FDA Issues Draft Guidance on Drug Supply Chain Traceability Data Standards
The Food and Drug Administration on Nov. 26 issued a draft guidance on standards for data exchange under the Drug Supply Chain Security Act (here). The year-old law requires an interface between FDA and drug manufacturers, wholesalers, repackagers, and dispensers that would allow for the electronic exchange of product and transaction information to enable verification of the legitimacy of drug products and improved efficiency of recalls (see 13121725). Comments on the proposed standards are due by Jan. 27.
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The draft guidance (here), titled “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information,” says “trading partners” under the law can use either paper or electronic methods to provide product tracing information to subsequent purchasers. Methods could include paper or electronic invoices; paper packing slips; Electronic Data Interchange standards like 856 Advance Ship Notice (ASN), which is currently used to provide the receiving entity with advance data on shipments; and the GS1 Electronic Product Code Information Services (EPCIS) standard. E-mail or web based platforms are acceptable for transmitting data, it said. Although FDA intends to establish standardized documentation for the exchange of data, the agency plans to do so in a subsequent guidance, it said.
(Federal Register 11/28/14)