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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1696a


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.1696a   Penicillin G benzathine and penicillin G procaine suspension.

(a) Specifications. Each milliliter of aqueous suspension contains penicillin G benzathine and penicillin G procaine, each equivalent to 150,000 units of penicillin G.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for the conditions of use in paragraph (d) of this section as follows:

(1) Nos. 054771, 055529, and 061133 for use as in paragraph (d)(1) of this section.

(2) Nos. 016592, 055529, and 061133 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(2)(iii) of this section.

(3) No. 054771 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(B), and (d)(2)(iii) of this section.

(c) Related tolerances. See §556.510 of this chapter.

(d) Conditions of use—(1) Horses, dogs, and beef cattle—(i) Amount—(A) Beef cattle. 2 milliliters per 150 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours.

(B) Horses. 2 milliliters per 150 pounds of body weight intramuscularly. Repeat dosage in 48 hours.

(C) Dogs. 1 milliliter per 10 to 25 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours.

(ii) Indications for use. Treatment of bacterial infections susceptible to penicillin G.

(iii) Limitations. Not for use in beef cattle within 30 days of slaughter. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Beef cattle—(i) Amount. 2 milliliters per 150 pounds of body weight subcutaneously. Repeat dosage in 48 hours.

(ii) Indications for use. (A) Treatment of bacterial pneumonia (Streptococcus spp., Actinomyces pyogenes, Staphylococcus aureus); upper respiratory infections such as rhinitis or pharyngitis (A. pyogenes); blackleg (Clostridium chauvoei).

(B) As in paragraph (d)(2)(ii)(A) of this section; and prophylaxis of bovine shipping fever in 300- to 500-pound beef calves.

(iii) Limitations. Not for use within 30 days of slaughter. For Nos. 000859, 055529, and 061133: A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

[66 FR 711, Jan. 4, 2001, as amended at 68 FR 34534, June 10, 2003; 70 FR 21947, Apr. 28, 2005; 70 FR 50182, Aug. 26, 2005; 73 FR 16754, Mar. 31, 2008; 75 FR 54017, Sept. 3, 2010; 77 FR 4897, Feb. 1, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR 16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 84 FR 8974, Mar. 13, 2019]

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