DRUG PEDIGREE RULE IS DELAYED
The introduction of drug pedigrees has been delayed after a federal court agreedto grant an injunction. The court made its ruling after a number of drug wholesalersrequested the postponement. The wholesalers claimed the mandate would bankruptthem because they would not be able to meet the requirement.
The rule, which was to go into effect last month, required anyone involved in thewholesale distribution of a drug, who is not the manufacturer or an authorized distributorof record, to document every individual or company that handles thatdrug. The government wanted to enforce drug pedigrees in an effort to lower therate of counterfeit drugs. The pedigrees would track the drugs from a manufacturingplant to a retail pharmacy.
"I think this will likely be a time for the industry to wait and see what the FDA'sresponse [to the injunction] is," responded Diane Darvey, directory of pharmacy regulatoryaffairs for the National Association of Chain Drug Stores.