Gottlieb: FDA May View State Drug Wholesaler Licensure As Fully Preempted Under DSCSA
US FDA Commissioner Scott Gottlieb says Congress intended to preempt all state licensure laws that were not identical to federal laws for licensing wholesalers and third-party logistics providers under the Drug Supply Chain Security Act.
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Highly anticipated proposed rulemaking from the FDA on licensing standards for wholesale distributors and third-party logistics providers has been repeatedly delayed, and the reasons for the delay are unclear. The rule is five years overdue under a DSCSA mandated timeline.
FDA's Draft Track and Trace Guidance Is Too Late As Serialization Systems Are Already In Place - Industry
The pharmaceutical industry sees many problems with US FDA’s draft guidance on product serialization to comply with the Drug Supply Chain Security Act of 2012, including requirements for “absolute uniformity.” Moreover, it’s coming out too late for companies that long ago set up serialization IT systems to comply with a November deadline.
As supply chain partners drill down into implementing the last phase of Drug Supply Chain Security Act serialization, they ask FDA for more clarity, and some relief, on exception handling for products with no serial numbers after full track-and-trace goes into effect.