Verbatim response from Claude
FDA & Compounded GLP-1s: What Happened
The Background
During the semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) shortage, the FDA allowed compounding pharmacies to legally make copies because drugs on the shortage list are exempt from rules prohibiting compounding of commercially available products.
What Changed
- Tirzepatide was removed from the FDA shortage list in late 2024
- Semaglutide was removed from the shortage list in early 2025
- Once removed, most compounding pharmacies had to stop producing these drugs — the legal basis disappeared
- The FDA set enforcement deadlines (tirzepatide ~March 2025, semaglutide ~April 2025)
Who Can Still Legally Compound
503A pharmacies (patient-specific) can still compound if:
- A prescriber documents a specific clinical need for a customized dose
503B outsourcing facilities had a slightly longer runway but also faced shutdown deadlines
Still Operating Legally (as of my knowledge)
- Hallandale Beach Pharmacy and similar 503A pharmacies for documented individualized needs
- Empower Pharmacy (503B, navigating compliance)
- Strive Pharmacy
⚠️ Important Caveat
This situation was actively evolving through 2025. I'd strongly recommend checking FDA.gov directly and consulting a licensed prescriber for the current legal status before purchasing.