The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013. Title 2 of the of the DQSA, the Drug Supply Chain Security Act (DSCSA) delineates steps to “achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.”
The DSCSA aids in safeguarding patients from exposure to counterfeit, stolen, contaminated or harmful drugs. Some DSCSA compliance requirements are already in play. The extended stabilization deadline is the second part of DSCSA, which addresses the Track and Trace serialization law, providing direction on how to track and trace transaction histories as prescription drugs move from pharmaceutical manufacturing sites to pharmacies. The deadline for manufacturers is May 27, 2025. While the deadline for wholesale distributors and 3PLs is August 27, 2025, in alignment with the deadlines of their partner organizations.
Identify products using unique, human and machine-readable barcodes on drug packages. These must include GTIN, EPCIS serialization, lot, and expiration dates for traceability.
The pharmaceutical supply chain must be interoperable to store and exchange serialized EPCIS data, enabling secure tracing of product ownership transfers.
Authorized trading partners (ATPs) must be electronically identifiable, and products can only be purchased from ATPs with valid licenses, EPCIS data, or, if applicable, a filed Waiver, Exception, and Exemption (WEE) collected from the vendor.
Validate the authenticity of suspect products with the manufacturer and inform trading partners.
Electronic Data Retention is required, ensuring the data is complete, accurate, and stored for 6 years.
DSCSA Standard Operating Procedures must be established to document the process to identify suspect drugs.
Licensure verification is required for all drug suppliers, maintaining DSCSA compliance between pharmacies and drug suppliers.
Using the FDA 3911 form, report suspect products at once.
Verify the inclusion of a Serial Shipping Container Code (SSCC) and EPCIS data upon receipt, and notify suppliers of any discrepancies.
