Questions to Ask About a Compounding Pharmacy

What should you ask a compounding pharmacy before you use its medicine?

If you feel unwell after any dose, contact your prescriber or pharmacist, and call emergency services if you think it is an emergency. Do not wait to finish a checklist.

Compounded drugs are not FDA-approved. FDA says it does not verify their safety, effectiveness, or quality before they are marketed. 1 That makes the pharmacy itself the thing worth checking. This page is a list of questions to put to the pharmacy, or to the provider that works with it. It is not a judgment of any one pharmacy, and it does not tell you whether a compounded medicine is right for you. That is a conversation for your prescriber. For the difference between compounded and brand-name medicines, see compounded vs. brand-name GLP-1 medicines.

Is the pharmacy licensed, and does it follow the rules for online pharmacies?

FDA’s BeSafeRx guidance says a legitimate online pharmacy requires a prescription from a licensed health care professional, is licensed by the state board of pharmacy in your state and the state where it operates, provides a physical address in the United States, and has a state-licensed pharmacist available to answer your questions. 3

Ask for the pharmacy’s legal name, address, and phone number, then check each point above yourself. A pharmacy that will not give you these details has answered your question.

Who compounded your exact product, and is it a 503A pharmacy or a 503B outsourcing facility?

Start with the facility that prepared the product in your hands. It may be the pharmacy that dispenses it or a different one, so ask for its name and check its status, not only the dispensing pharmacy’s. The two kinds of facility are overseen differently. FDA says drugs made in outsourcing facilities must follow current good manufacturing practice (CGMP) requirements, while drugs compounded in state-licensed pharmacies or by physicians under section 503A do not face the same standards. State boards of pharmacy handle day-to-day regulation of state-licensed pharmacies, and FDA inspects registered 503B outsourcing facilities on a risk-based schedule. 1

Neither label makes a compounded drug FDA-approved. Ask which one applies to the compounding facility and who oversees it. Then ask your prescriber whether that difference matters for your prescription.

Why was a compounded product chosen over an approved one?

FDA’s position is that compounded drugs should be used only when a patient’s medical need cannot be met by an FDA-approved drug. 2 This question belongs with your prescriber more than the pharmacy: “What is the specific reason for my prescription, and which approved options did we consider?” If the honest answer is mainly price, say so and ask for the whole picture. Our GLP-1 cost guide lays out the financial questions.

Which questions should you ask, and who should answer?

Question	Ask	What a clear answer sounds like
What is your legal name and state license?	Pharmacy	A name and address you can look up with the state board
Which facility compounded this exact product, and is it a 503A pharmacy or a 503B outsourcing facility?	Pharmacy	The facility’s name, which of the two it is, and who oversees it
Who is the pharmacist I can call?	Pharmacy	A named, state-licensed pharmacist and a working phone number
What does each line of the label mean?	Pharmacist	A walk-through of the product name, concentration, and directions, read against the actual device
How long can an opened vial be used?	Pharmacist	A specific date rule written on or with the product, checked against FDA’s guidance below
What if my delivery arrives warm or damaged?	Pharmacy	A named person to call and a stated plan, before you use anything
Why this preparation for me?	Prescriber	A reason tied to your own assessment, not to what the company sells
Where do I report a problem?	Pharmacy and prescriber	Both of them, plus FDA MedWatch

Take notes during the call and keep them with the label.

What should the label and storage instructions tell you?

Ask the pharmacist to read the label, the device, and the written directions together and confirm they agree. If any of them is unclear or inconsistent, resolve that before you use the product. Use your own product’s instructions and your prescriber’s guidance, never someone else’s.

On storage, FDA advises patients using multiple-dose vials to discard the vial within 28 days after first use, even if medication remains. 2 Put the date you open each vial in your records. If a delivery arrives in a state you did not expect, contact the pharmacy or your care team before using it.

What should you do if something looks wrong?

Contact the pharmacy and your prescriber first, with the label in front of you. FDA’s MedWatch program accepts reports from the public about problems with prescription medicines through its “Report a Problem” button. 4 FDA has said it received reports of adverse events, some requiring hospitalization, that may be related to dosing errors with compounded injectable semaglutide. 2 A written note of what arrived makes any report more useful.

Our care plan checklist covers what your provider should put in writing, and how to choose an online provider covers the provider side of the same decision.

Common questions

Is a licensed pharmacy the same as an approved medicine?

No. A pharmacy’s license is not an FDA approval of its compounded products. FDA states compounded drugs are not FDA-approved. 1

Can I ask my provider which pharmacy fills my prescription?

Yes. You can ask for the pharmacy’s name and contact details at any time. Keep them with your prescription.