Drugs

Do More to Prevent DSCSA Disruptions: Congress

A bipartisan group of 21 House members is urging FDA to take additional actions to minimize the potential for disruptions to the drug supply and patient care as the stabilization period for implementation of the Drug Supply Chain Security Act (DSCSA) ends on 11/27. In a 10/7 letter to FDA commissioner Robert Califf, the lawmakers say they understand there are remaining challenges for some drug supply chain participants to meet the law’s full implementation requirements by the deadline.

“Absent government intervention,” they write, “there will likely be disruptions that could lead to drug shortages and patients being unable to access critical medications. We were encouraged to see FDA’s recent announcement of exemptions from certain DSCSA requirements for many small dispensers and applicable trading partners until 11/27/2026. However, given the varying degrees of readiness among trading partners across the supply chain, we believe that FDA needs to take additional steps beyond the exemption to prevent shortages or access constraints.”

The letter says that if it determines that additional exemptions are needed, FDA should consider a phased approach that could have manufacturing-level trading partners comply with the 11/27 date and then have wholesalers comply six to eight months later, and pharmacies comply by 2/27/2026.

The legislators ask for an FDA status update with answers to these questions:

the number of national drug codes included in waiver, exception, and exemption (WEE) applications received by FDA;
the timeline for reviewing and considering WEE applications;
the number of WEE applications received by 10/7, with the number already approved and the number rejected;
the communications strategy FDA has engaged in with the industry to minimize supply chain disruption and support the implementation needs of trading partners and the strategy the agency plans to implement after the 11/27 compliance date;
how FDA will enforce DSCSA after 11/27 and what instructions are being given to state regulatory agencies;
whether FDA intends to communicate with each specific requested WEE’s scope and duration and subsequent determination to ensure supply chain partners are prepared and in compliance;
whether there is a WEE submission threshold that would prompt FDA to issue an FDA-initiated WEE exemption for the supply chain industry; and
how FDA will communicate and respond to any unintended supply chain disruptions as a result of DSCSA implementation.

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