More than a decade in the making, DSCSA compliance remains a work-in-progress for many across the pharmaceutical industry. Questions abound and authoritative answers can be hard to find. That’s what DSCSA Hub is all about. A panel of experts from across the industry gathered in one place to provide the vital answers that you need to continue your journey toward DSCSA compliance and beyond.
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Recent Answered Questions
Is it true that API (active pharmaceutical ingredient) sales are not regulated under DSCSA, and if so, does my partner, who only deals in API sales, need to pursue DSCSA compliance?
DSCSA requirements only apply to finished goods. If your company purchases APIs to create the finished drug, that is the point wher it become DSCSA traceable.
Does the recent FDA update on DSCSA readiness exceptions for small dispensers apply to wholesalers, or just dispensers/pharmacies selling to end-users? If a dispenser engages in wholesale, must they adopt DSCSA compliance now or can they wait until 2026?
The FDA has stated that any company can apply for a WEE, however you should not stop your work to be compliant by November, 27, 2024.
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