General information for licensed practices, not legal, regulatory or medical advice. Every clinical decision rests with your clinic's licensed provider.
This piece supports our complete guide to licensed, single source clinic sourcing.
What does a compounding pharmacy do?
Compounding is the practice of combining, mixing or altering drug ingredients to create a medication tailored to a need, for example a different strength or a form without a certain inactive ingredient. FDA describes compounding and its limits in Compounding and the FDA: questions and answers.
One point every buyer should know: compounded drugs are not FDA approved. FDA does not review them for safety, effectiveness or quality before they are sold. That is why the license and registration behind the source matter so much.
What is the difference between a 503A pharmacy and a 503B outsourcing facility?
The names come from sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. At a buyer level:
| 503A compounding pharmacy | 503B outsourcing facility | |
|---|---|---|
| Who oversees it | Mainly the state board of pharmacy | Registered with FDA and inspected by FDA |
| How it fills orders | For an identified individual patient, based on a prescription | May compound with or without a patient specific prescription |
| Quality standard | State rules and United States Pharmacopeia (USP) compounding standards | Current good manufacturing practice (CGMP) requirements |
| Office stock | Federal 503A conditions are tied to patient specific prescriptions; ask counsel and your state board | FDA describes office stock as an example of orders a 503B may fill; confirm with counsel |
| How to check it | State board of pharmacy license lookup | FDA's list of registered outsourcing facilities |
FDA's information for outsourcing facilities sets out 503B obligations in more detail. Our Week 21 piece, 503A vs 503B: what clinics need to know before ordering (coming soon), goes deeper on office stock.
Can a pharmacy compound a commercially available product?
Generally, not as a routine copy. Federal law limits a 503A pharmacy from compounding regularly or in inordinate amounts drugs that are essentially copies of a commercially available drug, and 503B facilities face similar limits on copies of approved drugs. FDA's human drug compounding pages explain the exceptions, such as a prescriber's documented determination of a significant difference for an identified patient, or a drug on FDA's shortage list. Whether a compounded product fits a patient is your provider's decision.
What should a clinic check before buying from a compounding pharmacy?
A short buyer checklist:
- License or registration. Confirm the state pharmacy license, or FDA registration for a 503B, and that it covers shipping into your state. In North Carolina, start with the NC Board of Pharmacy.
- Prescription rules. Know whether each order needs a patient specific prescription or can be office stock in your state.
- Paperwork. Ask how lot numbers, certificates of analysis and beyond use dates are documented. See our piece on certificates of analysis and batch traceability for what to ask.
- Storage and shipping. Confirm how temperature sensitive items are packed and what your team checks on receipt.
- Verification of your clinic. A legitimate source verifies your license and each ordering practitioner's NPI (National Provider Identifier, a unique ID you can look up in the CMS NPI Registry).
- No "research use only" product. Material labeled for research use is not sold for clinical use.
Red flags when buying compounded products
- No license number you can verify, or a license that doesn't cover your state.
- Willing to ship prescription items without verifying your clinic or provider.
- "Research use only" or "not for human consumption" labels.
- Claims that a compounded product is "FDA approved."
How do clinics buy compounded products through RevMed?
Clinics that order through RevMed open an account on the RevMed Portal, RevMed's online ordering account for verified practices. Through RevMed, products come from RevMed's licensed, vetted pharmacy and laboratory partners. License and NPI verification happens before you can order. Prescription and compounded products are dispensed only against a valid prescription or order from a licensed practitioner, and product availability may vary by state.
These are cash pay services. Your clinic pays for its own orders directly. RevMed describes the account as "one login, one invoice, and reorders on your schedule instead of a dozen vendor portals."
Our role is to help you open that account through our Partner Link, the referral link that opens your Portal account and connects it to us. We're based in Raleigh, your local contact for questions and introductions. See how it works for the steps.
Common questions
Are compounded medications FDA approved?
No. Compounded drugs are not FDA approved. FDA does not review them for safety, effectiveness or quality before sale, so check the source's license or registration.
Is a 503B outsourcing facility better than a 503A pharmacy?
Neither is better in general. They are regulated differently and fit different ordering needs. Which suits your clinic depends on your state, your ordering model and your provider.
Can a clinic keep compounded products as office stock?
It depends on the source type, federal rules and your state. Ask your counsel and state board before keeping any compounded product on the shelf.
How do I check a compounding pharmacy's license?
Use your state board of pharmacy's license lookup. For a 503B, also check FDA's list of registered outsourcing facilities.
How do clinics pay for compounded products ordered through RevMed?
These are cash pay services. Your clinic pays for its own orders directly.
Next step
Want one licensed source behind your compounded orders? Book a 15 minute intro, or open a verified account through our Partner Link.