𝗛𝗮𝘀 𝘁𝗵𝗲 𝗙𝗗𝗔 𝗴𝗼𝗻𝗲 𝗼𝗻 𝘁𝗵𝗲 𝗪𝗔𝗥𝗣𝗔𝗧𝗛 𝗮𝗳𝘁𝗲𝗿 𝗰𝗼𝗺𝗽𝗼𝘂𝗻𝗱𝗲𝗱 𝗚𝗟𝗣-𝟭'𝘀?

Ten pages of warning letters dropped this week, possibly a record.

Most came from CDER under the headline:

"Unlawful Sale of Unapproved and Misbranded Drugs to U.S. Consumers Over the Internet."

𝗜 𝗱𝗶𝗱𝗻'𝘁 𝗮𝗻𝗮𝗹𝘆𝘇𝗲 𝘁𝗵𝗲𝗺 𝗮𝗹𝗹, 𝗯𝘂𝘁 𝗺𝗼𝘀𝘁 𝗹𝗲𝘁𝘁𝗲𝗿𝘀 𝘀𝗲𝗲𝗺 𝘁𝗼 𝗯𝗲 𝗯𝗮𝘀𝗲𝗱 𝗼𝗻 𝗙𝗗𝗔’𝘀 𝗿𝗲𝘃𝗶𝗲𝘄 𝗼𝗳 𝗰𝗼𝗺𝗽𝗮𝗻𝘆 𝘄𝗲𝗯𝘀𝗶𝘁𝗲𝘀. 𝗧𝗵𝗲 𝗺𝗮𝗶𝗻 𝗽𝗮𝘁𝘁𝗲𝗿𝗻 𝘀𝗲𝗲𝗺𝘀 𝗰𝗹𝗲𝗮𝗿:

-Online compounding pharmacies promoting compounded GLP-1s (Ozempic, Wegovy, Mounjaro, Zepbound)

-Claims that compounded versions are “the same as” or “similar to” FDA-approved brands

-FDA’s language is blunt: Misbranding. False equivalence. Unlawful sale

If this is true, then the message is unmistakable. FDA is drawing a line: compounded GLP-1s cannot be marketed as legitimate substitutes for branded drugs.

𝗧𝗵𝗮𝘁 𝗿𝗮𝗶𝘀𝗲𝘀 𝗽𝗿𝗲𝘀𝘀𝗶𝗻𝗴 𝗾𝘂𝗲𝘀𝘁𝗶𝗼𝗻𝘀:

-Where is the boundary between education and misbranding when describing compounded products?

-How should legitimate pharmacies and clinicians adjust their messaging to protect both themselves and their patients?

-Is this surge in letters a one-time sweep or the start of a new regulatory era?

From where I sit, this feels like a pivotal moment for the compounded GLP-1 market.

Has anyone seen the FDA issue this many letters for the same type of violations in a single update before, or is this a new chapter in enforcement? 

𝗔𝗻𝗱 𝘄𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝘁𝗵𝗶𝘀 𝗺𝗲𝗮𝗻 𝗳𝗼𝗿 𝗰𝗼𝗺𝗽𝗼𝘂𝗻𝗱𝗲𝗱 𝗚𝗟𝗣-𝟭'𝘀: 𝗶𝘀 𝘁𝗵𝗶𝘀 𝗷𝘂𝘀𝘁 𝗮𝗻 𝗮𝗱𝗷𝘂𝘀𝘁𝗺𝗲𝗻𝘁 𝘁𝗼 𝗰𝗼𝗺𝗽𝗼𝘂𝗻𝗱𝗶𝗻𝗴 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗶𝗲𝘀' 𝗺𝗮𝗿𝗸𝗲𝘁𝗶𝗻𝗴 𝗼𝗿 𝘄𝗶𝗹𝗹 𝘁𝗵𝗲 𝗿𝗲𝘀𝘂𝗹𝘁 𝗯𝗲 𝗮 𝗿𝗲𝘀𝘁𝗿𝗶𝗰𝘁𝗶𝗼𝗻 𝗼𝗳 𝗮𝗰𝗰𝗲𝘀𝘀 𝘁𝗼 𝗻𝗼𝗻-𝗯𝗿𝗮𝗻𝗱 𝗚𝗟𝗣-𝟭'𝘀?