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: 21CFR524.154]

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 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 524.154 Bacitracin, neomycin, and polymyxin B ophthalmic ointment.

(a) Specifications. Each gram of ointment contains:

(1) 500 units bacitracin, 3.5 milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate; or

(2) 400 units bacitracin zinc, 5 mg neomycin sulfate (equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows:

(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (c) of this section.

(2) Nos. 000061, 043264, and 086189 for use of product described in paragraph (a)(2) as in paragraph (c) of this section.

(c) Conditions of use in dogs and cats - (1) Amount. Apply a thin film over the cornea 3 or 4 times daily.

(2) Indications for use. Treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to susceptible organisms.

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

[57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015; 88 FR 84701, Dec. 6, 2023]