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e-CFR data is current as of May 4, 2021

Title 21Chapter ISubchapter EPart 522 → §522.2120


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


§522.2120   Spectinomycin hydrochloride.

(a) Specifications. Each milliliter of solution contains 100 milligrams (mg) spectinomycin hydrochloride (as spectinomycin dihydrochloride pentahydrate).

(b) Sponsors. See sponsors in §510.600(c) of this chapter:

(1) Nos. 016592 and 054771 for use as in paragraph (d)(1) of this section; and

(2) No. 058198 for use as in paragraph (d)(2) of this section.

(c) Related tolerances. See §556.600 of this chapter.

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

(1) Turkeys (1- to 3-day-old poults) and chickens (newly hatched chicks)—(i) Amounts and indications for use. (A) Administer 5 mg per poult subcutaneously as an aid in the control of chronic respiratory disease (CRD) associated with Escherichia coli in 1- to 3-day-old turkey poults.

(B) Administer 10 mg per poult as a single subcutaneous injection in the nape of the neck as an aid in the control of airsacculitis associated with Mycoplasma meleagridis sensitive to spectinomycin in 1- to 3-day-old turkey poults.

(C) Administer 2.5 to 5 mg per chick as an aid in the control of mortality and to lessen severity of infections caused by M. synoviae, Salmonella typhimurium, S. infantis, and E. coli.

(ii) Limitations. For use only in 1- to 3-day-old turkey poults and newly hatched chicks.

(2) Dogs—(i) Amount. Administer 2.5 to 5.0 mg per pound of body weight by intramuscular injection twice daily. Treatment may be continued for 4 days.

(ii) Indications for use. For treatment of infections caused by gram-negative and gram-positive organisms susceptible to spectinomycin.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[86 FR 14820, Mar. 19, 2021]

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