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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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CVM Update - FDA Extends Cephalosporin Comment Period and Delays Final Rule, August 15, 2008
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CVM Update - FDA Issues Order Prohibiting Extralabel Use of Cephalosporin Antimicrobial Drugs in Food-Producing Animals, July 2, 2008
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CVM Update - Digitek® Safety Warning and Recall Notification, May 16, 2008
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CVM Update - CVM Working to Address Concerns about Supplies of Pergolide for Horses, May 11, 2007
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CVM Update - FDA Reminds Veterinarians on the Correct Use of Flunixin Meglumine, May 10, 2007
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CVM Update - FDA Clarifies Extra-label use of medicated feed in minor species per CPG #615.115, May 4, 2007
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FDA Warns Horse Owners and Veterinarians About Deaths Due To Unapproved Clenbuterol - Supplemental Information, December 1, 2006
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FDA Warns Horse Owners and Veterinarians About Deaths Due to Unapproved Clenbuterol, November 24, 2006
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ECP Not Approved for Use in Animals, April 5, 2006
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FDA Prohibits Use of Antiviral Drugs in Poultry to Help Keep Drugs Effective for Humans, March 20, 2006
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Reminder -- Extra-Label Use of Sulfonamides in Lactating Dairy Cattle, August 19, 2005
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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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FINAL RULES
Docket No. 2006N-0106, CVM 200618. New Animal Drugs; Adamantane and Neuraminidase Inhibitor Ant-Influenza Drugs; Extralabel Animal Drugs; Order of Prohibition. Pages 14374-14377 [FR Doc. 06-2689 ] March 22, 2006 [TXT] [PDF] [PRE-PUB] Comments due May 22, 2006, Effective June 20, 2006
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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 | | pdf |
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 | | pdf |
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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| | pdf | 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 hd - August 15, 2008, 1:39 PM ET
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