- FDA-approved?
- No
- 503A pharmacies
- Overseen mainly by state boards of pharmacy
- 503B outsourcing facilities
- Registered with FDA; must follow CGMP
- Same as a generic?
- No
Compounding in plain terms
Compounding means a pharmacist combines, mixes or alters ingredients to create a medication tailored to an individual patient. Classic examples include making a version of a drug without a dye someone is allergic to, or turning a tablet into a liquid for someone who cannot swallow pills.
Compounding is legal and long-standing. But it sits outside the FDA drug approval system. Federal law lets certain compounded drugs be sold without going through approval, which means nobody outside the pharmacy has checked a compounded product's safety, effectiveness or quality before it reaches you.
Not FDA-approved, and not a generic
An FDA-approved drug, branded or generic, has been reviewed by the FDA for safety and effectiveness for specific uses, and its manufacturing is held to federal standards. A generic is approved because it was shown to match the brand.
A compounded drug is neither. Compounded semaglutide is not Wegovy or Ozempic. Compounded tirzepatide is not Zepbound or Mounjaro. Results from the clinical trials of approved products do not automatically carry over to compounded versions, which may differ in ingredients, salt forms, strength or formulation.
503A pharmacies versus 503B outsourcing facilities
Federal law describes two kinds of compounders, named after sections of the Federal Food, Drug, and Cosmetic Act:
- 503A pharmacies compound for identified individual patients based on a prescription. State boards of pharmacy have primary day-to-day oversight. The FDA can inspect them, often in response to a problem, but they are not required to follow current good manufacturing practice (CGMP).
- 503B outsourcing facilities choose to register with the FDA, are inspected on a risk-based schedule, must follow CGMP and must report adverse events to the FDA. They can make larger batches.
Why a clinician might prescribe a compounded drug
There are legitimate reasons: a strength or dosage form that no manufacturer makes, a formulation without an ingredient you react to, a combination in a single preparation, or a hormone dose that approved products do not offer. Cost and availability can also be factors.
Your clinician should be able to explain why a compounded option was chosen for you and what FDA-approved alternatives exist. Choosing an approved product is always a valid option to discuss.
The risks to weigh
Because compounded drugs are not reviewed before sale, quality depends heavily on the pharmacy's practices. 503A pharmacies are not required to follow the manufacturing standards that apply to approved drugs, although federal rules against insanitary conditions still apply to every compounder. For compounded GLP-1 medications, the FDA has received reports of adverse events, some requiring hospitalization, linked to dosing errors, including mistakes in measuring doses from multi-dose vials.
Some substances face added restrictions. The FDA keeps lists of bulk ingredients that 503A pharmacies may or may not use, and in 2026 an FDA advisory committee reviewed several popular peptides. Advisory votes are not final decisions, so a substance's status can be in flux.
How HealifyMD handles compounded prescriptions
When a clinician prescribes a compounded medication through HealifyMD, the prescription goes to a licensed U.S. pharmacy, and the product is labeled for you as an individual patient. Every treatment page that involves a compounded product says so, and we do not describe compounded products as FDA-approved or as equivalent to a brand.
Your clinician also monitors you as they would with any prescription: checking side effects, ordering labs where the treatment calls for them and adjusting or stopping treatment when it is not helping. If you would prefer an FDA-approved product, say so. Some HealifyMD programs, such as our weight loss program membership for people on branded GLP-1 medications, are built around approved drugs.
"Research use only" is a different thing entirely
Products sold online as "research chemicals" or "not for human use" are not compounded medications. They are not prepared by a licensed pharmacy for a patient, and their contents are unverified. HealifyMD prescriptions are filled only by licensed U.S. pharmacies.
Questions worth asking about any compounded prescription
- Is there an FDA-approved product that would work for me, and why are we not using it?
- Which pharmacy will prepare it, and is it a 503A pharmacy or a 503B outsourcing facility?
- What exactly is in it, including the salt form and any added ingredients?
- How should it be stored, and how do I measure each dose accurately?
- What side effects should I report, and how will we know if it is working?
| Question | FDA-approved brand or generic | Compounded medication |
|---|---|---|
| Reviewed by FDA before sale | Yes | No |
| Proven safe and effective for its labeled use | Shown in data reviewed by FDA | Not evaluated by FDA |
| Who makes it | Manufacturer under FDA oversight | 503A pharmacy or 503B outsourcing facility |
| Batch quality standard | Current good manufacturing practice (CGMP) | CGMP for 503B; state pharmacy standards for 503A |
| Can trial results be applied to it? | Yes, for that product | No; trial data belongs to the approved product |
Common questions
Is a compounded medication safe?
It can be prepared carefully, but the FDA has not reviewed compounded drugs for safety, effectiveness or quality, so the risk depends partly on the pharmacy and on how the drug is used and monitored.
Is compounded the same as bioidentical?
No. Bioidentical describes a hormone's chemical structure, while compounded describes how a product was made; FDA-approved bioidentical hormones exist too.
Is compounded semaglutide the same as Wegovy?
No. Wegovy is an FDA-approved product; compounded semaglutide is not FDA-approved and has not been shown to be equivalent.
Are compounded medications cheaper?
Sometimes, but price alone is not a reason to choose one. Ask your clinician about the trade-offs, including FDA-approved options.
How can I check a pharmacy?
Ask your care team which pharmacy fills your prescription. The FDA's BeSafeRx resources explain how to look up a state-licensed online pharmacy.
Can I report a problem with a compounded drug?
Yes. Tell your clinician, and you can report adverse events or quality problems to the FDA's MedWatch program.
Does insurance cover compounded drugs?
Often not. HealifyMD prices are self-pay; check with your plan if you want to know about reimbursement.
Sources
We cite government agencies, professional societies and peer-reviewed research. See our editorial policy.
- Compounding and the FDA: Questions and AnswersU.S. Food and Drug Administration
- Information for Outsourcing FacilitiesU.S. Food and Drug Administration
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration
- MenopauseU.S. Food and Drug Administration
- BeSafeRx: Your Source for Online Pharmacy InformationU.S. Food and Drug Administration