FDA Extends Deadline for Pharmacies to Comply with New Track and Trace Requirements for Drug Shipments

The Food and Drug Administration (FDA) has extended the deadline for pharmacies to comply with new federal track and trace requirements on drug shipments established under the Drug Supply Chain Security Act (DSCSA).

The DSCSA, signed into law in 2013, requires extensive pharmaceutical compounding reforms and establishes a nationwide pharmaceutical “track and trace” system to deter drug counterfeiting, the Regulatory Affairs Professionals Society (RAPS) reports.Under the new law, every drug shipment must carry a unique serial number that will be used to track the shipment’s movement through the supply chain. At each stop in the chain, from manufacturer to end distributor, the entity in possession of the shipment is required to keep track of the product moving into and out of its possession. This tracking will allow federal regulators to trace the drug’s path in the event of a problem. The track and trace provisions were to take effect on July 1. But pharmacies say they need more time to design and implement the necessary new tracking systems, according to RAPS. On June 22, 2015, the National Community Pharmacists Association (NCPA) wrote to the FDA asking for a temporary reprieve from the July 1 deadline for compliance. NCPA said “about half” of its members did not know how information would be routed between wholesalers, secondary wholesalers, and pharmacies. NPCA asked the FDA to extend the compliance deadline to “forestall potential disruptions in the pharmaceutical supply chain.”

The FDA has agreed to give drug dispensers an additional four months—until November 1, 2015—to comply with DSCSA regulations. Though the compliance deadline remains July under the law, the FDA said it would use its “enforcement discretion” to give pharmacies the additional time to comply. “FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information,” the agency said. “FDA recognizes that some dispensers may need additional time beyond July 1, 2015, to work with trading partners to ensure that the product tracing information required by section 582 is captured and maintained by dispensers,” RAPS reports.

The FDA said the compliance deadline has not changed for manufacturers, wholesale distributors, and re-packagers. As of July, they are required to meet the law’s track and trace provisions.

 

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