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Table of Contents
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The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
allows veterinarians to prescribe extralabel uses of certain
approved animal drugs and approved human drugs for animals under
certain conditions. Extralabel (or extra-label) use refers to
the use of an approved drug in a manner that is not in accordance
with the approved label directions. The key constraints of AMDUCA
are that any extralabel use must be by or on the order of a
veterinarian within the context of a veterinarian-client-patient
relationship, must not result in violative residues in food-producing
animals, and the use must be in conformance with the implementing
regulations published at 21 CFR Part 530. A list of drugs specifically
prohibited from extra-label use (530_41.txt
and 530_41.pdf) appears in the Code
of Federal Regulations.
The following list of documents pertains to the Animal Medicinal
Drug Use Clarification Act of 1994 and its implementation by
CVM.
CVM Updates
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FDA to Revise Its Compliance Policy Guide on Veterinary Compounding, September 1, 2004
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Reminder– Doramectin Not Permitted For Use In Dairy Cattle June 21, 2004
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CPG Available on Compounding
of Drugs for Use in Animals
July 15, 2003
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FDA Order Prohibits Extralabel
Use Of Phenylbutazone In Certain Dairy Cattle
February 28, 2003
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Reminder -- Extra-Label
Use of Fluoroquinolones Prohibited, September 19, 2002
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FDA Prohibits Nitrofuran
Drug Use in Food-Producing Animals, February 7, 2002
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Update on Illegal Compounding
of Clenbuterol Veterinary Drug Products, January 10,
2002
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CVM Makes the Analysis
of Comments on the Fluoroquinolone and Glycopeptide Prohibition
Available to the Public, January 15, 1998
Federal Law/U.S. Code of Federal Regulations
Federal Register Notices
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Docket No. 03D-0290, CVM 200316. Compounding of Drugs for
Use in Animals Compliance Policy Guide; Availability. Page
41591 July 14, 2003 [FR Doc. 03-17758 ] | txt
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The
Guidance -- Compliance Policy Guide Section
608.400 - Compounding of Drugs for Use in Animals .
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Docket No. 03N-0024, CVM 200328. New Animal Drugs;
Phenylbutazone; Extralabel Animal Drug Use; Order of Prohibition;
Correction. Page 14134 [FR Doc. 03-06891]
March 24, 2003 | htm
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Docket No. 03N-0024, CVM 200058. New Animal Drugs;
Phenylbutazone; Extralabel Animal Drug Use; Order of Prohibition.
Pages 9528--9530 [FR Doc. 03-04741] February
28, 2003 | htm|
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| Effective May 29, 2003 Comments
April 29, 2003
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Topical
Nitrofurans; Extralabel Animal Drug Use; Order of Prohibition,
February 6, 2002
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Extralabel
Animal Drug Use; Fluoroquinolones and Glycopeptides; Order
of Prohibition, May 22, 1997
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AMDUCA
Fluoroquinolone and Glycopeptide Prohibition: Analysis of
Comments, January 15, 1998
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Extralabel
Drug Use in Animals; Final Rule, November
7, 1996
AMDUCA Satellite Teleconference,
February 12, 1997
Web page updated by mdt, September 1, 2004, 3:10 PM ET
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