The Drug Supply Chain Security Act (DSCSA), enacted in 2013, preempts a 50-state patchwork of pedigree requirements to create one federal traceability solution for prescription medicines. The DSCSA sets out a 10-year timeline to build an electronic, interoperable system for the exchange of transaction documentation [transaction information (TI), transaction history (TH) and transaction statements (TS)] to enable the tracing of prescription medicines throughout the pharmaceutical supply chain, with the final milestone quickly approaching.
Manufacturers and wholesale distributors must provide lot TI, TH and TS.
Product identifiers by manufacturers
Manufacturers must affix product identifiers to each package and homogenous case.
Product identifiers by repackagers
Repackagers must affix product identifiers to each package and homogenous case.
Verification by distributors
The compliance policy described is limited to the requirements that wholesale distributors verify saleable returned products prior to further distribution and have verification systems in place to comply with the requirements of section 582(c)(4)(D) of the FD&C Act; it does not extend to the other requirements in section 582 of the FD&C Act.The FDA has announced it will not enforce the saleable returns verification requirement until November 27, 2023.Wholesale distributors must only accept serialized product. They must also verify product identifiers with the manufacturer before redistributing returns.
Verification by dispensers
This compliance policy does not address any of the other verification requirements set forth in section 582(d)(4) of the FD&C Act.The FDA has announced it will not enforce the verification requirement for suspect products until November 27, 2023. Dispensers must only accept products with product identifiers and also have verification requirements for suspect products.
Manufacturers, distributors and dispensers must provide and receive TI (including product identifier) and TS in a secure, electronic and interoperable manner.
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