2%)70-130.
Zoalene92-10411.35 g/lb (2.5%)85-115.

1Percent of labeled amount.

2Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.

Category II

DrugAssay limits percent1 Type A Type B maximum (100x)Assay limits percent1 Type B/C2
Amprolium94-11411.35 g/lb (2.5%)80-120.
Apramycin88-1127.5 g/lb (1.65%)80-120.
Carbadox90-1102.5 g/lb (0.55%)75-125.
Clopidol94-10611.4 g/lb (2.5%)90-115/80-120.
Famphur100-1105.5 g/lb (1.21%)90-115/80-120.
Fenbendazole93-1138.87 g/lb (1.96%)75-125
Florfenicol90-1109.1 g/lb (2.0%)Swine feed: 85-115
Catfish feed: 80-110
Salmonid feed: 80-110
Halofuginone hydrobromide90-115272.0 g/ton (.03%)75-125.
Hygromycin B90-1101,200 g/ton (0.13%)75-125.
Ivermectin95-1051,180 g/ton (0.13%)80-110.
Maduramicin ammonium90-110545 g/ton (.06%)80-120.
Morantel tartrate90-11066.0 g/lb (14.52%)85-115.
Neomycin80-1207.0 g/lb (1.54%)70-125.
Oxytetracycline80-12010.0 g/lb (2.2%)65-135.
Neomycin sulfate80-120100 g/lb (22.0%)70-125.
Nicarbazin (granular)90-1105.675 g/lb (1.25%)85-115/75-125
Narasin90-1105.675 g/lb (1.25%)85-115/75-125
Nicarbazin (powder)98-1065.675 g/lb (1.25%)85-115/80-120
Nitarsone90-1108.5 g/lb (1.87%)85-120.
Novobiocin85-11517.5 g/lb (3.85%)80-120.
Pyrantel tartrate90-11036 g/lb (7.9%)75-125.
Robenidine95-1151.5 g/lb (0.33%)80-120.
Ronnel85-11527.2 g/lb (6.0%)80-120.
Sulfadimethoxine90-1105.675 g/lb (1.25%)85-115/75-125.
Ormetoprim (5/3)90-1103.405 g/lb (0.75%)85-115.
Ormetoprim (5/1)90-11017.0 g/lb (3.75%)85-115.
Sulfaethoxypyridazine95-10550.0 g/lb (11.0%)85-115.
Sulfamerazine85-11518.6 g/lb (4.0%)85-115.
Sulfamethazine85-11510.0 g/lb (2.2%)80-120.
Chlortetracycline85-11510.0 g/lb (2.2%)85-125/70-130.
Penicillin85-1155.0 g/lb (1.1%)85-125/70-130.
Sulfamethazine85-11510.0 g/lb (2.2%)80-120.
Chlortetracycline85-11510.0 g/lb (2.2%)85-125/70-130.
Sulfamethazine85-11510.0 g/lb (2.2%)80-120.
Tylosin80-12010.0 g/lb (2.2%)75-125.
Sulfaquinoxaline98-10611.2 g/lb (2.5%)85-115.
Thiabendazole94-10645.4 g/lb (10.0%)>7% 85-115; <7% 90-110.
Tiamulin hydrogen fumarate90-11510 g/lb90-115/70-130
Tilmicosin90-11037.9 g/lb (8.35%)85-115.
Zilpaterol90-110680 g/t (0.075%)80-110/75-115

1Percent of labeled amount.

2Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.

(e) When drugs from both categories are in combination, the Category II requirements will apply to the combination drug product.

[51 FR 7392, Mar. 3, 1986]

Editorial Note: For Federal Register citations affecting §558.4, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.5   Requirements for liquid medicated feed.

(a) What types of liquid medicated feeds are covered by this section? This section covers the following types of liquid medicated feed:

(1) Type B feed that is intended for further manufacture of other medicated feeds (§558.3(b)(3)) or:

(2) Type C feed that is intended for the following:

(i) Further manufacture of another Type C feed, or

(ii) Top-dressing (adding on top of the usual ration) (§558.3(b)(4)).

(b) How is liquid free-choice medicated feed regulated? Liquid free-choice medicated feed is covered by this section and by §510.455.

(c) What is required for new animal drugs intended for use in liquid feed? Any new animal drug intended for use in liquid feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) or index listed under section 572 of the act. Such approvals under section 512 of the act must be:

(1) An original NADA,

(2) A supplemental NADA, or

(3) An abbreviated NADA.

(d) What are the approval requirements under section 512 of the act for new animal drugs intended for use in liquid feed? An approval under section 512 of the act for a new animal drug intended for use in liquid feed must contain the following information:

(1) Data, or a reference to data in a master file (MF), that shows the relevant ranges of conditions under which the drug will be chemically stable in liquid feed under field use conditions; and

(2) Data, or a reference to data in an MF, that shows that the drug is physically stable in liquid feed under field conditions; or

(3) Feed labeling with recirculation or agitation directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(e) How are chemical and physical stability data to be submitted? The data must be submitted as follows:

(1) Directly in the NADA,

(2) By a sponsor, or

(3) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder.

(f) What will be stated in the published approval for a new animal drug intended for use in liquid feed? The approval of a new animal drug intended for use in liquid feed as published in this subchapter will include the following requirements:

(1) The formula and/or specifications of the liquid medicated feed, where the owner of this information requests such publication; and/or

(2) A statement that the approval has been granted for a proprietary formula and/or specifications.

(g) When is a medicated feed mill license required for the manufacture of a liquid medicated feed? An approved medicated feed mill license is required for the manufacture of the following types of feeds:

(1) All liquid medicated feeds that contain a Category II drug, and

(2) Liquid medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications.

(h) What measures are in place to prevent certain drugs, approved for use in animal feed or drinking water but not in liquid medicated feed, from being diverted to use in liquid feeds? Any product containing any form of bacitracin, oxytetracycline, or chlortetracycline, intended for oral administration via animal feed and/or drinking water, and not approved for use in a liquid medicated feed must include in its labeling the following statement: “FOR USE IN ___ ONLY. NOT FOR USE IN LIQUID MEDICATED FEEDS.” The blank may be filled in with the words: “DRY FEEDS”, “DRINKING WATER”, or “DRY FEEDS AND DRINKING WATER”.

(i) Can the labeling provisions of paragraph (h) of this section be waived, and how can I apply for a waiver? (1) The labeling provisions of paragraph (h) of this section may be waived if there is evidence to indicate that it is unlikely a new animal drug would be used in the manufacture of a liquid medicated feed.

(2) To obtain a waiver, you must submit a letter requesting a waiver to the Office of New Animal Drug Evaluation (HFV-100), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.

(3) The letter must include a copy of the product label; a description of the formulation; and information to establish that the physical, chemical, or other properties of the new animal drug are such that diversion to use in liquid medicated feed is unlikely.

(j) What else do I need to know about the labeling provisions of paragraph (h) of this section? The labeling provisions of paragraph (h) of this section may be implemented without prior approval as provided for in §514.8(c)(3) of this chapter.

[69 FR 30197, May 27, 2004, as amended at 71 FR 74785, Dec. 13, 2006; 72 FR 69131, Dec. 6, 2007]

§558.6   Veterinary feed directive drugs.

(a) What conditions must I meet if I am a veterinarian issuing a veterinary feed directive (VFD)?

(1) You must be appropriately licensed.

(2) You must issue a VFD only within the confines of a valid veterinarian-client-patient relationship (see definition at §530.3(i) of this chapter).

(3) You must complete the VFD in writing and sign it or it will be invalid.

(4) You must include all of the following information in the VFD or it will be invalid:

(i) You and your client's name, address and telephone and, if the VFD is faxed, facsimile number.

(ii) Identification and number of animals to be treated/fed the medicated feed, including identification of the species of animals, and the location of the animals.

(iii) Date of treatment, and, if different, date of prescribing the VFD drug.

(iv) Approved or index listed indications for use.

(v) Name of the animal drug.

(vi) Level of animal drug in the feed, and the amount of feed required to treat the animals in paragraph (a)(4)(ii) of this section.

(vii) Feeding instructions with the withdrawal time.

(viii) Any special instructions and cautionary statements necessary for use of the drug in conformance with the approval.

(ix) Expiration date of the VFD.

(x) Number of refills (reorders) if necessary and permitted by the approval.

(xi) Your license number and the name of the State issuing the license.

(xii) The statement: “Extra-label use, (i.e., use of this VFD feed in a manner other than as provided for in the VFD drug approval) is strictly prohibited.”

(xiii) Any other information required by the VFD drug approval regulation.

(5) You must produce the VFD in triplicate.

(6) You must issue a VFD only for the approved or indexed conditions and indications for use of the VFD drug.

(b) What must I do with the VFD if I am a veterinarian?

(1) You must give the original VFD to the feed distributor (directly or through the client).

(2) You must keep one copy of the VFD.

(3) You must give the client a copy of the VFD.

(4) You may send a VFD to the client or distributor by facsimile or other electronic means provided you assure that the distributor receives the original signed VFD within 5 working days of receipt of the facsimile or other electronic order.

(5) You may not transmit a VFD by telephone.

(c) What are the VFD recordkeeping requirements?

(1) The VFD feed distributor must keep the VFD original for 2 years from the date of issuance. The veterinarian and the client must keep their copies for the same period of time.

(2) All involved parties must make the VFD available for inspection and copying by FDA.

(3) All involved parties (the VFD feed distributor, the veterinarian, and the client) must keep VFD's transmitted by facsimile or other electronic means for a period of 2 years from date of issuance.

(4) All involved parties must have a copy of the VFD before distribution of a VFD feed to the ultimate user.

(d) What are the notification requirements if I am a distributor of animal feed containing a VFD drug?

(1) You must notify FDA only once, by letter, that you intend to distribute animal feed containing a VFD drug.

(i) The notification letter must include the complete name and address of each business site from which distribution will occur.

(ii) A responsible person from your firm must sign and date the notification letter.

(iii) You must submit the notification letter to the Center for Veterinary Medicine, Division of Animal Feeds (HFV-220), 7500 Standish Pl., Rockville, MD 20855, prior to beginning your first distribution.

(iv) You must notify the Center for Veterinary Medicine at the above address within 30 days of any change in name or business address.

(2) If you are a distributor who ships an animal feed containing a VFD drug to another consignee-distributor in the absence of a valid VFD, you must obtain an “acknowledgment letter,” as defined in §558.3(b)(11), from the consignee-distributor. The letter must include a statement affirming that the consignee-distributor has complied with “distributor notification” requirements of paragraph (d)(1) of this section.

(e) What are the additional recordkeeping requirements if I am a distributor?

(1) You must keep records of receipt and distribution of all medicated animal feed containing a VFD drug.

(2) You must keep these records for 2 years from date of receipt and distribution.

(3) You must make records available for inspection and copying by FDA.

(f) What cautionary statements are required for VFD drugs and animal feeds containing VFD drugs? All labeling and advertising must prominently and conspicuously display the following cautionary statement: “Caution: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice.”

[65 FR 76929, Dec. 8, 2000, as amended at 72 FR 69131, Dec. 6, 2007]

§558.15   Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

(a) The Commissioner of Food and Drugs will propose to revoke currently approved subtherapeutic (increased rate of gain, disease prevention. etc.) uses in animal feed of antibiotic and sulfonamide drugs whether granted by approval of new animal drug applications, master files and/or antibiotic or food additive regulations, by no later than April 20, 1975, or the nitrofuran drugs by no later than September 5, 1975, unless data are submitted which resolve conclusively the issues concerning their safety to man and animals and their effectiveness under specific criteria established by the Food and Drug Administration based on the guidelines included in the report of the FDA task force on the use of antibiotics in animal feeds. All persons or firms previously marketing identical, related, or similar products except the nitrofuran drugs not the subject of an approved new animal drug application must submit a new animal drug application by July 19, 1973, or by December 4, 1973, in the case of nitrofuran drugs, if marketing is to continue during the interim. New animal drug entities with antibacterial activity not previously marketed, now pending approval or submitted for approval prior to, on, or following the effective date of this publication, shall satisfy such criteria prior to approval.

(b) Any person interested in developing data which will support retaining approval for such uses of such antibiotic, nitrofuran, and sulfonamide drugs pursuant to section 512(l) of the Federal Food, Drug, and Cosmetic Act shall submit to the Commissioner the following:

(1) By July 19, 1973, records and reports of completed, ongoing, or planned studies, including protocols, on the tetracyclines, streptomycin, dihydrostreptomycin, penicillin, and the sulfonamides; for all other antibiotics by October 17, 1973; and for the nitrofuran drugs by March 4, 1974. The Food and Drug Administration encourages sponsors to consult with the Center for Veterinary Medicine on protocol design and plans for future studies.

(2) By April 20, 1974, data from completed studies on the tetracyclines, streptomycin, dihydrostreptomycin, the sulfonamides, and penicillin assessing the effect of the subtherapeutic use of the drug in feed on the salmonella reservoir in the target animal as compared to that in nonmedicated controls. Failure to complete the salmonella studies for any of these drugs by that time will be grounds for proceeding to immediately withdraw approval.

(3) By April 20, 1975, data satisfying all other specified criteria for safety and effectiveness, including the effect on the salmonella reservoir for any antibiotic or sulfonamide drugs and by September 5, 1975, for the nitrofuran drugs, approved for subtherapeutic use in animal feeds. Drug efficacy data shall be submitted for any feed-use combination product containing such drug and any feed-use single ingredient antibiotic, nitrofuran, or sulfonamide not reviewed by the National Academy of Sciences—National Research Council, Drug Efficacy Study covering drugs marketed between 1938 and 1962.

(4) Progress reports on studies underway every January 1 and July 1 until completion.

(c) Failure on the part of any sponsor to comply with any of the provisions of paragraph (b) of this section for any of the antibacterial drugs included in paragraph (b)(1) of this section, or interim results indicating a health hazard, will be considered as grounds for immediately proceeding to withdraw approval of that drug for use in animal feeds under section 512(l) of the act in the case of failure to submit required records and reports and under section 512(e) where new information shows that such drug is not shown to be safe.

(d) Criteria based upon the guidelines laid down by the task force may be obtained from the Food and Drug Administration, Center for Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855.

(e) Reports as specified in this section shall be submitted to: Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation (HFV-100), 7500 Standish Pl., Rockville, MD 20855.

(f) Following the completion of the requirements of paragraphs (a) and (b) of this section and the studies provided for therein:

(1) Those antibiotic, nitrofuran, and sulfonamide drugs which fail to meet the prescribed criteria for subtherapeutic uses but which are found to be effective for the therapeutic purposes will be permitted in feed only for high-level, short-term therapeutic use and only by or on the order of a licensed veterinarian.

(2) Animal feeds containing antibacterial drugs permitted to remain in use for subtherapeutic purposes shall be labeled to include a statement of the quantity of such drugs.

(g) The submission of applications and data required by paragraphs (a) and (b) of this section is not required for the continued manufacture of any Type A medicated article which is produced solely from a Type A article that is in compliance with the requirements of this section: Provided, That the Type A medicated article contains no drug ingredient whose use in or on animal feed requires an approved application pursuant to section 512(m) of the act and/or where the Type A article is approved by regulation in this part.

(1) The following antibacterial Type A articles manufactured by the designated sponsors are eligible for interim marketing based on their compliance with the requirements of this section:

Drug sponsorType A articleSpeciesUse levelsIndications for use
Fermenta Animal Health Co.Bacitracin methylene disalicylateChicken turkeys, swine, and cattleSec. 558.76Sec. 558.76.

(2) [Reserved]

[51 FR 8811, Mar. 14, 1986; 51 FR 11014, Apr. 1, 1986, as amended at 51 FR 28547, Aug. 8, 1986; 53 FR 20843, June 7, 1988; 54 FR 37098, Sept. 7, 1989; 54 FR 51386, Dec. 15, 1989; 55 FR 8460, 8462, Mar. 8, 1990; 56 FR 41912, Aug. 23, 1991; 56 FR 64702, Dec. 12, 1991; 57 FR 6476, Feb. 25, 1992; 57 FR 8577, Mar. 11, 1992; 57 FR 14639, Apr. 22, 1992; 58 FR 17515, Apr. 5, 1993; 58 FR 30119, May 26, 1993; 61 FR 51589, Oct. 3, 1996; 64 FR 992, Jan. 7, 1999; 64 FR 37673, July 13, 1999; 71 FR 16221, Mar. 31, 2006; 75 FR 16002, Mar. 31, 2010]

Subpart B—Specific New Animal Drugs for Use in Animal Feeds

§558.55   Amprolium.

(a) Approvals. Type A medicated articles: 25 percent to No. 016592 in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(b) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(c) Related tolerances. See §556.50 of this chapter.

(d) Conditions of use

(1) Cattle. It is used as follows:

Amprolium in grams per tonIndications for useLimitationsSponsor
(i) 113.5 to 11, 350; to provide 5 milligrams per kilogram of body weight per dayCalves: As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zuerniiTop-dress on or mix in the daily ration. Feed for 21 days when experience indicates that coccidiosis is likely to be a hazard, as the sole source of amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal016592
(ii) 113.5 to 11, 350; to provide 10 milligrams per kilogram of body weight per dayCalves: As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zuerniiTop-dress on or mix in the daily ration. Feed for 5 days as the sole source of amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal016592

(2) Chickens. It is used as follows:

Amprolium in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 36.3 to 113.5Replacement chickens: For development of active immunity to coccidiosisFeed continuously until onset of production as follows:016592
Growing conditionsUp to 5 weeks of ageFrom 5 to 8 weeks of ageOver 8 weeks of age
Amprolium in grams per tonAmprolium in grams per tonAmprolium in grams per ton
Severe exposure to coccidiosis113.572.6-113.536.3-113.5
   (0.0125%)(0.008%-0.0125%)(0.004%-0.0125%)
Moderate exposure to coccidiosis72.6-113.554.5-113.536.3-113.5
   (0.008%-0.0125%)(0.006%-0.0125%)(0.004%-0.0125%)
Slight exposure to coccidiosis36.3-113.536.3-113.536.3-113.5
   (0.004%-0.0125%)(0.004%-0.0125%)(0.004%-0.0125%)
Amprolium in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(ii) 36.3 to 113.5Bacitracin methylene disalicylate 4 to 50Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed according to subtable in item (i). Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter054771
(iii) 72.6 to 113.5Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella onlyFeed continuously as the sole ration; as sole source of amprolium016592
(iv) 72.6 to 113.5Bambermycins 1 to 2Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella only; and for increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in §510.600(c) of this chapter016592
(v) 113.51. Laying chickens: For prevention of coccidiosisFeed continuously as the sole ration; as the sole source of amprolium016592
   2. Laying chickens: For treatment of coccidiosis in moderate outbreaksFeed for 2 weeks
(vi) 113.5 to 2271. Replacement chickens: For prevention of coccidiosis where immunity to coccidiosis is not desiredFeed continuously from day-old until onset of production; as the sole source of amprolium016592
   2. Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desiredFeed continuously as the sole ration; as sole source of amprolium
(vii) 113.5 to 227Bambermycins 1 to 2Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired; and for increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in §510.600(c) of this chapter016592
(viii) 227Laying chickens: For treatment of coccidiosis in severe outbreaks.Feed for 2 weeks016592

(3) Turkeys. It is used as follows:

Amprolium in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 113.5Bambermycins 1 to 4Growing turkeys: For prevention of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as the sole source of amprolium; bambermycins as provided by No. 016592 in §510.600(c) of this chapter016592
(ii) 113.5 to 227Turkeys: For prevention of coccidiosisFeed continuously as the sole ration; as sole source of amprolium016592

(4) Pheasants. It is used as follows:

Amprolium in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 159Growing pheasants: For the prevention of coccidiosis caused by Eimeria colchici, E. duodenalis, and E. phasianiFeed continuously as sole ration. Use as sole source of amprolium016592
(ii) [Reserved]

[41 FR 10985, Mar. 15, 1976]

Editorial Note: For Federal Register citations affecting §558.55, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.58   Amprolium and ethopabate.

(a) Specifications. Type A medicated articles containing:

(1) 25 percent amprolium and 8 percent ethopabate or 5 percent amprolium and 1.6 percent ethopabate;

(2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent amprolium and 0.16 percent ethopabate.

(b) Approvals. See No. 016592 in §510.600(c) of this chapter.

(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(d) Related tolerances. See §§556.50 and 556.260 of this chapter.

(e) Conditions of use. It is used in chicken feed as follows:

Amprolium and ethopabate in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(1) Amprolium 113.5 and ethopabate 3.6Broiler chickens: As an aid in the prevention of coccidiosisFeed continuously as sole ration; as sole source of amprolium. Not for laying chickens016592
(2) Amprolium 113.5 and ethopabate 3.6Lincomycin 2 to 4Broiler chickens: As an aid in the prevention of coccidiosis; for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration; as sole source of amprolium. Not for laying chickens
Lincomycin as provided by No. 054771 in §510.600(c) of this chapter
054771
(3) Amprolium 113.5 and ethopabate 36.3Broiler chickens and replacement chickens: where immunity to coccidiosis is not desired: As an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occurFeed continuously as sole ration; as sole source of amprolium. Not for chickens over 16 weeks of age016592
(4) Amprolium 113.5 and ethopabate 36.3Bacitracin 4 to 501. Broiler chickens and replacement chickens: where immunity to coccidiosis is not desired; to aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gain in broiler chickens raised in floor pensFeed as the sole ration from the time chickens are placed on litter until past the time when coccidiosis is ordinarily a hazard. Not for chickens over 16 weeks of age; do not feed to laying chickens; as sole source of amprolium; not for use as a treatment for outbreaks of coccidiosis. Bacitracin as bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter016592
(5) Amprolium 113.5 and ethopabate 36.3Bacitracin 4 to 502. Broiler chickens: As an aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for improved feed efficiencyFeed as the sole ration from the time chickens are placed on litter until market weight. Not for chickens over 16 weeks of age; do not feed to laying chickens; as sole source of amprolium; not for use as a treatment for coccidiosis. Bacitracin zinc as provided by No. 054771 in §510.600(c) of this chapter054771
(6) Amprolium 113.5 and ethopabate 3.6Bambermycins 1 to 3Broiler chickens: As an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gain, improved feed efficiencyFeed continuously as the sole ration; as sole source of amprolium
Bambermycins as provided by No. 016592 in §510.600(c) of this chapter
016592
(7) Amprolium 113.5 and ethopabate 36.3Virginiamycin 15Broiler chickens; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration; as sole source of amprolium. Do not feed to laying chickens. Not for chickens over 16 weeks of age
Virginiamycin as provided by No. 066104 in §510.600(c) of this chapter
066104
(8) Amprolium 113.5 and ethopabate 36.3Virginiamycin 5 to 15Broiler chickens; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gainFeed continuously as the sole ration; as sole source of amprolium. Do not feed to laying chickens. Not for chickens over 16 weeks of age
Virginiamycin as provided by No. 066104 in §510.600(c) of this chapter
066104
(9) Amprolium 227 and ethopabate 3.6For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosisNot for laying chickens016592
(10) Amprolium 227 and ethopabate 3.6Chlortetracycline 100 to 200For chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracyclineDo not feed to chickens producing eggs for human consumption. Feed for 7 to 14 days054771
(11) Amprolium 227 and ethopabate 3.6Chlortetracycline 200 to 400For chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracyclineIn low calcium feed containing 0.8% dietary calcium and 1.5% sodium sulfate; feed continuously as sole ration for 7 to 14 days; do not feed to chickens producing eggs for human consumption054771

[41 FR 10990, Mar. 15, 1976]

Editorial Note: For Federal Register citations affecting §558.58, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.59   Apramycin.

(a) Approvals. Type A articles to sponsors identified in §510.600(c) of this chapter as follows:

(1) 000986 for 75 grams apramycin (as apramycin sulfate) per pound for use as in paragraph (d)(1) of this section.

(2) [Reserved]

(b) [Reserved]

(c) Related tolerances. See §556.52 of this chapter.

(d) Conditions of use—(1) Swine—(i) Amount. 150 grams per ton.

(ii) Indications for use. For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli.

(iii) Limitations. Use for 14 days. Withdraw 28 days before slaughter.

(2) [Reserved]

[51 FR 9190, Mar. 18, 1986]

§558.76   Bacitracin methylene disalicylate.

(a) Approvals. Type A medicated articles: 10, 25, 30, 40, 50, 60, or 75 grams per pound to 054771 in §510.600(c) of this chapter.

(b) Special considerations. The quantities of antibiotics are expressed in terms of the equivalent amount of antibiotic standard.

(c) Related tolerances. See §556.70 of this chapter.

(d) Conditions of use. (1) It is used as follows:

Bacitracin methylene disalicylate in grams per tonCombination in grams
per ton
Indications for useLimitationsSponsor
(i) 4 to 50Chickens, turkeys, and pheasants; increased rate of weight gain and improved feed efficiency1054771
(ii) 5 to 20Quail not over 5 weeks of age; increased rate of weight gain and improved feed efficiency1054771
(iii) 10 to 25Chickens; for increased egg production and improved feed efficiency for egg productionFor first 7 months of production054771
(iv) 10 to 30Swine: for increased rate of weight gain and improved feed efficiencyFor growing and finishing swine054771
   Chlortetracycline approximately 400, varying with body weight and food consumption to provide 10 milligrams per pound of body weight per daySwine; for increased rate of weight gain and improved feed efficiency; for treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracyclineFeed for not more than 14 days; bacitracin methylene disalicylate provided by No. 054771; chlortetracycline provided by Nos. 054771 and 048164 in §510.600(c) of this chapter054771
048164
      Swine; for control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracyclineFeed for not more than 14 days; chlortetracycline and BMD as provided by 046573 in §510.600(c) of this chapter054771
(v) [Reserved]
(vi) 50Broiler chickens; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin054771
      Replacement chickens; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.Feed continuously as sole ration054771
(vii)-(viii) [Reserved]
(ix) 100 to 200Broiler chickens; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin054771
      Replacement chickens; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.Feed continuously as sole ration. Start at first clinical signs of disease, vary dosage based on severity of infection, administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 g/t)054771
(x) 200Turkeys; as an aid in the control of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylene disalicylate054771
      Quail; for the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylene disalicylate.From Type A medicated articles containing 25, 40, or 50 grams of bacitracin methylene disalicylate. Feed continuously as the sole ration054771
(xi) 2501. Growing/Finishing Swine: For control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery but where signs of the disease have not yet occurred; or following an approved treatment of the disease conditionAs the sole ration. Not for use in swine weighing more than 250 pounds. Diagnosis should be confirmed by a veterinarian when results are not satisfactory054771
   2. Pregnant sows: For control of clostridial enteritis caused by C. perfringens in suckling pigletsAs the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory

1These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(2) It is used as bacitracin methylene disalicylate in feed for animals as follows:

(i) Amount. 70 milligrams per head per day.

(a) Indications for use. Feedlot beef cattle; reduction in the number of liver condemnations due to abscesses.

(b) Limitations. Administer continuously throughout the feeding period.

(ii) Amount. 250 milligrams per head per day.

(a) Indications for use. Feedlot beef cattle; reduction in the number of liver condemnations due to abscesses.

(b) Limitations. Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period.

(3) Bacitracin methylene disalicylate may also be used in combination with:

(i) Amprolium as in §558.55.

(ii) Amprolium and ethopabate as in §558.58.

(iii) Decoquinate as in §558.195.

(iv) Diclazuril as in §558.198.

(v) Fenbendazole as in §588.258.

(vi) Halofuginone as in §558.265.

(vii) Hygromycin B as in §588.274.

(viii) Ivermectin as in §558.300.

(ix) Lasalocid sodium as in §558.311.

(x) Monensin as in §588.355.

(xi) Narasin as in §558.363.

(xii) Nicarbazin alone and with narasin as in §558.366.

(xiii) Nitarsone as in §558.369.

(xiv) Robenidine as in §558.515.

(xv) Salinomycin as in §558.550.

(xvi) Semduramicin as in §558.555.

(xvii) Zoalene as in §558.680.

[41 FR 10993, Mar. 15, 1976]

Editorial Note: For Federal Register citations affecting §558.76, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.78   Bacitracin zinc.

(a) Specifications. Type A medicated articles containing bacitracin zinc equivalent to 10, 25, 40, or 50 grams per pound bacitracin.

(b) Approvals. See No. 054771 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.70 of this chapter.

(d) Conditions of use. (1) It is used as follows:

Bacitracin zinc in grams per tonCombinations in grams per tonIndications for useLimitationsSponsor
(i) 4 to 50   Chickens: for increased rate of weight gain and improved feed efficiencyGrowing chickens054771
(ii) 4 to 50   Turkeys and pheasants: for increased rate of weight gain and improved feed efficiencyGrowing turkeys and pheasants054771
(iii) 5 to 20Quail; for increased rate of weight gain and improved feed efficiencyGrowing quail; feed as the Type C feed to starting quail through 5 weeks of age054771
(iv) 10 to 25Laying chickens; improved feed efficiency and increased egg production054771
(v) 10 to 50Swine; increased rate of weight gain and improved feed efficiencyGrowing and finishing swine054771
(vi) 20Growing-finishing swine; increased rate of weight gainIn Type C feed054771
(vii) 20 to 40Growing-finishing swine; improved feed efficiency......do054771

(2) It is used in feed for growing cattle at 35 to 70 milligrams per head per day as follows:

(i) To aid in stimulating growth and improving feed efficiency.

(ii) For increased rate of weight gain and improved feed efficiency; see sponsor 054771.

(3) Bacitracin zinc may also be used in combination with:

(i) Amprolium and ethopabate as in §558.58.

(ii) Clopidol as in §558.175.

(iii) Decoquinate as in §558.195.

(iv) Lasalocid as in §558.311.

(v) Monensin as in §558.355.

(vi) Naracin as in §558.363.

(vii) Nitarsone as in §558.369.

(viii) Robenidine as in §558.515.

(ix) Salinomycin as in §558.550.

[41 FR 10994, Mar. 15, 1976]

Editorial Note: For Federal Register citations affecting §558.78, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.95   Bambermycins.

Link to an amendment published at 79 FR 19815, April 10, 2014.

(a) Approvals. See sponsors in §510.600(c) of this chapter for use of Type A medicated articles as in paragraph (d) of this section:

(1) No. 016592: 2, 4, and 10 grams per pound for use as in paragraphs (d)(1), (d)(2), (d)(3), and (d)(4) of this section.

(2) Nos. 012286 and 017790: 2 grams for use as in paragraph (d)(2) of this section and 0.4 and 2 grams per pound for use as in paragraph (d)(3).

(b) Special considerations. (1) Bambermycins liquid Type B feeds may be manufactured from dry bambermycins Type A articles. The liquid Type B feeds must have a pH of 3.8 to 7.5, moisture content of 30 to 45 percent.

(2) The expiration date for the liquid Type B feed is 8 weeks after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 1 week after date of manufacture.

(c) [Reserved]

(d) Conditions of use—(1) Chickens. Use in medicated feed as follows:

Bambermycins in grams/tonIndications for useLimitationsSponsor
(i) 1 to 2Broiler chickens: For increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration016592.
(ii) [Reserved]

(2) Turkeys. Use in medicated feed as follows:

Bambermycins in grams/tonIndications for useLimitationsSponsor
(i) 1 to 2Growing turkeys: For improved feed efficiencyFeed continuously as the sole ration012286, 016592, 017790.
(ii) 2Growing turkeys: For increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration012286, 016592, 017790.

(3) Swine. Use in medicated feed as follows:

Bambermycins in grams/tonIndications for useLimitationsSponsor
(i) 2Growing-finishing swine: For increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration012286, 016592, 017790.
(ii) 2 to 4Growing-finishing swine: For increased rate of weightFeed continuously as the sole ration012286, 016592, 017790.

(4) Cattle.

Bambermycins in grams/tonIndications for useLimitationsSponsor
(i) 1 to 4Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiencyFeed continuously at a rate of 10 to 20 milligrams per head per day016592.
(ii) 2 to 40Pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gainFeed continuously at a rate of 10 to 40 milligrams per head per day in at least 1 pound and not more than 10 pounds of feed. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day016592.

(iii) Used as a free-choice Type C medicated loose-mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows:

(a) Specifications.

IngredientInternational Feed No.Percent
Deflorinated phosphate (20.5% calcium, 18.5% phosphorus)6-01-08042.50
Sodium chloride (salt)6-04-15220.10
Calcium carbonate (38% calcium)6-01-06915.24
Corn distillers dried grains w/solubles5-28-2369.57
Magnesium oxide6-02-7565.15
Vitamin and trace mineral premix *.........3.72
Mineral oil.........1.00
Yeast (primary dehydrated yeast)7-05-5330.75
Bambermycins Type A article (10 g/lb).........0.60
Iron oxide6-02-4310.50
Magnesium sulfate (67%)6-02-7580.32
Selenium premix (270 mg/lb) *.........0.21
Copper sulfate6-01-7200.18
Potassium sulfate (0.33%)6-06-0980.16

*Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(b) Amount per ton. 120 grams.

(c)Indications for use. For increased rate of weight gain.

(d) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers). Feed a nonmedicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(iv) Use free-choice Type C medicated feeds for pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows:

(a) Amount. Feed continuously to provide 10 to 40 milligrams of bambermycins per head per day.

(b) Indications for use. For increased rate of weight gain.

(c) Limitations. Each use in a free-choice Type C medicated feed must be the subject of an approved new animal drug application (NADA) or supplemental NADA as required by 21 CFR 510.455. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(5) Bambermycins may also be used in combination with:

(i) Amprolium as in §558.55.

(ii) Amprolium and ethopabate as in §558.58.

(iii) Clopidal as in §558.175.

(iv) Diclazuril as in §558.198.

(v) Halofuginone as in §558.265.

(vi) Lasalocid as in §558.311.

(vii) Monensin as in §558.355.

(viii) Narasin alone or with nicarbazin as in §558.363.

(ix) Nicarbazin as in §558.366.

(x) Salinomycin as in §558.550.

(xi) Zoalene as in §558.680.

[40 FR 13959, Mar. 27, 1975]

Editorial Note: For Federal Register citations affecting §558.95, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.105   [Reserved]

§558.115   Carbadox.

(a) Approvals. Type A medicated articles: 2.2. percent (10 grams per pound) to 066104 in §510.600(c) of this chapter.

(b) Related tolerances. See §556.100 of this chapter.

(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(d) Conditions of use. It is used for swine as follows:

(1) Amount per ton. 10-25 grams (0.0011-0.00275 percent).

(i) Indications for use. For increase in rate of weight gain and improvement of feed efficiency.

(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.

(2) Amount per ton. 50 grams (0.0055 percent).

(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); increased rate of weight gain and improved feed efficiency.

(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.

(3) Amount per ton. Carbadox 50 grams (0.0055 percent) plus pyrantel tartrate, 96 grams (0.0106 percent).

(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections.

(ii) Limitations. Do not feed to swine over 75 pounds; do not feed within 10 weeks of slaughter; consult a veterinarian before feeding to severely debilitated animals; feed continuously as sole ration. Do not use in complete feeds containing less than 15 percent crude protein.

(4) Amount. Carbadox, 10 to 25 grams per ton of feed; plus oxytetracycline, 10 milligrams per pound of body weight.

(i) Indications for use. For treatment of bacterial enteritis caused by Escherichia coli and S. choleraesuis susceptible to oxytetracycline, for treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and for increased rate of weight gain and improved feed efficiency.

(ii) Limitations. Feed continuously for 7 to 14 days. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.

[40 FR 13959, Mar. 27, 1975, as amended at 40 FR 45164, Oct. 1, 1975; 40 FR 57798, Dec. 12, 1975; 42 FR 761, Jan. 4, 1977; 51 FR 7396, Mar. 3, 1986; 63 FR 59216, Nov. 3, 1998; 66 FR 47963, Sept. 17, 2001; 69 FR 51173, Aug. 18, 2004]

§558.128   Chlortetracycline.

(a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride or, for products intended for use in milk replacer, chlortetracycline hydrochloride.

(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) Nos. 054771, 048164, and 066104: 50 to 100 grams per pound (g/lb) of Type A medicated article.

(2) No. 012286: 50, 90, or 100 grams per pound of Type A medicated article.

(c) Related tolerances. See §556.150 of this chapter.

(d) Special considerations. (1) In milk replacers or starter feed; include on labeling the warning: “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.”

(2) Manufacture for use in free-choice feeds as in paragraph (e)(4)(iii) of this section must conform to §510.455 of this chapter.

(3) When manufactured for use as in paragraph (e)(5)(iv) of this section, include on labeling the warning: “Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.”

(e) Conditions of use—(1) Chickens. It is used as follows:

Chlortetracycline amountIndications for useLimitationsSponsor
(i) 10 to 50 g/tonChickens: For increased rate of weight gain and improved feed efficiency.   
   
Do not feed to chickens producing eggs for human consumption.
054771
   
012286,
054771,
048164,
066104.
(ii) 100 to 200 g/tonChickens: For control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.1. Feed continuously for 7 to 14 d.
   
2. Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption.
054771.
   
012286,
054771,
048164,
066104.
(iii) 200 to 400 g/tonChickens: For the control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline.1. Feed continuously for 7 to 14 d.
   
2. Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption.
054771.
   
012286,
054771,
048164,
066104.
(iv) 500 g/tonChickens: For the reduction of mortality due to E. coli infections susceptible to chlortetracycline.1. Feed for 5 d; 0-day withdrawal time when formulated from AUREOMYCIN Type A medicated articles or Type B medicated feeds under NADA 48-761.
2. Feed for 5 d; withdraw 24 h prior to slaughter; do not feed to chickens producing eggs for human consumption.
054771.
   
   
   
012286,
046573,
048164,
066104.

(2) Turkeys. It is used as follows:

Chlortetracycline amountIndications for useLimitationsSponsor
(i) 10 to 50 g/tonGrowing turkeys: For increased rate of weight gain and improved feed efficiency.Do not feed to turkeys producing eggs for human consumption.012286,
054771,
048164,
066104.
(ii) 200 g/tonTurkeys: For control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline.Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption.012286,
054771,
048164,
066104.
(iii) 400 g/ton1. Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline.Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption.012286,
054771,
048164,
066104.
      
2. Turkey poults not over 4 weeks of age: For reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline.
      
012286,
054771,
048164,
066104.
(iv) 25 mg/lb of body weightTurkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline.Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption.012286,
054771,
048164,
066104.

(3) Swine. It is used as follows:

Chlortetracycline amountIndications for useLimitationsSponsor
(i) 10 to 50 g/tonGrowing swine: For increased rate of weight gain and improved feed efficiency.   012286,
054771,
048164,
066104.
(ii) 50 to 100 g/tonSwine: For reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E. Streptococci susceptible to chlortetracycline.   012286,
054771,
048164,
066104.
(iii) 400 g/tonBreeding swine: For the control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline.Feed continuously for not more than 14 d.012286,
054771,
048164,
066104.
(iv) 10 mg/lb of body weight1. Swine: For the treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline.Feed approximately 400 g/t, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 d; withdraw 5 d prior to slaughter for sponsor 012286.012286,
054771,
048164,
066104.
      
2. Swine: For the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline.
   
Feed for not more than 14 d.
   
054771.

(4) Cattle. It is used as follows:

Chlortetracycline amountIndications for useLimitationsSponsor
(i) 0.1 mg/lb of body weight daily.Calves (up to 250 lb): For increased rate of weight gain and improved feed efficiency.See paragraph (d)(1) of this section.012286,
054771,
048164,
066104.
(ii) 0.5 mg/lb of body weight daily.Beef cattle (over 700 lb); control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.Withdraw 48 h prior to slaughter. To sponsor Nos. 054771 and 048164: zero withdrawal time.012286,
054771,
048164,
066104.
(iii) 0.5 to 2.0 mg/lb of body weight daily.Beef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplsmosis caused by A. marginale susceptible to chlortetracycline.In free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approved Type A articles. See paragraph (d)(2) of this section.054771.
(iv) 10 mg/lb of body weight daily1. Calves, beef and nonlactating dairy cattle; treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 d; in feed including milk replacers; withdraw 10 d prior to slaughter. To sponsor No. 048164: zero withdrawal time. See paragraph (d)(1) of this section.012286,
048164,
066104.
      2. Calves (up to 250 lb): For the treatment of bacterial enteritis caused by E. coli susceptible to chlortetracycline.See paragraph (d)(1) of this section.012286,
054771,
048164,
066104.
(v) 500 to 4,000 g/tonCalves, beef and nonlactating dairy cattle; treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.Feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. To sponsor No. 054771 under NADA 046-699: 24-h withdrawal time. To sponsor No. 054771 under NADA 048-761: zero withdrawal time.054771.
(vi) 4,000 to 20,000 g/tonCalves, beef and nonlactating dairy cattle; treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.As a top dress, varying with body weight and feed consumption, to provide 10 mg/lb per day. Treat for not more than 5 days. See paragraph (d)(1) of this section.054771.
(vii) 25 to 70 mg/head/dayCalves (250 to 400 lb): For increased rate of weight gain and improved feed efficiency.See paragraph (d)(1) of this section.012286,
054771,
048164,
066104.
(viii) 70 mg/head/dayGrowing cattle (over 400 lb): For increased rate of weight gain, improved feed efficiency, and reduction of liver condemnation due to liver abscesses.See paragraph (d)(1) of this section.012286,
054771,
048164,
066104.
(ix) 350 mg/head/day1. Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 046-699: 48-h withdrawal time. To sponsor No. 054771 under NADA 048-761 and No. 048164: zero withdrawal time.012286,
054771,
048164,
066104.
      2. Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline.Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 046-699: 48-h withdrawal time. To sponsor No. 054771 under NADA 048-761 and No. 048164: zero withdrawal time.012286,
054771,
048164,
066104.

(5) Minor species. It is used as follows:

Chlortetracycline amountIndications for useLimitationsSponsor
(i) 20 to 50 g/tonGrowing sheep; increased rate of weight gain and improved feed efficiency.   054771,
048164,
066104.
(ii) 80 mg/head/dayBreeding sheep; reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus infection susceptible to chlortetracycline.   054771,
048164,
066104.
(iii) 200 to 400 g/tonDucks: For the control and treatment of fowl cholera caused by P. multocida susceptible to chlortetracycline.Feed in complete ration to provide from 8 to 28 mg/lb of body weight per day depending upon age and severity of disease, for not more than 21 d. Do not feed to ducks producing eggs for human consumption.054771.
(iv) 10 mg/g of finished feed daily.Psittacine birds (cockatoos, macaws, and parrots) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline.Feed continuously for 45 d; each bird should consume daily an amount of medicated feed equal to one fifth of its body weight.
   
See paragraph (d)(3) of this section.
054771.

(6) It is used as a free-choice, loose mineral Type C feed as follows:

(i) Specifications.

IngredientPercentInternational Feed No.
Dicalcium Phosphate46.206-26-335
Sodium Chloride (Salt)15.006-04-152
Magnesium Oxide10.676-02-756
Cottonseed Meal10.005-01-625
Trace Mineral/Vitamin Premix13.80
Calcium Carbonate3.506-01-069
Dried Cane Molasses3.004-04-695
Potassium Chloride2.006-03-755
Mineral Oil2.008-03-123
Iron Oxide0.506-02-431
Chlortetracycline Type A medicated article (90 gram/lb)3.33

1Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(ii) Amount. 6,000 grams per ton.

(iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.

(iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day.

(v) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(7) Chlortetracycline may also be used in combination with:

(i) Amprolium and ethopabate as in §558.58.

(ii) Bacitracin methylene disalicylate as in §558.76.

(iii) Clopidol as in §558.175.

(iv) Decoquinate as in §558.195.

(v) Hygromycin B as in §558.274.

(vi) Laidlomycin as in §558.305.

(vii) Lasalocid as in §558.311.

(viii) Monensin as in §558.355.

(ix) Robenidine as in §558.515.

(x) Salinomycin as in §558.550.

(xi) Tiamulin as in §558.600.

[41 FR 10995, Mar. 15, 1976]

Editorial Note: For Federal Register citations affecting §558.128, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.140   Chlortetracycline and sulfamethazine.

(a) Approvals. Type A medicated articles: 35 grams of chlortetracycline per pound with 7.7 percent (35 grams) of sulfamethazine to Nos. 054771 and 048164 in §510.600(c) of this chapter.

(b) Related tolerances. See §§556.150 and 556.670 of this chapter.

(c) It is used in feed for beef cattle as follows:

(1) Amount per head per day. Chlortetracycline, 350 milligrams plus sulfamethazine, 350 milligrams.

(2) Indications for use. Aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever.

(3) Limitations. Feed for 28 days, withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

[61 FR 35954, July 9, 1996, as amended at 64 FR 15684, Apr. 1, 1999; 66 FR 46706, Sept. 7, 2001; 68 FR 22294, Apr. 28, 2003; 69 FR 62407, Oct. 26, 2004; 79 FR 13544, Mar. 10, 2014]

§558.145   Chlortetracycline, procaine penicillin, and sulfamethazine.

(a) Approvals. Type A medicated articles: (1) 20 grams of chlortetracycline per pound, 4.4 percent (20 grams) of sulfamethazine, and procaine penicillin equivalent in activity to 10 grams of penicillin per pound to 054771 in §510.600(c) of this chapter.

(2) 40 grams of chlortetracycline per pound, 8.8 percent of sulfamethazine, and penicillin procaine equivalent in activity to 20 grams of penicillin per pound to Nos. 048164 and 054771 in §510.600(c) of this chapter.

(b) Specifications. (1) The antibiotic substance refers to the antibiotic or feed-grade antibiotic.

(2) The antibiotic activities are expressed in terms of the appropriate antibiotic standards.

(3) Type C medicated feed contains in each ton, 100 grams of chlortetracycline, 50 grams of penicillin as procaine penicillin, and 100 grams of sulfamethazine.

(c) Related tolerances. See §§556.150, 556.510, and 556.670 of this chapter.

(d) Conditions of use. (1) It is administered to swine in a Type C feed for reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); prevention of these diseases during times of stress; maintenance of weight gains in the presence of atrophic rhinitis; growth promotion and increased feed efficiency in swine weighing up to 75 pounds.

(2) Withdraw 15 days prior to slaughter.

[40 FR 13959, Mar. 27, 1975, as amended at 43 FR 19385, May 5, 1978; 47 FR 39814, Sept. 10, 1982; 48 FR 30615, July 5, 1983; 51 FR 7396, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 56 FR 14019, Apr. 5, 1991; 61 FR 18082, Apr. 24, 1996; 62 FR 14300, Mar. 26, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001; 68 FR 47237, Aug. 8, 2003; 69 FR 62407, Oct. 26, 2004; 79 FR 13544, Mar. 11, 2014]

§558.175   Clopidol.

(a) Specifications. Type A medicated article containing 25 percent clopidol.

(b) Approvals. See No. 016592 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use. It is used as follows:

Clopidol in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(1) 113.5  Broiler chickens and re-placement chickens intended for use as caged layers: As an aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivatiDo not feed to chickens over 16 weeks of age016592
(2) 113.5Bacitracin methylene disalicylate 4 to 50Broiler chickens: As in paragraph (d)(1) of this section; for increased rate of weight gainFeed continuously as the sole ration from the time chicks are placed in floor pens until slaughter. Do not feed to chickens over 16 weeks of age; bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter016592
(3) 113.5Bacitracin zinc 5 to 25Broiler chickens: As in paragraph (d)(1) of this section; for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration; bacitracin zinc as provided by No. 054771 in §510.600(c) of this chapter054771, 016592
(4) 113.5Bambermycins 1 to 2Broiler chickens: As an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration. Do not feed to chickens over 16 weeks of age016592
(5) 113.5Chlortetracycline 100 to 200Broiler and replacement chickens: As in paragraph (d)(1) of this section; for control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracyclineFeed continuously as sole ration from the time chicks are placed in floor pens for 7 to 14 days016592
(6) 113.5Lincomycin 2 to 4Broiler chickens: As in paragraph (d)(1) of this section; for increased rate of weight gain and improved feed efficiencyDo not feed to chickens over 16 weeks of age; as lincomycin hydrochloride monohydrate054771
(7) 227  Broiler and replacement chickens intended for use as caged layers: As in paragraph (d)(1) of this sectionFeed continuously as the sole ration; feed up to 16 weeks of age if intended for use as caged layers; withdraw 5 days before slaughter if given at the level of 0.025 percent in feed or reduce level to 0.0125 percent 5 days before slaughter016592
(8) 227Bambermycins 1 to 2Broiler chickens: As an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration until 5 days before slaughter. Withdraw 5 days before slaughter or feed 113.5 g/ton clopidol and 1 to 2 g/ton bambermycins during those 5 days before slaughter. Do not feed to chickens over 16 weeks of age016592
(9) 113.5 or 227  Turkeys: As an aid in the prevention of leucocytozoonosis caused by Leucocytozoon smithiFor turkeys grown for meat purposes only; feed continuously as the sole ration at 0.0125 or 0.025 percent clopidol depending on management practices, degree of exposure, and amount of feed eaten; withdraw 5 days before slaughter016592

[68 FR 17882, Apr. 14, 2003, as amended at 72 FR 60551, Oct. 25, 2007; 74 FR 61028, Nov. 23, 2009; 79 FR 10965, 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014]

§558.185   Coumaphos.

(a) Specifications. Type A medicated articles containing 1.12, 2.0, 11.2, or 50 percent coumaphos.

(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) No. 000859 for use of Type A medicated articles containing 1.12, 2.0, 11.2, or 50 percent coumaphos as in paragraphs (e)(2) and (e)(3) of this section.

(2) No. 051311 for use of Type A medicated articles containing 1.12 percent coumaphos as in paragraph (e)(1) of this section.

(c) Related tolerances. See 40 CFR 180.189.

(d) Special considerations. Labeling shall bear the following caution statement: “The active ingredient coumaphos is a cholinesterase inhibitor. Do not use this product on animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.” Also, see §500.25 of this chapter.

(e) Conditions of use—(1) Beef and dairy cattle—(i) Amount. 0.0002 lb. (0.091 gram) per 100 lb. body weight per day for 6 consecutive days. Should conditions warrant, repeat treatment at 30-day intervals.

(ii) Indications for use. Control of gastrointestinal roundworms (Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Trichostrongylus spp.).

(iii) Limitations. Feed in the normal grain ration to which the animals are accustomed, but not in rations containing more than 0.1 percent coumaphos. Do not feed to animals less than 3 months old. Do not feed to sick animals or animals under stress, such as those just shipped, dehorned, castrated, or weaned within the last 3 weeks. Do not feed in conjunction with oral drenches or with feeds containing phenothiazine.

(2) Laying chickens—(i) Amount. Coumaphos 27.2 grams per ton (0.003 percent).

(ii) Indications for use. For control of capillary worm (Capillaria obsignata) and as an aid in control of common round worm (Ascaridia galli) and cecal worm (Heterakis gallinae).

(iii) Limitations. In Type C feed; administer continuously as the total feed ration for 14 days; when reinfection occurs, treatment may be repeated but not sooner than 3 weeks after the end of the previous treatment; do not feed to chickens within 10 days of vaccination or other conditions of stress; treatment of colored breeds of commercial layers should be avoided while in production since these breeds appear to be more sensitive to coumaphos than white breeds; as sole medication; medications in general should be avoided while birds are approaching peak production; such interruption of normal feeding practices may upset the flock and lower egg production; diagnosis by competent personnel is essential; flock condition and production records should be carefully evaluated prior to treatment.

(3) Replacement pullets—(i) Amount. Coumaphos 36.3 grams per ton (0.004 percent).

(ii) Indications for use. For control of capillary worm (Capillaria obsignata) and as an aid in control of common roundworm (Ascaridia galli) and cecal worm (Heterakis gallinae).

(iii) Limitations. In Type C feed; administer before the onset of production; diagnosis by competent personnel is essential; administer continuously as total feed ration for from 10 to 14 days; do not feed to chickens under 8 weeks of age nor within 10 days of vaccination or other conditions of stress; if birds are maintained on contaminated litter or exposed to infected birds, a second 10 to 14 day treatment is recommended but not sooner than 3 weeks after the end of the previous treatment; as sole medication; if reinfection occurs after production begins, repeat treatment as recommended for laying flocks.

[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 1463, Jan. 7, 1977; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 61 FR 34729, July 3, 1996; 69 FR 70056, Dec. 2, 2004; 70 FR 32489, June 3, 2005; 75 FR 24394, May 5, 2010]

§558.195   Decoquinate.

(a) Specifications. Type A medicated article containing 6 percent decoquinate.

(b) Approvals. See No. 054771 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.170 of this chapter.

(d) Special considerations. (1) Bentonite should not be used in decoquinate feeds.

(2) Type A medicated articles may be used to manufacture dry or liquid Type B cattle (including veal calf), sheep, and goat feeds as in paragraphs (e)(2) and (e)(3) of this section.

(3) Type C cattle feeds may be manufactured from decoquinate liquid Type B feeds having a pH between 5.0 to 6.5 and containing a suspending agent to maintain a viscosity of not less than 500 centipoises.

(e) Conditions of use. It is used as follows:

(1) Chickens.

Decoquinate in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 27.2   Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti.Do not feed to laying chickens.054771
(ii) 27.2Bacitracin methylene disalicylate 4 to 50Broiler chickens: As in paragraph (e)(1)(i) of this section; and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration; do not feed to laying chickens. Bacitracin methylene disalicylate as provided by No. 054771in §510.600(c) of this chapter.054771
(iii) 27.2Bacitracin zinc 10 to 50Broiler chickens: As in paragraph (e)(1)(ii) of this section.Feed continuously as sole ration; do not feed to laying chickens. Bacitracin zinc as provided by No. 054771 in §510.600(c) of this chapter.054771
(iv) 27.2Chlortetracycline 100 to 200Chickens: As in paragraph (e)(1)(i) of this section; control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.Feed continuously for 7 to 14 days; do not feed to chickens producing eggs for human consumption.054771
(v) 27.2Chlortetracycline 200 to 400Chickens: As in paragraph (e)(1)(i) of this section; and for control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline.As in paragraph (e)(1)(vi) of this section.054771
(vi) 27.2Lincomycin 2Broiler chickens: As in paragraph (e)(1)(ii) of this section.Feed as sole ration; do not feed to laying chickens; lincomycin provided by No. 000009 in §510.600(c) of this chapter.054771
054771

(2) Cattle.

Decoquinate in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 12.9 to 90.8   Cattle (including ruminating and nonruminating calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis and E. zuerniiFeed Type C feed or milk replacer to provide 22.7 milligrams (mg) per 100 pounds (lb) of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section.054771
(ii) 12.9 to 90.8Chlortetracycline 500 to 4,000.Calves, beef, and nonlactating dairy cattle: As in paragraph (e)(2)(i) of this section; for treatment of bacterial enteritis caused by Escherichia coli; and for treatment of bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.Feed Type C feed to provide 22.7 mg decoquinate and 1 gram chlortetracycline per 100 lb body weight per day for not more than 5 days. When consumed, feed 22.7 mg decoquinate per 100 lb body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline) Type A medicated articles under NADA 141-147. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline) Type A medicated articles under NADA 141-185. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by No. 054771 in §510.600(c) of this chapter.054771
(iii) 12.9 to 90.8Monensin 5 to 30Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; and for improved feed efficiency.Feed only to cattle fed in confinement for slaughter. Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of this section and §558.355(d)(8). Monensin as provided by No. 000986 in §510.600(c) of this chapter.054771
(iv) 13.6 to 27.2Chlortetracycline approximately 400 (varying with body weight and feed consumption to provide 10 mg/lb of body weight per day)Calves, beef and nonlactating dairy cattle: As in paragraph (e)(2)(i) of this section; for treatment of bacterial enteritis caused by E. coli; and for treatment of bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.Feed Type C feed to provide 22.7 mg decoquinate and 1 gram (g) chlortetracycline per 100 lb body weight (0.5 mg/kg) per day for not more than 5 days. Type C feed may be prepared from Type B feed containing 535.8 to 5,440 g/ton decoquinate and 6,700 to 80,000 g/ton chlortetracycline. When consumed, feed 22.7 mg decoquinate per 100 lb body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from chlortetracycline Type A medicated articles under NADA 141-147 and ANADA 200-359. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline) Type A medicated articles under NADA 141-185. Do not feed to calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by Nos. 054771 and 048164 in §510.600(c) of this chapter.054771
048164
(v) 13.6 to 27.2Monensin 5 to 30 plus tylosin 8 to 10Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for improved feed efficiency; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.Feed only to cattle fed in confinement for slaughter. Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb body weight per day, 50 to 360 mg of monensin per head per day, and 60 to 90 mg of tylosin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Also see paragraph (d)(1) of this section and §558.355(d)(8). Monensin as provided by No. 000986, and tylosin as provided by Nos. 000986 and 016592 in §510.600(c) of this chapter016592, 054771
(vi) 90.9 to 535.7   Cattle (including ruminating and nonruminating calves and veal calves): As in paragraph (e)(2)(i) of this section.Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section.054771
(vii) 90.9 to 535.7Chlortetracycline 4,000 to 20,000.Calves, beef, and nonlactating dairy cattle: As in paragraph (e)(2)(i) of this section; for treatment of bacterial enteritis caused by Escherichia coli; and for treatment of bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg decoquinate and 1 gram chlortetracycline per 100 lb body weight per day for not more than 5 days. When consumed, feed 22.7 mg decoquinate per 100 lb body weight per day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline) Type A medicated articles under NADA 141-147. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline) Type A medicated articles under NADA 141-185. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by No. 054771 in §510.600(c) of this chapter.054771

(3) Minor species.

Decoquinate in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 12.9 to 90.8   1. Young sheep: For the prevention of coccidiosis caused by Eimeria ovinoidalis, E. crandallis, E. parva, and E. bakuensis.Feed Type C feed or milk replacer at a rate to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for food.054771
      2. Young goats: For the prevention of coccidiosis caused by E. christenseni and E. ninakohlyakimovae.Feed Type C feed or milk replacer at a rate to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for food.
(ii) 90.9 to 535.7   1. Young sheep: As in item 1 of paragraph (e)(3)(i) of this section.Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lbs of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for food.054771
      2. Young goats: As in item 2 of paragraph (e)(3)(i) of this section.Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lbs of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for food.   

[67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, 2003; 69 FR 26499, May 13, 2004; 69 FR 52816, Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR 67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005; 78 FR 25183, Apr. 30, 2013; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 79 FR 17860, Mar. 31, 2014]

§558.198   Diclazuril.

(a) Specifications. Type A medicated article containing 0.2 percent diclazuril.

(b) Approvals. See No. 016592 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.185 of this chapter.

(d) Conditions of use. (1) Chickens. For chickens it is used as follows:

Diclazuril grams/ton Combination grams/ton Indications for use Limitations Sponsor
(i) 0.91 (1 part per million (ppm))   Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima.Feed continuously. Not for use in hens producing eggs for human food.016592
(ii) 0.91 (1 ppm)Bacitracin methylene disalicylate 4 to 50Broiler chickens: As in item (i) of this table; for increased rate of weight gain and improved feed efficiency.As in item (i) of this table. Bacitracin methylene disalicylate provided by 054771.016592
(iii) 0.91 (1 ppm)Bambermycins 1 to 2Broiler chickens: As in item (i) of this table); for increased rate of weight gain and improved feed efficiency.As in item (i) of this table. Bambermycins provided by 057926.016592
(iv) 0.91 (1 ppm)Virginiamycin 5Broiler chickens: As in item (i) of this table; for increased rate of weight gain and improved feed efficiency.As in item (i) of this table; Virginiamycin provided by 066104.016592
(v) 0.91 (1 ppm)Virginiamycin 5 to 15Broiler chickens: As in item (i) of this table; for increased rate of weight gain.As in item (i) of this table. Virginiamycin provided by 066104.016592

(2) Turkeys. For turkeys it is used as follows:

Diclazuril grams/tonCombination grams/tonIndications for useLimitationsSponsor
(i) 0.91 (1 ppm)  Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. gallopavonis and E. meleagrimitis.Feed continuously as the sole ration. Do not feed to breeding turkeys. Not for use in hens producing eggs for human consumption.016592
(ii) 0.91 (1 ppm).Bacitracin methylene disalicylate 4 to 50.Growing turkeys: As in paragraph (d)(2)(i) of this section; for increased rate of weight gain and improved feed efficiency.As in paragraph (d)(2)(i) of this section. Bacitracin methylene disalicylate provided by No. 054771 in §510.600(c) of this chapter.016592
(iii) 0.91 (1 ppm).Bambermycins 1 to 2Growing turkeys: As in paragraph (d)(2)(i) of this section; for improved feed efficiency.As in paragraph (d)(2)(i) of this section. Bambermycins provided by No. 057926 in §510.600(c) of this chapter.016592
(iv) 0.91 (1 ppm).Bambermycins 2Growing turkeys: As in paragraph (d)(2)(i) of this section; for increased rate of weight gain and improved feed efficiency.As in paragraph (d)(2)(i) of this section. Bambermycins provided by No. 057926 in §510.600(c) of this chapter.016592

[64 FR 35923, July 2, 1999, as amended at 65 FR 50134, Aug. 17, 2000; 66 FR 47962, 47963, Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR 34830, May 16, 2002; 67 FR 47257, July 18, 2002; 67 FR 48549, July 25, 2002; 69 FR 9947, Mar. 3, 2004; 72 FR 60552, Oct. 25, 2007; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014]

§558.205   Dichlorvos.

(a) Approvals. Type A medicated articles: 3.1 and 9.6 percent to 054628 in §510.600(c) of this chapter.

(b) Special considerations. (1) Dichlorvos is to be included in meal or mash or mixed with feed in crumble form only after the crumble feed has been manufactured. Do not mix in feeds to be pelleted nor with pelleted feed. Do not soak the feed or administer as wet mash. Feed must be dry when administered. Do not use in animals other than swine. Do not allow fowl access to feed containing this preparation or to feces from treated animals.

(2) Dichlorvos is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. If human or animal poisoning should occur, immediately consult a physician or a veterinarian. Atropine is antidotal.

(3) Labeling for Type A articles and Type B feeds must include a statement that containers or materials used in packaging such Type A articles and Type B feeds are not to be reused and all such packaging materials must be destroyed after the product has been used.

(c) Related tolerances. See §556.180 of this chapter.

(d) Conditions of use. It is used in feed for swine as follows:

(1) Amount per ton. Dichlorvos, 348 grams (0.0384 percent).

(i) Indications for use. For the removal and control of mature, immature, and/or fourth-stage larvae of the whipworm (Trichuris suis), nodular worm (Oesophagostomum sp. ), large roundworm (Ascaris suum) and the thick stomach worm (Ascarops strongylina) of the gastrointestinal tract.

(ii) Limitations. For swine up to 70 pounds body weight, feed as sole ration for 2 consecutive days. For swine from 70 pounds to market weight, feed as sole ration at the rate of 8.4 pounds of feed per head until the medicated feed has been consumed. For boars, open or bred gilts, and sows, feed as sole ration at the rate of 4.2 pounds per head per day for 2 consecutive days.

(2) Amount per ton. Dichlorvos, 479 grams (0.0528 percent).

(i) Indications for use. For the removal and control of mature, immature, and/or fourth-stage larvae of the whipworm (Trichuris suis), nodular worm (Oesophagostomum sp. ), large roundworm (Ascaris suum), and the thick stomach worm (Ascarops strongylina) of the gastrointestinal tract.

(ii) Limitations. For boars, open or bred gilts, and sows, feed as sole ration at the rate of 6 pounds per head for one feeding.

(3) Amount per ton. Dichlorvos, 334-500 grams (0.0366-0.0550 percent).

(i) Indications for use. An aid in improving litter production efficiency by increasing pigs born alive, birth weights, survival to market, and rate of weight gain. Treatment also removes and controls mature, immature and/or fourth stage larvae of whipworm (Trichuris suis), nodular worm (Oesophagostomum supp. ) large roundworm (Ascaris suum), and the thick stomach worm (Ascarops strongylina) occurring in the gastrointestinal tract of the sow or gilt.

(ii) Limitations. For pregnant swine; mix into a gestation feed to provide 1,000 milligrams per head daily during last 30 days of gestation.

[40 FR 13959, Mar. 27, 1975, as amended at 40 FR 50258, Oct. 29, 1975; 48 FR 46515, Oct. 13, 1983; 51 FR 7397, Mar. 3, 1986; 51 FR 28547, Aug. 8, 1986; 52 FR 2684, Jan. 26, 1987; 62 FR 35077, June 30, 1997; 78 FR 21060, Apr. 9, 2013]

§558.235   Efrotomycin.

(a) Approvals. Type A medicated article: 14.5 grams per pound to 050604 in §510.600(c) of this chapter.

(b) Conditions of use—(1) Swine—(i) Amount. 3.6 grams per ton.

(A) Indications for use. For improved feed efficiency.

(B) Limitations. Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds.

(ii) Amount. 3.6 to 14.5 grams per ton.

(A) Indications for use. For increased rate of weight gain.

(B) Limitations. Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds.

(2) [Reserved]

[57 FR 38442, Aug. 25, 1992, as amended at 62 FR 63271, Nov. 28, 1997]

§558.248   Erythromycin.

(a) Approvals. Type A medicated articles: (1) 2.2 percent to 061623 in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(2) 5 and 10 percent to 061623 for use in paragraphs (d)(1)(i) and (ii) of this section.

(b) Special considerations. The levels of antibiotic are expressed in terms of erythromycin master standard. One gram of erythromycin thiocyanate is equivalent to 0.925 gram of erythromycin master standard.

(c) Related tolerances. See §556.230 of this chapter.

(d) Condition of use. (1) It is used as follows:

Erythromycin thiocyanate in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 4.6 to 18.5Chickens; growth promotion and feed efficiency,
061623
(ii) 9.25 to 18.5Turkeys; growth promotion and feed efficiencyFor turkeys not over 12 weeks of age,
061623
(iii) 9.25 to 64.75Swine; increase in weight gain, improved feed efficiency in starter pigs (9.25 to 64.75) and grower-finishing pigs (9.25)Starter ration for animals up to 35 lb body weight061623
(iv) 18.5Laying chickens; aids in increasing egg production061623
(v) 92.51. Chickens; as an aid in the prevention of chronic respiratory disease during periods of stressFeed for 2 d before stress and 3 to 6 d after stress; withdraw 24 h before slaughter061623
   2. Chickens; as an aid in the prevention of infectious coryzaFeed for 7 to 14 d; withdraw 24 h before slaughter
   3. Turkeys; as an aid in the prevention of chronic respiratory disease during periods of stressFeed for 2 d before stress and 3 to 6 d after stress
(vi) 1851. Chickens; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory diseaseFeed for 5 to 8 d; do not use in birds producing eggs for food purposes; withdraw 48 h before slaughter061623
   2. Turkeys; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory diseaseFeed for 5 to 8 d; do not use in birds producing eggs for food purposes061623

(2) In feed for feedlot beef cattle at 37 milligrams per head per day as an aid in stimulating growth and improving feed efficiency.

[41 FR 10999, Mar. 15, 1976, as amended at 45 FR 56799, Aug. 26, 1980; 49 FR 31281, Aug. 6, 1984; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 54 FR 12189, Mar. 24, 1989; 66 FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 79 FR 10982, Feb. 27, 2014]

§558.254   Famphur.

(a) Approvals. Type A medicated articles: 13.2 and 33.3 percent to 000061 in §510.600(c) of this chapter.

(b) Special considerations. Famphur is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.

(c) Related tolerances. See §556.273 of this chapter.

(d) Conditions of use. It is used in the feed for cattle as follows:

(1) Amount. 1.1 milligrams per pound body weight per day.

(i) Indications for use. For control of grubs and as an aid in control of sucking lice.

(ii) Limitations. For beef cattle and nonlactating dairy cows; feed for 30 days; withdraw from dry dairy cows and heifers 21 days prior to freshening; withdraw 4 days prior to slaughter.

(2) Amount. 2.3 milligrams per pound body weight per day.

(i) Indications for use. For control of grubs.

(ii) Limitations. For beef cattle and nonlactating dairy cows; feed for 10 days; withdraw from dry dairy cows and heifers 21 days prior to freshening; withdraw 4 days prior to slaughter.

[41 FR 11000, Mar. 15, 1976, as amended at 51 FR 7397, Mar. 3, 1986; 57 FR 7652, Mar. 4, 1992; 62 FR 55161, Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997]

§558.258   Fenbendazole.

(a) Specifications. Type A medicated articles: 4 percent (18.1 grams per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/lb) fenbendazole.

(b) Approvals. See No. 000061 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.275 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use—(1) Turkeys.

Amount fenbendazole in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
14.5 (16 parts per million)  Growing turkeys: For the removal and control of gastrointestinal worms: roundworms, adult and larvae (Ascaridia dissimilis); cecal worms, adult and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Blackhead)Feed continuously as the sole ration for 6 days. For growing turkeys only000061

(2) Swine.

Amount fenbendazole in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 10 to 300 (to provide 9 milligrams per kilogram (mg/kg) of body weight) given over a 3- to 12-day period  For the removal and control of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus)Feed as sole ration000061
(ii) 10 to 80 (to provide 9 mg/kg of body weight)Lincomycin 20As in paragraph (e)(2)(i) of this section; for increased rate of gain in growing-finishing swineFeed as sole ration. Do not feed to swine that weigh more than 250 pounds (lbs); lincomycin as provided by 054771 in §510.600(c) of this chapter000061
(iii) 10 to 80 (to provide 9 mg/kg of body weight)Lincomycin 40As in paragraph (e)(2)(i) of this section; for control of swine dysentery in animals on premises with a history of swine dysentery, but where symptoms have not yet occurredFeed as sole ration. Do not feed to swine that weigh more than 250 lbs.; lincomycin as provided by 054771 in §510.600(c) of this chapter000061
(iv) 10 to 80 (to provide 9 mg/kg of body weight)Lincomycin 100As in paragraph (e)(2)(i) of this section; for the treatment of swine dysenteryFeed as sole ration. Do not use within 6 days of slaughter. Do not feed to swine that weigh more than 250 lbs.; lincomycin as provided by 054771 in §510.600(c) of this chapter000061
(v) 10 to 80 (to provide 9 mg/kg of body weight)Lincomycin 200As in paragraph (e)(2)(i) of this section; for reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniaeFeed as sole ration. Do not use within 6 days of slaughter. Do not feed to swine that weigh more than 250 pound (lb); lincomycin as provided by 054771 in §510.600(c) of this chapter000061
(vi) 10 to 300 (to provide 9 mg/kg of body weight)Bacitracin methylene disalicylate 10 to 30Growing/finishing swine: As in paragraph (e)(2)(i) of this section; for increased rate of weight gain and improved feed efficiencyFeed as sole ration. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 054771 in §510.600(c) of this chapter054771
(vii) 10 to 300 (to provide 9 mg/kg of body weight)Bacitracin methylene disalicylate 2501. Growing/finishing swine: As in paragraph (e)(2)(i) of this section; for control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery, but where signs of disease have not yet occurred; or following an approved treatment of the disease condition1. Growing/finishing swine: Feed as sole ration. Not for use in growing and finishing swine that weigh more than 250 lbs. Diagnosis of swine dysentery should be confirmed by a veterinarian when results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by054771 in §510.600(c) of this chapter054771
    2. Pregnant sows: As in paragraph (e)(2)(i) of this section; for control of clostridial enteritis in suckling pigs caused by Clostridium perfringens2. Pregnant sows: Feed as sole ration. Diagnosis of clostridial enteritis should be confirmed by a veterinarian when results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 054771 in §510.600(c) of this chapter  

(3) Cattle.

Amount fenbendazoleIndications for useLimitationsSponsor
(i) 5 mg/kg body weight (2.27 mg/lb)Dairy and beef cattle: For the removal and control of: Lungworms (Dictyocaulus viviparus); Stomach worms: barberpole worms (Haemonchus contortus), brown stomach worms (Ostertagia ostertagi), small stomach worms (Trichostrongylus axei); Intestinal worms: hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia oncophora and C. punctata); Bankrupt worms (Trichostrongylus colubriformis); and Nodular worms (Oesophagostomum radiatum).Feed as the sole ration or as a top dress for one day. Retreatment may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle the milk discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.000061
(ii) [Reserved]

(iii) Free-choice feeds—(A) Amount. 5 mg/kg body weight (2.27 mg/lb), including the following formulations:

Ingredient1PercentInternational Feed No.
(1) Free-choice, dry Type C feed:    
      Salt (sodium chloride)59.006-04-152
      Monosodium phosphate31.166-04-288
      Dried cane molasses3.124-04-695
      Zinc sulfate0.766-05-556
      Copper sulfate0.456-01-720
      Fenbendazole 20% Type A article5.51n/a
(2) Free-choice, dry Type C feed:    
      Salt (sodium chloride)35.936-04-152
      Dicalcium phosphate (18.5% P)32.446-00-080
      Calcium carbonate (38% Ca)15.936-01-069
      Magnesium oxide (56% Mg)10.146-02-756
      Zinc sulfate1.476-05-556
      Mineral oil1.008-03-123
      Dried cane molasses (46% sugars)0.984-04-695
      Potassium iodide0.016-03-759
      Fenbendazole 20% Type A article2.10n/a
(3) Free-choice, liquid Type C feed:
      Cane molasses280.9024-13-251
      Water9.36n/a
      Urea solution, 55%7.055-05-707
      Phosphoric acid 75% (feed grade)2.006-03-707
      Xantham gum0.208-15-818
      Trace minerals0.20n/a
      Vitamin premix0.01n/a
      Fenbendazole 20% Type A article0.278n/a

1The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer for other free-choice cattle feeds. Formulation modifications require FDA approval prior to marketing. Selenium is not approved for the free-choice formulations described in paragraph (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published regulations (see 21 CFR 573.920).

2The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the brix value of the molasses to the industry standard of 79.5 brix.

(B) Indications for use. As in paragraph (e)(3)(i) of this section.

(C) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle the milk discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

(4) Horses.

Amount fenbendazole in grams per tonIndications for useLimitationsSponsor
(i) 4,5405 mg/kg body weight (2.27 mg/lb) for the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.), and pinworms (Oxyuris equi); 10 mg/kg body weight (4.54 mg/lb) for the control of ascarids (Parascaris equorum).Feed at the rate of 0. 1lb of feed per 100 lb of body weight to provide 2.27 mg fenbendazole/lb of body weight in a 1-day treatment or 0.2 lb of feed per 100 lb of body weight to provide 4.54 mg fenbendazole/lb of body weight in a 1-day treatment. All horses must be eating normally to ensure that each animal consumes an adequate amount of the medicated feed. Regular deworming at intervals of 6 to 8 weeks may be required due to the possibility of reinfection. Do not use in horses intended for human consumption.000061
(ii) [Reserved]         

(5) Zoo and wildlife animals.

Species/ClassAmount fenbendazoleIndications for useLimitationsSponsor
(i) Feral swine (Sus scrofa)3 mg/kg/day for 3 days.For the removal and control of kidney worm (Stephanurus dentatus), roundworm (Ascaris suum), nodular worm (Oesophagostomum dentatum)Use as complete feed. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season000061
(ii) Ruminants (subfamily Antilopinae, Hippotraginae, Caprinae)2.5 mg/kg/day for 3 days.For the removal and control of small stomach worm (Trichostrongylus spp.), thread necked intestinal worm (Nematodirus spp.), barberpole worm (Haemonchus spp.), whipworm (Trichuris spp.)Use as complete feed. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season000061
(iii) Rocky mountain bighorn sheep (Ovis c. canadensis)10 mg/kg/day for 3 days.For the removal and control of Protostrongylus sppUse as complete feed. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season000061

[66 FR 58935, Nov. 26, 2001, as amended at 68 FR 34534, June 10, 2003; 72 FR 66046, Nov. 27, 2007; 73 FR 58873, Oct. 8, 2008; 74 FR 61517, Nov. 25, 2009; 79 FR 13545, Mar. 11, 2014]

§558.261   Florfenicol.

(a) Specifications. Type A medicated articles containing florfenicol in the following concentrations:

(1) 40 grams per kilogram for use as in paragraph (e)(1) of this section.

(2) 500 grams per kilogram for use as in paragraph (e)(2) of this section.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Special considerations—(1) Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See §558.6 of this chapter for additional requirements.

(2) The expiration date of veterinary feed directives (VFDs) for florfenicol medicated feeds:

(i) For freshwater-reared finfish, must not exceed 15 days from the date of issuance.

(ii) For swine must not exceed 90 days from the date of issuance.

(3) VFDs for florfenicol shall not be refilled.

(d) Related tolerances. See §556.283 of this chapter.

(e) Conditions of use—(1) Swine

Florfenicol in grams/ton of feedIndications for useLimitations
182For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis, and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD.Feed continuously as a sole ration for 5 consecutive days. The safety of florfenicol on swine reproductive performance, pregnancy, and lactation have not been determined. Feeds containing florfenicol must be withdrawn 13 days prior to slaughter.

(2) Fish

Florfenicol in grams/ton of feedIndications for useLimitations
(i) 182 to 2,724Catfish: For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluriFeed as a sole ration for 10 consecutive days to deliver 10 to 15 milligrams (mg) florfenicol per kilogram (kg) of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.
(ii) 182 to 1,816Freshwater-reared salmonids: For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum and furunculosis associated with Aeromonas salmonicidaFeed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.
(iii) 182 to 2,724Freshwater-reared finfish: For the control of mortality due to columnaris disease associated with Flavobacterium columnareFeed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish for freshwater-reared warmwater finfish and other freshwater-reared finfish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.
(iv) 273 to 2,724Freshwater-reared warmwater finfish: For the control of mortality due to streptococcal septicemia associated with Streptococcus iniaeFeed as a sole ration for 10 consecutive days to deliver 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.

[70 FR 70047, Nov. 21, 2005, as amended at 71 FR 70304, Dec. 4, 2006; 72 FR 19798, Apr. 20, 2007; 72 FR 65885, Nov. 26, 2007; 77 FR 32012, May 31, 2012; 79 FR 18159, Apr. 1, 2014]

§558.265   Halofuginone.

(a) Specifications. Type A medicated articles containing 6 grams of halofuginone hydrobromide per kilogram.

(b) Approvals. See No. 016592 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.308 of this chapter.

(d) Conditions of use. (1) It is used in feed for broiler chickens as follows:

(i) Amount. 2.72 grams per ton.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(B) Limitations. Feed continuously as sole ration; withdraw 4 days before slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.

(ii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus bambermycins 1 to 2 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain and improved feed efficiency.

(B) Limitations. Feed continuously as sole ration; withdraw 5 days before slaughter; do not feed to layers.

(iii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus virginiamycin 5 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain and improved feed efficiency.

(B) Limitations. Feed continuously as sole ration; withdraw 6 days before slaughter; do not feed to layers.

(iv) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus virginiamycin 5 to 15 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, and E. maxima; for increased rate of weight gain.

(B) Limitations. Feed continuously as sole ration; withdraw 6 days before slaughter; do not feed to layers.

(v) [Reserved]

(vi) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus bacitracin methylene disalicylate 10 to 50 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, E. maxima and for improved feed efficiency.

(B) Limitations. Feed continuously as sole ration; withdraw 5 days before slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.

(vii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus lincomycin 2 to 4 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for improved feed efficiency.

(B) Limitations. Feed continuously as sole ration; withdraw 4 days before slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.

(viii) [Reserved]

(2) It is used in feed for turkeys as follows:

(i) Amount per ton. 1.36 to 2.72 grams.

(A) Indications for use. For the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis.

(B) Limitations. Feed continuously as sole ration; withdraw 7 days before slaughter; do not feed to layers or water fowl; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.

(ii) Amount per ton. Halofuginone hydrobromide 1.36 to 2.72 grams plus bacitracin methylene disalicylate 10 to 50 grams.

(A) Indications for use. For prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis., and E. gallopavonis, and for increased rate of weight gain in growing turkeys.

(B) Limitations. Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl. Keep out of lakes, ponds, and streams. Halofuginone is toxic to fish and aquatic life. Halofuginone is an irritant to eyes and skin. Avoid contact with skin, eyes, or clothing.

(iii) Amount per ton. 1.36 to 2.72 grams of halofuginone hydrobromide plus 2 grams of bambermycins.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria adenoides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain in growing turkeys.

(B) Limitations. Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl. Halofuginone hydrobromide is toxic to fish and other aquatic life. Keep out of lakes, ponds, and streams. Halofuginone hydrobromide is an eye and skin irritant. Avoid contact with skin, eyes, and clothing.

(3) It is used in feed for replacement cage laying chickens and replacement broiler breeder chickens as follows:

(i) Amount per ton. 2.72 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati/E. mitis, and E. brunetti.

(B) Limitations. Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Withdraw 4 days before slaughter. Do not feed to laying chickens or water fowl. Halofuginone hydrobromide is toxic to fish and aquatic life. Keep out of lakes, ponds, and streams. Halofuginone hydrobromide is an irritant to eyes and skin. Avoid contact with skin, eyes, and clothing.

(ii) [Reserved]

[50 FR 33719, Aug. 21, 1985, as amended at 50 FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR 1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54 FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, 1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; 66 FR 47962, Sept. 17, 2001; 71 FR 27956, May 15, 2006; 79 FR 10982, Feb. 27, 2014]

§558.274   Hygromycin B.

Link to an amendment published at 79 FR 19815, April 10, 2014.

(a) Approvals. See sponsor numbers in §510.600(c) of this chapter for Type A medicated articles or Type B medicated feeds as follow:

(1) No. 000986: 2.4 and 8 grams per pound (g/lb).

(2) Nos. 012286 and 051311: 2.4 g/lb.

(3) No. 017790: 0.6 g/lb.

(4) No. 054771: 0.6 and 1.6 g/lb.

(b) Related tolerances. See §556.330 of this chapter.

(c) Conditions of use. It is used in feed as follows:

(1) Chickens

Hygromycin B in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 8 to 12Chickens: For control of infestation of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata)Withdraw 3 days before slaughter000986
012286
017790
054771
(ii) 8 to 12Tylosin 4 to 50Chickens: For control of infestations of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata); growth promotion and feed efficiencyWithdraw 3 days before slaughter. Tylosin as tylosin phosphate as provided by No. 000986 in §510.600 of this chapter000986

(2) Swine

Hygromycin B in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 12Swine: For control of infestation of large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum), and whipworms (Trichuris suis)Withdraw 15 days before slaughter000986
012286
017790
054771
(ii) 12Tylosin 10 to 100Swine: For control of infestations of large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum), and whipworms (Trichuris suis); growth promotion and feed efficiencyFeed continuously as follows: Animal weight (lbs.):
   Up to 40  .  .  .  20 to 1001
   41 to 100  .  .  .  20 to 401
   101 to market weight  .  .  .  10 to 201
Withdraw 15 days before slaughter. Tylosin as tylosin phosphate as provided by No. 000986 in §510.600 of this chapter
000986

1Amount of Tylosin (g/t).

[79 FR 10982, Feb. 27, 2014]

§558.295   Iodinated casein.

(a) Approvals. See 017762 in §510.600(c) of this chapter.

(b) NAS/NRC status. The use of this drug is NAS/NRC reviewed and found effective. Applications for these uses need not include efficacy data as required by §514.111 of this chapter but may require bioequivalency or safety data.

(c) Conditions of use—(1) Ducks—(i) Amount per ton. 100 to 200 grams.

(ii) Indications for use. For increased rate of weight gain and improved feathering in growing ducks.

(2) Dairy cows—(i) Amount per pound. 12 to 112 grams per 100 lb of body weight.

(ii) Indications for use. For increased milk production in dairy cows.

(iii) Limitations. This drug is effective for limited periods of time, and the effectiveness is limited to the declining phase of lactation. Administration must be accompanied with increased feed intake; administration may increase heat sensitivity of the animal.

[45 FR 41631, June 20, 1980]

§558.300   Ivermectin.

(a) Specifications. Type A medicated article containing 2.72 grams ivermectin per pound (g/lb).

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.344 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use in swine. It is used in feed as follows:

Ivermectin in g/ton of feedCombination in g/ton of feedIndications for useLimitationsSponsor
(1) 1.8 (to provide 0.1 milligram per kilogram (mg/kg) of body weight per day)   Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis).Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter.050604
(2) 1.8 (to provide 0.1 mg/kg of body weight per day)Bacitracin methylene disalicylate, 10 to 30Weaned, growing-finishing swine: As in paragraph (e)(1) of this section; and for increased rate of weight gain and improved feed efficiency.For use in swine feed only. Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter.050604
(3) 1.8 (to provide 0.1 mg/kg of body weight per day)Bacitracin methylene disalicylate, 250Weaned, growing-finishing swine: As in paragraph (e)(1) of this section; and for control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery, but where symptoms have not yet occurred, or following an approved treatment of disease condition.For use in swine feed only. Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter.050604
(4) 1.8 (to provide 0.1 mg/kg of body weight per day)Lincomycin, 20Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis); and for increased rate of weight gain.Feed as the only feed for 7 consecutive days. Not to be fed to swine that weigh more than 250 lbs. Withdraw 5 days before slaughter. Also see paragraphs (c)(1) and (c)(2) in §558.325 of this chapter.050604
(5) 1.8 (to provide 0.1 mg/kg of body weight per day)Lincomycin, 40Weaned, growing-finishing swine: As in paragraph (e)(4) of this section; and for control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred.Feed as the only feed for 7 consecutive days. Not to be fed to swine that weigh more than 250 lbs. Also see paragraphs (c)(1) and (c)(2) in §558.325 of this chapter. Withdraw 5 days before slaughter. A separate feed containing 40 g/ton lincomycin may be continued to complete the lincomycin treatment.050604
(6) 1.8 (to provide 0.1 mg/kg of body weight per day)Lincomycin, 100Weaned, growing-finishing swine: As in paragraph (e)(4) of this section; and for treatment of swine dysentery.Feed as the only feed for 7 consecutive days followed by a separate feed containing 100 g/ton lincomycin for an additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 lbs. Also see paragraphs (c)(1) and (c)(2) in §558.325 of this chapter.050604
(7) 1.8 (to provide 0.1 mg/kg of body weight per day)Lincomycin, 200Weaned, growing-finishing swine: As in paragraph (e)(4) of this section; and for reduction in severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae.Feed as the only feed for 7 consecutive days followed by a separate feed containing 200 g/ton lincomycin for an additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 lbs. Also see paragraphs (c)(1) and (c)(2) in §558.325 of this chapter.050604
(8) 1.8 to 11.8 (to provide 0.1 mg/kg of body weight per day)Adult and breeding swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis).Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter.050604
(9) 1.8 to 11.8 (to provide 0.1 mg/kg of body weight per day)Bacitracin methylene disalicylate, 250Pregnant sows: As in paragraph (e)(8) of this section; and for control of clostridial enteritis caused by Clostridium perfringens in suckling piglets.Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter. Feed bacitracin methylene disalicylate Type C medicated feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours.050604
(10) 18.2 to 120 (to provide 0.1 mg/kg of body weight per day)   Adult and breeding swine: As in paragraph (e)(8) of this section.Top dress on daily ration for individual treatment for 7 consecutive days. Withdraw 5 days before slaughter.050604

[72 FR 37437, July 10, 2007]

§558.305   Laidlomycin.

(a) Specifications. Type A medicated articles containing 50 grams laidlomycin propionate potassium per pound.

(b) Approvals. See No. 054771 in §510.600(c) of this chapter.

(c) Tolerances. See §556.346 of this chapter.

(d) Special considerations. (1) Laidlomycin liquid Type B feeds may be manufactured from dry laidlomycin Type A articles. The liquid Type B feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(2) The expiration date for the liquid Type B feed is 21 days after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 7 days after date of manufacture.

(3) Labeling for all Type B feeds (liquid and dry) and Type C feeds containing laidlomycin shall bear the following statements:

(i) Do not allow horses or other equines access to feeds containing laidlomycin propionate potassium.

(ii) The safety of laidlomycin propionate potassium in unapproved species has not been established.

(iii) Not for use in animals intended for breeding.

(e) Conditions of use. It is used in cattle being fed in confinement for slaughter as follows:

Laidlomycin in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(1) 5   For improved feed efficiency and increased rate of weight gain.Feed continuously in a Type C feed at a rate of 30 to 75 mg/head/day.054771
(2) 5Chlortetracycline10 mg/lb body weightFor improved feed efficiency and increased rate of weight gain; and for treatment of bacterial enteritis caused by Echerichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.054771
(3) 5Chlortetracycline 350 mg/head/dayFor improved feed efficiency and increased rate of weight gain; and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.054771
(4) 5 to 10   For improved feed efficiency.Feed continuously in a Type C feed at a rate of 30 to 150 milligrams/head/day.054771
(5) 5 to 10Chlortetracycline 10 mg/pound body weightFor improved feed efficiency; and for treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.Feed continuously at a rate of 30 to 150 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.054771
(6) 5 to 10Chlortetracycline 350 mg/head/dayFor improved feed efficiency; and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.Feed continuously at a rate of 30 to 150 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.054771

[59 FR 18297, Apr. 18, 1994, as amended at 60 FR 53509, Oct. 16, 1995; 62 FR 9929, Mar. 5, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001; 68 FR 13839, Mar. 21, 2003; 68 FR 42590, July 18, 2003; 69 FR 30198, May 27, 2004; 79 FR 13545, Mar. 11, 2014]

§558.311   Lasalocid.

(a) Specifications. A minimum of 90 percent of lasalocid activity is derived from lasalocid A.

(b) Approvals. Type A medicated articles approved for sponsors identified in §510.600(c) of this chapter for use as in paragraph (e) of this section as follows:

(1) 3.0, 3.3, 3.8, 4.0, 4.3, 4.4, 5.0, 5.1, 5.5, 5.7, 6.0, 6.3, 6.7, 7.2, 7.5, 8.0, 8.3, 10.0, 12.5, 15, 20, and 50 percent activity to No. 054771 for use as in paragraphs (e)(1) (i), (ii), (iii), (iv), and (x) of this section.

(2) 15 percent activity to No. 066104 as provided by No. 054771 for use as in paragraph (e)(1)(v) of this section.

(3) 15, 20, 33.1, and 50 percent activity to No. 054771 for use in cattle feeds as in paragraphs (e)(1)(vi), (vii), (ix), (xi), (xii), and (xv) of this section, and for use in sheep as in paragraph (e)(1)(viii) of this section.

(4) 15 percent activity to No. 054771 for use in Type C rabbit feeds as in paragraph (e)(1)(xvi) of this section and for use in ruminant free-choice Type C feeds as in paragraphs (e)(2), (e)(3), and (e)(4) of this section.

(5) 15 and 20 percent activity to Nos. 012286 and 017800 for use in free-choice mineral feeds for cattle as in paragraph (e)(1)(xviii) of this section.

(6) 20 percent activity as a liquid Type A article to No. 054771 for use in cattle feeds as in paragraphs (e)(1)(vi), (e)(1)(vii), (e)(1)(ix), (e)(1)(xi), (e)(1)(xii), and (e)(3) of this section, and for use in sheep feeds as in paragraph (e)(1)(viii) of this section.

(7) 20 percent activity to No. 054771 for use as follows:

(i) Chukar partridges as in paragraph (e)(1)(xiii).

(ii) Turkeys as in paragraph (e)(1)(xiv).

(iii) Rabbits as in paragraph (e)(1)(xvi).

(8) [Reserved]

(9) 15 percent activity to No. 068287 for use in free-choice protein blocks for cattle as in paragraphs (e)(1)(xix) of this section.

(c) Related tolerance. See §556.347 of this chapter.

(d) Special considerations. (1) Type C cattle and sheep feeds may be manufactured from lasalocid liquid Type B feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(2) A physically stable lasalocid liquid feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.

(3) If a manufacturer is unable to meet the requirements of paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure approval of a positionally stable liquid feed by:

(i) Either filing a new animal drug application for the product or establishing a master file containing data to support the stability of its product;

(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental new animal drug application to establish physical stability; and

(iii) Requesting the sponsor of an approved new animal drug application to file a supplement to provide for use of its lasalocid Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the supplemental new animal drug application will be approved. The approval will provide a basis for the individual liquid feed manufacturer to manufacture under a medicated feed license the liquid mediated feed described in the master file. A manufacturer who seeks to market a physically unstable lasalocid liquid feed with mixing directions different from the standard directions established in paragraph (d)(1) of this section may also follow this procedure.

(4) If adequate information is submitted to show that a particular liquid feed containing lasalocid is stable outside the pH of 4.0 to 8.0, the pH restriction described in paragraphs (d)(1) and (d)(2) of this section may be waived.

(5) Required label statements:

(i) For liquid Type B feed (cattle and sheep): Mix thoroughly with grain and/or roughage prior to feeding. Feeding undiluted, mixing errors, or inadequate mixing (recirculation or agitation) may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.

(ii) For Type A articles or Type B feeds (cattle and sheep): Feeding undiluted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.

(iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(6) Lasalocid Type A medicated articles containing lasalocid dried fermentation residue are for use in cattle and sheep feed only.

(7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(1)(xii) and (e)(1)(xviii) of this section must be the subject of an approved NADA or supplemental NADA as provided in §510.455 of this chapter.

(e)(1) Conditions of use. It is used as follows:

Lasalocid sodium activity in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 68 (0.0075 pct) to 113 (0.0125 pct)For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maximaFor broiler or fryer chickens only; feed continuously as the sole ration054771
   Bambermycins 1 to 2Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Bambermycins provided by No. 016592 in §510.600(c) of this chapter.016592
(iii) 68 (0.0075 pct)Lincomycin 2 (0.00022 pct)Broiler or fryer chickens; for the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; for increased rate of weight gain and improved feed efficiencyFor broiler and fryer chickens only; feed continuously as sole ration; withdraw 5 d before slaughter; Type C feed must be used within 4 weeks of manufacture; as lincomycin hydrochloride monohydrate054771
(iv) 68 (0.0075 percent)Bacitracin 10 to 50For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiencyFor broiler or fryer chickens only; feed continuously as the sole ration; bacitracin methylene disalicylate provided by No. 054771 in §510.600(c) of this chapter054771
(v) 68 (0.0075 pct) to 113 (0.0125 pct)Virginiamycin 20For prevention of coccidiosis caused by Eimeria tenella E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiencyFor broiler and fryer chickens only; feed continuously as sole ration; do not feed to laying chickens; lasalocid sodium provided by No. 054771 in §510.600(c) of this chapter054771
(vi) 10 (0.0011 pct) to 30 (0.0033 pct)Cattle; for improved feed efficiencyIn Type C feeds; for cattle fed in confinement for slaughter only; feed continuously in complete feed to provide not less than 100 mg nor more than 360 mg of lasalocid sodium activity per head per day054771
   Oxytetracycline 7.5Cattle: for improved feed efficiency and reduction of incidence and severity of liver abscessesIn Type C feeds, for beef cattle fed in confinement for slaughter; feed continuously at 100 to 360 mg/head/day lasalocid and 75 mg/head/day oxytetracycline. As monoalkyl (C8−C18) trimethyl ammonium oxytetracycline054771
(vii) 25 (0.0027 pct) to 30 (0.0033 pct)Cattle; for improved feed efficiency and increased rate of weight gainIn Type C feeds; for cattle fed in confinement for slaughter only; feed continuously in complete feed to provide not less than 250 mg nor more than 360 mg of lasalocid sodium activity per head per day054771
   Oxytetracycline 7.5Cattle: for improved feed efficiency, increased rate of weight gain, and reduction of incidence and severity of liver abscessesIn Type C feeds, for beef cattle fed in confinement for slaughter; feed continuously at 250 to 360 mg/head/day lasalocid and 75 mg/head/day oxytetracycline. As monoalkyl (C8−C18) trimethyl ammonium oxytetracycline054771
(viii) 20 (0.0022 pct) to 30 (0.0033 pct)Sheep; for the prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva, and E. intricataIn Type C feeds; for sheep maintained in confinement; feed continuously in complete feed to provide not less than 15 mg nor more than 70 mg of lasalocid sodium activity per head per day depending on body weight054771
(ix)Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.Feed continuously at a rate of not less than 60 mg or more than 300 mg of lasalocid per head per day when on pasture; the drug must be contained in at least 1 pound of feed.054771
(x) 68 (0.0075 pct) to 113 (0.0125 pct)Bacitracin 4 to 50Broiler chickens; for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for improved feed efficiencyFor broiler chickens only; feed continuously as the sole ration; bacitracin methylene disalicylate provided by No. 054771 in §510.600(c) of this chapter054771
(xi) 68 (0.0075 pct) to 113 (0.0125 pct)Bacitracin zinc 4 to 50Broiler chickens. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Bacitracin zinc and lasalocid sodium as provided by No. 054771 in §510.600(c) of this chapter.054771
(xii)Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.Feed continuously on a free-choice basis at a rate of not less than 60 mg or more than 300 mg of lasalocid per head per day.054771
(xiii)Cattle; for control of coccidiosis caused by Eimeria bovis and Eimeria zuerniiFor cattle; hand feed at a rate of 1 mg of lasalocid per 2.2 pounds body weight per day to cattle weighing up to 800 pounds with a maximum of 360 mg of lasalocid per head per day054771
(xiv) 113 (0.0125 pct)Chukar partridges; for prevention of coccidiosis caused by Eimeria legionensisFeed continuously as sole ration up to 8 weeks of age054771
(xv) 68 (0.0075 pct) to 113 (0.0125 pct)   Growing turkeys; for prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides.Feed continuously as sole ration054771
   Bacitracin 4 to 50Growing turkeys; for prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides; for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration054771
   Bacitracin methylene disalicylate 4 to 50Growing turkeys; for prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides; for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter.054771
   Virginiamycin 10 to 20Growing turkeys; for prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides, and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. As lasalocid sodium provided by 063238 and virginiamycin provided by 066104.054771
(xvi)Replacement calves; for control of coccidiosis caused by E. bovis and E. zuernii.In milk replacer powder; hand feed at a rate of 1 mg of lasalocid per 2.2 lb body weight per day; include on labeling warning: “A withdrawal period has not been established for lasalocid in pre-ruminating calves. Do not use in calves to be processed for veal”054771
(xvii) 113 (0.0125 pct)Rabbits; for prevention of coccidiosis caused by Eimeria stiedaeFeed continuously as sole ration up to 61/2 weeks of age054771
(xviii) 1440Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain.Feed continuously on a free-choice basis at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day.021930
017800
(xix) 300Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain.Feed continuously on a free-choice basis at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day.068287
(xx) 10 to 30Chlortetracycline 25 to 1001. Cattle fed in confinement for slaughter: For improved feed efficiency; and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg of lasalocid sodium activity per head per day.054771
      2. Cattle under 700 pounds fed in confinement for slaughter: For improved feed efficiency; and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg of lasalocid sodium activity per head per day.054771
(xxi) 10 to 30Chlortetracycline 500 to 2000Cattle fed in confinement for slaughter: For improved feed efficiency; and for treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb body weight per day and not less than 100 mg nor more than 360 mg of lasalocid sodium activity per head per day.054771
(xxii) 25 to 30Chlortetracycline 25 to 42.21. Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency; and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg of lasalocid sodium activity per head per day.054771
      2. Cattle under 700 pounds fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency; and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg of lasalocid sodium activity per head per day.054771
(xxiii) 25 to 30Chlortetracycline 500 to 1200Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency; and for treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb body weight per day and not less than 250 mg nor more than 360 mg of lasalocid sodium activity per head per day.054771
(xxiv) 30 to 181.8Chlortetracycline 25 to 28001. Beef cattle under 700 pounds: For control of coccidiosis caused by Eimeria bovis and E. zuernii; and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.Hand feed continuously at a rate of 350 mg chlortetracycline per head per day and 1 mg lasalocid per 2.2 lb body weight per day with a maximum of 360 mg lasalocid per head per day.054771
      2. Beef cattle up to 800 pounds: For control of coccidiosis caused by Eimeria bovis and E. zuernii; and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.Hand feed continuously at a rate of 350 mg chlortetracycline per head per day and 1 mg lasalocid per 2.2 lb body weight per day with a maximum of 360 mg lasalocid per head per day.054771
(xxv) 30 to 181.8Chlortetracycline 500 to 4000Cattle up to 800 pounds: For control of coccidiosis caused by Eimeria bovis and E. zuernii; and for treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.Hand feed continuously for not more than 5 days to provide 10 mg chlortetracycline per lb body weight per day and 1 mg lasalocid per 2.2 lb body weight per day with a maximum of 360 mg lasalocid per head per day.054771
(xxvi) 30 to 600Chlortetracycline 25 to 7001. Pasture cattle (slaughter, stocker, feeder cattle, and beef replacement heifers): for increased rate of weight gain; and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.Hand feed continuously at a rate of 350 mg chlortetracycline and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 lb of feed. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.054771
      2. Pasture cattle under 700 pounds (slaughter, stocker, feeder cattle, and beef replacement heifers): for increased rate of weight gain; and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.Hand feed continuously at a rate of 350 mg chlortetracycline and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 lb of feed. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.054771
(xxvii) 30 to 600Chlortetracycline 25 to 1100Pasture cattle over 700 pounds (slaughter, stocker, feeder cattle, and beef replacement heifers): For increased rate of weight gain; and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.Hand feed continuously at a rate of 0.5 mg chlortetracycline per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 lb of feed. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.054771
(xxviii) 30 to 600.Chlortetracycline 500 to 4000.Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain; and for treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.Hand feed continuously for not more than 5 days to provide 10 mg chlortetracycline per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 lb of feed. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.054771

(2) It is used as a free-choice mineral Type C feed as follows:

(i) Specifications.

IngredientPercentInternational feed No.
Defluorinated phosphate (20.5% Ca, 18.5% P)35.96-01-080
Sodium chloride (salt)20.06-04-152
Calcium carbonate (38% Ca)18.06-01-069
Cottonseed meal10.05-01-621
Potassium chloride3.06-03-755
Selenium premix (0.02 percent Se)13.0
Dried cane molasses (46% sugars)2.54-04-695
Magnesium sulfate1.76-02-758
Vitamin premix11.4
Magnesium oxide (58% Mg)1.26-02-756
Potassium sulfate1.26-06-098
Trace mineral premix11.04
Lasalocid Type A medicated article (68 g/lb)21.06

1Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

2To provide 1,440 g lasalocid per ton, use 21.2 lbs (1.06%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 15.88 lbs per ton (0.794%), adding molasses.

(ii) Amount. 1,440 grams per ton.

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers); feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.

(v) Sponsor. See No.054771 in §510.600(c) of this chapter.

(3) It is used as a ruminant free-choice liquid Type C feed as follows:

(i) Specifications.

IngredientPercentInternational feed No.
Cane molasses55.1674-13-241
Condensed molasses fermentation solubles24.0
50% Urea Solution (23% N)12.0
Ammonium polyphosphate solution1.06-08-42
Phosphoric acid (54%)3.06-03-707
Xanthan gum0.058-15-818
Water4.0
Trace mineral premix10.5
Vitamin premix10.2
Lasalocid Type A medicated article (90.7 g/lb)20.083

1Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

2To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of a lasalocid liquid Type A medicated article containing 90.7 g/lb. If using a dry lasalocid Type A medicated article containing 68 g/lb, use, use 2.206 lbs per ton (0.111%), replacing molasses. If using a dry lasalocid Type A medicated article containing 90.7 g/lb, use 1.652 lbs per ton (0.083%), adding molasses.

(ii) Amount. 150 grams per ton.

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). Feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.

(v) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(4) It is used as a free-choice, loose mineral Type C feed as follows:

(i) Specifications.

IngredientPercentInternational feed No.
Monocalcium phosphate (21% P)57.706-01-082
Salt17.556-04-152
Distillers dried grains w/ solubles5.405-28-236
Dried cane molasses (46% Sugars)5.204-04-695
Potassium chloride4.906-03-755
Trace mineral/vitamin premix13.35
Calcium carbonate (38% Ca)2.956-01-069
Mineral oil1.058-03-123
Magnesium oxide (58% Mg)1.006-02-756
Iron oxide (52% Fe)0.106-02-431
Lasalocid Type A medicated article (68 g/lb)20.80

1Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

2To provide 1,088 g lasalocid per ton, use 16 lbs (0.80%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 12 lbs per ton (0.6%), adding molasses.

(ii) Amount. 1,088 grams per ton.

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. Feed continuously on a free-choice basis at a rate of 60 to 300 mg lasalocid per head per day.

(v) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(5) Lasalocid may also be used in combination with:

(i) Melengestrol acetate alone or in combination with tylosin as in §558.342.

(ii) [Reserved]

[41 FR 44382, Oct. 8, 1976]

Editorial Note: For Federal Register citations affecting §558.311, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

Editorial Note: At 79 FR 13545, Mar. 11, 2014, §558.311 was amended; however, the amendment could not be incorporated due to inaccurate amendatory instruction.

§558.325   Lincomycin.

Link to an amendment published at 79 FR 19815, April 10, 2014.

(a) Approvals. Type A articles and Type B feeds approved for sponsors in §510.600(c) of this chapter for specific uses as in paragraph (d) of this section as follows:

(1) No. 054771 for 20 and 50 grams per pound.

(2) No. 051311 for 2.5 and 8 grams per pound.

(b) Related tolerances. See §556.360 of this chapter.

(c) Special considerations—(1) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following directions: “CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.”

(2) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following directions: “CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.”

(3) Labeling of Type A medicated articles and single-ingredient Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following directions:

(i) No. 054771: “CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined. Not for use in swine intended for breeding when lincomycin is fed at 20 grams per ton of complete feed.”

(ii) No. 051311:“CAUTION: Not to be fed to swine that weigh more than 250 lb.”

(d) Conditions of use—(1) Chickens. It is used in feed as follows:

Lincomycin grams/tonIndications for useLimitationsSponsor
(i) 2Broilers: For control of necrotic enteritis caused by Clostridium spp. or other susceptible organisms.As lincomycin hydrochloride monohydrate.054771
(ii) 2 to 4Broilers: For increased rate of weight gain and improved feed efficiency.As lincomycin hydrochloride monohydrate.054771

(2) Swine. It is used in feed as follows:

Lincomycin grams/tonIndications for useLimitationsSponsor
(i) 20Growing-finishing swine: For increased rate of weight gain.Feed as sole ration.054771
(ii) 401. For control of swine dysentery.Feed as sole ration; for use in swine on premises with a history of swine dysentery but where symptoms have not yet occurred, or following use of lincomycin at 100 grams (g)/ton for treatment of swine dysentery.054771
051311
   2. For control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis.Feed as sole ration, or following use of lincomycin at 100 g/ton for control of porcine proliferative enteropathies (ileitis).054771
(iii) 1001. For treatment of swine dysentery.Feed as sole ration for 3 weeks or until signs of disease disappear.054771
051311
   2. For control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis.Feed as sole ration for 3 weeks or until signs of disease disappear.054771
(iv) 200For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae.Feed as sole ration for 3 weeks.054771
051311

(3) Lincomycin may also be used in combination with:

(i) Amprolium and ethopabate as in §558.58.

(ii) Clopidol as in §558.175.

(iii) Decoquinate as in §558.195.

(iv) Fenbendazole as in §588.258.

(v) Halofuginone as in §558.265.

(vi) Ivermectin as in §558.300.

(vii) Lasalocid sodium as in §558.311.

(viii) Monensin as in §588.355.

(ix) Nicarbazin alone and with narasin as in §558.366.

(x) Pyrantel as in §558.485.

(xi) Robenidine as in §558.515.

(xii) Salinomycin as in §558.550.

(xiii) Zoalene as in §558.680.

[40 FR 13959, Mar. 27, 1975]

Editorial Note: For Federal Register citations affecting §558.325, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.340   Maduramicin.

(a) Approvals. Type A medicated articles: 4.54 grams per pound to 054771 in §510.600(c) of this chapter.

(b) Tolerances. See §556.375 of this chapter.

(c) Conditions of use—(1) Amount. 4.54 to 5.45 grams per ton (5 to 6 parts per million) (1 to 1.2 pounds per ton).

(i) Indications for use. For prevention of coccidiosis caused by Eimeria acervulina, E. tenella, E. brunetti, E. maxima, E. necatrix, and E. mivati.

(ii) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Withdraw 5 days before slaughter.

(2) [Reserved]

[54 FR 5229, Feb. 2, 1989, as amended at 54 FR 26732, June 26, 1989; 54 FR 32635, Aug. 9, 1989; 54 FR 33885, Aug. 17, 1989; 55 FR 23, Jan. 2, 1990; 55 FR 8460, Mar. 8, 1990; 55 FR 49616, Nov. 30, 1990; 59 FR 8134, Feb. 18, 1994; 61 FR 18082, Apr. 24, 1996; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001; 79 FR 13545, Mar. 11, 2014]

§558.342   Melengestrol.

(a) Specifications. (1) Dry Type A medicated articles containing 100 or 200 milligrams (mg) melengestrol acetate per pound.

(2) Liquid Type A medicated article containing 500 mg melengestrol acetate per pound.

(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) No. 054771 for use of products described in paragraph (a) of this section.

(2) No. 000986 for use of product described in paragraph (a)(2) of this section.

(c) Related tolerances. See §556.380 of this chapter.

(d) Special considerations. (1) Type B or C medicated feeds may be manufactured from melengestrol acetate liquid Type A articles or Type B or C medicated feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(2) A physically stable melengestrol acetate liquid Type B or C feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.

(3) Combination Type B or C medicated feeds containing lasalocid must be labeled in accordance with §558.311(d)(5) of this chapter.

(4) Liquid combination Type B or C medicated feeds containing melengestrol acetate and lasalocid must be manufactured in accordance with §558.311(d) of this chapter.

(5) Combination Type B or C medicated feeds containing monensin must be labeled in accordance with §558.355(d) of this chapter.

(6) Liquid combination Type B or C medicated feeds containing melengestrol acetate and monensin must be manufactured in accordance with §558.355(f)(3)(i) of this chapter.

(7) Liquid combination Type B or C medicated feeds containing melengestrol acetate and tylosin must be manufactured in accordance with §558.625(c) of this chapter.

(8) Liquid melengestrol acetate may not be mixed with oxytetracycline in a common liquid feed supplement.

(e) Conditions of use—(1) Cattle.

Melengestrol acetate in mg/head/dayCombination in mg/head/dayIndications for useLimitationsSponsor
(i) 0.25 to 0.5  Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat).Administer 0.5 to 2.0 pounds (lb)/head/day of medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to provide 0.25 to 0.5 mg melengestrol acetate/head/day.054771, 000986
(ii) 0.5  Heifers intended for breeding: For suppression of estrus (heat).Administer 0.5 to 2.0 lb/head/day of Type C feed containing 0.25 to 1.0 mg melengestrol acetate/lb to provide 0.5 mg melengestrol acetate/head/day. Do not exceed 24 days of feeding.054771, 000986
(iii) 0.25 to 0.5Lasalocid 100 to 360Heifers fed in confinement for slaughter: As in paragraph (e)(1)(i) of this section.Add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 30 grams (g) of lasalocid per ton; or add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate plus 50 to 720 mg lasalocid/lb to a ration of nonmedicated feed to provide 0.25 to 0.5 mg melengestrol acetate and 100 to 360 mg lasalocid/head/day.  
Lasalocid provided by No. 054771 in §510.600(c) of this chapter.
054771, 000986
(iv) 0.25 to 0.5Lasalocid 100 to 360 plus tylosin 90.Heifers fed in confinement for slaughter: As in paragraph (e)(1)(i) of this section; and for reduced incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.To administer 0.25 to 0.5 mg melengestrol acetate plus 100 to 360 mg lasalocid plus 90 mg tylosin/head/day:
1. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to a medicated feed containing 10 to 30 g lasalocid and 8 to 10 g tylosin per ton; or
2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 50 to 720 mg lasalocid/lb to 4.5 to 18 lb of a dry medicated feed containing 10 to 40 g tylosin per ton; or
3. Add 0.5 to 2.0 lb/head/day of a dry pelleted medicated feed containing 0.125 to 1.0 mg melengestrol acetate (from a dry Type A article), 50 to 720 mg lasalocid, and 45 to 180 mg tylosin/lb to a ration of nonmedicated feed.
Lasalocid provided by No. 054771, and tylosin provided by Nos. 000986 and 016592 in §510.600(c) of this chapter
054771, 000986, 016592
(v) [Reserved]
  (vi)-(vii) [Reserved]
(viii) 0.25 to 0.5Oxytetracycline 75Heifers fed in confinement for slaughter: As in paragraph (e)(1)(i) of this section; and for reduction of liver condemnation due to liver abscesses.Add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb per pound to a feed containing 6 to 10 g oxytetracycline per ton; or add at the rate of 0.5 to 2.0 lb/head/day a dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 37.5 to 150 mg oxytetracycline/lb to provide 0.25 to 0.5 mg melengestrol acetate and 75 mg oxytetracycline/head/day.
Oxytetracycline as provided by No. 066104 in §510.600(c) of this chapter.
054771
(ix) 0.25 to 0.5Tylosin 60 to 90Heifers fed in confinement for slaughter: As in paragraph (e)(1)(i) of this section; and for reduced incidence of liver abscesses caused by F. necrophorum and Actinomyces (Corynebacterium) pyogenes.To administer 0.25 to 0.5 mg melengestrol acetate with 60 to 90 mg tylosin/head/day:
1. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to a medicated feed containing 8 to 10 g tylosin per ton; or
2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to 4.5 to 18 pounds of a dry medicated feed containing 10 to 40 g tylosin per ton; or
3. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate (from a dry Type A article) plus 45 to 180 mg tylosin/lb to a ration of nonmedicated feed.
Tylosin provided by Nos. 000986 and 016592 in §510.600(c) of this chapter
054771
000986
016592
(x) 0.25 to 0.5Monensin 50 to 480.Heifers fed in confinement for slaughter: As in paragraph (e)(1)(i) of this section; and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.Add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg melengestrol acetate/head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/head/day.
   
Monensin provided by No. 000986 in §510.600(c) of this chapter.
054771
000986
(xi) 0.25 to 0.5Monensin 50 to 480, plus tylosin 60 to 90Heifers fed in confinement for slaughter: As in paragraph (e)(1)(i) of this section; for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes.Feed continuously as sole ration (liquid or dry) at a rate of 0.5 to 2.0 lb/head/day to provide 0.25 to 0.5 mg/head/day melengestrol acetate; 0.14 to 0.42 mg monensin/lb body weight/day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day; and 60 to 90 mg/head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into a complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin in the amount of complete feed consumed by an animal per day.
   
Monensin provided by No. 000986 and tylosin provided by Nos. 000986 and 016592 in §510.600(c) of this chapter.
054771
016592

(2) Melengestrol may also be used with:

(i) Ractopamine as in §558.500 of this chapter.

(ii) Zilpaterol as in §558.665 of this chapter.

[42 FR 28535, June 3, 1977]

Editorial Note: For Federal Register citations affecting §558.342, see the List of CFR Section Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.348   Mibolerone.

(a) Approvals. To No. 054771in §510.600(c) of this chapter for a canned dog food, each 612 ounce can containing 30 or 60 micrograms of mibolerone.

(b) Conditions of use—(1) Amount. 30 micrograms for animals weighing up to 25 pounds; 60 micrograms for animals weighing 26 to 50 pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 micrograms for animals weighing over 100 pounds, or German Shepherds or German Shepherd mix weighing 30 to 80 pounds.

(2) Indications for use. For the prevention of estrus (heat) in adult female dogs not intended primarily for breeding purposes.

(3) Limitations. Administer daily at least 30 days before expected initiation of heat and continue as long as desired, but for not more than 12 months. Mibolerone should not be used in bitches before first estrous period or in purebred Bedlington terriers. It is not intended for animals being used primarily for breeding purposes. Use orally in adult female dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[47 FR 6617, Feb. 16, 1982, as amended at 79 FR 13545, Mar. 11, 2014]

§558.355   Monensin.

(a) Specifications. Type A medicated articles containing monensin, USP.

(b) Approvals. Approvals for Type A medicated articles containing the specified levels of monensin activity granted to firms identified by sponsor numbers in §510.600(c) of this chapter for the conditions of use indicated in paragraph (f) of this section are as follows:

(1) To No. 000986: 36.3 (for export only), 44, 45, 60, or 90.7 grams per pound for use as in paragraphs (f)(1)(i) and (f)(4) of this section.

(2) To 000986: 110 grams per lb., paragraphs (f)(1) (i), (iii), (iv), (v), (ix), and (x).

(3) [Reserved]

(4) To No. 000986: 45, 60, or 90.7 grams per pound for use as in paragraph (f)(2) of this section.

(5) To 066104: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraphs (f)(1)(xiii), (xx), and (xxi) of this section.

(6) To No. 000986: 45, 60, or 90.7 grams per pound for use as in paragraph (f)(5) of this section.

(7) To 000986: 20, 30, 45, 60, 80, and 90.7 grams per pound, as monensin sodium, paragraph (f)(3) of this section.

(8) To 054771: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraph (f)(1)(xiv) of this section.

(9) To 054771: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraphs (f)(1)(xv) and (xvi) of this section.

(10) To 016592: 45 and 60 grams per pound, as monensin sodium, paragraph (f)(1)(xvii) of this section.

(11) To 054771: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraphs (f)(1)(xiv), (xviii), (xix), (xxiii), (xxiv), (xxv), (xxvi), and (xxvii) of this section.

(12) To 066104: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraph (f)(1)(xxii) of this section.

(13) To No. 012286: 60 and 80 grams per pound, paragraph (f)(3)(v) of this section.

(14) To 000986: 60, 80, and 90.7 grams per pound, as monensin sodium, paragraph (f)(6) of this section.

(c) [Reserved]

(d) Special considerations. (1) Type C chicken feed containing monensin as the mycelial cake shall bear an expiration date of 90 days after its date of manufacture.

(2)-(3) [Reserved]

(4) Liquid Type B feeds shall bear an expiration date of 8 weeks after its date of manufacture.

(5) All Type A medicated articles containing monensin shall bear the following warning statement: When mixing and handling monensin Type A medicated articles, use protective clothing, impervious gloves, and a dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water.

(6) All formulations containing monensin shall bear the following caution statement: Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal.

(7) Type A medicated articles containing monensin intended for use in cattle and goats shall bear, in addition to the caution statement in paragraph (d)(6) of this section, the following statements:

(i) Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions.

(ii) Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats.

(iii) Must be thoroughly mixed in feeds before use.

(iv) Do not feed undiluted.

(v) Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result.

(vi) Do not feed to lactating goats.

(vii) If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing (see paragraphs (d)(10)(i) and (d)(10)(ii) of this section).

(viii) A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

(ix) You may notice the following: Reduced voluntary feed intake in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Rule out monensin as the cause of reduced feed intake before attributing to other causes such as illness, feed management, or the environment. Reduced milk fat percentage in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Increased incidence of cystic ovaries and metritis in dairy cows fed monensin. Reduced conception rates, increased services per animal, and extended days open and corresponding calving intervals in dairy cows fed monensin. Have a comprehensive and ongoing nutritional, reproductive, and herd health program in place when feeding monensin to dairy cows.

(x) Inadequate mixing (recirculation or agitation) of monensin liquid Type B or Type C medicated feeds has resulted in increased monensin concentration which has been fatal to cattle and could be fatal to goats.

(8) Type A medicated articles containing monensin intended for use in chickens, turkeys, and quail shall bear the following statements:

(i) Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal.

(ii) Must be thoroughly mixed in feeds before use.

(iii) Do not feed undiluted.

(iv) Do not feed to laying chickens.

(v) Do not feed to chickens over 16 weeks of age.

(vi) For replacement chickens intended for use as cage layers only.

(vii) Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis.

(viii) In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain.

(9) Type B feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in:

(i) Cattle (as described in paragraphs (f)(3)(i) through (f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i) through (d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section.

(ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and (f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i) through (d)(7)(iv), (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section.

(iii) Goats: See paragraphs (d)(6) and (d)(7)(i) through (d)(7)(vi) of this section.

(iv) Chickens: See paragraphs (d)(8)(i) through (d)(8)(vi), and (d)(8)(viii) of this section.

(v) Turkeys: See paragraphs (d)(8)(i), (d)(8)(ii), (d)(8)(iii), and (d)(8)(vii) of this section.

(vi) Quail: See paragraphs (d)(8)(i), (d)(8)(ii), and (d)(8)(iii) of this section.

(10) Type C feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in:

(i) Cattle (as described in paragraphs (f)(3)(i) through (f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section. Paragraph (d)(7)(vii) of this section does not apply to free-choice Type C medicated feeds as defined in §510.455 of this chapter.

(ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and (f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i), (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section. Paragraph (d)(7)(vii) of this section does not apply to free-choice Type C medicated feeds as defined in §510.455 of this chapter.

(iii) Goats: See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), and (d)(7)(vi) of this section.

(iv) Chickens: See paragraphs (d)(8)(i), (d)(8)(iv), (d)(8)(v), (d)(8)(vi), and (d)(8)(viii) of this section.

(v) Turkeys: See paragraphs (d)(8)(i) and (d)(8)(vii) of this section.

(vi) Quail: See paragraph (d)(8)(i) of this section.

(11) Type B and Type C liquid feeds requiring recirculation or agitation that contain monensin and are intended for use in cattle (including dairy cows) and goats shall bear the caution statement specified in paragraph (d)(7)(x) of this section.

(12) Mixing directions for liquid feeds requiring recirculation or agitation:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(e) Related tolerances. See §556.420 of this chapter.

(f) Conditions of use. It is used as follows:

(1) Broiler chickens—(i) Amount per ton. Monensin, 90-110 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Feed continuously as the sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens.

(ii) [Reserved]

(iii) Amount per ton. Monensin, 90-110 grams plus bacitracin, 5-25 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as bacitracin methylene disalicylate provided by No. 054771 in §510.600(c) of this chapter; as monensin sodium.

(iv) Amount per ton. Monensin, 90-110 grams plus bacitracin, 10 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as zinc bacitracin provided by No. 054771 in §510.600(c) of this chapter; as monensin sodium.

(v) Amount per ton. Monensin, 90-110 grams plus bacitracin, 10-30 grams.

(a) Indications for use. For improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as zinc bacitracin provided by No. 054771 in §510.600(c) of this chapter; as monensin sodium.

(vi) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins, 1 to 2 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; and as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella,E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Feed continuously as sole ration; do not feed to laying chickens. Bambermycins provided by No. 016592 in §510.600(c) of this chapter.

(vii) [Reserved]

(viii) Amount per ton. Monensin, 90 to 110 grams plus oxytetracycline, 200 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of complicated chronic respiratory disease (CRD or air-sac infection) caused by Mycoplasma gallisepticum and Escherichia coli.

(b) Limitations. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; do not feed to laying chickens; feed continuously as sole ration; as monensin sodium.

(ix) Amount per ton. Monensin, 90-110 grams plus lincomycin, 2 grams.

(a) Indications for use. For increase in rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; to be fed as a sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as monensin sodium.

(x)-(xii) [Reserved]

(xiii) Amount per ton. Monensin, 90 to 110 grams, plus 5 grams virginiamycin.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati; for increased rate of weight gain and improved feed efficiency.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; as monensin sodium provided by No. 000986 in §510.600 of this chapter; virginiamycin provided by No. 066104 in §510.600 of this chapter.

(xiv) Amount per ton. Monensin, 90 to 110 grams, plus 500 grams chlortetracycline.

(a) Indications for use. As an aid in the reduction of mortality due to Escherichia coli infections susceptible to such treatment. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed for 5 days as the sole ration; withdraw 24 hours before slaughter; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; not to be fed continuously for more than 5 days; as monensin sodium; as chlortetracycline hydrochloride provided by Nos. 054771 and 048164 in §510.600(c) of this chapter.

(xv)-(xx)[Reserved]

(xxi) Amount per ton. Monensin, 90 to 110 grams, plus virginiamycin, 5 to 15 grams.

(a) Indications for use. For increase in rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; as monensin sodium provided by No. 000986 in §510.600 of this chapter; virginiamycin provided by No. 066104 in §510.600 of this chapter.

(xxii) Amount per ton. Monensin, 90 to 110 grams plus oxytetracycline, 500 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. Mivati, and E. maxima; as an aid in the reduction of mortality due to air-sacculities (air-sac infection) caused by Escherichia coli sensitive to oxytetracycline.

(b) Limitations. Feed for 5 days as sole ration. Do not feed to laying chickens. Withdraw 24 hours before slaughter. As monensin sodium provided by No. 000986 in §510.600(c) of this chapter. As mono-alkyl (C8-C18) trimethylammonium oxytetracycline provided by No. 066104 in §510.600(c) of this chapter.

(xxiii) [Reserved]

(xxiv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylene disalicylate, 4 to 50 grams.

(xxv) Amount per ton. Monensin, 90 to 110 grams plus bacitracin, 4 to 50 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as bacitracin zinc provided by No. 054771 in §510.600(c) of this chapter, as monensin sodium.

(xxvi)-(xxvii)[Reserved]

(xxviii) Amount per ton. Monensin, 90 to 110 grams, plus tylosin phosphate, 4 to 50 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, for increased rate of weight gain, and improved feed efficiency.

(b) Limitations. Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. As monensin sodium and tylosin phosphate provided by No. 000986 in §510.600(c) of this chapter.

(xxix) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 50 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 054771 in §510.600(c) of this chapter.

(xxx) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 100 to 200 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 054771 in §510.600(c) of this chapter.

(2) Turkeys—(i) Amount per ton. Monensin, 54 to 90 grams.

(a) Indications for use. For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis.

(b) Limitations. For growing turkeys only; as monensin sodium; feed continuously as sole ration. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis.

(ii) Amount per ton. Monensin, 54 to 90 grams, and bacitracin methylene disalicylate, 4 to 50 grams.

(a) Indications for use. For prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, for increased rate of weight gain, and for improved feed efficiency.

(b) Limitations. For growing turkeys only; as monensin sodium; feed continuously as sole ration. Do not allow horses, other equines, mature turkeys or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter.

(iii) Amount per ton. Monensin, 54 to 90 grams, and bacitracin methylene disalicylate, 200 grams.

(a) Indications for use. For the prevention of coccidiosis caused by Eimeria adenoides, E. meleagrimitis, and E. gallopavonis, and as an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylene disalicylate.

(b) Limitations. For growing turkeys only; as monensin sodium; feed continuously as sole ration. Do not allow horses, other equines, mature turkeys or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter.

(iv) Amount per ton. Monensin, 54 to 90 grams, with virginiamycin, 10 to 20 grams.

(a) Indications for use. For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.

(b) Limitations. For growing turkeys only. Feed continuously as sole ration. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses, mature turkeys, and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Virginiamycin as provided by No. 066104 in §510.600(c) of this chapter.

(v) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 1 to 2 grams.

(a) Indications for use. For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for improved feed efficiency in growing turkeys.

(b) Limitations. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in §510.600(c) of this chapter.

(vi) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 2 grams.

(a) Indications for use. For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.

(b) Limitations. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in §510.600(c) of this chapter.

(3) Cattle—(i) Amount per ton. Monensin, 5-40 grams.

(a) Indications for use. Improved feed efficiency.

(b) Limitations. (1) Feed only to cattle being fed in confinement for slaughter. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). Complete feeds may be manufactured from monensin liquid Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their labels must bear appropriate mixing directions as defined in paragraph (d)(12) of this section. The liquid feed must bear caution statement as follows: Inadequate mixing, (recirculation or agitation), of liquid feeds has resulted in increased monensin concentration which has been fatal to cattle.

(2) An approved physically stable monensin liquid feed will not be subject to the requirements for mixing directions defined in paragraph (d)(12) of this section. A manufacturer may secure approval of a physically stable liquid feed by:

(i) Either filing an NADA for the product or by establishing a master file containing data to support the stability of its product;

(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental NADA to establish physical stability; and

(iii) Requesting No. 000986 in §510.600(c) of this chapter to file a supplemental NADA to provide for the use of its monensin Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the agency will approve the supplemental NADA. The approval will provide a basis for the individual liquid feed manufacturer to manufacture the liquid medicated feed under a medicated feed mill license described in the master file. A manufacturer who seeks to market a physically unstable monensin liquid feed with mixing directions different from the standard established in paragraph (d)(12) of this section may also follow this procedure.

(ii) Amount per ton. Monensin, 5 to 40 grams; plus tylosin, 8 to 10 grams.

(a) Indications for use. Cattle fed in confinement for slaughter: For improved feed efficiency; and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.

(b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously as sole ration at the rate of 50 to 480 milligrams of monensin and 60 to 90 milligrams of tylosin per head per day. Combination drug liquid Type B medicated feeds may be used to manufacture dry Type C medicated feeds and shall conform to mixing instructions as in 558.625(c) of this chapter. Tylosin provided by Nos. 000986 and 016592 in §510.600(c) of this chapter.

(iii) Amount per ton. Monensin, 15 to 400 grams.

(a) Indications for use. Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.

(b) Limitations. For increased rate of weight gain, feed at a rate of 50 to 200 milligrams monensin per head per day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams per head per day every other day in not less than 2 pounds of feed. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending on severity of challenge, up to 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per day in not less than 1 pound of feed.

(iv) Amount. Monensin at concentrations in free-choice Type C medicated feeds to provide 50 to 200 mg per head per day.

(a) Indications for use. Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.

(b) Limitations. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with grain or other feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or water-deprived cattle should be adapted to the pasture and to unmedicated supplement before using the monensin medicated supplement. The product's effectiveness in cull cows and bulls has not been established. See paragraph (d) of this section for other required label warnings.

(v) [Reserved]

(vi) Amount per ton. Monensin, 25 to 400 grams.

(a) Indications for use. For improved feed efficiency; for prevention and control of coccidiosis due to E. bovis and E. zuernii.

(b) Limitations. Feed to mature reproducing beef cows. Feed as supplemental feed, either hand-fed in a minimum of 1 pound of feed or mixed in a total ration. For improved feed efficiency, feed continuously at a rate of 50 to 200 milligrams monensin per head per day. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per head per day.

(vii) Amount per ton. Monensin, 10 to 40 grams.

(a) Indications for use. For prevention and control of coccidiosis due to E. bovis and E. zuernii.

(b) Limitations. For cattle fed in confinement for slaughter, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day.

(ix) [Reserved]

(x) Amount per ton. 1,620 grams monensin, USP.

(a) Indications for use. Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.

(b) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows:

IngredientPercentInternational feed No.
Monocalcium phosphate (21% phosphorus, 15% calcium)29.496-01-082
Sodium chloride (salt)24.376-04-152
Dried cane molasses20.04-04-695
Ground limestone (33% calcium) or calcium carbonate (38% calcium)13.756-02-632
Cane molasses3.04-04-696
Processed grain by-products (as approved by AAFCO)5.0
Vitamin/trace mineral premix12.5
Monensin Type A article, 90.7 grams per pound0.89
Antidusting oil1.0

1Content of the vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. The amount of selenium and ethylenediamine dihydroiodide (EDDI) must comply with the published requirements. (For selenium see 21 CFR 573.920; for EDDI see 51 FR 11483 (April 3, 1986).)

(c) Limitations. Feed at a rate of 50 to 200 milligrams per head per day. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with grain or other feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or water-deprived cattle should be adapted to the pasture and to unmedicated mineral supplement before using the monensin mineral supplement. The product's effectiveness in cull cows and bulls has not been established.

(xi) Amount per ton. Monensin, 10 to 200 grams.

(a) Indications for use. For prevention and control of coccidiosis due to E. bovis and E. zuernii.

(b) Limitations. For calves excluding veal calves. Feed at a rate of 0.14 to 1.0 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 200 milligrams per head per day.

(xii) Amount per ton. Monensin, 10 to 40 grams; plus tylosin, 8 to 10 grams.

(a) Indications for use. Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to E. bovis and E. zuernii; and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.

(b) Limitations. Feed only to cattle being fed in confinement for slaughter. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligrams monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day; and 60 to 90 milligrams of tylosin per head per day. Tylosin provided by Nos. 000986 and 016592 in §510.600(c) of this chapter.

(xiii) Amount per ton. Monensin, 11 to 22 grams.

(A) Indications for use. For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) in dairy cows.

(B) Limitations. Feed continuously to dry and lactating dairy cows in a total mixed ration (“complete feed”). See special labeling considerations in paragraph (d) of this section.

(xiv) Amount per ton. Monensin, 11 to 400 grams.

(A) Indications for use. For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) in dairy cows.

(B) Limitations. Feed continuously to dry and lactating dairy cows in a component feeding system (including top dress). The Type C medicated feed must be fed in a minimum of 1 lb of feed to provide 185 to 660 mg/head/day monensin to lactating cows or 115 to 410 mg/head/day monensin to dry cows. See special labeling considerations in paragraph (d) of this section.

(4) Replacement chickens intended for use as cage layers—(i) Amount per ton. Monensin, 90 to 110 grams.

(i)(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(ii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 4 to 50 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain, and improved feed efficiency.

(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 054771 in §510.600(c) of this chapter.

(iii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 50 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 054771 in §510.600(c) of this chapter.

(iv) Limitations. Do not feed to laying chickens; feed continuously as sole ration; as monensin sodium; do not feed to chickens over 16 weeks of age.

(v) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 100 to 200 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 054771 in §510.600(c) of this chapter.

(vi)-(vii) [Reserved]

(5) Bobwhite quail—(i) Amount per ton. Monensin, 73 grams.

(ii) Indications for use. For the prevention of coccidiosis in growing bobwhite quail caused by Eimeria dispersa and E. Lettyae.

(iii) Limitations. Feed continuously as the sole ration; do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin.

(6) Goats—(i) Amount per ton. Monensin, 20 grams.

(a) Indications for use. For the prevention of coccidiosis caused by Eimeria crandallis, E. christenseni, and E. ninakohlyakimovae.

(b) Limitations. (1) Feed continuously. Feed only to goats being fed in confinement. Do not feed to lactating goats. Type C feeds may be manufactured from monensin liquid Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their labels must bear appropriate mixing directions, as defined in paragraph (d)(12) of this section. See special labeling considerations in paragraph (d) of this section.

(2) An approved physically stable monensin liquid feed will not be subject to the requirements for mixing directions defined in paragraph (d)12) of this section. A manufacturer may secure approval of a physically stable liquid feed by:

(i) Either filing an NADA for the product or by establishing a master file containing data to support the stability of its product;

(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental NADA to establish physical stability; and

(iii) Requesting No. 000986 in §510.600(c) of this chapter to file a supplemental NADA to provide for the use of its monensin Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the agency will approve the supplemental NADA. The approval will provide a basis for the individual liquid feed manufacturer to manufacture the liquid medicated feed under a medicated feed mill license described in the master file. A manufacturer who seeks to market a physically unstable monensin liquid feed with mixing directions different from the standard established in paragraph (d)(12) of this section may also follow this procedure.

(ii) [Reserved]

(7) Free-choice feeds—(i) Amount. 150 milligrams per pound of protein-mineral block (0.033 percent).

(a) [Reserved]

(b) Conditions of use—(1) Indications for use. For increased rate of weight gain; and for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii in pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers) which may require supplemental feed.

(2) Limitations. Provide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds of block) per head per day, at least 1 block per 10 to 12 head of cattle. Roughage must be available at all times. Do not allow animals access to other protein blocks, salt or mineral, while being fed this product. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section.

(ii) Amount. 400 milligrams per pound of protein-mineral block (0.088 percent).

(a) Sponsor. See No. 067949 in §510.600(c) of this chapter.

(b) Conditions of use—(1) Indications for use. For increased rate of weight gain in pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers).

(2) Limitations. Provide 80 to 200 milligrams of monensin (0.2 to 0.5 pounds of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or minerals containing salt. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section.

(iii) Amount. 175 milligrams per pound of protein-mineral block (0.038 percent).

(a) Sponsor. See No. 017800 in §510.600(c) of this chapter.

(b) Conditions of use—(1) Indications for use. For increased rate of weight gain in pasture cattle (slaughter, stocker, and feeder).

(2) Limitations. Provide 40 to 200 milligrams of monensin (0.25 to 1.13 pounds or 4 to 18 ounces of block) per head per day, at least 1 block per 4 head of cattle. Do not allow cattle access to salt or mineral while being fed this product. Ingestion by cattle of monensin at levels of 600 milligrams per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section.

(iv) Amount. 400 milligrams per pound of block (0.088 percent).

(a) Sponsor. See No. 051267 in §510.600(c) of this chapter.

(b) Conditions of use—(1) Indications for use. For increased rate of weight gain in pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers).

(2) Limitations. Provide 50 to 200 milligrams of monensin (2 to 8 ounces of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or mineral supplements in addition to the blocks. Ingestion by cattle of monensin at levels of 600 milligrams per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section.

(8) Monensin may also be used in combination with:

(i) Decoquinate alone or with tylosin as in §558.195.

(ii) Melengestrol acetate alone or with tylosin as in §558.342.

(iii) Ractopamine alone or in combination as in §558.500.

(iv) Tilmicosin alone or in combination as in §558.618.

(v) Zilpaterol alone or in combination as in §558.665.

[40 FR 13959, Mar. 27, 1975]

Editorial Note: For Federal Register citations affecting §558.355, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

Editorial Note: At 79 FR 13545, Mar. 11, 2014, § 558.355 was amended; however, the amendment could not be incorporated due to inaccurate amendatory instruction.

§558.360   Morantel tartrate.

(a) Approvals. Type A medicated articles: 88 grams per pound to 066104 in §510.600(c) of this chapter.

(b) Related tolerances. See §556.425 of this chapter.

(c) Special considerations. (1) Do not use in Type B or Type C medicated feeds containing bentonite.

(2) Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(d) Conditions of use—(1) Amount. 0.44 to 4.4 grams of morantel tartrate per pound of feed.

(2) Indications for use—(i) Cattle. For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine (Oesophagostomum radiatum).

(ii) Goats. For removal and control of mature gastrointestinal nematode infections of goats including Haemonchus contortus, Ostertagia (Teladorsagia) circumcincta, and Trichostrongylus axei.

(3) Limitations. Feed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat cattle within 14 days of slaughter; do not treat goats within 30 days of slaughter.

[46 FR 50950, Oct. 16, 1981, as amended at 47 FR 53352, Nov. 26, 1982; 51 FR 7399, Mar. 3, 1986; 51 FR 9005, Mar. 17, 1986; 52 FR 11642, Apr. 10, 1987; 59 FR 17922, Apr. 15, 1994; 66 FR 47963, Sept. 17, 2001]

§558.363   Narasin.

(a) Approvals. Type A medicated articles containing specified levels of narasin approved for sponsors identified in §510.600(c) of this chapter for use as in paragraph (d) of this section are as follows:

(1) To 000986: 36, 45, 54, 72, and 90 grams per pound, paragraph (d)(1)(i) of this section.

(2) [Reserved]

(3) To 000986: 36 grams per pound, with 36 grams per pound nicarbazin, paragraph (d)(1)(iii) of this section.

(4) To 016592: 36, 45, 54, 72, and 90 grams per pound, with 2 and 10 grams per pound bambermycins, paragraph (d)(1)(iv) of this section.

(5)-(6) [Reserved]

(7) To 054771: 36, 45, 54, 72, or 90 grams per pound, with 10, 25, 40, or 50 grams per pound bacitracin zinc, paragraph (d)(1)(x) of this section.

(8) To 000986: 45.4 grams per pound for use as in paragraph (d)(2) of this section.

(b) Tolerances. See §556.428 of this chapter.

(c) Special considerations. An expiration date of 2 months (8 weeks) is required for narasin Type C medicated swine feeds.

(d) Conditions of use. It is used as follows:

(1) Broiler chickens—(i) Amount per ton. Narasin, 54 to 90 grams.

(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal.

(ii) Amount per ton. Narasin, 27 to 45 grams, plus nicarbazin, 27 to 45 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(B) Limitations. For broiler chickens only. Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these animals has been fatal. Withdraw 5 days before slaughter. The 2 drugs can be combined only at a 1:1 ratio for the 27 to 45 grams per ton range. Only granular nicarbazin as provided by No. 000986 in §510.600(c) of this chapter may be used in the combination.

(iii) Amount per ton. Narasin, 54 to 72 grams, plus bambermycins, 1 to 2 grams.

(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as the sole ration. May be fatal if fed to adult turkeys, horses, or other equines. Narasin as provided by No. 000986; bambermycins by No. 016592 in §510.600(c) of this chapter.

(iv) Amount per ton. Narasin 54 to 72 grams, and bacitracin methylene disalicylate 10 to 50 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati, E. necatrix, and E. tenella, for increased rate of weight gain, and for improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by 000986, bacitracin methylene disalicylate by 046573 in §510.600(c) of this chapter.

(v) Amount per ton. Narasin, 54 to 72 grams and bacitracin zinc, 4 to 50 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin as provided by 000986, bacitracin zinc by 046573 in §510.600(c) of this chapter.

(vi) Amount per ton. Narasin, 54 to 72 grams, plus tylosin, 4 to 50 grams.

(A) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, for increased rate of weight gain, and improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin and tylosin as provided by 000986 in §510.600(c) of this chapter.

(2) Growing-finishing swine—(i) Amount per ton. Narasin, 13.6 to 27.2 grams.

(A) Indications for use. For increased rate of weight gain when fed for at least 4 weeks.

(B) Limitations. Feed continuously for at least 4 weeks to swine during the growing-finishing period as the sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.

(ii) Amount per ton. Narasin, 18.1 to 27.2 grams.

(A) Indications for use. For increased rate of weight gain and improved feed efficiency when fed for at least 4 weeks.

(B) Limitations. Feed continuously for at least 4 weeks to swine during the growing-finishing period as the sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.

(3) Narasin may also be used for broilers in combination with:

(i) Nicarbazin with lincomycin as in §558.366.

(ii) Nicarbazin and bacitracin methylene disalicylate as in §558.366.

[51 FR 29098, Aug. 14, 1986]

Editorial Note: For Federal Register citations affecting §558.363, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

Editorial Note: At 79 FR 13545, Mar. 11, 2014, §558.363 was amended; however, the amendment could not be incorporated due to inaccurate amendatory instruction.

§558.364   Neomycin sulfate.

(a) Approvals. Type A medicated article: 325 grams per pound to 054771 in §510.600(c) of this chapter.

(b) Related tolerances. See §556.430 of this chapter.

(c) [Reserved]

(d) Conditions of use. Neomycin sulfate is used as follows:

Neomycin SulfateCombinationIndications for UseLimitationsSponsor
(1) 250 to 2,250 grams per ton (g/t) of dry type C feed.         Cattle, swine, sheep, and goats. For treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin.To provide 10 milligrams (mg) of neomycin sulfate per pound of body weight per day for a maximum of 14 days. The concentration of neomycin sulfate required in medicated feed must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects feed consumption. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in dry feeds only. Not for use in liquid feed supplements.054771
(2) 400 to 2,000 g/t of type C milk replacer.      Do.To provide 10 mg of neomycin sulfate per pound of body weight per day for a maximum of 14 days. Amount consumed will vary depending on animal's consumption and weight. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in milk replacers only.054771

[64 FR 70576, Dec. 17, 1999, as amended at 65 FR 45881, July 26, 2000; 79 FR 13545, Mar. 11, 2014]

§558.365   Nequinate.

(a) Approvals. Type A medicated articles: 4 percent to No. 051311 in §510.600(c) of this chapter.

(b) Related tolerances. See §556.440 of this chapter.

(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(d) Conditions of use. It is used as follows:

(1) Broiler or fryer chickens—(i) Amount per ton. Nequinate, 18.16 grams.

(ii) Indications for use. An aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(iii) Limitations. Feed continuously as the sole ration.

(2) Roaster chickens or replacement chickens for caged layers—(i) Amount per ton. Nequinate, 18.16 grams (0.002 percent).

(ii) Indications for use. An aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(iii) Limitations. Feed continuously as the sole ration; do not feed to chickens over 16 weeks of age.

[40 FR 13959, Mar. 27, 1975, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2685, Jan. 26, 1987; 66 FR 45167, Aug. 28, 2001; 70 FR 32489, June 3, 2005]

§558.366   Nicarbazin.

(a) Specifications. Type A medicated articles containing 25 percent nicarbazin.

(b) Approvals. See Nos. 000986, 060728, and 066104 in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(c) Related tolerances. See §556.445 of this chapter.

(d) Conditons of use. It is used in chicken feed as follows:

Nicarbazin in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
27 to 45Narasin 27 to 45Broiler chickens; prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati.Sec. 558.363(d)(1)(iii)000986
   Narasin 27 to 45 and bacitracin methylene disalicylate 4 to 50Broiler chickens; prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati; for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Withdraw 5 days before slaughter. Do not allow turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Narasin and nicarbazin as provided by 000986, bacitracin methylene disalicylate by 054771000986
   Narasin 27 to 45 and bacitracin methylene disalicylate 50.Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.Feed continuously as sole ration. Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin and nicarbazin as provided by No. 000986, bacitracin methylene disalicylate by No. 054771 in §510.600(c) of this chapter.054771
  Narasin 27 to 45 and bacitracin methylene disalicylate 100 to 200.Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin and nicarbazin as provided by No. 000986, bacitracin methylene disalicylate by No. 054771 in §510.600(c) of this chapter.054771
   Narasin 27 to 45, and bambermycins 1 to 2Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Bambermycins provided by No. 016592; nicarbazin and narasin by No. 066104 in §510.600(c) of this chapter000986
   Narasin 27 to 45 and Lincomycin 2 to 4Broiler chickens; prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati; for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Withdraw 5 days before slaughter. Do not allow turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Narasin and nicarbazin as provided by 000986, lincomycin by054771000986
90.8 to 181.6 (0.01 to 0.02 pct)Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosisFeed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton066104
   Bacitracin methylene disalicylate 4 to 50Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter054771
   Bacitracin methylene disalicylate 30Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter066104
   Bacitracin methylene disalicylate 50Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter054771
113.5 (0.0125 pct)   Chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosisFeed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter000986
060728
   Bacitracin methylene disalicylate 30Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency......do060728
   Bacitracin zinc 4 to 50.Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiency.For broiler chickens only. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Discontinue medication 4 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Nicarbazin as provided by 066104, bacitracin zinc by 054771.066104
054771
  Bambermycins 1 to 2Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Nicarbazin as provided by 066104.057926
   Bambermycins 1 to 2Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Bambermycins provided by No. 016592 in §510.600(c) of this chapter016592
  Lincomycin 2 (0.00044 pct)Broiler chickens; aid in preventing outbreaks of secal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain.Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter.060728
066104

[42 FR 56729, Oct. 28, 1977; 43 FR 1942, Jan. 13, 1978, as amended at 44 FR 40887, July 13, 1979; 50 FR 13562, Apr. 5, 1985; 51 FR 7399, Mar. 3, 1986; 54 FR 1928, Jan. 18, 1989; 60 FR 29483, June 5, 1995; 61 FR 1832, Jan. 24, 1996; 61 FR 14021, Mar. 29, 1996; 61 FR 14483, Apr. 2, 1996; 62 FR 29011, May 29, 1997; 63 FR 13124, Mar. 18, 1998; 63 FR 57248, Oct. 27, 1998; 64 FR 4966, Feb. 2, 1999; 64 FR 18574, Apr. 15, 1999; 64 FR 20164, Apr. 26, 1999; 64 FR 49384, Sept. 13, 1999; 65 FR 11889, Mar. 7, 2000; 66 FR 46706, Sept. 7, 2001; 66 FR 47962, Sept. 17, 2001; 66 FR 63500, Dec. 7, 2001; 67 FR 30327, May 6, 2002; 71 FR 16224, Mar. 31, 2006; 71 FR 27957, May 15, 2006; 73 FR 15884, Mar. 26, 2008; 75 FR 7555, Feb. 22, 2010; 78 FR 52429, Aug. 23, 2013; 79 FR 10983, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014]

§558.369   Nitarsone.

(a) Approvals. Type A medicated articles: 50 percent to 054771 in §510.600(c) of this chapter.

(b) Related tolerances. See §556.60 of this chapter.

(c) [Reserved]

(d) Conditions of use. It is used as follows:

(1) Chickens and turkeys—(i) Amount. Nitarsone, 0.01875 percent.

(ii) Indications for use. As an aid in the prevention of blackhead.

(iii) Limitations. Early medication is essential to prevent spread of disease. Adequate drinking water must be provided near feeder at all times. The drug is not effective in preventing blackhead in birds infected more than 4 or 5 days. Discontinue use 5 days before slaughtering animals for human consumption to allow elimination of the drug from edible tissues. The drug is dangerous for ducks, geese, and dogs. Overdosage or lack of water may result in leg weakness or paralysis. Use as sole source of arsenic.

(2) Turkeys—(i) Amount. Nitarsone 0.01875 percent, plus bacitracin methylene disalicylate or bacitracin zinc 4 to 50 grams per ton.

(ii) Indications for use. As an aid in the prevention of blackhead, and for increased rate of weight gain and improved feed efficiency.

(iii) Limitations. For growing turkeys. Feed continuously as sole ration. Early medication is essential to prevent spread of disease. Adequate drinking water must be provided near feeders at all times. Overdosage or lack of water may result in leg weakness or paralysis. The drug is not effective in preventing blackhead in birds infected more than 4 or 5 days. Discontinue use 5 days before slaughtering animals for human consumption to allow elimination of the drug from edible tissues. The drug is dangerous for ducks, geese, and dogs. Use as sole source of arsenic.

[46 FR 47535, Sept. 29, 1981, as amended at 47 FR 14152, Apr. 2, 1982; 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8460, Mar. 8, 1990; 57 FR 8578, Mar. 11, 1992; 63 FR 39028, July 21, 1998; 71 FR 16223, Mar. 31, 2006; 79 FR 13545, Mar. 11, 2014]

§558.415   Novobiocin.

(a) Specifications. Type A medicated article containing 25 grams of novobiocin activity per pound.

(b) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.460 of this chapter.

(d) Conditions of use. It is used in animal feeds as follows:

(1) Chickens—(i) Amount. Novobiocin, 6-7 mgs. per lb. body weight per day.

(a) Indications for use. Aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin.

(b) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; not for laying chickens; feed 5 to 7 days; withdraw 4 days before slaughter.

(ii) Amount. Novobiocin, 10-14 mgs. per lb. body weight per day.

(a) Indications for use. Treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin.

(b) Limitations. Administer, as sole ration, feed which contains not less than 350 grams of novobiocin activity per ton of feed; not for laying chickens; feed 5 to 7 days; withdraw 4 days before slaughter.

(2) Turkeys—(i) Amount. Novobiocin, 4-5 mgs. per lb. body weight per day.

(a) Indications for use. Aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin.

(b) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; not for laying turkeys; feed 5 to 7 days; withdraw 4 days before slaughter.

(ii) Amount. Novobiocin, 5-8 mgs. per lb. body weight per day.

(a) Indications for use. Aid in the control of recurring outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin following initial treatment with 7-8 mgs. per pound body weight per day.

(b) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; feed 5 to 7 days; not for laying turkeys; withdraw 4 days before slaughter.

(iii) Amount. Novobiocin, 7-8 mgs. per lb. body weight per day.

(a) Indications for use. Treatment of staphylococcal synovitis and generalized staphylococcal infection susceptible to novobiocin; treatment of acute outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin.

(b) Limitations. Administer, as sole ration, feed which contains not less than 350 grams of novobiocin activity per ton of feed; feed 5 to 7 days; not for laying turkeys; withdraw 4 days before slaughter.

(3) Mink—(i) Amount. 20 mgs. per lb. body weight per day.

(ii) Indications for use. For treatment of generalized infections, abscesses, or urinary infections caused by staphylococcal or other novobiocin sensitive organisms.

(iii) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; feed for 7 days.

(4) Ducks—(i) Amount. Novobiocin, 350 grams per ton.

(ii) Indications for use. Control of infectious serositis and fowl cholera in ducks caused by Pasteurella anatipestifer and P. multocida, susceptible to novobiocin.

(iii) Limitations. Administer, as sole ration, for 5 to 7 days, continue medication for 14 days if necessary, repeat if reinfection occurs; discontinue use at least 3 days before slaughter; not for use in laying ducks.

[40 FR 13959, Mar. 27, 1975, as amended at 45 FR 42263, June 24, 1980; 51 FR 7399, Mar. 3, 1986; 52 FR 36402, Sept. 29, 1987; 79 FR 13545, Mar. 11, 2014]

§558.430   Nystatin.

(a) Specifications. Type A medicated article containing 20 grams of nystatin activity per pound.

(b) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.470 of this chapter.

(d) Conditions of use. It is used for chickens and turkeys as follows:

(1) Amount. 50 grams per ton.

(i) Indications for use. Chickens and turkeys; aid in control of crop mycosis and mycotic diarrhea (Candida albicans).

(ii) Limitations. Growing and laying chickens; growing turkeys.

(2) Amount. 100 grams per ton.

(i) Indications for use. Chickens and turkeys; treatment of crop mycosis and mycotic diarrhea (Candida albicans).

(ii) Limitations. Growing and laying chickens; growing turkeys; to be fed for 7 to 10 days.

[41 FR 11002, Mar. 15, 1976, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 53 FR 40729, Oct. 18, 1988; 55 FR 8461, Mar. 8, 1990; 57 FR 8578, Mar. 11, 1992; 79 FR 13545, Mar. 11, 2014]

§558.435   Oleandomycin.

(a) Approvals. Type A medicated articles: 5 grams of activity per pound to 066104 in §510.600(c) of this chapter.

(b) Related tolerances. See §556.480 of this chapter.

(c) Special considerations. Do not use bentonite in Type B or Type C medicated feeds containing oleandomycin. Oleandomycin refers to oleandomycin or feed-grade oleandomycin.

(d) Conditions of use. It is used in animal feed as follows:

(1) Chickens and turkeys—(i) Amount per ton. Oleandomycin, 1 to 2 grams.

(ii) Indications for use. For increased rate of weight gain and improved feed efficiency for broiler chickens and growing turkeys.

(2) Swine—(i) Amount per ton. Oleandomycin, 5 to 11.25 grams.

(ii) Indications for use. For increased rate of weight gain and improved feed efficiency in growing-finishing swine.

[40 FR 13959, Mar. 27, 1975, as amended at 44 FR 40283, July 10, 1979; 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 66 FR 47963, Sept. 17, 2001]

§558.450   Oxytetracycline.

(a) Approvals. Type A medicated articles:

(1) 10, 20, 30, 50, 100, and 200 grams per pound to No. 066104 in §510.600(c) of this chapter.

(2) 50, 100, and 200 grams per pound to No. 048164 in §510.600(c) of this chapter.

(b) Special considerations. (1) In accordance with §558.5 labeling shall bear the statement: “FOR USE IN DRY ANIMAL FEED ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.”

(2) The articles in paragraph (a)(1) of this section contain an amount of mono-alkyl (C8-C18) trimethylammonium oxytetracycline expressed in terms of an equivalent amount of oxytetracycline hydrochloride or an amount of oxytetracycline dihydrate base expressed in terms of an equivalent amount of oxytetracycline hydrochloride.

(3) 50-, 100-, and 200-gram per pound articles in paragraph (a)(2) of this section contain oxytetracycline dihydrate expressed in terms of an equivalent amount of oxytetracycline hydrochloride. Another 100-gram per pound article in paragraph (a)(2) of this section contains oxytetracycline hydrochloride.

(c) Related tolerances. See §556.500 of this chapter.

(d) Conditions of use—(1) Chickens

Oxytetracycline amountIndications for useLimitationsSponsor
(i) 10 to 50 grams per ton (g/ton)Chickens: For increased rate of weight gain and improved feed efficiency.Feed continuously; do not feed to chickens producing eggs for human consumption.066104,
048164
(ii) 100 to 200 g/tonChickens: For control of infectious synovitis caused by Mycoplasma synoviae and control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline.Feed continuously for 7 to 14 days (d); do not feed to chickens producing eggs for human consumption; in low calcium feeds, withdraw 3 d before slaughter.066104,
048164
(iii) 400 g/tonChickens: For control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline.Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feeds, withdraw 3 d before slaughter.066104,
048164
(iv) 500 g/tonChickens: For reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracycline.Feed continuously for 5 d; do not feed to chickens producing eggs for human consumption; withdraw 24 hours before slaughter; in low calcium feeds, withdraw 3 d before slaughter.066104,
048164

(2) Turkeys

Oxytetracycline amountIndications for useLimitationsSponsor
(i) 10 to 50 g/tonGrowing turkeys: For increased rate of weight gain and improved feed efficiency.Feed continuously; do not feed to turkeys producing eggs for human consumption.066104,
048164
(ii) 100 g/tonTurkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline.Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption.066104,
048164
(iii) 200 g/tonTurkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracycline.Feed continuously for 7 to 14 d; for No. 066104 withdraw 5 d before slaughter; for No. 048164 zero-day withdrawal time; do not feed to turkeys producing eggs for human consumption.066104,
048164
(iv) 25 milligrams/pound (mg/lb) of body weight dailyTurkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline.Feed continuously for 7 to 14 d; for No. 066104 withdraw 5 d before slaughter; for No. 048164 zero-day withdrawal time; do not feed to turkeys producing eggs for human consumption.066104,
048164

(3) Swine

Oxytetracycline amountIndications for useLimitationsSponsor
(i) 10 to 50 g/tonSwine: For increased rate of weight gain and improved feed efficiency.Feed continuously.066104,
048164
(ii) 10 mg/lb of body weight daily1. Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by P. multocida susceptible to oxytetracycline.Feed continuously for 7 to 14 d.066104,
048164
   2. Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline.Feed continuously for 14 d.066104,
048164

(4) Cattle

Oxytetracycline amountIndications for useLimitationsSponsor
(i) 0.05 to 0.1 mg/lb of body weight dailyCalves (up to 250 lb): For increased rate of weight gain and improved feed efficiency.Feed continuously in milk replacer or starter feed.066104,
048164
(ii) 10 mg/lb of body weight daily1. Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline.Feed continuously for 7 to 14 d; for No. 048164, withdraw 5 d before slaughter; for No. 066104, zero-day withdrawal time.066104,
048164
   2. Calves: For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline.Feed continuously for 7 to 14 d in milk replacer or starter feed; for No. 048164, withdraw 5 d before slaughter; for No. 066104, zero-day withdrawal time.066104,
048164
(iii) 25 mg/head/dayCalves (250 to 400 lb): For increased rate of weight gain and improved feed efficiency.Feed continuously.066104,
048164
(iv) 75 mg/head/dayGrowing cattle (over 400 lb): For increased rate of weight gain, improved feed efficiency, and reduction of liver condemnation due to liver abscesses.Feed continuously.066104,
048164
(v) 0.5 to 2.0 g/head/dayCattle: For prevention and treatment of the early stages of shipping fever complex.Feed 3 to 5 d before and after arrival in feedlots.066104,
048164

(5) Minor species

Oxytetracycline amountIndications for useLimitationsSponsor
(i) 10 to 20 g/tonSheep: For increased rate of weight gain and improved feed efficiency.Feed continuously.066104,
048164
(ii) 10 mg/lb of body weight dailySheep: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracycline.Feed continuously for 7 to 14 d; withdraw 5 d before slaughter.066104,
048164
(iii) 200 mg/colonyHoney bees: For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline.Remove at least 6 weeks prior to main honey flow.066104,
048164
(iv) 250 mg/kilogram of fish/day (11.35 g/100 lb of fish/day)Pacific salmon: For marking of skeletal tissue.For salmon not over 30 g body weight; administer as sole ration for 4 consecutive days; fish not to be liberated for at least 7 d following the last administration of medicated feed.066104
(v) 2.5 to 3.75 g/100 lb of fish/day1. Salmonids: For control of ulcer disease caused by Hemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by A. liquefaciens, and pseudomonas disease.Administer in mixed ration for 10 d; do not liberate fish or slaughter fish for food for 21 d following the last administration of medicated feed.066104
   2. Catfish: For control of bacterial hemorrhagic septicemia caused by A. liquefaciens and pseudomonas disease.Administer in mixed ration for 10 d; do not liberate fish or slaughter fish for food for 21 d following the last administration of medicated feed; do not administer when water temperature is below 16.7 °C (62 °F).066104
(vi) 3.75 g/100 lb of fish/day1. Freshwater-reared salmonids: For control of mortality due to coldwater disease associated with Flavobacterium psychrophilum.Administer in mixed ration for 10 d; do not liberate fish or slaughter fish for food for 21 d following the last administration of medicated feed.066104
   2. Freshwater-reared Oncorhynchus mykiss: For control of mortality due to columnaris disease associated with Flavobacterium columnare.Administer in mixed ration for 10 d; do not liberate fish or slaughter fish for food for 21 d following the last administration of medicated feed.066104
(vii) 1 g/lb of medicated feedLobsters: For control of gaffkemia caused by Aerococcus viridans.Administer as sole ration for 5 consecutive days; withdraw medicated feed 30 d before harvesting lobsters.066104

(6) Oxytetracycline may be used in accordance with the provisions of this section in the combinations as follows:

(i) Carbadox as in §558.115.

(ii) Lasalocid as in §558.311.

(iii) Melengestrol acetate as in §558.342.

(iv) Robenidine hydrochloride as in §558.515.

(v) Salinomycin as in §558.550.

[61 FR 51590, Oct. 3, 1996, as amended at 63 FR 41192, Aug. 3, 1998; 66 FR 32740, June 18, 2001; 66 FR 45167, Aug. 28, 2001; 66 FR 47963, Sept. 17, 2001; 67 FR 51081, Aug. 7, 2002; 69 FR 28821, May 19, 2004; 69 FR 51173, Aug. 18, 2004; 69 FR 62407, Oct. 26, 2004; 71 FR 27958, May 15, 2006; 71 FR 44887, Aug. 8, 2006; 71 FR 53006, Sept. 8, 2006; 72 FR 70774, Dec. 13, 2007; 73 FR 45875, Aug. 7, 2008]

§558.455   Oxytetracycline and neomycin.

(a) Specifications. Type A medicated articles containing oxytetracycline equivalent to 50 grams per pound (g/lb) oxytetracycline hydrochloride and 50 g/lb neomycin sulfate or oxytetracycline equivalent to 100 g/lb oxytetracycline hydrochloride and 100 g/lb neomycin sulfate.

(b) Sponsors. See Nos. 048164 and 066104 in §510.600(c) of this chapter.

(c) Related tolerances. See §§556.430 and 556.500 of this chapter.

(d) Special considerations. Cattle feeds shall bear the following warning statement: “Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.”

(e) Indications for use—(1) Chickens. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount in grams per ton of feedIndications for useLimitationsSponsors
(i) 10 to 50Chickens: For increased rate of weight gain and improved feed efficiency.Feed continuously; do not feed to chickens producing eggs for human consumption; in low calcium feeds withdraw 3 days before slaughter.048164
066104
(ii) 100 to 200Chickens: For control of infectious synovitis caused by Mycoplasma synoviae; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline.Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feed, withdraw 3 d before slaughter.048164
066104
(iii) 400Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to oxytetracycline.Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feeds, withdraw 3 d before slaughter.048164
066104
(iv) 500Chickens: For reduction of mortality due to air sacculitis (air-sac- infection) caused by E. coli susceptible to oxytetracycline.Feed continuously for 5 d; do not feed to chickens producing eggs for human consumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter.048164
066104

(2) Turkeys. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amountIndications for useLimitationsSponsors
(i) 10 to 50 grams per ton (g/ton) of feedGrowing turkeys: For increased rate of weight gain and improved feed efficiency.Feed continuously; do not feed to turkeys producing eggs for human consumption.048164
066104
(ii) 100 g/ton of feedTurkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline.Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption.048164
066104
(iii) 200 g/ton of feedTurkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracycline.Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not feed to turkeys producing eggs for human consumption.048164
066104
(iv) To provide 25 milligrams per pound (mg/lb) of body weight daily.Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline.Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not feed to turkeys producing eggs for human consumption.048164
066104

(3) Swine. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amountIndications for useLimitationsSponsors
(i) 10 to 50 g/ton of feedSwine: For increased rate of weight gain and improved feed efficiency.Feed continuously.048164
066104
(ii) To provide 10 mg/lb of body weight daily.1. Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis and treatment of bacterial pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin.Feed continuously for 7 to 14 d; withdraw 5 d before slaughter.048164
066104
   2. Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline.Feed continuously for not more than 14 d; withdraw 5 d before slaughter.048164
066104

(4) Cattle and sheep. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amountIndications for useLimitationsSponsors
(i) 10 to 20 g/ton of feedSheep: For increased rate of weight gain and improved feed efficiency.Feed continuously.048164
066104
(ii) To provide 0.05 to 0.1 mg/lb of body weight daily.Calves (up to 250 lb): For increased rate of weight gain and improved feed efficiency.Feed continuously; in milk replacers or starter feed.048164
066104
(iii) To provide 10 mg/lb of body weight daily.1. Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin.Feed continuously for 7 to 14 d; in feed or milk replacers. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter.048164
066104
   2. Calves (up to 250 lb): For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin.Feed continuously for 7 to 14 d; in milk replacers or starter feed. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter.048164
066104
   3. Sheep: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin.Feed continuously for 7 to 14 d. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Withdraw 5 d before slaughter.048164
066104
(iv) To provide 25 mg/head/dayCalves (250 to 400 lb): For increased rate of weight gain and improved feed efficiency.Feed continuously.048164
066104
(v) To provide 75 mg/head/dayGrowing cattle (over 400 lb): For increased rate of weight gain; improved feed efficiency, and reduction of liver condemnation due to liver abscesses.Feed continuously.048164
066104
(vi) To provide 0.5 to 2.0 g/head/ dayCattle: For prevention and treatment of the early stages of shipping fever complex.Feed 3 to 5 d before and after arrival in feedlots. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older.048164
066104

[71 FR 16225, Mar. 31, 2006, as amended at 74 FR 40724, Aug. 13, 2009]

§558.460   Penicillin.

(a) Specifications. As penicillin procaine G or feed grade penicillin procaine.

(b) Sponsors. Type A medicated articles: To 066104, 100 and 227 grams per pound. To 054771, 100 and 227 grams per pound.

(c) Related tolerances. See §556.510 of this chapter.

(d) Conditions of use. (1) It is used as follows:

Penicillin in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 2.4 to 50   Chickens, turkeys, and pheasants; for increased rate of weight gain and improved feed efficiency.Do not feed to poultry producing eggs for human consumption.054771, 066104.
(ii) 5 to 20   Quail; for increased rate of weight gain and improved feed efficiency.Quail; not over 5 weeks of age.054771, 066104.
(iii) 10 to 50   Swine; for increased rate of weight gain and improved feed efficiency.054771, 066104.

(2) [Reserved]

[41 FR 11004, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 FR 36995, July 19, 1977; 47 FR 42103, Sept. 24, 1982; 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 58 FR 30120, May 26, 1993; 60 FR 39847, Aug. 4, 1995; 63 FR 36179, July 2, 1998; 65 FR 45880, July 26, 2000; 66 FR 47963, Sept. 17, 2001; 71 FR 16227, Mar. 31, 2006; 78 FR 52430, Aug. 23, 2013; 79 FR 10983, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014]

§558.464   Poloxalene.

(a) Approvals. (1) Dry Type A medicated articles: 53 percent to 054771 in §510.600(c) of this chapter.

(2) Liquid Type A medicated articles: 99.5 percent to 054771 in §510.600(c) of this chapter.

(b) Conditions of use. (1) For prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle.

(2) Poloxalene dry Type A article and liquid Type A article must be thoroughly blended and evenly distributed in feed prior to use. This may be accomplished by adding the Type A article to a small quantity of feed, mixing thoroughly, then adding this mixture to the remaining feed and again mixing thoroughly. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily and continued during exposure to bloat producing conditions. If bloating conditions are severe, the dose is doubled. Treatment should be started 2 to 3 days before exposure to bloat-producing conditions. Repeat dosage if animals are exposed to bloat-producing conditions more than 12 hours after the last treatment. Do not exceed the higher dosage levels in any 24-hour period.

[40 FR 39857, Aug. 29, 1975, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 56 FR 50654, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 79 FR 13545, Mar. 11, 2014]

§558.465   Poloxalene free-choice liquid Type C feed.

(a) Approvals. Type A medicated articles: 99.5 percent to 066104 in §510.600(c) of this chapter.

(b) Conditions of use. (1) For control of legume (alfalfa, clover) and wheat pasture bloat in cattle, use 7.5 grams of poloxalene per pound of liquid Type C feed (1.65 percent weight/weight). Each animal must consume 0.2 pound of Type C feed per 100 pounds of body weight daily for adequate protection.

(2) For control of legume (alfalfa, clover) bloat in cattle grazing of prebloom legumes, use 10.00 grams of poloxalene per pound of liquid Type C feed (2.2 percent weight/weight). Each animal must consume 0.15 pound of Type C feed per 100 pounds of body weight daily for adequate protection. If consumption exceeds 0.2 pound of Type C feed per 100 pounds of body weight daily, cattle should be changed to a Type C feed containing 7.5 grams of poloxalene per pound.

(3) Poloxalene liquid Type A article must be thoroughly blended and evenly distributed into a liquid Type C feed and offered to cattle in a covered liquid Type C feed feeder with lick wheels. The formula for the liquid Type C feed, on a weight/weight basis, is as follows: Ammonium polyphosphate 2.66 percent, phosphoric acid (75 percent) 3.37 percent, sulfuric acid 1.00 percent, water 10.00 percent, and molasses sufficient to make 100.00 percent, vitamins A and D and/or trace minerals may be added. One free-turning lick wheel per 25 head of cattle must be provided.

(4) The medicated liquid Type C feed must be introduced at least 2 to 5 days before legume consumption to accustom the cattle to the medicated liquid Type C feed and to lick wheel feedings. If the medicated liquid wheel Type C feed feeding is interrupted, this 2- to 5-day introductory feeding should be repeated.

[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 21281, Apr. 26, 1977; 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 56 FR 50654, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001]

§558.485   Pyrantel.

Link to an amendment published at 79 FR 19815, April 10, 2014.

(a) Specifications. Type A medicated articles containing 9.6, 19.2, 48, or 80 grams per pound pyrantel tartrate.

(b) Approvals. See sponsors in §510.600(c) of this chapter for uses as in paragraph (e) of this section:

(1) No. 066104: 9.6, 19.2, 48, and 80 grams per pound for use as in paragraph (e)(1) of this section.

(2) [Reserved]

(3) No. 017790: 9.6 and 19.2 grams per pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this section.

(4) [Reserved]

(5) No. 051311: 19.2 and 48 grams per pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this section.

(6) No. 034936: 9.6 and 19.2 grams per pound for use as in paragraphs (e)(1)(i) and (e)(1)(ii) of this section.

(7) Nos. 017135 and 054771: 48 grams per pound for use as in paragraph (e)(2) of this section.

(c) Related tolerances. See §556.560 of this chapter.

(d) Special considerations. (1) See §500.25 of this chapter. Consult a veterinarian before using in severely debilitated animals.

(2) Do not mix in Type B or Type C medicated feeds containing bentonite.

(e) Conditions of use. It is used as follows:

(1) Swine—(i) Amount per ton. 96 grams (0.0106 percent).

(A) Indications for use. Aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections.

(B) Limitations. Feed continuously as the sole ration in a Type C feed; withdraw 24 hours prior to slaughter.

(ii) Amount per ton. 96 grams (0.0106 percent).

(A) Indications for use. For the removal and control of large roundworm (Ascaris suum) infections.

(B) Limitations. Feed for 3 days as the sole ration in a Type C feed; withdraw 24 hours prior to slaughter.

(iii) Amount per ton. 800 grams (0.0881 percent).

(A) Indications for use. For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum) infections.

(B) Limitations. As sole ration for a single therapeutic treatment in Type C feed; feed at the rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb, and 5 lb of feed per head for animals 200 lb or over; withdraw 24 hours prior to slaughter.

(iv) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and carbadox, 50 grams (0.0055 percent).

(A) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections.

(B) Limitations. Do not feed to swine weighing over 75 pounds; do not feed within 10 weeks of slaughter; consult a veterinarian before feeding to severely debilitated animals; feed continuously as sole ration. Do not use in Type C feeds containing less than 15 percent crude protein.

(v) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and tylosin, 40 to 100 grams, as tylosin phosphate.

(A) Indications for use. For prevention of swine dysentery (vibrionic); aid in the prevention of migration and establishment of large roundworms (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp. ) infections.

(B) Limitations. Use 100 grams tylosin per ton for at least 3 weeks followed by 40 grams tylosin per ton until market weight; withdraw 24 hours before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(vi) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and tylosin 40 to 100 grams, as tylosin phosphate.

(A) Indications for use. Treatment and control of swine dysentery (vibrionic); aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp. ) infections.

(B) Limitations. Administer tylosin in feed as tylosin phosphate after treatment with tylosin in drinking water as tylosin base; 0.25 grams per gallon in drinking water for 3 to 10 days, 40 to 100 grams tylosin per ton in feed for 2 to 6 weeks; withdraw 24 hours before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(vii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 40 grams, as lincomycin hydrochloride monohydrate.

(A) Indications for use. For control of swine dysentery; aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.

(B) Limitations. Feed as sole ration; for use in swine on premises with a history of swine dysentery but where symptoms have not yet occurred; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(viii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 100 grams, then 40 grams, as lincomycin hydrochloride monohydrate.

(A) Indications for use. For treatment and control of swine dysentery; aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.

(B) Limitations. Feed 100 grams per ton for 3 weeks or until signs of disease disappear, followed by 40 grams per ton; feed as sole ration; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(ix) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 100 grams, as lincomycin hydrochloride monohydrate.

(A) Indications for use. For treatment of swine dysentery; aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.

(B) Limitations. Feed 100 grams per ton 3 weeks or until signs of disease disappear, followed by 40 grams per ton; feed as sole ration; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(x) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 100 or 40 grams.

(A) Indications for use. For treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections.

(B) Limitations. Administer in accordance with paragraph (c)(2)(i), (c)(2)(ii), or (c)(2)(iii) of §558.325 and paragraph (e)(1)(ii)(B) of this section.

(xi) Amount per ton. Pyrantel tartrate, 800 grams (0.0881 percent) and lincomycin, 100 or 40 grams.

(A) Indications for use. For treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infections.

(B) Limitations. Administer in accordance with paragraph (c)(2)(i), (c)(2)(ii), or (c)(2)(iii) of §558.325 and paragraph (e)(1)(iii)(B) of this section.

(xii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 200 grams as lincomycin hydrochloride monohydrate.

(A) Indications for use. For the reduction in severity of swine mycoplasma pneumonia caused by Mycoplasma hyopneumoniae; aid in the prevention of migration and establishment of large roundworms (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.

(B) Limitations. Feed as sole ration for 21 days; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter; consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(C) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(2) Horses—(i) Amount. Feed continuously at the rate of 1.2 milligrams per pound (2.64 milligrams per kilogram) of body weight.

(A) Indications for use. Prevention of Strongylus vulgaris larval infections; control of adult large strongyles (S. vulgaris, and S. edentatus), adult and 4th stage larvae small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage larvae pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids (Parascaris equorum).

(B) Limitations. Administer either as a top-dress (not to exceed 20,000 grams per ton) or mixed in the horse's daily grain ration (not to exceed 1,200 grams per ton) during the time that the animal is at risk of exposure to internal parasites. Not for use in horses intended for food. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(ii) [Reserved]

[40 FR 13959, Mar. 27, 1975]

Editorial Note: For Federal Register citations affecting §558.485, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.500   Ractopamine.

(a) Specifications. Type A medicated articles containing 9 or 45.4 grams of ractopamine hydrochloride per pound.

(b) Approvals. See Nos. 000986 and 054771 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.570 of this chapter.

(d) Special considerations. (1) Labeling of Type B and Type C feeds shall bear the following: “Not for animals intended for breeding.”

(2) Labeling of Type B and Type C swine feeds shall bear the following:

(i) “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton.”

(ii) “Ractopamine may increase the number of injured and/or fatigued pigs during marketing.”

(3) Labeling of Type B and Type C tom turkey feeds shall bear the following: “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.6 g/ton.”

(4) Tylosin in combinations as tylosin phosphate.

(5) Ractopamine liquid Type B cattle feeds may be manufactured from dry ractopamine Type A articles. The liquid Type B feeds must be maintained at a pH of 4.5 to 7.5 or, if in combination with monensin and/or tylosin, at a pH of 4.5 to 6.0. Mixing directions for liquid Type B feeds requiring recirculation or agitation: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(e) Conditions of use—(1) Swine

Ractopamine in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 4.5 to 9.0For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine, weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughterFeed continuously as sole ration000986, 054771
(ii) 4.5 to 9.0Tylosin
40 or 100
Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of swine dysentery associated with Brachyspira hyodysenteriae and porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.Feed 100 grams per tons (g/ton) continuously as sole ration for at least 3 weeks followed by 40 g/ton until market weight.000986
(iii) 4.5 to 9.0Tylosin
100
Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of porcine proliferative enteropathies (PPE, ileitis) associated with L. intracellularis.Feed continuously as sole ration for 21 days.000986
(iv) 4.5 to 9.0Tylosin
40 to 100
Finishing swine: As in paragraph (e)(1)(i) of this section; for treatment and control of swine dysentery associated with B. hyodysenteriae and for control of porcine proliferative enteropathies (PPE, ileitis) associated with L. intracellularis.Feed continuously as sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water as in §520.2640(d)(3) of this chapter.000986

(2) Cattle

Ractopamine in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 8.2 to 24.6   Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feedFeed continuously as sole ration during the last 28 to 42 days on feed.000986, 054771
(ii) 8.2 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/dayCattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuernii.As in paragraph (e)(2)(i) of this section; see paragraph §§558.355(d) of this chapter.000986
(iii) [Reserved]
(iv) 8.2 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.As in paragraph (e)(2)(i) of this section; see §§558.355(d) and 558.625(c) of this chapter.000986, 054771
(v) [Reserved]
(vi) 9.8 to 24.6   Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feedFeed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding000986
(vii) 9.8 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/dayCattle fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuernii.As in paragraph (e)(2)(vi) of this section; see paragraph §§558.355(d) of this chapter.000986
(viii) 9.8 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/dayHeifers fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat).As in paragraph (e)(2)(vi) of this section; see §§558.342(d) and 558.355(d) of this chapter. Melengestrol acetate as provided by No. 054771 or 021641 in §510.600(c) of this chapter.000986
(ix) 9.8 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10Cattle fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.As in paragraph (e)(2)(vi) of this section; see §§558.355(d) and 558.625(c) of this chapter.000986
(x) 9.8 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/dayHeifers fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat).As in paragraph (e)(2)(vi) of this section; see paragraphs §§558.342(d), 558.355(d) and 558.625(c) of this chapter. Melengestrol acetate as provided by Nos. 054771 and 021641 in §510.600(c) of this chapter.000986
(xi) Not to exceed 800; to provide 70 to 400 mg/head/day.   Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section.Top dress in a minimum of 1.0 lb of medicated feed.000986, 054771
(xii) Not to exceed 800; to provide 70 to 400 mg/head/dayMonensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day.Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.Top dress ractopamine in a minimum of 1.0 lb of medicated feed during the last 28 to 42 days on feed. Not for animals intended for breeding. See §558.355(d).000986
(xiii) Not to exceed 800; to provide 70 to 400 mg/head/dayMonensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10.Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.Top dress ractopamine in a minimum of 1.0 lb of medicated feed during the last 28 to 42 days on feed. Not for animals intended for breeding. See §§558.355(d) and 558.625(c).000986

(3) Turkeys

Ractopamine in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 4.6 to 11.8 (5 to 13 ppm)   Finishing hen turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 7 to 14 days prior to slaughter.Feed continuously as sole ration during the last 7 to 14 days prior to slaughter.000986
(ii) 4.6 to 11.8 (5 to 13 ppm)   Finishing tom turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 14 days prior to slaughter.Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality.000986
(iii) 4.6 to 11.8 (5 to 13 ppm)Monensin 54 to 90Finishing hen turkeys: As in paragraph (e)(3)(i) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.Feed continuously as sole ration during the last 7 to 14 days prior to slaughter. See §558.355(d).000986
(iv) 4.6 to 11.8 (5 to 13 ppm)Monensin 54 to 90Finishing tom turkeys: As in paragraph (e)(3)(ii) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality. See §558.355(d).000986

[67 FR 71820, Dec. 3, 2002, as amended at 68 FR 54659, Sept. 18, 2003; 69 FR 12068, Mar. 15, 2004; 69 FR 51174, Aug. 18, 2004; 71 FR 31074, June 1, 2006; 71 FR 67301, Nov. 21, 2006; 72 FR 10358, Mar. 8, 2007; 72 FR 41619, July 31, 2007; 72 FR 56897, Oct. 5, 2007; 72 FR 62571, Nov. 6, 2007; 72 FR 65667, Nov. 23, 2007; 72 FR 70777, Dec. 13, 2007; 73 FR 72715, Dec. 1, 2008; 73 FR 75323, Dec. 11, 2008; 74 FR 66914, Dec. 17, 2009; 75 FR 1276, Jan. 11, 2010; 75 FR 5888, Feb. 5, 2010; 75 FR 20917, Apr. 22, 2010; 75 FR 54018, Sept. 3, 2010; 77 FR 31724, May 30, 2012; 78 FR 63872, Oct. 25, 2013; 79 FR 13546, Mar. 11, 2014]

§558.515   Robenidine.

(a) Approvals. Type A medicated articles: 30 grams per pound to 054771 in §510.600(c) of this chapter.

(b) Special considerations. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Do not use in Type B or Type C medicated feeds containing bentonite.

(c) Related tolerances. See §556.580 of this chapter.

(d) Conditions of use. It is used in feed for chickens as follows:

Robenidine hydrochloride in grams/ton Combination in
grams/ton
Indications for use Limitations Sponsor
30 (0.0033 pct)   For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix.Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days prior to slaughter.054771
   Bacitracin (as bacitracin methylene disalicylate) 4 to 30For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For increased rate of weight gain.Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.054771
   Bacitracin (as bacitracin methylene disalicylate) 27 to 50For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For improved feed efficiency.Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.054771
   Bacitracin (as bacitracin methylene disalicylate) 50For broiler and fryer chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.Feed continuously as sole ration. Do not feed to laying hens. Withdraw 5 days before slaughter.054771
   Bacitracin (as bacitracin methylene disalicylate) 100 to 200For broiler and fryer chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.To control a necrotic enteritis outbreak, start medication at first clinical signs of disease; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin methylene disalicylate to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter.054771
   Bacitracin (as bacitracin zinc) 4 to 30For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For increased rate of weight gain.Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.054771
054771
   Bacitracin (as bacitracin zinc) 27 to 50For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For improved feed efficiency.Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.054771
054771
   Chlortetracycline 100 to 200For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.Feed continuously as sole ration up to 14 days. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter.
   Chlortetracycline 200 to 400For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline.Feed continuously as sole ration up to 14 days. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter.
   Chlortetracycline 500For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. As an aid in the reduction of mortality due to E. coli susceptible to chlortetracycline.Feed continuously as sole ration up to 5 days. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter.054771
   Lincomycin 2For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For increase in rate of weight gain and improved feed efficiency.Feed continuously as the sole ration. Do not feed to laying hens. Withdraw 5 days before slaughter.054771
   Oxytetracycline 400For broiler chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For control of CRD and air sac infection caused by Mycoplasma gallisepticum and E. coli susceptible to oxytetracycline.Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days before slaughter.066104

[40 FR 13959, Mar. 27, 1975]

Editorial Note: For Federal Register citations affecting §558.515, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.550   Salinomycin.

(a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin activity per pound (as salinomycin sodium biomass).

(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section:

(1) No. 054771 for use as in paragraph (d) of this section.

(2) No. 016592 for use as in paragraphs (d)(1)(i), (d)(1)(iii) through (d)(1)(xvi), (d)(1)(xxiii) and (d)(1)(xxiv), (d)(2)(i), (d)(3)(i), and (d)(4) of this section.

(3) No. 048164 for use as in paragraphs (d)(1)(xv) and (d)(1)(xvi) of this section.

(c) [Reserved]

(d) Conditions of use. (1) Broilers: It is used as follows:

(i)(a) Amount per ton. Salinomycin 40 to 60 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(c) Limitations. Feed continuously as sole ration. Do not feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses.

(ii) [Reserved]

(iii)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin methylene disalicylate 4 to 30 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati for incresed rate of weight gain and improved feed efficiency.

(c) Limitation. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentially fed to adult turkeys or horses. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter.

(iv)-(v) [Reserved]

(vi)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin methylene disalicylate 4 to 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin MD as provided by No. 054771 in §510.600(c) of this chapter.

(vii)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin zinc 10 to 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin zinc as provided by No. 054771 in §510.600(c) of this chapter.

(viii)-(ix) [Reserved]

(x)(a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 5 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers or to chickens over 16 weeks of age. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104 in §510.600(c) of this chapter.

(xi)(a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 5 to 15 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain.

(c) Limitations. See paragraph (d)(1)(x)(c) of this section.

(xii) [Reserved]

(xiii)(a) Amount per ton. Salinomycin 40 to 60 grams and lincomycin 2 to 4 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati and for improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. Do not allow horses, adult turkeys, guinea pigs, rabbits, hamsters, or ruminants access to this feed. Ingestion by these species may result in severe gastrointestinal effects or may be fatal. Lincomycin hydrochloride monohydrate as provided by No. 054771 in §510.600(c) of this chapter.

(xiv)-(xv) [Reserved]

(xvi)(a) Amount per ton. Salinomycin 40 to 60 grams and chlortetracycline 500 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E., necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.

(c) Limitations. Do not feed to layers. In feeds containing 0.8 percent dietary calcium. Not to be fed for more than 5 days. Not approved for use with pellet binders. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlortetracycline as provided by Nos. 054771 and 048164; salinomycin as provided by Nos. 054771 and 016592 in §510.600(c) of this chapter.

(xvii)-(xix) [Reserved]

(xx)(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin methylene disalicylate, 50 grams.

(B) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(C) Limitations. Feed continuously as sole ration. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in §510.600(c) in this chapter.

(xxi)(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin methylene disalicylate, 100 to 200 grams.

(B) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(C) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in §510.600(c) in this chapter.

(xxii) Amount per ton. Salinomycin, 40 to 60 grams; plus tylosin, 4 to 50 grams.

(A) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided by 054771; tylosin phosphate as provided by 000986 in §510.600(c) of this chapter.

(xxiii) Amount per ton. Salinomycin, 40 to 60 grams; plus bambermycins, 1 to 3 grams.

(a) Indications for use. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for improved feed efficiency.

(b) Limitations. Feed continuously as sole ration. Do not feed to laying chickens; not approved for use with pellet binders; may be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided by Nos. 054771 and 016592; bambermycins by No. 016592 in §510.600(c) of this chapter.

(xxiv) [Reserved]

(2) Quail—(i)(a) Amount per ton. Salinomycin 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by E. dispersa and E. lettyae.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Do not feed to laying hens producing eggs for human consumption.

(ii) [Reserved]

(3) Roaster and replacement (breeder and layer) chickens: It is used as follows:

(i)(A) Amount per ton. Salinomycin 40 to 60 grams.

(B) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(C) Limitations. Feed continuously as sole ration. Do not feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders. May be fatal if accidentally fed to horses or adult turkeys.

(ii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 4 to 50 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.

(B) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in §510.600(c) of this chapter.

(iii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 50 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(B) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in §510.600(c) of this chapter.

(iv) [Reserved]

(v) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 100 to 200 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(B) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 054771 ; bacitracin methylene disalicylate as provided by 054771 in §510.600(c) of this chapter.

(vi)-(vii) [Reserved]

(4) Chickens: It is used in chicken feed as follows:

(i) Amount per ton. Salinomycin, 40 to 60 grams; plus oxytetracycline, 500 grams.

(a) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for reduction of mortality due to air sacculitis (air-sac-infection) caused by Escherichia coli susceptible to oxytetracycline.

(b) Limitations. Feed continuously for 5 days; do not feed to chickens producing eggs for human consumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter. Salinomycin as provided by Nos. 054771 and 016592; oxytetracycline as provided by No. 066104 in §510.600(c) of this chapter.

(ii) [Reserved]

[48 FR 30616, July 5, 1983]

Editorial Note: For Federal Register citations affecting §558.550, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.555   Semduramicin.

(a) Specifications. Type A medicated article containing:

(1) 22.7 grams (g) per pound (lb) (50 g/kilogram (kg)) semduramicin (as semduramicin sodium).

(2) 22.7 g/lb (50 g/kg) semduramicin (as semduramicin sodium biomass).

(b) Approvals. See No. 066104 in §510.600(c) of this chapter for use of product described in paragraph (a)(1) as in paragraph (d) of this section; for use of product described in paragraph (a)(2) as in paragraph (e) of this section.

(c) Related tolerances. See §556.597 of this chapter.

(d) Conditions of use in chickens. It is used in chicken feed as follows:

Semduramicin in grams per tonCombinations in grams per tonIndications for useLimitationsSponsor
(1) 22.7 (25 ppm)   Broiler chickens: For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. necatrix, and E. tenella.Do not feed to laying hens.066104
(2) 22.7Bacitracin methylene disalicylate 10 to 50Broiler chickens: As in paragraph (d)(1) of this section; for improved feed efficiency.Feed continuously as sole ration. Do not feed to laying hens. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter.066104
(3) 22.7Virginiamycin 5Broiler chickens: As in paragraph (d)(1) of this section; for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Do not feed to laying hens. Virginiamycin as provided by No. 066104 in §510.600(c) of this chapter.066104
(4) 22.7Virginiamycin 5 to 15Broiler chickens: As in paragraph (d)(1) of this section; for increased rate of weight gain.Feed continuously as sole ration. Do not feed to laying hens. Virginiamycin as provided by No. 066104 in §510.600(c) of this chapter.066104
(5) 22.7Virginiamycin 20Broiler chickens: As in paragraph (d)(1) of this section; for prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin.Feed continuously as sole ration. Do not feed to laying hens. Virginiamycin as provided by No. 066104 in §510.600(c) of this chapter.066104

(e) Conditions of use in chickens. It is used in chicken feed as follows:

Semduramicin in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(1) 22.7 (25 ppm)   Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis.Do not feed to laying hens.066104
(2) 22.7Virginiamycin 5Broiler chickens: As in paragraph (e)(1) of this section; for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin provided by No. 066104 in §510.600(c) of this chapter.066104
(3) 22.7Virginiamycin 5 to 15Broiler chickens: As in paragraph (e)(1) of this section; for increased rate of weight gain.Feed continuously as sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin provided by No. 066104 in §510.600(c) of this chapter.066104
(4) 22.7Virginiamycin 20Broiler chickens: As in paragraph (e)(1) of this section; for prevention of necrotic enteritis caused by C. perfringens susceptible to virginiamycin.Feed continuously as sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin provided by No. 066104 in §510.600(c) of this chapter.066104

[59 FR 17477, Apr. 13, 1994, as amended at 60 FR 57928, Nov. 24, 1995; 61 FR 29481, June 11, 1996; 61 FR 43451, Aug. 23, 1996; 61 FR 66584, Dec. 18, 1996; 62 FR 66985, Dec. 23, 1997; 64 FR 48296, Sept. 3, 1999; 66 FR 47964, Sept. 17, 2001; 69 FR 13221, Mar. 22, 2004; 70 FR 41961, July 21, 2005; 73 FR 812, Jan. 4, 2008; 74 FR 41631, Aug. 18, 2009; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014]

Editorial Note: At 79 FR 13546 , March 11, 2014, §558.555 was amended; however, the amendment could not be incorporated due to inaccurate amendatory instruction.

§558.575   Sulfadimethoxine, ormetoprim.

(a) Approvals. Type A medicated articles to sponsors as identified in §510.600(c) of this chapter for uses as in paragraph (d) of this section as follows:

(1) 25 percent sufadimethoxine and 15 percent ormetoprim to 054771 for use for poultry as in paragraphs (d)(1), (d)(2), (d)(3), (d)(4), and (d)(7) of this section.

(2) 25 percent sulfadimethoxine and 5 percent ormetoprim to No. 015331 for use for fish as in paragraphs (d)(5) and (d)(6) of this section.

(b) Related tolerances. See §§556.490 and 556.640 of this chapter.

(c) [Reserved]

(d) Conditions -of use. It is used in feeds for animals as follows:

(1) Broiler chickens—(i) Amount per ton. Sulfadimethoxine, 113.5 grams (0.0125 percent) plus ormetoprim, 68.1 grams (0.0075 percent).

(a) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely, E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to H. gallinarum (infectious coryza), E. coli (colibacillosis) and P. multocida (fowl cholera).

(b) Limitations. Feed as sole ration; withdraw 5 days before slaughter.

(ii) [Reserved]

(2) Replacement chickens—(i) Amount per ton. Sulfadimethoxine, 113.5 grams (0.0125 percent) plus ormetoprim, 68.1 grams (0.0075 percent).

(ii) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to H. galmaxima, and bacterial infections due to H. gallinarum (infectious coryza), E. coli (colibacillosis) and P. multocida (fowl cholera).

(iii) Limitations. Feed as a sole ration; do not feed to chickens over 16 weeks (112 days) of age; withdraw 5 days before slaughter.

(3) Turkeys—(i) Amount per ton. Sulfadimethoxine, 56.75 grams (0.00625 percent) plus ormetoprim, 34.05 grams (0.00375 percent).

(ii) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to turkeys, namely, E. adenoeides, E. gallopavonis, and E. meleagrimitis and bacterial infection due to P. multocida (fowl cholera).

(iii) Limitations. Do not feed to turkeys producing eggs for food; withdraw 5 days before slaughter.

(4) Ducks—(i) Amount per ton. Sulfadimethoxine, 227 grams (0.025 percent) plus ormetoprim, 136.2 grams (0.015 percent).

(a) Indications for use. As an aid in the control of bacterial infections due to P. multocida (fowl cholera) in ducks, including breeding ducks.

(b) Limitations. Feed as sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; do not feed to ducks producing eggs for food.

(ii) Amount per ton. Sulfadimethoxine, 454 grams (0.05 percent) plus ormetoprim, 272.4 grams (0.03 percent).

(a) Indications for use. As an aid in the control of bacterial infections due to E. coli, Riemerella anatipestifer, and severe challenge of P. multocida (fowl cholera) in ducks.

(b) Limitations. Feed as a sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; not for breeding ducks; do not feed to ducks producing eggs for food.

(5) Salmonids—(i) Amount. 50 milligrams of active ingredients per kilogram of body weight per day.

(ii) Indications of use. For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination.

(iii) Limitations. Administer for 5 consecutive days; withdraw 42 days before release as stocker fish or slaughter.

(6) Catfish—(i) Amount. 50 milligrams of active ingredients per kilogram of body weight per day.

(ii) Indications for use. For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination.

(iii) Limitations. Administer for 5 consecutive days; withdraw 3 days before slaughter or release as stocker fish.

(7) Chukar partridges—(i) Amount per ton. Sulfadimethoxine 113.5 grams (0.0125 percent) plus ormetoprim 68.1 grams (0.0075 percent).

(ii) Indications for use. For prevention of coccidiosis caused by Eimeria kofoidi and E. legionensis.

(iii) Limitations. Feed continuously to young birds up to 8 weeks of age as sole ration.

[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23, 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR 2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63 FR 27846, May 21, 1998; 64 FR 26672, May 17, 1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, Sept. 7, 2001; 70 FR 52292, Sept. 2, 2005; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014]

§558.582   Sulfamerazine.

(a) Approvals. Type A medicated articles: 99 percent to 054771 in §510.600(c) of this chapter.

(b) Related tolerances. See §556.660 of this chapter.

(c) Conditions of use. It is used in fish feed for rainbow trout, brook trout, and brown trout as follows:

(1) Amount. 10 grams of sulfamerazine per 100 pounds of fish per day.

(2) Indications for use. Control of furunculosis.

(3) Limitations. Treat for not more than 14 days; do not treat within 3 weeks of marketing or stocking in stream open to fishing.

[41 FR 11005, Mar. 15, 1976, as amended at 51 FR 7400, Mar. 3, 1986; 61 FR 18082, Apr. 24, 1996; 63 FR 27846, May 21, 1998; 66 FR 46707, Sept. 7, 2001; 79 FR 13546, Mar. 11, 2014]

§558.586   Sulfaquinoxaline.

(a) Specifications. Type A medicated articles containing 40 percent sulfaquinoxaline.

(b) Approvals. See No. 000859 in §510.600(c) of this chapter.

(c) Special considerations. (1) For control of outbreaks of disease, medication should be initiated as soon as the diagnosis is determined. Medicated chickens, turkeys, and rabbits must actually consume enough medicated feed which provides a recommended dose of approximately 3.5 to 60 milligrams per pound per day in chickens, 2.5 to 100 milligrams per pound per day in turkeys, and 2.8 to 68 milligrams per pound per day in rabbits depending upon age and class of animal, ambient temperature, and other factors. Consult a veterinarian or poultry pathologist for diagnosis.

(2) [Reserved]

(d) Conditions of use. It is used as follows:

(1) Chickens—(i) Amount. 0.015 percent.

(a) Indications for use. As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti under average conditions of exposure.

(b) Limitations. Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption.

(ii) Amount. 0.0175 percent.

(a) Indications for use. As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti where excessive exposure to coccidia is increased due to overcrowding or other management factors.

(b) Limitations. Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption.

(iii) Amount. 0.1 to 0.05 percent.

(a) Indications for use. As an aid in controlling outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti.

(b) Limitations. Feed at 0.1 percent level for first 48 to 72 hours. Skip 3 days; 0.05 percent for 2 days, skip 3 days; 0.05 percent for 2 days. If bloody droppings recur, give 0.05 percent for another 2 days. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption.

(2) Turkeys—(i) Amount. 0.0175 percent.

(a) Indications for use. As an aid in preventing outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides.

(b) Limitations. Feed 0.0175 percent continuously during time birds are closely confined. May be continued for week to 10 days after flock is transferred to range to reduce danger of an outbreak following moving of the flock. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption.

(ii) Amount. 0.05 percent.

(a) Indications for use. As an aid in controlling outbreaks of coccidiosis caused by Eimeria meleagrimitis, and E. adenoeides.

(b) Limitations. Feed 0.05 percent for 2 days. Follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Again follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Continue this schedule if necessary till all signs of the outbreaks have subsided. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption.

(3) Chickens and turkeys—(i) Amount. 0.05 or 0.1 percent.

(a) Indications for use. As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline.

(b) Limitations. Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption.

(ii) [Reserved]

(4) Rabbits—(i) Amount. 0.025 percent.

$(a) Indications for use. As an aid in preventing coccidiosis caused by Eimeria stiedae.

$(b) Limitations. Treatment to be started after weaning. Feed continuously for 30 days or feed medicated feed for 2 days out of every week until marketing. Do not treat within 10 days of slaughter.

(ii) Amount. 0.1 percent.

(a) Indications for use. As an aid in controlling outbreaks of coccidiosis caused by Eimeria stiedae.

$(b) Limitations. Feed for 2 weeks. Do not treat within 10 days of slaughter.

[48 FR 3965, Jan. 28, 1983, as amended at 51 FR 7400, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 29843, July 23, 1990; 59 FR 33197, June 28, 1994; 69 FR 60547, Oct. 12, 2004; 78 FR 17597, Mar. 22, 2013]

§558.600   Tiamulin.

(a) Specifications. Type A article containing 363.2 grams of tiamulin hydrogen fumarate per pound.

(b) Approvals. See No. 058198 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.738 of this chapter.

(d) Special considerations—(1) Swine being treated with tiamulin should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.

(2) The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been determined.

(3) Use as sole source of tiamulin.

(e) Conditions of use—(1) Swine. It is used as follows:

Tiamulin hydrogen fumarate in grams per tonCombination in grams per tonIndications for useLimitations Sponsor
(i) [Reserved]         
(ii) 351. For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulinFeed continuously as sole ration on premises with a history of swine dysentery but where signs of disease have not yet occurred or following approved treatment of disease. Withdraw 2 days before slaughter058198
2. For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularisFeed continuously as the sole ration for not less than 10 days. Withdraw 2 days before slaughter058198
(iii) 35Chlortetracycline, approximately 400 (varying with body weight and feed consumption to provide 10 milligrams of chlortetracycline per pound of body weight daily)For treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida sensitive to chlortetracycline, and control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae sensitiveto tiamulinFeed continuously as sole ration for 14 days. Use as only source of chlortetracycline. Withdraw 2 days before slaughter
As chlortetracycline calcium complex, Type A medicated articles containing the equivalent of 50 to 100 grams per pound of chlortetracycline hydrochloride provided by 054771 and 048164 in §510.600(c) of this chapter. Use as only source of tiamulin
048164,
058198
(iv) 200For treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulinFeed continuously as the sole feed for 14 consecutive days. Withdraw feed 7 days before slaughter058198

(2) [Reserved]

[67 FR 7268, Feb. 19, 2002, as amended at 69 FR 62407, Oct. 26, 2004; 70 FR 75018, Dec. 19, 2005; 74 FR 6, Jan. 2, 2009; 77 FR 24139, Apr. 23, 2012; 79 FR 13546, Mar. 11, 2014]

§558.615   Thiabendazole.

(a) Approvals. Dry Type A medicated articles: 22, 44.1, 66.1, and 88.2 percent to 050604 in §510.600(c) of this chapter. The 66.1 percent Type A is solely for the manufacture of cane molasses liquid Type B feed which is mixed in dry feeds. The 88.2 percent Type A is used solely for the manufacture of an aqueous slurry for adding to a Type C dry cattle feed.

(b) Special considerations. Do not use in Type B or Type C medicated feed containing bentonite.

(c) Related tolerances. See §556.730 of this chapter.

(d) Conditions of use. It is used in feed for animals as follows:

(1) Cattle—(i) Amount. 3 grams per 100 lb. body weight.

(a) Indications for use. Control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Nematodirus spp., Oesophagostomum radiatum).

(b) Limitations. Use 3 grams per 100 lb. body weight at a single dose; may repeat once in 2 to 3 weeks; do not treat animals within 3 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.

(ii) Amount. 5 grams per 100 lb. body weight.

(a) Indications for use. Control of severe infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Nematodirus spp., Oesophagostomum radiatum); control of infections of Cooperia spp.

(b) Limitations. 5 grams per 100 lb. body weight at a single dose or divided into 3 equal doses, administered 1 dose each day, on succeeding days; may repeat once in 2 to 3 weeks; do not treat animals within 3 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.

(2) Goats—(i) Amount. 3 grams per 100 lb. body weight.

(ii) Indications for use. Control of severe infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ).

(iii) Limitations. 3 grams per 100 lb. body weight at a single dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.

(3) Sheep and goats—(i) Amount. 2 grams per 100 lb. body weight.

(ii) Indications for use. Control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp.; Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ); also active against ova and larvae passed by sheep from 3 hours to 3 days after the feed is consumed (good activity against ova and larvae of T. colubriformis and axei, Ostertagia spp., Nematodirus spp., Strongyloides spp.; less effective against those of Haemonchus contortus and Oesophagostomum spp. ).

(iii) Limitations. Use 2 grams per 100 lb. body weight at a single dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.

(4) For swine—(i) Amount. 45.4-908 grams per ton (0.005-0.1 percent).

(ii) Indications for use. Aid in the prevention of infections of large roundworms (genus Ascaris).

(iii) Limitations. Administer continuously feed containing 0.05-0.1 percent thiabendazole per ton for 2 weeks followed by feed containing 0.005-0.02 percent thiabendazole per ton for 8-14 weeks; do not treat animals within 30 days of slaughter.

(5) Pheasants—(i) Amount. 454 grams per ton (0.05 percent) continuously for 2 weeks (14 days).

(ii) Indications for use. For the treatment of gapeworms (Syngamus trachea) in pheasants.

(iii) Limitations. Do not use treated pheasants for food for 21 days after last day of treatment. Fertility, hatchability, and other reproductive data are not available on use in breeding animals.

[40 FR 13959, Mar. 27, 1975, as amended at 47 FR 49641, Nov. 2, 1982; 49 FR 29958, July 25, 1984; 51 FR 7400, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 62 FR 63271, Nov. 28, 1997]

§558.618   Tilmicosin.

(a) Specifications. Type A medicated article containing 90.7 grams (g) per pound tilmicosin as tilmicosin phosphate (200 g per kilogram).

(b) Approvals. See Nos. 000986 and 016592 in §510.600(c) of this chapter.

(c) Special considerations—(1) Tilmicosin medicated feeds are restricted to use under a veterinary feed directive (VFD). See §558.6 of this chapter for required label statements and other limitations.

(2) VFDs for tilmicosin phosphate shall not be refilled.

(3) Labeling of tilmicosin Type B or Type C medicated feeds must bear the following warnings:

(i) Do not allow horses or other equines access to feeds containing tilmicosin.

(ii) [Reserved]

(4) Special considerations for use of tilmicosin medicated swine feeds include the following:

(i) The expiration date of VFDs for tilmicosin must not exceed 90 days from the time of issuance.

(ii) Labeling of tilmicosin Type B or Type C medicated feeds for swine must bear the following warning: “Do not use in any feeds containing bentonite. Bentonite in feeds may affect the efficacy of tilmicosin.”

(iii) Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production without ceasing administration for reevaluation of antimicrobial use by a licensed veterinarian before reinitiating a further course of therapy with an appropriate antimicrobial.

(5) Special consideration for use of tilmicosin medicated cattle feeds include the following:

(i) The expiration date of VFDs for cattle must not exceed 45 days from the time of issuance.

(ii) Labeling of tilmicosin Type B or Type C medicated feeds for cattle must bear the following warning: “Do not use in any feeds containing bentonite, cottonseed meal, or cottonseed hulls. Bentonite, cottonseed meal, or cottonseed hulls in feeds may affect the efficacy of tilmicosin.”

(iii) To assure both food safety and responsible use in cattle, administration of feed containing tilmicosin to cattle experiencing an outbreak of BRD must be initiated during the first 45 days of the production period, shall not exceed a single 14-consecutive-day treatment, should not occur concurrent with or following administration of an injectable macrolide, and should not occur within 3 days following administration of a nonmacrolide injectable BRD therapy. Tilmicosin medicated feed treatment has not been evaluated in cattle with severe clinical disease. Cattle with severe clinical illness should be evaluated for individual treatment with an alternative non-macrolide therapy.

(d) Related tolerances. See §556.735 of this chapter.

(e) Conditions of use. It is used in feed as follows:

(1) Swine

Tilmicosin
phosphate
in grams/ton
Combination in grams/tonIndications for useLimitationsSponsor
(i) 181 to 363Swine: For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocidaFeed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product000986, 016592
(ii) [Reserved]

(2) Cattle

Tilmicosin
phosphate
in grams/ton
Combination in grams/tonIndications for useLimitationsSponsor
(i) 568 to 757Beef and nonlactating dairy cattle: For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of beef and nonlactating dairy cattle, where active BRD has been diagnosed in at least 10 percent of the animals in the groupFeed continuously for 14 days to provide 12.5 mg tilmicosin/kg of bodyweight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in preruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product000986
(ii) 568 to 757Monensin, 5 to 40Cattle fed in confinement for slaughter: For improved feed efficiency; and for the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10 percent of the animals in the groupFeed continuously for 14 days to provide 12.5 mg tilmicosin/kg of bodyweight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See §558.355(d) of this chapter000986
(iii) 568 to 757Monensin, 10 to 40Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10 percent of the animals in the groupFeed continuously for 14 days to provide 12.5 mg tilmicosin/kg of bodyweight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See §558.355(d) of this chapter000986

[61 FR 68148, Dec. 27, 1996; 62 FR 15391, Apr. 1, 1997, as amended at 64 FR 13679, Mar. 22, 1999; 65 FR 76930, Dec. 8, 2000; 67 FR 21997, May 2, 2002; 69 FR 78306, Dec. 30, 2004; 76 FR 76894, Dec. 9, 2011; 77 FR 60623, Oct. 4, 2012; 78 FR 19987, Apr. 3, 2013]

§558.625   Tylosin.

Link to an amendment published at 79 FR 19815, April 10, 2014.

(a) Specifications. Type A medicated articles containing tylosin phosphate.

(b) Approvals. Type A medicated article levels of tylosin granted to firms as sponsor(s) and identified by drug listing numbers in §510.600(c) of this chapter for the specific usage indicated in paragraph (f) of this section.

(1) To 000986: 10, 40, 100 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.

(2)-(4) [Reserved]

(5) To No. 051311: 0.4, 0.8, 1, and 8 grams per pound, paragraph (f)(1)(vi)(a) of this section; 10 and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.

(6)-(8) [Reserved]

(9) [Reserved]

(10) To No. 012286: 0.4, 0.8, and 1.6 grams per pound, paragraph (f)(1)(vi)(a) of this section; 20, 40, and 100 grams per pound, paragraphs (f)(1)(i) through (vi) of this section.

(11)-(24) [Reserved]

(25) To 066104: 4, 8, and 10 grams per pound, paragraph (f)(1)(vi)(a) of this section; 20 and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.

(26)-(32) [Reserved]

(33) To 034936: 0.8 and 2 grams per pound, paragraph (f)(1)(vi)(a) of this section; 4, 8, and 10 grams per pound, paragraphs (f)(1)(i), (iii), (iv), and (vi) of this section; 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section; 100 grams per pound, paragraphs (f)(1) (i), (ii), (iii), (iv), and (vi) of this section.

(34) [Reserved]

(35)-(38) [Reserved]

(39) To 061623: 10 grams per pound, paragraph (f)(1)(vi)(a) of this section.

(40)-(47) [Reserved]

(48) To 017790: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.

(49)-(53) [Reserved]

(54) To 054771: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.

(55)-(56) [Reserved]

(57)-(62) [Reserved]

(63)-(77) [Reserved]

(78) To 050972: 0.36, 0.4, 0.72, and 0.8 gram per pound, paragraph (f)(1)(vi)(a) of this section; 1 gram per pound, paragraphs (f)(1)(vi) (a), (b), and (d) of this section.

(79)-(80) [Reserved]

(81)-(84) [Reserved]

(85) To 047126: 10, 40, and 100 grams per pound, paragraphs (f)(1) (i) through (vi) of this section.

(86)-(88) [Reserved]

(89) To 048164: 5, 10, 20, and 40 grams per pound, paragraph (f)(1) (i) through (vi) of this section.

(90) No. 016592: 100 grams per pound for use as in paragraph (f) of this section.

(c) Special considerations. (1) Type C medicated feeds for cattle may be manufactured from tylosin liquid Type B medicated feeds which have a pH between 4.5 and 6.0 and which bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(2) Tylosin liquid Type B medicated feeds used to make Type C medicated feeds for cattle may be manufactured from tylosin Type A medicated articles according to the following mixing directions:

(i) [Reserved]

(ii) Maintain a pH between 4.5 and 6.0.

(3) Tylosin liquid Type B medicated feeds must bear an expiration date of 31 days after the date of manufacture.

(d) [Reserved]

(e) Related tolerances. See §556.740 of this chapter.

(f) Conditions of use. (1) It is used in animal feeds as follows:

(i) For beef cattle—(a) Amount per ton. 8-10 grams.

(b) Indications for use. For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.

(c) Limitations. As tylosin phosphate; each animal must receive not more than 90 milligrams per day and not less than 60 milligrams per day; feed continuously as sole ration.

(ii) Broiler chickens—(a) Amount per ton. Tylosin, 800-1000 grams.

(b) Indications for use. To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum.

(c) Limitations. As tylosin phosphate; withdraw 5 days before slaughter; administer in feed to chickens 0 to 5 days of age, follow with second administration in feed for 24-48 hours at 3 to 5 weeks of age.

(iii) Chickens—(a) Amount per ton. Tylosin, 4-50 grams.

(1) Indications for use. For increased rate of weight gain and improved feed efficiency.

(2) Limitations. As tylosin phosphate.

(iv) Laying chickens—(a) Amount per ton. Tylosin, 20-50 grams.

(b) Indications for use. For improved feed efficiency.

(c) Limitations. As tylosin phosphate.

(v) Replacement chickens—(a) Amount per ton. Tylosin, 1,000 grams.

(b) Indications for use. To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum.

(c) Limitations. As tylosin phosphate; withdraw 5 days before slaughter; administer in feed to chickens 0 to 5 days of age, follow with second administration in feed for 24 to 48 hours at 3 to 5 weeks of age.

(vi) Swine—(a) Amount per ton. Tylosin, 10-100 grams.

(1) Indications for use. For increased rate of weight gain and improved feed efficiency.

(2) Limitations. As tylosin phosphate; continuous use as follows: Grams per ton: 20-100, prestarter or starter; 20-40, grower; 10-20, finisher.

(b) Amount per ton. Tylosin, 40 or 100 grams.

(1) Indications for use. For control of swine dysentery associated with Brachyspira hyodysenteriae, and for control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis.

(2) Limitations. Use 100 grams per ton for at least 3 weeks followed by 40 grams per ton until market weight; as tylosin phosphate.

(c) Amount per ton. Tylosin, 40-100 grams.

(1) Indications for use. For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

(2) Limitations. Administer as tylosin phosphate in feed for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water as in §520.2640(d)(3) of this chapter.

(d) Amount per ton. Tylosin, 100 grams.

(1) Indications for use. Maintaining weight gains and feed efficiency in presence of atrophic rhinitis.

(2) Limitations. As tylosin phosphate.

(vi) Pyrantel tartrate in accordance with §558.485.

(e) Amount per ton. Tylosin 100 grams.

(1) Indications for use. For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

(2) Limitations. As tylosin phosphate, administer for 21 days.

(2) Tylosin may also be used in combination with:

(i) Decoquinate and monensin as in §558.195.

(ii) Hygromycin B as in §558.274.

(iii) Melengestrol acetate alone or in combination with certain ionophores as in §558.342.

(iv) Monensin as in §558.355.

(v) Narasin as in §558.363.

(vi) Pyrantel tartrate as in §558.485.

(vii) Ractopamine alone or in combination as in §558.500.

(viii) Salinomycin as in §558.550.

(ix) Zilpaterol alone or in combination as in §558.665.

[40 FR 13959, Mar. 27, 1975]

Editorial Note: For Federal Register citations affecting §558.625, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.630   Tylosin and sulfamethazine.

Link to an amendment published at 79 FR 19815, April 10, 2014.

(a) Specifications. Type A medicated articles containing equal amounts of tylosin phosphate and sulfamethazine, available in concentrations of 4, 5, 10, 20, or 40 grams each, per pound.

(b) Approvals. See sponsor numbers in §510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) No. 000986: 10 or 40 grams per pound each for use as in paragraph (e)(2)(i) of this section.

(2) [Reserved]

(3) No. 051311: 40 grams per pound each for use as in paragraph (e)(2)(ii) of this section.

(4) [Reserved]

(5) Nos. 000986, 012286, 034936, and 054771: 5, 10, 20, or 40 grams per pound each for use as in paragraph (e)(2)(ii) of this section.

(6) No. 000986: 40 grams per pound each for use as in paragraph (e)(2)(iii) of this section.

(c) Special considerations. Labeling shall bear the statement: “Do not use in medicated feeds containing in excess of 2% bentonite.”

(d) Related tolerances. See §§556.670 and 556.740 of this chapter.

(e) Conditions of use. It is used in feed for swine as follows:

(1) Amount per ton. 100 grams tylosin and 100 grams sulfamethazine.

(2) Indications for use-(i) Maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes); for reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses.

(ii) Maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes).

(iii) For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; and control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes).

(3) Limitations. Withdraw 15 days before swine are slaughtered.

[73 FR 34185, June 17, 2008, as amended at 73 FR 35341, June 23, 2008; 75 FR 55677, Sept. 14, 2010; 76 FR 17778, Mar. 31, 2011; 77 FR 4897, Feb. 1, 2012; 78 FR 14669, Mar. 7, 2013; 79 FR 13546, Mar. 11, 2014]

§558.635   Virginiamycin.

Link to an amendment published at 79 FR 19815, April 10, 2014.

(a) Approvals. Type A medicated articles. (1) 1.1 percent activity (5 grams per pound), 2.2 percent activity (10 grams per pound), 4.4 percent activity (20 grams per pound), 11 percent activity (50 grams per pound), and 50 percent activity (227 grams per pound) used as in paragraph (d) of this section; and 30 percent activity (136.2 grams per pound) for the manufacture of Type C medicated feed for cattle used as in paragraph (d)(3); to 066104 in §510.600(c) of this chapter.

(2) 2.2 percent activity (10 grams per pound) to 054771, and 017790 in §510.600(c) of this chapter for use as in paragraphs (d)(1)(iv) and (d)(1)(v) of this section.

(b) Related tolerances. See §556.750 of this chapter.

(c) Special considerations. (1) Not for use in breeding swine over 120 pounds.

(2) Dilute Type A article with at least 10 pounds of a feed ingredient prior to final mixing in 1 ton of Type C feed.

(d) Conditions of use—(1) Swine. It is used as follows:

(i) 100 grams per ton for 2 weeks, for treatment of swine dysentery in nonbreeding swine over 120 pounds.

(ii) 100 grams per ton for 2 weeks, 50 grams per ton thereafter, for treatment and control of swine dysentery in swine up to 120 pounds.

(iii) 25 grams per ton, as an aid in control of dysentery in swine up to 120 pounds. For use in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred.

(iv) 10 grams per ton from weaning up to 120 pounds for increased rate of weight gain and improved feed efficiency, followed by 5 grams per ton to market weight for increased rate of weight gain and improved feed efficiency. For continuous use from weaning to market weight.

(v) 10 grams per ton from weaning up to 120 pounds for increased rate of weight gain and improved feed efficiency, followed by 5 to 10 grams per ton to market weight for increased rate of weight gain. For continuous use from weaning to market weight.

(2) Poultry. It is used as follows:

(i) 5 to 15 grams per ton for increased rate of weight gain, for use in broiler chickens, not for use in layers.

(ii) 5 grams per ton for increased rate of weight gain and improved feed efficiency in broiler chickens, not for use in layers.

(iii) 20 grams per ton for prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin in broiler chickens; not for use in layers.

(iv) 10 to 20 grams per ton for increased rate of weight gain and improved feed efficiency in growing turkeys.

(3) Cattle. It is used as follows:

(i) 16.0 to 22.5 grams per ton to provide 100 to 340 milligrams per head per day for increased rate of weight gain.

(ii) 13.5 to 16.0 grams per ton to provide 85 to 240 milligrams per head per day for reduction of incidence of liver abscesses.

(iii) 11.0 to 16.0 grams per ton to provide 70 to 240 milligrams per head per day for improved feed efficiency.

(iv) Feed continuously as sole ration to cattle fed in confinement for slaughter. Not for use in animals intended for breeding.

(4) Virginiamycin may be used in combination with:

(i) Amprolium and ethopabate as in §558.58.

(ii) Diclazuril as in §558.198.

(iii) Halofuginone as in §558.265.

(iv) Lasalocid as in §558.311.

(v) Monensin as in §558.355.

(vi) Salinomycin as in §558.550.

(vii) Semduramicin as in §558.555.

[40 FR 13959, Mar. 27, 1975]

Editorial Note: For Federal Register citations affecting §558.635, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§558.665   Zilpaterol.

(a) Specifications. Type A medicated articles containing 21.77 grams (g) zilpaterol hydrochloride per pound.

(b) Approvals. See No. 000061 in §510.600(c) of this chapter.

(c) Tolerances. See §556.765 of this chapter.

(d)Special considerations—(1) Labeling of Type B and Type C cattle feeds shall bear the following:

(i) Do not allow horses or other equines access to feed containing zilpaterol.

(ii) Not for use in animals intended for breeding.

(iii) Do not use in veal calves.

(2) Type B Liquid Feeds can be manufactured containing 68 to 680 g zilpaterol hydrochloride/ton. The liquid Type B feeds must be maintained at a pH of 3.8 to 7.5. For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(e) Conditions of use in cattle. It is administered in feed as follows:

Zilpaterol in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(1) 6.8 to provide 60 to 90 mg/head/day   Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed.Feed continuously as the sole ration during the last 20 to 40 days on feed. Withdrawal period: 3 days.000061
(2) 6.8 to provide 60 to 90 mg/head/dayMelengestrol acetate to provide 0.25 to 0.5 mg/ head/dayHeifers fed in confinement for slaughter: As in paragraph (e)(1) of this section; and for suppression of estrus (heat).As in paragraph (e)(1) of this section; see paragraph §§558.342(d) of this chapter. Melengestrol acetate as provided by Nos. 000986 or 054771 in §510.600(c) of this chapter000061
(3) 6.8 to provide 60 to 90 mg/head/dayMonensin 10 to 40Cattle fed in confinement for slaughter: As in paragraph (e)(1) of this section; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.As in paragraph (e)(1) of this section; see paragraph §558.355(d) of this chapter. Monensin as provided by No. 000986 in §510.600(c) of this chapter.000061
(4) 6.8 to provide 60 to 90 mg/head/dayMelengestrol acetate to provide 0.25 to 0.5 mg/ head/dayHeifers fed in confinement for slaughter: As in paragraph (e)(1) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat).As in paragraph (e)(1) of this section; see §§558.342(d) and 558.355(d) of this chapter. Monensin as provided by No. 000986; and melengestrol acetate as provided by Nos. 000986 or 054771 in §510.600(c) of this chapter000061
(5) 6.8 to provide 60 to 90 mg/head/dayMonensin 10 to 40, plus tylosin 8 to 10Cattle fed in confinement for slaughter: As in paragraph (e)(1) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterum (Actinomyces) pyogenesAs in paragraph (e)(1) of this section; see §§558.355(d) and 558.625(c) of this chapter. Monensin as provided by No. 000986; tylosin as provided by Nos. 000986 or 016592 in §510.600(c) of this chapter000061 016592
(6) 6.8 to provide 60 to 90 mg/head/day.Monensin 10 to 40, plus tylosin 8 to 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day.Heifers fed in confinement for slaughter: As in paragraph (e)(1) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat).As in paragraph (e)(1) of this section; see §§558.342(d), 558.355(d), and 558.625(c) of this chapter. Monensin as provided by No. 000986; tylosin as provided by Nos. 000986 or 016592; and melengestrol acetate as provided by Nos. 000986 or 054771 in §510.600(c) of this chapter000061

[71 FR 53006, Sept. 8, 2006, as amended at 72 FR 9245, Mar. 1, 2007; 72 FR 6019, Feb. 1, 2008; 73 FR 14385, Mar. 18, 2008; 73 FR 16755, Mar. 31, 2008; 73 FR 18959, Apr. 8, 2008; 73 FR 19432, Apr. 10, 2008; 74 FR 61517, Nov. 25, 2009; 75 FR 11451, Mar. 11, 2010; 77 FR 31724, May 30, 2012; 78 FR 42008, July 15, 2013]

§558.680   Zoalene.

(a) Specifications. Type A medicated article containing 25 percent zoalene.

(b) Approvals. See No. 054771 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.770 of this chapter.

(d) Conditions of use—(1) Chickens

Zoalene in grams/tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 36.3 to 113.5Replacement chickens: For development of active immunity to coccidiosisGrower ration not to be fed to birds over 14 weeks of age; as follows:054771
Growing conditionsStarter ration
Grams per ton
Grower ration
Grams per ton
Severe exposure113.5 (0.0125%)75.4-113.5
(0.0083%-0.0125%)
Light to moderate exposure75.4-113.5
(0.0083%-0.0125%)
36.3-75.4
(0.004%-0.0083%)
Zoalene in grams/tonCombination in grams per tonIndications for useLimitationsSponsor
(ii) 36.3-113.5Bacitracin methylene disalicylate 4 to 50Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration as in subtable in item (i). Grower ration not to be fed to birds over 14 weeks of age. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter054771
(iii) 36.3-113.5Bacitracin methylene disalicylate 50Replacement chickens: For development of active immunity to coccidiosis; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed continuously as sole ration as in subtable in item (i). Grower ration not to be fed to birds over 14 weeks of age. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter054771
(iv) 36.3-113.5Bacitracin methylene disalicylate 100 to 200Replacement chickens: For development of active immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed continuously as sole ration as in subtable in item (i). To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter054771
(v) 113.5Broiler chickens: For prevention and control of coccidiosisFeed continuously as sole ration054771
(vi) 113.5Bacitracin methylene disalicylate 4 to 50Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter054771
(vii) 113.5Bacitracin methylene disalicylate 50Broiler chickens: For prevention and control of coccidiosis; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed continuously as sole ration. Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter054771
(viii) 113.5Bacitracin methylene disalicylate 100 to 200Broiler chickens: For prevention and control of coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton)
Bacitracin methylene disalicylate as provided by No. 054771 in §510.600(c) of this chapter
054771
(ix) 113.5Bambermycins 1Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Do not feed to chickens over 14 weeks of age. Bambermycins as provided by No. 016592 in §510.600(c) of this chapter016592
(x) 113.5Lincomycin 2Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Do not feed to laying chickens. As lincomycin hydrochloride monohydrate provided by No. 054771 in §510.600(c) of this chapter054771

(2) Turkeys

Zoalene in grams/tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 113.5 to 170.3Growing turkeys: For prevention and control of coccidiosisFeed continuously as sole ration. For turkeys grown for meat purposes only. Do not feed to laying birds054771
(ii) 113.5 to 170.3Bacitracin methylene disalicylate 4 to 50Growing turkeys: For prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration until 14 to 16 weeks of age. For turkeys grown for meat purposes only. Do not feed to laying birds054771

[41 FR 11005, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 FR 20817, Apr. 22, 1977; 42 FR 36995, July 19, 1977; 51 FR 7401, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8461, Mar. 8, 1990; 57 FR 8403, Mar. 10, 1992; 57 FR 8578, Mar. 11, 1992; 61 FR 35957, July 9, 1996; 63 FR 38750, July 20, 1998; 67 FR 6868, Feb. 14, 2002; 71 FR 16223, Mar. 31, 2006; 71 FR 27958, May 15, 2006; 76 FR 17027, Mar. 28, 2011; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014]



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