The introduction of drug pedigrees has been delayed after a federal court agreed to grant an injunction. The court made its ruling after a number of drug wholesalers requested the postponement. The wholesalers claimed the mandate would bankrupt them because they would not be able to meet the requirement.
The rule, which was to go into effect last month, required anyone involved in the wholesale distribution of a drug, who is not the manufacturer or an authorized distributor of record, to document every individual or company that handles that drug. The government wanted to enforce drug pedigrees in an effort to lower the rate of counterfeit drugs. The pedigrees would track the drugs from a manufacturing plant to a retail pharmacy.
"I think this will likely be a time for the industry to wait and see what the FDA's response [to the injunction] is," responded Diane Darvey, directory of pharmacy regulatory affairs for the National Association of Chain Drug Stores.