FDA Issues Draft Guidance Addressing Delayed Enforcement of DSCSA Requirements Related to Product Identifiers – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
FDA issued a draft guidance for industry that informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on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, FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions. The compliance policy outlined in the draft guidance, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy, applies solely to products without a product identifier that are introduced into commerce by a manufacturer between November 27, 2017, and November 26, 2018. While manufacturers work to meet product identifier requirements, they must comply with other Drug Supply Chain Security Act (DSCSA) requirements, indicates FDA’s website. Before FDA begins work on the final version of the guidance, the agency is accepting either electronic or written comments by September 1, 2017, which may be submitted following the instructions provided in the Federal Register.