ASHP Urges Temporary Dispenser Exemption for Track and Trace Requirements

ASHP led a joint letter in partnership with several pharmacy organizations to the Food and Drug Administration (FDA) requesting “that the agency implement a phased enforcement approach by providing a blanket waiver, exception, or exemption for dispensers until manufacturer-level trading partners can provide all necessary Electronic Product Code Information Services (EPCIS) data to downstream trading partners.”

The Drug Supply Chain Security Act (DSCSA) compliance requirements will take effect on Nov. 27.

The letter also requests that any extensions granted to upstream trading partners be applied and communicated to downstream trading partners. Finally, the groups requested a meeting with FDA to discuss the state of DSCSA readiness. Signatories on the letter included the American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, American Pharmacists Association, American Society of Consultant Pharmacists, National Association of Chain Drug Stores, National Alliance of State Pharmacy Associations, and the National Community Pharmacists Association. 

The letter followed concerns expressed by members that their pharmacies are currently receiving, on average, less than half of the required EPCIS data from upstream trading partners. Given that data flows down from manufacturers through the supply chain, pharmacy compliance with DSCSA is entirely dependent on upstream readiness. A phased enforcement approach would allow DSCSA implementation to continue without penalizing dispensers who cannot comply simply because they have not received the requisite data.

“Building an effective track and trace system is a challenge, but it will ultimately strengthen supply chain safety,” said Tom Kraus, ASHP vice president of government relations. “However, that can be achieved when all the partners in the supply chain are ready. Safety and efficacy should not be sacrificed for the sake of speed.”

ASHP will update members regarding FDA’s response. We will also provide additional resources related to DSCSA compliance in the coming weeks.