FDA Issues Guidance on Prescription Drug Products

 

Last month, the U.S. Food and Drug Administration (FDA) issued this guidance to help ensure prescription drug products were identified and traced properly as they move through the supply chain:

 

Draft Guidance

Product Identifiers Under the Drug Supply Chain Security Act - Questions and Answers

Federal Register Notice

Final Guidance

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry

Federal Register Notice

Final Guidance

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

Federal Register Notice

 

This guidance is in compliance with the Drug Supply Chain Security Act.

 

Additionally, FDA created a decision tree to help trading partners determine whether a drug package or homogenous case should have a product identifier or if the package or case is considered grandfathered. This graphic walks through the scenarios for each trading partner – a manufacturer or repackager selling a product; a repackager buying a product; or a wholesale distributor or dispenser buying or selling product – and whether a product packaged by 11/27/2018 with or without a product identifier can continue moving through the supply chain.

 

If you have any questions, please send them to drugtrackandtrace@fda.hhs.gov.

 

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