FDA draft guidance for industry on drug product tracing
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry.
FDA is issuing these questions and answers to assist industry and State governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on State product tracing requirements and on standards, requirements, and regulations with respect to wholesale distributor and third-party logistics provider (3PL) licensing. Title II is also referred to as the Drug Supply Chain Security Act (Federal Register, 8 October 2014).
Click here for the announcement in the federal register.
Click here to download the draft guidance (154 kB).
Traceability is one of the subjects covered in the online NVC module Safety and pharmaceutical packaging.
This item is also included in our monthly overview, the NVC Members-only Update. If you have any questions, please contact us: info@nvc.nl, +31-(0)182-512411.