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When a telehealth provider says your GLP-1 comes from a “licensed compounding pharmacy,” it usually means one of two kinds of facility, named after sections of the Federal Food, Drug, and Cosmetic Act.
Side by side
| 503A pharmacy | 503B outsourcing facility | |
|---|---|---|
| What it is | A state-licensed pharmacy (or physician) compounding for individual patients | A facility that registers with FDA as an outsourcing facility |
| Needs a patient-specific prescription? | Yes | No (can make batches) |
| Primary oversight | State boards of pharmacy | FDA, including inspections |
| Manufacturing standard | State and USP standards | Federal CGMP requirements |
| Product FDA-approved? | No | No |
What each can do with GLP-1s in 2026
- 503A: may compound semaglutide or tirzepatide for an individual patient with a prescription. It may not regularly compound “essentially copies” of a commercially available drug unless a prescriber documents a significant difference for that patient.
- 503B: may use bulk ingredients only if they’re on the 503B bulks list or the drug is on FDA’s shortage list. FDA says semaglutide and tirzepatide are on neither right now.
Why it matters to you
- Ask your provider which pharmacy fills your prescription and whether it’s 503A or 503B.
- For a 503A pharmacy, verify its license with your state board of pharmacy.
- For a 503B facility, FDA keeps a public list of registered outsourcing facilities.
- Either way, the medication is not FDA-approved. FDA hasn’t reviewed it for safety, effectiveness, or quality.
Want help evaluating a provider? Use our 9-point checklist.
Sources
- FDA: Compounding laws and policies
- FDA: Information for outsourcing facilities
- FDA: Clarifies policies for compounders (updated Apr 1, 2026)
We cite primary sources (FDA, peer-reviewed journals, provider sites) wherever we can, and we date every price. Found an error? Tell us and we'll fix it.
This article is for information only and isn't medical advice. Talk with a licensed clinician before starting, stopping, or changing any medication. Individual results vary, and no outcome is guaranteed.