FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements – FDA Law Blog

Wooden gavel sitting on law books“On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act (“DSCSA”) prior to May 2015. The guidance, states in relevant part:” . . .

Read the full article: via FDA Law Blog: In Keeping With the Spirit of the Season, FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements.

Read the FDA guidance: DSCSA Implementation: Product Tracing Requirements — Compliance Policy – FDA Guidance for Industry (PDF)


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