General information for licensed practices, not legal, regulatory or medical advice. Confirm requirements with your state boards and your counsel.
What is sterile compounding?
USP General Chapter <797>, as quoted by CDC, defines sterile compounding as "combining, admixing, diluting, pooling, reconstituting, repackaging or altering a drug or bulk drug substances to create a sterile medication." USP notes that medications required to be sterile "include those administered through injection, intravenous infusion (IV), intraocular (injection in the eye) or intrathecal (injection in the spine)."
One more fact clinic buyers should keep straight: per FDA, "Compounded drugs are not FDA-approved." That's why the quality of the pharmacy behind them matters so much.
What is a compounding pharmacy cleanroom?
A cleanroom is a controlled space where air quality, surfaces, people and workflow are managed to keep sterile preparations from being contaminated. In plain terms, USP <797> standards cover things like:
- Facilities and engineering controls, meaning classified clean areas and the hoods or isolators where compounding happens.
- Personnel training and garbing, including how staff gown and glove and how their technique is checked.
- Environmental monitoring, such as air and surface sampling on a schedule.
- Cleaning and disinfection routines for the space and equipment.
- Beyond-use dates, meaning how long a preparation can be used after it's made.
- Documentation, so every batch can be traced.
USP explains why this matters: compounded medications made without standards "may be sub-potent, super potent or contaminated."
What types of pharmacies will perform sterile compounding?
Two main types, with different oversight:
| State-licensed compounding pharmacy (often called 503A) | FDA-registered outsourcing facility (503B) | |
|---|---|---|
| Primary oversight | "Generally, state boards of pharmacy have primary responsibility for the day-to-day oversight" (FDA) | "Primarily overseen by FDA and inspected by FDA according to a risk-based schedule" (FDA) |
| Quality standard | State pharmacy law and rules (ask which USP chapters your state enforces) | Must comply with current good manufacturing practice (CGMP) requirements (FDA) |
| FDA inspections | FDA does "surveillance and for-cause inspections" | Risk-based schedule |
| Where to check | Your state board of pharmacy | FDA's list of registered outsourcing facilities |
Not every pharmacy does sterile work. Many compounding pharmacies make only non-sterile preparations, so ask directly. For how ordering differs between the two types, see our 503A vs 503B guide (coming soon; not linked until that page clears counsel review). We don't cover legal interpretation here.
What questions should a clinic ask before ordering sterile compounded products?
Use this vetting checklist:
Licensing and oversight
- Is the pharmacy licensed in its home state and permitted to ship into your state?
- Is it a state-licensed pharmacy, an FDA-registered outsourcing facility or both?
- When was its last state board or FDA inspection, and were any findings issued? Will it share how they were resolved?
- Does it hold any third-party compounding accreditation, and from which body?
USP <797> and the cleanroom
- Does it perform sterile compounding on site, and in what kind of classified space?
- How often does it run environmental monitoring, and what happens when a result is out of range?
- How are compounding staff trained, observed and requalified?
- How does it assign beyond-use dates?
Testing and documentation
- What testing is done on finished preparations (for example sterility and endotoxin), and are results available?
- Does each shipment include lot numbers and a certificate of analysis where applicable?
- How are products packed and shipped to protect temperature and sterility?
Recalls and communication
- How will you be notified of a recall, and how fast?
- Who is your contact for quality questions?
- Are pharmacists available to answer your practitioners' clinical questions?
A pharmacy that answers these clearly, in writing, is easier to trust. Vague answers are a signal to keep looking.
How does a single source change vetting?
Vetting one pharmacy is work. Vetting several for different product lines multiplies it. Through RevMed, clinics order from RevMed's licensed, vetted pharmacy and laboratory partners through one account. License and NPI verification means RevMed checks your clinic's license and each ordering practitioner's National Provider Identifier 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.
You should still ask your own questions, and we'll help you get answers. We're based in Raleigh, your local contact for questions and introductions. See how it works.
For the supply closet side, our med spa supplies checklist and IV therapy supplies guide cover what clinics usually keep on hand.
Common questions
Are compounded drugs FDA-approved?
No. FDA states, "Compounded drugs are not FDA-approved."
Who inspects compounding pharmacies?
State boards of pharmacy have primary day-to-day oversight of state-licensed pharmacies. FDA primarily oversees registered outsourcing facilities and inspects them on a risk-based schedule.
What is USP <797>?
It's the USP standard for sterile compounding. It covers facilities, engineering controls, personnel training, environmental monitoring, beyond-use dates and related practices.
Does every compounding pharmacy have a cleanroom?
No. Some only make non-sterile preparations. Ask whether sterile compounding is done on site.
How can I check whether a facility is a registered outsourcing facility?
FDA publishes a list of registered human drug compounding outsourcing facilities. The link is in the sources below.
Next step
Want help asking the right questions? Verified clinics order from RevMed's licensed, vetted pharmacy and laboratory partners through one account for the whole supply closet. Book a 15 minute intro, or open a verified account through our Partner Link.