May 15, 2007


 New drug pedigrees create tangential details for veterinarians

Posted May 1, 2007osted May 1, 2007

Veterinarians do not need to keep drug pedigrees under new federal requirements, but they do need to keep records when returning unsellable human drugs to a distributor and to sign forms when requesting samples of human drugs from a distributor.

A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug. The Food and Drug Administration began requiring pedigrees for human prescription drugs in late 2006, when the agency started enforcing the relevant portion of the Prescription Drug Marketing Act (see JAVMA, Feb. 15, 2007).

According to the FDA Center for Veterinary Medicine, the PDMA does not cover veterinary prescription drugs. Therefore, veterinarians have almost no new requirements under the PDMA.

A minor exception occurs when veterinarians return human drugs that they purchased from a distributor and that are not in sellable condition—because of expiration, damage, or other reasons. In this situation, veterinarians need to keep records of the return to the distributor for three years.

Generally, if a distributor sells human drugs to a pharmacy or veterinarian for animal use, then the distributor must meet the pedigree requirements. For samples of human drugs, the distributor will ask veterinarians to sign a form attesting that they requested and received the samples.

State requirements for drug pedigrees also can apply to veterinarians.