Drug Supply Chain Security Act (DSCS)

In 2019 the FDA announced it had received comments and feedback from wholesale distributors expressing concern with industrywide readiness for implementation of the verification of saleable returned product requirement for wholesale distributors. Specifically, stakeholders have described challenges with implementation of verification of the product identifier on saleable returned drug product packages or sealed homogenous cases due to a number of factors, including:

1.      The very large volume of saleable returned product requiring verification.

2.      The need to refine and test verification systems during actual production using real-time volumes of saleable returned product rather than simply in pilots.

3.      The complexities of building an interoperable, electronic system with the capabilities to timely and efficiently verify the large volume of saleable returned products amid immature technologies.

While this was noted, the FDA will continue with the agreed implementation date of November 27, 2020 (FDA, 2019).

FDA (2019) Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry, U.S. Department of Health and Human Services Food and Drug Administration, September 2019 at: https://www.fda.gov/media/131005/download (accessed 6^th November 2019)

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)