Compounding is a licensed pharmacy preparing a medication for an individual patient — a different strength, a different form, or without an ingredient the patient reacts to. It is legal, long-established, and genuinely necessary in many situations.
What compounding is not
Compounded drugs are not FDA-approved. The agency does not review them for safety, efficacy or manufacturing quality the way it reviews a commercial product. That is the central trade-off, and it should be stated plainly rather than buried.
503A and 503B
Traditional compounding pharmacies operate under section 503A and prepare medications for individual patients with a prescription. Outsourcing facilities under 503B produce larger batches, register with the FDA, and follow current good manufacturing practice standards.
503B facilities are held to a higher manufacturing standard. Where a treatment is available from one, that's our preference.
What to require from any provider
- The name and state license number of the pharmacy preparing your medication.
- Third-party potency testing by lot, available on request.
- Sterility testing for anything injectable.
- A certificate of analysis matching the lot number on your vial.
- Clear labeling of beyond-use dates and storage requirements.
Why compounded GLP-1s exist
During a declared drug shortage, compounding of a commercially available drug is permitted under specific conditions. Those conditions change as shortage status changes, which is why this corner of the market shifts quickly and why your provider should be able to explain their current legal basis without hedging.