General information for licensed clinics, not legal, regulatory or medical advice.
This piece supports our complete guide to running a men's health or TRT clinic. We don't name or recommend specific pharmacies here. The goal is to help you check any pharmacy yourself.
What is a hormone or men's health compounding pharmacy?
It's a pharmacy that prepares customized medications, including hormone preparations, based on a prescription. Some focus on men's health or hormone therapy. Compounded drugs aren't FDA approved, which is why checking the pharmacy matters so much.
What's the difference between 503A and 503B?
- 503A pharmacies are state licensed and compound for individual patients based on a prescription. In North Carolina, the NC Board of Pharmacy licenses them, including out of state pharmacies shipping into the state.
- 503B outsourcing facilities register with FDA, follow current good manufacturing practice requirements and are inspected by FDA. They can produce larger batches.
FDA's compounding pages explain both in more detail.
How do you vet a compounding pharmacy?
Licenses
- Look up the pharmacy with the NC Board of Pharmacy.
- For 503B, confirm it's on FDA's registered outsourcing facility list.
- Check for public disciplinary actions or FDA warning letters.
Controlled substances
Testosterone and anabolic steroids are Schedule III controlled substances under DEA rules. Your counsel should confirm what that means for prescribing, storage and records in your clinic. Ask the pharmacy:
- Is it DEA registered for the schedules involved?
- How does it verify prescriptions and prescribers?
- How does it ship controlled substances?
Quality
- Ask for certificates of analysis and lot information.
- Ask about testing for potency, and for sterility and endotoxins on any injectable preparation.
- Ask how they handle recalls and notify clinics.
Service
- How do they handle shipping, packaging and temperature?
- Who do you call when something's wrong, and how fast do they respond?
- How do they handle prescriptions sent through your EMR?
What are the warning signs?
- Doesn't ask for a prescription or license
- Sells products labeled "for research use"
- Can't produce a license number or quality documents
- Pushes marketing claims about results
- Offers inducements tied to prescription volume
FDA's BeSafeRx page lists warning signs for online pharmacies, and they're a good gut check.
Should you search "near me"?
Location matters less than licensing. A pharmacy across town and a pharmacy across the country both need to be licensed to dispense in North Carolina. A nearby pharmacy can be convenient for pickups and relationships. Either way, the checks above apply.
How does this connect to single source supply?
Fewer suppliers means fewer pharmacies to vet and monitor. Testosterone is a controlled substance with its own federal and state requirements, so confirm its sourcing with your pharmacy and counsel. Other products, such as wellness items and supplies, can often be consolidated into one verified account. See why men's health clinics are moving to licensed single source supply.
Where does RevMed fit?
For the wellness side of your clinic, RevMed Shop lets verified clinics order equipment, diagnostics, peptides, consumables and wellness products from one account. For what's in its current catalog, ask RevMed directly once your clinic is verified. RevMed puts it this way: "One source, not ten. Fewer vendors means fewer markups, fewer minimums and less time ordering."
The plan:
- Open your clinic account through our Partner Link.
- Launch with RevMed's setup support, if you're adding a wellness line.
- Order from one source for wellness products.
Common questions
Are compounded hormones FDA approved?
No. Compounded drugs aren't FDA approved, which is why pharmacy verification matters.
Can an out of state pharmacy ship to our clinic?
Only if it's licensed to dispense into North Carolina. Check with the NC Board of Pharmacy.
How often should we recheck a pharmacy?
At least yearly, and any time something changes, such as a new product or a quality problem.
Do you recommend a specific pharmacy?
No. This guide is meant to help you check any pharmacy yourself.
Next step
Want simpler sourcing for your wellness products? Book a 15 minute intro, or open your clinic account.