FDA Enforcement Delay of Wholesale Distributor Verification Requirement for Saleable Returns – LSPediA

“The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product.

If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.”

Read the full source article:  FDA Enforcement Delay of Wholesale Distributor Verification Requirement for Saleable Returns – LSPediA

View the FDA final guidance document:  Wholesale Distributor Verification Requirement for Saleable Returned Drug Product — Compliance Policy – Guidance for Industry (PDF)


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

Share