FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected

FDALogoLast week the US FDA Center for Drug Evaluation and Research (CDER) published an update to their guidance agenda for calendar 2016.  Originally published in January, this is the mid-year update, when the CDER has a shorter window to think about and, presumably, can be more accurate.  What has changed since January?  The number of Drug Supply Chain Security Act (DSCSA)-related draft guidance they expect to publish by year end remains the same, as reported by our friends at the Regulatory Affairs Professionals Society (RAPS).

In fact, according to RAPS, those same six draft guidances were on last year’s guidance agenda, so how useful is this agenda?  Not very.  For DSCSA-related items, it’s more just a list of guidance documents that are overdue and that they will get around to someday.  If you had held your breath for publication by the end of last year, you’d be dead by now.  Does anyone still think these draft guidances will be published by the end of this year?  We have nothing else but to believe (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”).

Here are the six DSCSA draft guidances that have been listed on every CDER guidance agenda since January 2015:

  • Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
  • Products Eligible for Grandfather Status
  • Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
  • The Product Identifier for Human, Finished, Prescription Drugs
  • Verification Systems for Prescription Drugs
  • Waivers, Exceptions and Exemptions from Product Tracing Requirements

If it should come to pass that all six of these will be published by the end of this year, CDER will be very busy between now and then, and I will be busy analyzing and writing about them after publication.  Until that time we’ll all just have to enjoy our August vacations.