Resources & FAQ

The FDA has developed materials for state officials, including overviews of the requirements and standards for licensure, a summary of the 2015 Intergovernmental Meeting, and two Long-Term Information-Sharing Agreements to facilitate the exchange of information about DSCSA between FDA and the states.

Frequently Asked Questions

The Drug Supply Chain Security Act (DSCASA) is a 2013 law to identify and quarantine suspect (potentially illegitimate) drugs within the US pharmaceutical supply chain. Many of the details and ramifications of the law are still uncertain.

The difficulty for Pharmacies to implement compliance measures is compounded by a lack of awareness of DSCSA requirements and education on federal supply chain compliance regulations. Changing data formats (e.g. ASN and now EPCIS), mixtures of serialized and non-serialized products in the supply chain, requirements of volumes of data, and short (24 hour) response times place a heavy burden on pharmacists who already have a full plate. Creating and maintaining DSCSA compliance measures requires subject matter expertise in design, implementation, and maintenance of compliance systems, ASN, and other data repositories.

As new requirements are being planned and implemented over the coming years, the burden to stay knowledgeable and current is overwhelming. Final implementation is scheduled for November 27, 2023 with requirements for dispensers to participate in an interoperable database to document drugs received and/or shipped to the pharmacy. The comprehensive requirements for DSCSA compliance still remain to be fully articulated by the FDA in their guidance documentation.