GLP-1 Updates
FDA GLP-1 Announcement — What It Means for You
TLDR
The FDA issued a broad statement following an aggressive move by a large telehealth company involving compounded GLP-1 medications. No new bans or rules are in place today, but the situation signals a shifting regulatory landscape. Compounded GLP-1s remain legal for now. Patients should stay informed, use reputable providers, and understand branded alternatives.
Source: FDA public announcement
Hi everyone — Dr. Michel here. We’ve received dozens of questions overnight about the FDA’s latest announcement regarding compounded GLP-1 medications. Here’s what actually happened, what it means, and what patients should know — calmly and clearly.
What Happened
- Thursday: A major telehealth company announced it would sell compounded copies of Novo’s newly approved oral Wegovy pill for $49/month — just six weeks after FDA approval.
- Friday: Novo Nordisk threatened legal action.
- Shortly after: The FDA issued a statement about restricting GLP-1 APIs for non-approved compounded drugs, and HHS referred the company to the DOJ for investigation.
The Broader Concern
This aggressive move by one company appears to have triggered a regulatory response that could impact the entire compounding industry. Until now, the space had been relatively stable, with legitimate pharmacies operating within existing law and patients receiving medications.
What We Know So Far
- The FDA’s language is broad and references restricting GLP-1 APIs intended for non-approved compounded drugs.
- This technically includes compounded semaglutide and tirzepatide.
- If API access is restricted, even legitimate pharmacies could be affected.
- The broader regulatory environment has been increasingly favorable to branded manufacturers.
What to Keep an Eye On
- This is a statement of intent, not a new regulation or ban.
- No new rules, deadlines, or enforcement timelines have been announced.
- 503A and 503B compounding with valid prescriptions remains legal today.
- Any enforcement would require DOJ involvement, which takes time.
The Bottom Line
Compounded GLP-1 medications are unlikely to disappear overnight — but the industry is evolving. We will continue to monitor developments and update patients as new information becomes available.
What You Should Do Now
- Stay informed and avoid panic decisions
- Work with reputable, transparent providers
- Understand your branded GLP-1 options
- Check insurance formularies and manufacturer savings programs
- Discuss a backup plan with your healthcare provider
— Dr. Michel
