[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR500.46]

[Page 9-10]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 500--GENERAL--Table of Contents
 
        Subpart B--Specific Administrative Rulings and Decisions
 
Sec.  500.46  Hexachlorophene in animal drugs.

    (a) The Commissioner of Food and Drugs has determined that there are 
no adequate data to establish that animal drugs containing 
hexachlorophene are safe and effective for any animal use other than in 
topical products for use on non-food-producing animals as part of a 
product preservative system at a level not to exceed 0.1 percent; that 
there is no information on the potential risk to humans from exposure to 
hexachlorophene by persons who apply animal products containing the drug 
at levels higher than 0.1 percent; and that there is likewise no 
information on human exposure to animals on which these animal drugs 
have been used and no information on possible residues of 
hexachlorophene in edible products of food-producing animals treated 
with new animal drugs that contain any quantity of hexachlorophene.
    (b) Animal drugs containing hexachlorophene for other than 
preservative use on non-food-producing animals at levels not exceeding 
0.1 percent are considered new animal drugs and shall be the subject of 
new animal drug applications (NADA's).
    (c) Any person currently marketing animal drugs that contain 
hexachlorophene other than as part of a product preservative system for 
products used on non-food-producing animals at a level not exceeding 0.1 
percent shall submit a new animal drug application, supplement an 
existing application, or reformulate the product by September 29, 1977. 
Each application or supplemental application shall include adequate data 
to establish that the animal drug is safe and effective. If the animal 
drug is currently subject to an approved new animal drug application, 
each reformulation shall require an approved supplemental application. 
The interim marketing of these animal drugs may continue until the 
application has been approved, until it has been determined that the 
application is not approvable under the provisions of Sec.  514.111 of 
this chapter, or until an existing approved application has been 
withdrawn.
    (d) After September 29, 1977, animal drugs that contain 
hexachlorophene other than for preservative use on non-food-producing 
animals at a level not exceeding 0.1 percent that are introduced into 
interstate commerce shall be deemed to be adulterated within the meaning 
of section 501(a)(5) of the act (21 U.S.C. 351(a)(5)) unless such animal 
drug is the subject of a new animal drug application submitted pursuant 
to paragraph (c) of this section. Action to withdraw approval of new 
animal drug applications will be initiated if supplemental new animal 
drug applications have not been submitted in accordance with this 
section.
    (e) New animal drug applications submitted for animal drugs 
containing hexachlorophene for use in or on food-

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producing animals shall include adequate data to assure that edible 
products from treated animals are safe for human consumption under the 
labeled conditions of use.

[42 FR 33725, July 1, 1977; 42 FR 37975, July 26, 1977]