[Federal Register Volume 68, Number 134 (Monday, July 14, 2003)]
[Notices]
[Page 41591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17758]



[[Page 41591]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0290]


Compounding of Drugs for Use in Animals Compliance Policy Guide; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration is announcing the 
availability of a compliance policy guide (CPG) for FDA staff and 
industry entitled ``Sec. 608.400 - Compounding of Drugs for Use in 
Animals,'' which provides guidance on how FDA intends to address 
compounding of animal drugs.

DATES: Submit written or electronic comments at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Director, Division of Compliance Policy (HFC-230), Office of 
Enforcement, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. Send one self-addressed adhesive label to assist 
that office in processing your request or fax your request to 301-827-
0482. Submit written comments on the CPG to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the document.

FOR FURTHER INFORMATION CONTACT: Neal Bataller, Center for Veterinary 
Medicine (HFV-230), Food and Drug Administration, 7500 Standish Pl., 
rm. E441, Rockville, MD 20855, 301-827-0163, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On July 3, 1996, FDA issued a CPG section 608.400 ``Compounding of 
Drugs for Use in Animals,'' which provided guidance to FDA's field and 
headquarters staff with regard to the compounding of drugs for use in 
animals by veterinarians and pharmacists. It described the factors FDA 
intended to consider in exercising its enforcement discretion regarding 
the illegal compounding of drugs intended for use in animals.
    FDA is updating this CPG to ensure that its enforcement policy 
regarding the compounding of drugs intended for use in animals is 
consistent, to the extent practicable, with its enforcement policy 
regarding the compounding of drugs intended for use in humans. FDA 
issued the latter enforcement policy entitled ``Pharmacy Compounding 
Compliance Policy Guide'' that published in the Federal Register of 
June 7, 2002 (67 FR 39409). FDA issued this CPG after the U.S. Supreme 
Court ruled that a statutory provision governing the compounding of 
drugs intended for human use was unconstitutional. Because of that 
court decision, FDA determined that it needed to issue guidance to the 
compounding industry on what types of compounding might be subject to 
enforcement action under current law. The guidance was based in part on 
an earlier CPG.
    In addition to ensuring that its policies regarding the compounding 
of drugs intended for use in humans and animals are consistent, FDA is 
revising its previous animal drug compounding CPG to ensure it is 
consistent with the current animal drug compounding regulations, which 
are codified at 21 CFR part 530.

II. Significance of Guidance

    This compliance policy guidance is being issued as a level 1 
guidance consistent with FDA's good guidance practices (GGPs) 
regulation in Sec.  10.115 (21 CFR 10.115). It is being implemented 
immediately without prior public comment, under Sec.  10.115(g)(2), 
because of the agency's urgent need to explain how, in light of the 
recent court decision and revised policy regarding drugs for human use, 
it intends to exercise its enforcement discretion regarding compounded 
drugs for animal use. However, under GGPs, FDA requests comments on the 
guidance and will revise the document, if appropriate. Comments will be 
considered by the agency in the development of future policy.
    This compliance policy guidance represents the agency's current 
thinking on the enforcement of the act with regard to drug products 
compounded for use in animals. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
applicable statutes and regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the CPG at any time. 
Two paper copies of any mailed comments are to be submitted, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. A copy of the CPG and received comments may be seen in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain copies of the CPG at 
FDA's Office of Regulatory Affairs Web site at http://www.fda.gov/ora 
under ``Compliance References.''

    Dated: July 8, 2003.
John M. Taylor,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 03-17758 Filed 7-11-03; 8:45 am]
BILLING CODE 4160-01-S