FDA delays enforcement of drug tracing requirement for dispensers

The Food and Drug Administration will not enforce certain prescription drug tracing requirements against dispensers until Nov. 1, the agency said yesterday. Effective today under the Drug Supply Chain Security Act of 2013, manufacturers, whole distributors, dispensers and repackagers of certain prescription drugs must provide product tracing information to subsequent purchasers of the drugs. They also must capture and maintain the information for at least six years after the transaction. FDA said it will not enforce the second requirement against dispensers before Nov. 1 because some may need more time to electronically capture and maintain the information. According to the guidance, the enforcement delay does not apply to manufacturers, whole distributors or repackagers, nor to transactions in which dispensers must provide the subsequent owner with product tracing information. “If a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, FDA recommends that the dispenser work with the previous owner to receive this information,” the agency said.