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Drug Supply Chain Security Act (DSCSA) - Enhanced Drug Distribution Security Requirements for Interoperable, Electronic Tracing of Products at the Package Level

The DSCSA requires all pharmaceutical trading partners to implement a fully electronic, interoperable system to trace and verify prescription drugs at the…

What Drug Supply Chain Security Act (DSCSA) - Enhanced Drug Distribution Security Requirements for Interoperable, Electronic Tracing of Products at the Package Level requires

The DSCSA requires all pharmaceutical trading partners to implement a fully electronic, interoperable system to trace and verify prescription drugs at the individual package level throughout the U.S. supply chain. As mandated by Section 582 of the FD&C Act, this includes exchanging secure transaction information (TI) and transaction statements (TS) for each product movement and verifying product identifiers upon request or for saleable returns.

Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:

Primary source: https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

SHA-256 integrity: 16ddf80ce37881378d12b3166c8da19b966878f8bbaa9b1a90ec73d77007bb00

Primary Citations — 7 traced to source

  • Federal Food, Drug, and Cosmetic Act, Section 582(g)(1): Enhanced Drug Distribution Security
  • Federal Food, Drug, and Cosmetic Act, Section 582(b)(4): Manufacturer Requirements

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