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: 21CFR529.400]

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 529 -- CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

Sec. 529.400 Chlorhexidine tablets and suspension.

(a) Specification. Each tablet and each 28-milliliter syringe of suspension contain 1 gram of chlorhexidine dihydrochloride.

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

(c) Related tolerances. See § 556.120 of this chapter.

(d) Conditions of use - (1) Amount. Place 1 or 2 tablets deep in each uterine horn; or infuse a solution of 1 tablet disolved in an appropriate amount of clean boiled water; or infuse one syringe of suspension into the uterus.

(2) Indications for use. For prevention or treatment of metritis and vaginitis in cows and mares when caused by pathogens sensitive to chlorhexidine dihydrochloride.

(3) Limitations. Prior to administration, remove any unattached placental membranes, any excess uterine fluid or debris, and carefully clean external genitalia. Use a clean, sterile inseminating pipette for administrating solutions and suspensions. Treatment may be repeated in 48 to 72 hours.

[43 FR 10705, Feb. 23, 1979, as amended at 79 FR 10973, Feb. 27, 2014; 81 FR 67152, Sept. 30, 2016; 84 FR 32993, July 11, 2019]

Editorial Note:

At 79 FR 10973, Feb. 27, 2014, § 529.400 was amended by revising the section heading, however, the section heading was not provided, therefore, the amendment could not be incorporated because of an inaccurate amendatory instruction.