Life Sciences Horizons Brochure 2025 - Flipbook - Page 5
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2025 Horizons Life Sciences and Health Care
Drug Supply Chain Security Act: Enhanced drug distribution security requirements
The Drug Supply Chain Security Act (DSCSA) outlines
steps to build an electronic interoperable system
that will identify and trace certain prescription drugs
distributed in the U.S. It initially included a ten-year
phase-in period for “trading partners” (i.e., drug
and biologic manufacturers, wholesale distributors,
dispensers, and repackagers) to implement systems
and processes for electronically exchanging required
information at the product package level (the “enhanced
drug distribution security requirements”).
We expect that some stakeholders will continue to experience
challenges in meeting applicable timeframes for compliance
with these enhanced requirements in 2025. Consistent with other
anticipated deregulatory initiatives, new FDA leadership may
consider further accommodations and enforcement discretion to
address specific regulatory challenges and avoid drug shortages.
Although the requirements were scheduled to take effect in
November 2023, FDA announced in August 2023 a one-year
“stabilization period” ending in November 2024 that provided
trading partners additional time to implement the required
systems. In July and October 2024, FDA issued exemptions to
provide small business dispensers and certain connected trading
partners, respectively, additional time to finalize their systems.
Under the exemptions, FDA will not enforce the enhanced drug
distribution security requirements against products transacted
between eligible trading partners until:
27 May 2025 for manufacturers and repackagers,
27 August 2025 for wholesale distributors,
27 November 2025 for dispensers with at least 26 full-time
employees (FTEs) licensed as pharmacists or pharmacy
technicians, and
27 November 2026 for small business dispensers with fewer
than 26 FTEs.
For trading partners to be eligible for the exemptions, they must
have initiated data connections with immediate trading partners
and have documented those efforts. Trading partners who are
not eligible for the above exemptions may continue to request
a waiver, exception, or exemption from the enhanced drug
distribution security requirements.
In delaying enforcement and issuing exemptions, FDA has
repeatedly emphasized the importance of ensuring patient
access amid concerns about potential shortages or supply chain
disruptions resulting from implementation of the electronic
interoperable system. Importantly, FDA’s public meetings reflect
a clear effort to work with stakeholders to ensure supply chain
continuity while standing up the required systems.
Stakeholders continuing to experience implementation
challenges should document steps taken, engage with FDA,
and consider participating in FDA’s upcoming town halls taking
place throughout 2025. These town halls provide stakeholders
with an important opportunity to share their progress and voice
remaining areas of concern to the agency.
David Horowitz
Partner
Washington, D.C.
Deborah Cho
Counsel
Washington, D.C.
Katie Kramer
Associate
Washington, D.C.
