If your clinician writes a compounded hormone, you are not walking into a regular pharmacy. The preparation was mixed for a prescription. FDA has not reviewed that finished bottle the way it reviews an approved patch, tablet, or gel. This page is how to ask questions before you swallow, rub on, or inject it.
Key facts
- Compounded drugs are not FDA-approved. The agency does not review their safety, effectiveness, or quality before they are marketed.13
- When a patient can use an available FDA-approved drug, FDA recommends that practitioners prescribe that drug rather than a compounded one.2
- A facility that registered as an outsourcing facility has sent FDA its paperwork. Registration means only that FDA received the information. It does not mean the drugs are approved, and it does not mean the facility is in compliance with current good manufacturing practice.2
- If a compounded drug is contaminated or contains too much active ingredient, FDA says it can cause serious injury or death. Labels may also omit directions that help people use the drug safely.1
- This site does not pick a pharmacy for you and does not send you to open an account.
What is in the bottle
FDA describes compounding as a licensed pharmacist or physician (or, at an outsourcing facility, someone under a pharmacist’s supervision) combining, mixing, or altering ingredients to make a medication tailored to one patient.3 That can mean a dose that is not sold as a finished product, a cream instead of a pill, or a version without a dye you react to. It is also why the bottle skipped the approval path that branded estradiol patches and testosterone products went through.
Compounded drugs can serve an important medical need for certain patients. They also pose risks. If your clinician cannot say why an approved product will not work, that is the first question. FDA’s line is the other way around: use the approved drug when it will do.23
What FDA registration covers
An outsourcing facility under section 503B compounds sterile drugs (and may also compound non-sterile ones), elects to register with FDA, must have a licensed pharmacist supervise the compounding, and may or may not have a named patient’s prescription in hand.2
Registration is facility-specific. A recent satisfactory FDA inspection gives some assurance about conditions at that moment. FDA calls inspections a snapshot. Conditions can change.2
Ask which shop made your prescription, and who licensed the building. A logo on a shipper box is not a license.
Questions that change the answer
- What is the pharmacy’s legal name, city, and state license number? Check the state board of pharmacy.
- Did a registered outsourcing facility make this? If they say they registered with FDA, that still is not an approval stamp.2
- Why is this not an FDA-approved product? Get a reason you can repeat: dose, form, allergy, shortage. “Bioidentical” is not a reason.
- Who tested the batch, and will they show you the result? If they will not show anything, believe that.
- If it is sterile (an injection, a pellet, an implant), who is allowed to handle it?
- What happens if you feel worse? Ask who you call, and who they call.
What we are not claiming
- We do not name a compounding pharmacy, a pellet brand, or a “My Account” signup.
- We do not say compounded hormones are safer, more natural, or more precise than approved products. That claim needs trials the finished compound does not have.
- We do not walk through dosing, stacks, or where to buy.
- We do not treat “FDA registered” as a quality grade. FDA says the paperwork only means they received it.2
If you came here about the hormones themselves, start with menopause or testosterone. Those pages grade the evidence. This one only grades the bottle.
FAQ
My clinician said the pharmacy is “FDA registered.” Does that mean the cream is approved?
No. FDA says registration means they received the facility’s paperwork. It does not mean the drugs are approved, and it does not mean the facility is in compliance with current good manufacturing practice.2
Should I refuse compounded hormones?
Not automatically. FDA’s own sentence is narrower: if an approved drug can meet the need, use that. If it cannot, you still get to ask who made yours and how they know what is in it.2
Why does FDA keep saying compounded drugs can be risky?
Because they skip premarket review. If the batch is contaminated or contains too much active ingredient, the agency says that can cause serious injury or death. Labels may also leave off directions that help people use the drug safely.1