The federal Drug Supply Chain Security Act (DSCSA) established new licensing, track-and-trace, and preemption standards for pharmaceutical manufacturers and distributors in the U.S. Although more than two years have passed since enactment of the DSCSA in November 2013, FDA has yet to publish key implementation standards. While industry awaits important regulations and guidance from the FDA, it can be difficult to assess compliance in the interim. Certain state agencies have stepped in to fill perceived voids, further complicating efforts toward national uniformity for operations.
This webinar will address:
- Overview of DSCSA requirements
- Status of FDA regulations and guidance
- Update on state licensing laws and prospects for national uniformity of standards
- Key timelines affecting manufacturers
Christina M. Markus
King & Spalding LLP