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: 21CFR522.2063]

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. 522.2063 Pyrilamine.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of pyrilamine maleate.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for uses in paragraph (c) of this section.

(1) No. 000061 for use as in paragraph (c)(1)(i), (2), and (3) of this section.

(2) No. 061133 for use as in paragraph (c)(1)(ii), (2), and (3) of this section.

(c) Conditions of use - (1) Amount. (i) Horses, 40 to 60 mg per 100 pounds (lbs) body weight; foals, 20 mg/100 lbs body weight. Administer by intramuscular, subcutaneous, or intravenous injection. Dosage may be repeated every 6 to 12 hours whenever necessary.

(ii) Horses, 40 to 60 mg/100 lbs body weight; foals, 20 mg/100 lbs body weight. Administer by slow intravenous injection. Dosage may be repeated every 6 to 12 hours if necessary.

(2) Indications for use. It is intended for treating horses in conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.

(3) Limitations. 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.

[79 FR 16195, Mar. 25, 2014, as amended at 84 FR 8974, Mar. 13, 2019]