February 15, 2007

 

 Federal requirements for drug pedigrees do not affect veterinarians - February 15, 2007

 
Federal requirements for drug pedigrees do not affect veterinarians
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Veterinarians do not need to keep drug pedigrees under federal requirements that the Food and Drug Administration began enforcing in December 2006.

A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug—including the date of those transactions and the names and addresses of all parties to them.

The Prescription Drug Marketing Act of 1987 and Prescription Drug Amendments of 1992 established requirements relating to the wholesale distribution of human prescription drugs. A primary purpose of the PDMA was to increase safeguards to prevent the introduction and retail sale of substandard, ineffective, and counterfeit human drugs in the U.S. drug supply chain.

According to the FDA Center for Veterinary Medicine, the PDMA does not cover veterinary prescription drugs. However, if a distributor sells human drugs to a pharmacy or veterinarian for animal use, then the distributor must meet the pedigree requirements. Veterinarians have no new requirements under the PDMA and PDA.

Compliance Policy Guide 160.900, "Prescription Drug Marketing Act—Pedigree Requirements under 21 CFR Part 203," is available at www.fda.gov by clicking on Manuals and Publications under Reference Room, and then clicking on Compliance Policy Guides under Compliance.

Guidance for industry, in question-and-answer form, is available at www.fda.gov/cder/regulatory/PDMA/PDMA_qa.pdf [PDF]. Question 22 specifically addresses veterinary prescription drugs and human drugs for animal use.