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FDA Gives Drug Makers One-Year Reprieve From DSCSA Product Identifier Requirement

 
• By Joanne S. Eglovitch

FDA will not take enforcement action against pharmaceutical manufacturers that miss this year’s serialization deadline under DSCSA. Enforcement won't begin until a year later. The serialization requirement is the second wave of a three-part system for tracking and tracing pharmaceutical products through the supply chain to thwart drug counterfeiters.

FDA will give pharmaceutical manufacturers an extra year before penalizing them for failing to meet a Nov. 27 Drug Supply Chain Security Act (DSCSA) deadline for starting to affix individual pharmaceutical packages with a unique serial code to allow tracking shipments to US dispensers, the agency said June 30.

This action was prompted by industry complaints on their lack of readiness to meet the legislation's product identifier requirement. The...

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