v. 28 – Q4 2023
v.28 Q4 2023 update: Added references to the final DSCSA Verification guidance document that was recently released by the FDA in December.
Market Executive Summary |
In the USA, the federal law called the Drug Supply Chain Security Act (DSCSA) requires tracing (by lot) and verification (by serialization) of certain prescription drug products.
Required is a Product Identifier, uniquely identifying packages and homogenous cases with 4 data elements in both machine and human readable format.
Trading partners have different requirements as related to their respective roles in the supply chain.
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Key Dates |
- November 27, 2023: Fully interoperable, electronic system for tracing including Product Identifiers
- 1-Year Enforcement delay, bring the new enforcement date to November 27th, 2024.
- November 27, 2020: Dispensers cannot accept product without Product Identifiers affixed; Dispensers must verify PI of suspect and illegitimate product.
- 3-Year enforcement delay bringing new enforcement date to November 27th, 2023.Enforcement delay is ONLY for verifying suspect and illegitimate products, not including the requirement for ensuring a product is encoded with a product identifier.
- Additional 1-Year Enforcement delay, bring the new enforcement date to November 27th , 2024.
- November 27, 2019: (saleable returns verification enforcement discretion to 2020) Wholesale distributors cannot accept product without Product Identifiers affixed; wholesale distributors cannot resell returns with verification of Product Identifiers.
- Addition 3-year Enforcement Delay to the Sept 2019 1-Year delay bringing the new enforcement date to November 27th, 2023.
- Additional 1-Year Enforcement delay, bring the new enforcement date to November 27th , 2024.
- November 27, 2018: Repackagers – 4 element Product Identifier required on product entering the supply chain
- November 27, 2017: (enforcement discretion to 2018) Manufacturers – 4 element Product Identifier required on product entering the supply chain
- July 1, 2015: (adding dispensers to January 1 requirement)
- January 1, 2015: (all trading partners except dispensers) Authorized trading partners only; T3 required to be passed with each transaction
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