[Federal Register Volume 71, Number 130 (Friday, July 7, 2006)]
[Page 38650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10672]



Food and Drug Administration

[Docket No. 1990D-0428]

Human-Labeled Drugs Distributed and Used in Animal Medicine; 
Withdrawal of Compliance Policy Guide

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of a compliance policy guide (CPG) that was issued on March 
19, 1991.

DATES: July 7, 2006.

FOR FURTHER INFORMATION CONTACT: Diane D. Jeang, Division of Compliance 
Policy (HFC-230), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-632-6833.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 30, 1992 (57 FR 33729), FDA announced the availability 
of a revised CPG 7125.35 entitled ``Human-Labeled Drugs Distributed and 
Used in Animal Medicine.'' The CPG is being withdrawn because it is 
obsolete. This CPG explained how FDA would exercise its enforcement 
discretion with respect to the distribution and use of human-labeled 
drug products for use in animals.
    The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) 
was signed into law on October 22, 1994. AMDUCA allows veterinarians to 
prescribe extralabel uses of approved animal drugs and approved human 
drugs for animals under certain conditions. An extralabel use must be 
by or on the order of a licensed veterinarian within the context of a 
veterinarian-client-patient relationship and must be in conformance 
with the implementing regulations published in part 530 (21 CFR part 
530). A list of drugs specifically prohibited from extralabel use in 
animals is in Sec.  530.41.
    With the enactment of AMDUCA and the issuance of implementing 
regulations, FDA is withdrawing CPG 7125.35 because it is obsolete. On 
September 24, 1998, a CPG section 615.100 entitled ``Extralabel Use of 
New Animal Drugs in Food-Producing Animals (CPG 7125.06)'' was 
withdrawn for the same reason (63 FR 51074).

    Dated: June 20, 2006.
Margaret O'K. Glavin,
Associate Commissioner for Regulatory Affairs.
[FR Doc. E6-10672 Filed 7-6-06; 8:45 am]