DSCSA Grandfathering and The Effects To Your Business
Webinar and Regulatory Update
The U.S Drug Supply Chain Security Act (DSCSA) requires the FDA to publish guidance specifying how product can be "grandfathered" on the effective date. That guidance was due last November, however, it's still not decided. In the absence of the official guidance, what strategies should drug manufacturers, 3PLs, and CMOs adopt as the November 2017 serialization deadline approaches? Should they build up or thin down their warehouse supply of non-serialized products?
Dirk Rodgers, Systech's Regulatory Strategist, defined and expanded on grandfathering in the United States. In the event that the FDA published the overdue official draft guidance prior to this webinar, Dirk would review the guidance and likely implications.
Viewing this webinar you will learn:
- The definition of "grandfathered" and the implications to your business
- The DSCSA's point of view on "grandfathering" by drug manufacturers
- What options the FDA will have when specifying how and when grandfathering can be used
- The implications for each of the options the FDA is facing
- The current status of drug serialization and tracing around the world
Regulatory Strategist, Systech International
Dirk Rodgers is the Regulatory Strategist at Systech and founder of RxTrace.com where he writes regularly in an exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance.