What Is DSCSA? - Drug Supply Chain Security Act (DSCSA)?

What is the Drug Supply Chain Security Act (DSCSA)?

The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013. Title 2 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 is a law that the Food and Drug Administration (FDA) enforces to improve the security of prescription drugs 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, and the deadline for wholesale distributors is August 27, 2025. Third-party logistics providers (3PLs) will align with the deadlines of their partner organizations.

Requirements for Pharmaceutical Manufacturers, Distributors, and 3PLs:

Product Identification

Identify products using unique, human and machine-readable barcodes on drug packages. These must include GTIN, EPCIS serialization, lot, and expiration dates for traceability.

Interoperability & Product Tracing

The pharmaceutical supply chain must be interoperable to store and exchange serialized EPCIS data, enabling secure tracing of product ownership transfers.

Electronic Identification of ATPs

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.

Product Verification

Validate the authenticity of suspect products with the manufacturer and inform trading partners.

Data Storage

Electronic Data Retention is required, ensuring the data is complete, accurate, and stored for 6 years.

DSCSA Standard Operating Procedures

DSCSA Standard Operating Procedures must be established to document the process to identify suspect drugs.

Licensure

Licensure verification is required for all drug suppliers, maintaining DSCSA compliance between pharmacies and drug suppliers.

FDA 3911

Using the FDA 3911 form, report suspect products at once.

Enhanced Drug Distribution Security (EDDS)

Verify the inclusion of a Serial Shipping Container Code (SSCC) and EPCIS data upon receipt, and notify suppliers of any discrepancies.

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