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WASHINGTON — HDA submitted comments on Tuesday to the FDA in response to the agency’s request for information, “Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act” (RFI),” which asks how trading partners are using
the stabilization period to troubleshoot and mature secure, electronic, interoperable systems and processes for enhanced drug distribution security, as required under the DSCSA. The RFI also seeks information on the successes and strategies that trading partners have operationalized since the FDA’s issuance of its Stabilization Policy.
HDA asked the FDA to take an assertive and forward-leaning approach to lead the industry into the final phase of DSCSA implementation. Among the association’s recommendations, HDA asked FDA to:
1. Use the information collected from the RFI to promptly compose a comprehensive picture of supply chain readiness.
2. Acknowledge the reality of readiness in the supply chain and advise industry of FDA’s intention to use enforcement approaches following the end of the Stabilization Policy.
3. Commit to intensive communication strategies during the remainder of the Stabilization Policy, including the issuance of targeted “Dear Trading Partner” letters.
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