Before ordering from a compounding pharmacy, confirm its state license or FDA registration, ask for a Certificate of Analysis and sterility testing practices, check its inspection history, confirm it can legally ship to your state, and make sure each order comes with documentation.
A ten-point checklist
- Active license. Verify a 503A pharmacy with your state board of pharmacy.
- FDA registration. Confirm a 503B outsourcing facility appears on the FDA's list of registered outsourcing facilities. See the FDA's outsourcing facility registration Q&A.
- Inspection and recall history. Review the FDA's page on compounding inspections, recalls and other actions.
- Nonresident licensure. A pharmacy shipping into your state generally needs that state's license. Ask which states it holds.
- Certificate of Analysis. Ask for a COA for the products you order.
- Sterility and endotoxin testing. For injectables, ask how and how often products are tested.
- Quality standard. 503B facilities work under cGMP. Ask what standards a 503A pharmacy follows.
- Ingredient sourcing. Ask where active ingredients come from and whether suppliers are FDA-registered.
- Labeling and dating. Labels should identify the product as compounded and show lot and beyond-use dating.
- Shipping and support. Ask about cold-chain handling, turnaround time and who you call when an order is late.
Red flags
- No license or registration number you can verify
- Products sold "for research use only" to practices. These are not intended for human use and are not made by licensed pharmacies.
- Reluctance to provide a COA or testing information
- Claims that a compounded product is FDA-approved
Why a consortium can help
Vetting pharmacies one by one takes time. Working through a consortium of licensed 503A and 503B pharmacies lets you compare sources in one place and keeps documentation consistent. Read more in our 503A vs 503B guide or see compounding pharmacy for med spas.