What to ask so you know who is actually making your medication.
• Which specific pharmacy fills the prescription (named)?
• Is it 503A or 503B, and is its state license current?
• Is it independently accredited?
• Are per-batch potency/sterility/endotoxin results available?
• How is cold-chain shipping handled?
| What to know |
|---|
| Which specific pharmacy fills the prescription (named)? |
| Is it 503A or 503B, and is its state license current? |
| Is it independently accredited? |
| Are per-batch potency/sterility/endotoxin results available? |
| How is cold-chain shipping handled? |
The FDA resolved the tirzepatide (Dec 2024) and semaglutide (Feb 2025) shortages, and wind-down deadlines passed in 2025. On Apr 30, 2026 the FDA proposed excluding these drugs from the 503B bulks list; public comments are due by Jun 29, 2026. Patient-specific 503A compounding continues only narrowly, and cost alone is not a clinical need. Full regulatory status →
Compounded semaglutide and tirzepatide are not FDA-approved and are not the same as Wegovy, Ozempic, Zepbound, or Mounjaro. The FDA does not review compounded drugs for safety, effectiveness, or quality before marketing. Primary source: FDA — Human Drug Compounding.