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.
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 6th
November 2019)
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
No comments:
Post a comment
Pharmaceutical Microbiology Resources