[Federal Register: July 14, 2003 (Volume 68, Number 134)]
[Notices]
[Page 41591]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy03-63]
[[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:
nbatalle@cvm.fda.gov.
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