Compounded vs FDA-Approved Drugs at Clinics

Compounded vs FDA-approved: what clinic menus actually mean

An FDA-approved drug has been reviewed by FDA for safety, effectiveness and manufacturing quality. A compounded drug is mixed by a pharmacy for a patient or a clinic and is not FDA-approved. Section 503A pharmacies compound for individual prescriptions, and 503B outsourcing facilities register with FDA and follow manufacturing standards. Ask your clinic which one you're getting.

By Virtual Care Atlas Editorial Team

Editorial review: Virtual Care Atlas Editorial Team, October 19, 2026 · fact-checked against cited sources, not a clinical review

Published October 19, 2026

How we verify

Most clinics in our directory list a mix of services. Some involve FDA-approved drugs, while others usually involve compounded products. A pharmacy makes these for a specific patient or a clinic. Knowing which is which is the most useful question you can ask before you book.

What “FDA-approved” means

An FDA-approved drug has gone through FDA review of its safety, effectiveness and manufacturing quality for a specific use. Examples relevant to these clinics are Wegovy (semaglutide), approved for chronic weight management in 2021, and Zepbound (tirzepatide), approved in 2023. See our GLP-1 weight-loss guide.

What “compounded” means

Compounding generally means a pharmacist combining, mixing or altering drug ingredients to make a medication tailored to an individual patient. FDA is direct about the trade-off: compounded drugs are not FDA-approved. That means FDA doesn’t review their safety, effectiveness or quality before they’re marketed. Compounding can serve real needs, for example when a patient is allergic to an ingredient in the approved product.

503A vs 503B

The federal compounding law sets up two main paths:

	503A compounding pharmacy	503B outsourcing facility
Oversight	State-licensed pharmacy	Registers with FDA; FDA inspects on a risk-based schedule
Basis	Valid patient-specific prescription	May compound without patient-specific prescriptions (e.g. office stock)
Manufacturing standard	Federal 503A conditions plus state pharmacy rules	Current good manufacturing practice (CGMP); must report adverse events to FDA

Neither path makes the product FDA-approved.

Where the services in our directory fit

GLP-1 weight loss: FDA-approved products exist. Many clinics also advertise compounded semaglutide or tirzepatide. FDA’s GLP-1 statement covers its concerns, including dosing errors with compounded versions. As of May 31, 2026, FDA reported receiving 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide.
Peptide therapy: Many peptides that clinics market, such as BPC-157, aren’t FDA-approved drugs. FDA keeps a list of bulk drug substances that may present significant safety risks in compounding, and several of these peptides have appeared on it.
Hormone therapy: FDA-approved estrogen, progesterone and testosterone products exist. “Bioidentical” hormones from clinics are often compounded, and FDA commissioned a National Academies study on compounded bioidentical hormone therapy.
NAD+ IV and injections: These are generally compounded or prepared products. See our NAD+ guide for what the research reviews say.
Sermorelin: The branded product (Geref) was discontinued, so sermorelin offered today is typically compounded. See our sermorelin page.

What should I ask my clinic?

Is this product FDA-approved for this use, or compounded?
If compounded, which pharmacy makes it, and is it 503A or 503B?
Can I see the pharmacy label and lot number?

For more checks, see how to check a clinic before you book.

Frequently asked questions

Are compounded drugs FDA-approved?

No. FDA states that compounded drugs are not FDA-approved, which means the agency does not review their safety, effectiveness or quality before they are marketed.

What is the difference between a 503A pharmacy and a 503B outsourcing facility?

Under the Federal Food, Drug, and Cosmetic Act, section 503A covers state-licensed pharmacies compounding for individual patients based on a prescription. Section 503B covers outsourcing facilities that register with FDA, are subject to current good manufacturing practice requirements and are inspected by FDA.

Has FDA said anything about specific peptides used in compounding?

Yes. FDA keeps a list of bulk drug substances nominated for compounding that may present significant safety risks. Several peptides marketed by wellness clinics have appeared on it. Check FDA's current page, because the list changes.

How many adverse events has FDA logged for compounded GLP-1s?

FDA's GLP-1 statement reports that as of May 31, 2026 it had received 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. FDA notes it cannot always determine whether the drug caused the event, and that such events are likely underreported.