What Are Hot Issues for DSCSA Implementation? (Pt 4)


This is another update in a series of blog articles from the DSCSA experts at Covectra, Inc., a company dedicated to the art and science of supply chain integrity and US FDA DSCSA-compliant solutions implementation. We invite you to share your thoughts with us as the DSCSA’s challenging compliance mandates continue to require 2018 action and implementation in the pharmaceutical supply chain from manufacturers and their trading partners.

Finally, we got a special surprise…the long-awaited for FDA DSCSA draft guidance for waivers, exceptions and exemptions has been published.

Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry

This guidance gives industry stakeholders added clarity regarding a disciplined process.  Ultimately, the FDA’s process for waivers, exceptions, and exemptions will be on a case-by-case basis, and it will be governed by FDA’s internal subject matter experts.  It also could possibly be a precursor of the end of the enforcement delay for serialization and verification that is to take effect on November 27th 2018.  The statutory roadblock to ending the enforcement delay seems to have been removed.

The following are my highlights of the FDA Guidance for Industry:

  • FDA is limiting requests and defining the official request process
  • Only an authorized manufacturer, repackager, wholesale distributor, or dispenser may request an individual waiver
  • Only a manufacturer or repackager may request an exception
  • Any interested stakeholder may request an exemption
  • It appears that FDA will review waivers on a case-by-case basis, governed by FDA’s internal subject matter experts
  • FDA will post related information on a case-by-case basis
  • Exception may be limited to a fixed period (3 years) or less if material changes can shorten the length
  • FDA has not identified or initiated any broad class of exemptions or exceptions, but rather will define them as necessary in the future

Watch this blog for more future insights on the FDA guidance, GS1 workgroup initiatives, and FDA public meetings. In the meantime, feel free to contact us with your own experiences and thoughts regarding DSCSA Implementation concerns.