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The DSCSA Standards Guidance is here!

This morning, FDA met another of its milestones in implementing the Drug Supply Chain Security Act (DSCSA) and posted a Draft Guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information.  FDA is to be commended for both getting the Draft Guidance posted by the DSCSA’s statutory deadline of November 27, and for not unduly upsetting the Thanksgiving of everyone in the pharmaceutical supply chain.  (Our food colleagues are deep into the menu and vending labeling final rules FDA also announced this week.)

With trading partners required on January 1, 2015, to begin exchanging transaction data when covered pharmaceuticals change owners, guidance from the agency was imperative. FDA specifically recognizes that, although the guidance is a “draft,” “the DSCSA clearly intends for stakeholders to rely upon this draft guidance document before finalization.”  As such, FDA is immediately implementing the Draft Guidance.

The Draft Guidance is very brief even though it was preceded by establishment of a docket and request for comments, 79 Fed. Reg. 9745 (Feb. 20, 2014), a two-day public workshop, and a call for more comments arising from that workshop, 79 Fed. Reg. 18562 (April 2, 2014).  For the most part, the agency quotes the DSCSA and directs stakeholders to relevant statutory requirements and definitions.

FDA does offer significant comfort to pharmaceutical supply chain trading partners in that it specifically acknowledges that trading partners can utilize “current” methods for the interoperable exchange of transaction data to provide product tracing information to subsequent supply chain purchasers.  Acceptable methods for this data exchange include, but are not limited to:

  • Paper or electronic versions of invoices;
  • Paper versions of packing slips;
  • Electronic Data Interchange (EDI) standards, such as 856 Advance Ship Notice (ASN), which is currently used to provide the receiving entity with advance data on shipments;
  • EPCIS (Electronic Product Code Information Services), which defines a data-sharing interface that enables supply chain partners to capture and communicate data about the movement and status of objects in the supply chain; and
  • Email or Web-based platforms (such as Web portals).

This is the first time that FDA has specifically endorsed specific methods and systems as appropriate for the interoperable exchange of transaction data.  In the long run, paper-based systems are not interoperable or feasible.  Paper is, at best, a stop-gap measure until trading partners move toward the DSCSA’s ultimate goal of a true, interoperable, electronic system that can trace individually serialized prescription pharmaceuticals through the supply chain.

The Draft Guidance is a good first step, with much more work still to be done, and many questions still unanswered.  FDA’s next tasks are to establish systems to accept facility and other information from third-party logistics providers and wholesale distributors.  There is definitely more to come in the weeks and months ahead.   FDA is accepting comments on the Draft Guidance for 60 days.