FDA to Allow Grace Period for Drug Supply Chain Law's Product Tracing Requirements
Pharmaceutical manufacturers, distributors and repackagers will be given a four-month grace period before having to comply with product tracing requirements under the Drug Supply Chain Security Act (DSCSA), said the Food and Drug Administration in a guidance document issued Dec.…
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24 (here). Under DSCSA, “trading partners” are required to provide the next purchaser in the supply chain with product tracing information when engaging in transactions involving prescription drugs, and must maintain the information for at least six years after the relevant transaction. The product tracing requirements were set to take effect on Jan. 1, but in response to concern that “unforeseen complications” could disrupt the supply chain and impact patients’ access to needed prescription drugs, FDA will give manufacturers, wholesale distributors, and repackagers until May 1, 2015 before taking action against trading partners who are not in compliance, it said.