FDA publishes Q&A on DSCSA provisions – SecuringIndustry.com

FDA Logo in blue“The 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.”

Read the full article: via SecuringIndustry.com – FDA publishes Q&A on DSCSA provisions.

View the FDA’s draft guidance: The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers – FDA Draft Guidance For Industry (PDF)

Go to DREprof.com: The Designated Representative and Exemptee Training Website


Tags: , , , , , , , , , , , , , , ,