[Federal Register Volume 59, Number 185 (Monday, September 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23773]
[[Page Unknown]]
[Federal Register: September 26, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94D-0284]
Miscellaneous Compliance Policy Guides; Revocation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of three compliance policy guides (CPG's) because they are
outdated. This action is being taken to ensure that FDA's CPG's
accurately reflect FDA policy.
DATES: Effective September 26, 1994.
FOR FURTHER INFORMATION CONTACT: Judith A. Gushee, Center for
Veterinary Medicine (HFV-236), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1785.
SUPPLEMENTARY INFORMATION: FDA is revoking three of its CPG's because
either they no longer reflect FDA policy, or they have been superseded
by more comprehensive guidance. The following three guides are being
revoked:
(1) CPG 7125.03 ``Sale of Prescription-legend Veterinary Drugs''
The information contained in CPG 7125.03 also is found in
Compliance Program 7371.002, and the information in Compliance Program
7371.002 is more current and thorough than that contained in CPG
7125.03. Therefore, CPG 7125.03 is obsolete.
(2) CPG 7125.10 ``Veterinarian Use of New Animal Drug Substances''
This CPG states that veterinarians may use within their practice
whatever bulk drugs they may legally obtain, i.e., those that do not
require a new animal drug application (NADA). This policy implies that
the requirement for a NADA is the exceptional situation. In fact, in
most cases, an approved NADA is required before bulk drug substances
could be used by veterinarians to produce a finished pharmaceutical.
This position was upheld in United States v. 9/1 KG Containers, More or
Less, of an Article of Drug for Veterinary Use [Schuyler Laboratories,
Inc.], 854 F.2d 173 (7th Cir. 1988). Therefore, FDA is revoking CPG
7125.10 so that agency policy will not be misinterpreted. Furthermore,
FDA is in the process of developing policy guidance pertaining to the
compounding of drugs for veterinary use that will be issued in due
course.
(3) CPG 7126.02 ``Gentian Violet in Animal Feed''
In a memo dated August 16, 1991, FDA's Center for Veterinary
Medicine (CVM) informed all district offices and all resident posts
that this CPG was no longer CVM policy. CPG 7126.02 was not revoked at
the time. That oversight is now being corrected.
Dated: August 31, 1994.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 94-23773 Filed 9-23-94; 8:45 am]
BILLING CODE 4160-01-F
