Verbatim response from Claude
FDA & Compounded GLP-1s: What Happened
The Short Version
The FDA declared semaglutide (Ozempic/Wegovy) no longer in shortage in early 2025, which triggered a legal requirement for compounding pharmacies to stop making copies of it. A similar ruling applied to tirzepatide (Mounjaro/Zepbound).
Deadlines passed in early-to-mid 2025, meaning most compounders had to wind down or pivot.
Who Is Still Operating Legally
503A pharmacies (patient-specific compounding) can still legally compound if:
- A patient has a documented clinical difference needed (different dose, allergy accommodation, etc.)
- It's prescribed individually — not mass-produced
Legitimate options still operating within the rules:
- Hims & Hers – shifted to FDA-approved branded drugs or specific compounded formulations with clinical justification
- Ro – similar pivot to branded medications
- Henry – offering branded GLP-1s with telehealth support
- Nuvation/local 503A compounding pharmacies – with proper individual prescriptions
⚠️ Red Flags to Avoid
- Anyone still selling bulk compounded semaglutide cheaply without individual clinical justification is likely operating illegally
- Watch out for "peptide" loopholes being marketed aggressively
Bottom line: Work with a licensed telehealth provider who prescribes branded medications or has documented clinical rationale for compounding.