The SAFE Drug Act: This is the one targeting Compounding GLPs Not Research

Derek Pruski

5h (edited) • General discussion

I've been digging through every piece of legislation I can find. This one is different.

The SAFE Drug Act was introduced November 19th and it's clearly written to kill compounded GLP-1s:

→ 20 compounded prescriptions per month. That's it. Total.

→ New definition of "essentially a copy" that captures almost every semaglutide and tirzepatide script

→ Mandatory FDA reporting for out-of-state compounding (aka the entire telehealth model)

→ 503B outsourcing facilities get hit with pharma-level oversight

→ Uncapped FDA fees

This is different from Import Alert 66-80. That one creates supply friction. This one makes the business model illegal.

BUT—and this is important—this still doesn't explain what's happening in the research space. This bill targets compounding pharmacies, not research companies. So why are vendors liquidating and pointing to 12/31?

There's something else out there I haven't found yet.

Full breakdown of every section of the bill 👇

https://open.substack.com/pub/derekpruski/p/the-safe-drug-act-the-compounding?r=4jq1x8&utm_campaign=post&utm_medium=web&showWelcomeOnShare=true

2:20

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