v. 26 – Q2 2023
|Market Executive Summary
In the USA, the federal law called the Drug Supply Chain Security Act (DSCSA) requires tracing (by lot) and verification (by Serialisation) 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.
- November 27, 2023: Fully interoperable, electronic system for tracing including Product Identifiers
- 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.
- November 27, 2020: Dispensers cannot accept product without Product Identifiers affixed; Dispensers must verify PI of suspect and illegitimate product.
- Addition 3-year Enforcement Delay to the Sept 2019 1-Year delay bringing the new enforcement date to November 27th 2023.
- 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.
- 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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