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: 21CFR520.1921]

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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1921 Prochlorperazine, isopropamide, and neomycin.

(a) Specifications. Each capsule contains either:

(1) Capsule No. 1: 3.33 milligrams of prochlorperazine (as the dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 milligrams of neomycin base (as the sulfate); or

(2) Capsule No. 3: 10 milligrams of prochlorperazine (as the dimaleate), 5 milligrams of isopropamide (as the iodide), and 75 milligrams of neomycin base (as the sulfate).

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

(c) Conditions of use in dogs - (1) Amount. Administer capsules orally twice daily to dogs as follows:

Animal weight (pounds)	Number of capsules per dose
	Capsule No. 1	Capsule No. 3
10 to 20	1
20 to 30	2
Over 30	3	1
Over 60		2

(2) Indications for use. For the treatment infectious bacterial gastroenteritis associated with emotional stress.

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

[49 FR 14103, Apr. 10, 1984, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28827, May 20, 2014]