CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.2121]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.2121 Spectinomycin sulfate.

(a) Specifications. Each milliliter of solution contains spectinomycin sulfate tetrahydrate equivalent to 100 milligrams (mg) spectinomycin.

(b) Sponsor. See Nos. 054771 and 061133 in § 510.600(c) of this chapter.

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

(d) Conditions of use in cattle - (1) Amount. 10 to 15 mg per kilogram of body weight at 24-hour intervals for 3 to 5 consecutive days.

(2) Indications for use. For the treatment of bovine respiratory disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida , and Histophilus somni.

(3) Limitations. Do not slaughter within 11 days of last treatment. Do not use in female dairy cattle 20 months of age or older. Use in this class of cattle may cause residues in milk. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 31178, June 6, 2007, as amended at 79 FR 16195, Mar. 25, 2014; 88 FR 14899, Mar. 10, 2023]