[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR529.400]

[Page 323-324]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 529.400  Chlorhexidine tablets and suspension.

    (a) Specification. Each tablet and each 28-milliliter syringe of 
suspension contain 1 gram of chlorhexidine dihydrochloride.\1\
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    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.

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[[Page 324]]

    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) 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.\1\
    (2) Indications for use. For prevention or treatment of metritis and 
vaginitis in cows and mares when caused by pathogens sensitive to 
chlorhexidine dihydrochloride.\1\
    (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.\1\

[43 FR 10705, Feb. 23, 1979]