FDA Seizes Millions Worth of Unapproved New Drugs

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Updated January 31, 2021

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Guidance for FDA Staff and Industry Marketed Unapproved Drugs – Compliance Policy Guide

Sec. 440.100  Marketed New Drugs Without Approved NDAs or ANDAs 

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This makes me think twice. The FDA and US Marshals caught this one though, "Federal Agents Seize more than $24 Million in Unapproved New Drugs Products made after the FDA required an end to production." As a consumer, I wonder how many manufacturers simply ignore the regulations and get away with it. As a GMP trainer, this situation makes another good example to add to your gmp training war stories. Additional FDA-related resources related to this post:

1. Guidance for FDA Staff and IndustryMarketed Unapproved Drugs —Compliance Policy Guide
2. FDA cracking down on unapproved prescription drugs.(Practice Trends)(Food and Drug Administration): An article from: Internal Medicine News
3. Serious Problems With Generic Drug Makers In U.S. Continue To Be Discovered

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