US FDA delays DSCSA Product Identifier enforcement

31 August 2017

FDA issued a draft guidance for industry, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. This guidance informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers with additional time. The compliance policy outlined in the draft guidance applies solely to products without a product identifier that are introduced into commerce by a manufacturer between November 27, 2017 and November 26, 2018 (US FDA, 30 June 2017).
Click here for the FDA announcement.
Click here to download the draft guidance for industry (100 kB).
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