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The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.
FDA published guidance documents on June 3, 2021, that provide recommendations for complying with the Drug Supply Chain Security Act (DSCSA) in order to identify and trace drug products as they move through the supply chain. Two final guidance documents and two draft guidance documents were issued.
Product Identifiers Under the Drug Supply Chain Security Act, Questions and Answers clarifies the DSCSA requirement that manufacturers and repackagers put a product identifier on drug packages that includes a national drug code, serial number, lot number, and expiration date.
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification offers certain trading partners aid in identifying a suspect product. It also describes how to notify FDA of illegitimate products.
Definitions of Suspect Product and Illegitimate Product for Verification Obligation under DSCSA describes terms used to define “suspect” and “illegitimate” products and revises the March 2018 draft guidance, and Enhanced Drug Distribution Security at the Package Level under DSCSA details requirements for enhanced drug distribution security at the package level and provides recommendations on the system attributes necessary for secure tracing of product at the package level.