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Regulations.gov - Other Document

Something to be Thankful For? FDA Issues Long Awaited DSCSA Guidance

Posted: 01 Dec 2014 03:20 AM PST

By William T. Koustas & Anne Marie Murphy –

We have been closely following FDA’s implementation of the Drug Supply Chain Security Act ("DSCSA") (see here and here) and waiting for this day for over a year.  As our readers may know, the DSCSA requires certain members of the pharmaceutical supply chain (i.e., trading partners) to pass certain information beginning on January 1, 2015 in any transactions involving a prescription drug product.  The DSCSA also mandates that FDA issue a draft guidance document by November 27, 2014 that establishes standards for the “interoperable exchange of transaction information, transaction history, and transaction statements…”  (Product Tracing Information).  In a recent public appearance, an FDA official suggested that the guidance document was unlikely to by issued by the statutory deadline (see our previous post here).  So it was a surprise to us that this was released on time.

Industry has been inundating FDA with a variety of DSCSA-related questions, but this draft guidance, announced last week and titled “DSCSA Standards for the Interoperable for Tracing of Certain Human, Finished, Prescription Drugs:  How to Exchange Product Tracing Information” (Draft Guidance), only addresses one issue – how certain trading partners exchange Product Tracing Information starting on January 1, 2015.  FDA appears to have heard industry’s calls for flexibility, because the Draft Guidance indicates that trading partners may pass and receive Product Tracing Information in a variety ways, including, but not limited to, the following:

• Paper or electronic invoices;
• Paper packing slips;
• Electronic Data Interchange ("EDI") standards (e.g., 856 Advance Ship Notice ("ASN")); 
• EPIC (Electronic Product Code Information Services); and
• Email or web-based platforms.

The Draft Guidance suggests that nearly any method for passing Product Tracing Information will be acceptable on January 1, 2015, as long as it can handle all of the information required by the DSCSA.  FDA notes that it may revisit what methods of passing Product Tracing Information are acceptable as processes, capabilities, and electronic systems evolve and “are more widely accessible.”  Unfortunately, the Draft Guidance does not address any of the other issues that have been brought to FDA’s attention, such as clarifying statutory terms (e.g., co-licensed partner).  FDA notes, however, that it intends to issue additional guidance documents.  Presumably, those guidance documents will address some of the remaining questions.