The Drug Supply Chain Security Act (DSCSA) was enacted by Congress in 2013 as Title II of the Drug Quality and Security Act. It was established to enhance the traceability, security, and integrity of the pharmaceutical supply chain; readily identify compromised pharmaceuticals, such as counterfeit, stolen, contaminated, dangerous, or otherwise harmful drugs; and remove compromised products from the pharmaceutical supply chain before they reach patients. In addition, DSCSA requires wholesale distributors and third-party logistics providers to obtain national licensure.

As of November 24, 2024, DSCSA requires compliance with the mandate for real-time, fully electronic interoperability track-and-trace systems to the package level across the supply chain, from manufacturers to dispensers.

ACHC currently does not have a standard specific to DSCSA for PCAB and Pharmacy Accreditation programs. A DSCSA standard will be included when the next PCAB and Pharmacy Standards are released. However, federal oversight of pharmacies does mandate compliance with DSCSA, and ACHC is committed to educating and supporting pharmacies in meeting the requirements. Read More >