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: 21CFR522.1020]

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. 522.1020 Gelatin.

(a) Specifications. Each 100 milliliters contains 8 grams of gelatin in a 0.85 percent sodium chloride solution.

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

(c) Conditions of use - (1) Amount. The exact dosage to be administered must be determined after evaluating the animal's condition and will vary according to the size of the animal and the degree of shock. A suggested dosage range for small animals such as dogs is 4 to 8 cubic centimeters per pound body weight. The suggested dosage range for large animals such as sheep, calves, cows, or horses is 2 to 4 cubic centimeters per pound of body weight.

(2) Indications for use. For use to restore circulatory volume and maintain blood pressure in animals being treated for shock.

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

[79 FR 16189, Mar. 25, 2014]