FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015

SNI Guidance Document coverI was poking around on the FDA website yesterday to find out if any new DSCSA documents had been released recently.  I just returned from a near three-week trip to Western Europe and wanted to see if perhaps I missed something.  No.  Nothing released recently.  You can find a list of DSCSA documents released by the FDA on their website and the most recent one was published on December 31, 2014.

Back in January of this year the FDA published their annual list of guidance titles that they think they will publish in the coming year (updated in April).  That list included six titles of guidance documents related to the DSCSA that they expect to either publish in draft form, or finalize.  These include:

  1. DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

  2. DSCSA Implementation: Products Eligible for Grandfather Status

  3. DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices

  4. DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs

  5. DSCSA: Verification Systems for Prescription Drugs

  6. DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements

Notice that the first document in the list was published in draft form last December so by including it in this list, the FDA is signaling that they expect (hope?) to publish it in final rule form by the end of 2015.

This is a daunting list for those responsible for developing and publishing.  And considering that the year is just about half over, we should start to see some of these documents get published shortly.  Of course, no one can hold the FDA to the schedule implied by the list from January so it is possible that some of these documents could get pushed into early 2016.  However, according to the FDA’s own implementation plan, which was based on dates imposed by Congress within the text of the DSCSA, documents 1, 2, and 6 are due by November 27 of this year.  So maybe we’ll see those on the 26th of November!

The other three documents, 3, 4, and 5, appear to be “extra”.  That is, they were not required by Congress, but the FDA has apparently decided to provide some helpful guidance anyway on the standardization of data and documentation practices (see “Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?”), the DSCSA Product Identifier (see “The DSCSA Product Identifier On Drug Packages”), and DSCSA verification systems (see “Product Identifier Authentication (PIA)”).  I look forward to those and I will try to provide you with my thoughts on each one after they are made public.