Lack Of Readiness In Responding To DSCSA Verification Requests Major Concern
Roughly half of all pharmaceutical manufacturers have misgivings they will have the necessary systems to electronically verify saleable returns under DSCSA, even though they must respond to these requests within 24 hours.
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In draft guidance on evolving drug product tracking program, the US FDA gives thumbs-up on distributed or semi-distributed architecture for data security; support for aggregation and inference; a one-minute bar for verification.
Pharmaceutical manufacturers should have already begun serializing products and verifying saleable returns to comply with DSCSA, says FDA official who also asserted that licensing standards for wholesale distributors and third-party logistics providers will be forthcoming. This rule is already six years overdue under a DSCSA mandated timeline.
Wholesalers are given three more years to set up electronic systems to verify saleable returns under another reprieve from the FDA. Yet the reprieve does not extend to manufacturers, who must respond within 24 hours to wholesalers’ requests to manually verify that a returned product is not suspect.