The United States Food and Drug Administration (FDA) announced that it will be virtually hosting a public meeting on November 16, 2021, on Drug Supply Chain Security Act (DSCSA) implementation. The purpose of this meeting is to allow interested stakeholders the opportunity to provide input to the FDA on the enhanced drug distribution security provisions of the DSCSA that go into effect in 2023.
The DSCSA (Title II, Pub. L. 113-54) was signed into law on November 27, 2013, and, over ten years, builds layers of protection to secure the U.S. pharmaceutical supply chain. Pharmaceutical manufacturers, repackagers, wholesale distributors, and dispensers have worked diligently during this period, have made enormous investments in capital and resources, and now are pushing to achieve the statute’s final requirements, which go into effect in barely two years, on November 27, 2023. On June 4, 2021, the FDA released a Draft Guidance “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act,” which sets out the agency’s vision for 2023 DSCSA compliance. At the public meeting, the agency hopes to hear from the industry about the progress towards meeting the 2023 deadline for compliance, whether the Draft Guidance is helpful in advancing those goals, and where the agency could provide additional clarity and assistance.
Given the many comments submitted to the agency, the industry has significant concerns about the Draft Guidance. Most particularly is the concern that FDA seems to envision an “enhanced system” that does not exist, is not something industry has been collectively working together to build since 2014, and, at this late date, could not be developed in time to meet the 2023 deadline. We will be monitoring the public meeting and will provide a summary.
Registration and other information can be found here. Those who wish to attend the public meeting must register on or before October 26, 2021. The agency is providing an additional 60 days after the public meeting, until January 18, 2022, to submit written comments.
If you have any questions about the DSCSA and whether your business is ready for 2023, please contact us.