FDA Issues Two Draft Guidances for DSCSA Compliance 


The EPCIS communications standard is “recommended,” and trading partners are identified

As if laying the foundation blocks for the massive structure that will eventually be the interoperable, fully electronic drug-tracking system under the 2013 Drug Supply Chain Security Act (DSCSA), FDA has issued two more guidances to help pharma supply chain participants get ready for November 2023 implementation.

The first, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, is a straightforward recommendation for participants to employ the GS1 EPCIS standard for communicating product identification and transaction information. This is fairly non-controversial; the Healthcare Distribution Alliance (HDAA), the trade association of US drug wholesalers, has long promoted this standard. The GS1 organization, for its part, has written elements of the standard specifically for the needs of pharmaceutical trading partners. One nuance, though, is that HDAA and others specify version 1.2 of the standard; FDA is silent about what version to use.

The second guidance, Identifying Trading Partners Under the Drug Supply Chain Security Act, is also fairly straightforward in concept, but will be more difficult to put into practice. Under DSCSA, drug transactions, up and down the supply chain, are to occur only with “authorized trading partners,” and “authorization,” in large part, means, having an appropriate license and verified identity. Under various federal and state programs, most manufacturers, wholesalers, hospitals and pharmacies have such licensure; however, FDA is still finalizing a federal system for wholesaler licensure. Additionally, a new (for FDA) category of third-party logistics providers (3PLs) will also need licensure in most cases. “Salvagers” who recover expired product, as well as reverse-logistics service providers, among others, may or may not need authorized status, depending on the nature of their service. Depending on the volume of their trading activity (as opposed to dispensing), some pharmacies might need wholesaler licensure as well.

Both guidances are subject to 60-day review and commentary, which will end on September 5.

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