FDA Issues Guidances on Prescription Drug Identifier Requirements

September 21, 2018

The FDA released a trio of guidances on Drug Supply Chain and Security Act (DSCSA) requirements for drugmakers to attach identifiers to their prescription drugs.

A final guidance, the Product Identifier Requirements Under the Drug Supply Chain Security Act, notes that the agency pushed back the original enforcement date for product identifiers a year to Nov. 27, 2018, to minimize possible disruptions in distribution of prescription drugs. The delay was a response to feedback from stakeholders who ran into challenges, such as incapable and unready contract facilities, when trying to implement the product identifier requirements.

A separate final guidance, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier, outlines exemptions from certain requirements. It says that packages and homogenous cases of product without identifiers are exempt or grandfathered if documentation shows they were packaged or repackaged before the Nov. 27 effective date.

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