FDA publishes Q&A on DSCSA provisions

FDA websiteThe FDA has published a draft question-and-answer document to help guide the implementation of the US's traceability system for medicines.

The guidance - which is aimed at wholesalers and third-party logistics (3PL) companies - is the latest information from the US regulatory on the Drug Supply Chain Security Act (DSCSA) and is open for comment until December 8.

The DSCSA - also known as Title II of the Drug Quality and Security Act (DQSA) - was adopted last year and lays out a schedule for the introduction of a track-and-trace system for pharmaceutical products.

The primary objective of the DSCSA is to introduce full traceability for medicine packs through the supply chain within 10 years, with a requirement for all drug packages to carry a unique serial number within four years.

It requires the FDA to develop a series of guidance documents to aid in the implementation of the system, and the latest document comes after earlier guidance on issues such as the handling of suspect illegitimate drugs.

"The DSCSA … requires FDA to establish federal standards for licensing of wholesale drug distributors and 3PL providers," according to a notice detailing the new Q&A document on the Federal Register.

The main thrust of the document is to reiterate that the federal scheme envisaged under the DSCSA pre-empts any state initiatives on medicines traceability, wholesaler licensing and 3PL standards and licensing, and starts to come into effect from January 1, 2015. It also makes it explicitly clear that 3PLs cannot be licensed as wholesale drug distributors.
A full list of all forthcoming guidance, and a timeline for completion, can be viewed on the FDA's website.

Image courtesy of:
Gil C /

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