Verbatim response from Claude
FDA & Compounded GLP-1s: What Happened
The Core Issue
The FDA declared semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) shortages officially over in early-mid 2025. Under federal law, compounding pharmacies can only make copies of brand-name drugs during official shortages.
What This Means
- 503B outsourcing facilities had to stop producing large-scale compounded semaglutide/tirzepatide
- 503A compounding pharmacies (which fill individual prescriptions) faced similar restrictions
- The FDA sent warning letters to pharmacies continuing to compound these medications illegally
Who Is Still Operating Legally
Legitimate options remaining:
- Hims & Hers - pivoted to FDA-approved branded versions and personalized/combination formulations (different legal pathway)
- Ro - similarly shifted toward branded medications
- LifeMD / Henry Meds - prescribing branded versions with manufacturer savings programs
- Nuvation/local 503A pharmacies - some still compound if they can demonstrate a specific patient need or use slightly altered formulations
Important Caveats
- This space changes rapidly — always verify current legal status
- Be cautious of any telehealth company still advertising cheap compounded semaglutide
- Manufacturer savings cards (Novo Nordisk, Eli Lilly) can significantly reduce branded drug costs
Always consult your doctor and verify a pharmacy's 503 status before purchasing.