- FDA-approved?
- No
- Premarket review
- None for safety, effectiveness or quality
- Made by
- 503A pharmacies or 503B outsourcing facilities
- Same as brand?
- No
What compounding is for
Compounding exists to fill gaps that manufactured products leave. Classic examples include a patient who is allergic to a dye or filler in the commercial version, someone who can't swallow a tablet and needs a liquid, or a dose strength that no manufacturer makes.
Compounding also happens when an FDA-approved drug is in shortage, and some compounders produce versions of drugs in forms the commercial product doesn't come in, such as a dissolving tablet or a cream.
Compounded does not mean FDA-approved
This is the most important thing to understand. Compounded drugs are not FDA-approved. The FDA does not check them for safety, effectiveness or quality before they're sold, and they aren't required to carry the full prescribing information and boxed warnings that come with approved products.
A compounded version of a drug is also not the same thing as the brand-name product. Compounded semaglutide isn't Wegovy, and compounded tirzepatide isn't Zepbound. The ingredient may share a name, but the formulation, strength and testing are different, and the clinical trials behind the brand don't automatically apply.
Known risks
The FDA points to a few recurring problems with compounded products:
- Contamination or the wrong amount of active ingredient from poor compounding practices.
- Dosing errors, especially with injectables measured in units rather than milligrams. The FDA has received hundreds of adverse event reports linked to compounded semaglutide and tirzepatide, some involving hospitalization.
- Uncertainty about the source when drugs are bought online from sellers whose standards you can't verify.
- Exposure to risk without benefit when a compounded drug is used and an approved product would have worked.
Where compounded drugs are made
Compounding happens in two kinds of settings. 503A pharmacies compound for individual patients under state oversight. 503B outsourcing facilities can work at larger scale and must meet federal manufacturing standards. Neither produces FDA-approved drugs.
Compounded medications at HealifyMD
Many HealifyMD prescriptions are filled by licensed U.S. compounding pharmacies. Each compounded treatment page says so plainly. Before you start, your clinician should explain why a compounded option is being considered, how it differs from any FDA-approved alternative, and how dosing will be measured and adjusted.
It's also worth knowing what to watch for. Check that the label matches your prescription, keep injectables stored as directed, and confirm whether your dose is written in milligrams or in units, since mix-ups between the two are a common source of errors. If anything about the medicine looks different from one shipment to the next, ask before you use it.
Compounded medication: common questions
Are compounded drugs legal?
Yes, when they're made by licensed pharmacists, physicians or registered outsourcing facilities that follow federal and state rules, such as using permitted ingredients and, for 503A pharmacies, valid patient prescriptions.
Are compounded drugs generics?
No. A generic is FDA-approved and shown to be equivalent to the brand. A compounded drug has not been through that review.
Is a compounded drug weaker or stronger than the brand?
It can be either, depending on how it's prepared. Strength is set by the prescription and the pharmacy, which is why accurate measurement and follow-up matter.
Why do some people choose compounded medications?
Common reasons include allergies to an ingredient, a need for a dose or form that isn't sold commercially, drug shortages and cost. Your clinician should weigh those reasons against the lack of FDA review.
Can I report a problem with a compounded drug?
Yes. You or your clinician can report side effects or quality concerns to the FDA's MedWatch program, and you should tell your prescriber right away.
Does insurance cover compounded drugs?
Coverage varies and is often limited. HealifyMD does not bill insurance for compounded medications; prices are confirmed at your eligibility review.
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
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration
- Is It Really 'FDA Approved'?U.S. Food and Drug Administration
- Compounding Laws and PoliciesU.S. Food and Drug Administration