Verbatim response from Claude
FDA and Compounded GLP-1s: What Happened
The Background
During the semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) shortages, the FDA allowed compounding pharmacies to legally produce these drugs. This opened up a large market of lower-cost alternatives.
What Changed
The FDA declared the semaglutide shortage officially resolved in early 2025 and the tirzepatide shortage resolved in late 2024/early 2025, which triggered deadlines for compounders to stop production:
- 503B outsourcing facilities faced earlier cutoff deadlines
- 503A pharmacies (patient-specific prescriptions) faced phased deadlines into 2025
- The FDA sent warning letters and took enforcement action against many operations
Who Is Still Operating Legally (as of mid-2025)
The landscape shifted significantly. Generally still permissible:
- 503A compounding pharmacies filling individualized prescriptions with specific clinical justifications
- Telehealth platforms that pivoted to FDA-approved branded drugs include Hims & Hers, Ro, and Noom
Important Caution
This situation is rapidly evolving. I'd recommend checking:
- FDA.gov for current shortage status
- A licensed prescriber for your specific options
Always verify any pharmacy's 503A/503B status before purchasing.