What the FDA says, in its own words

Compounded GLP-1s are not FDA-approved

Unapproved versions skip FDA's review for safety, effectiveness and quality.

“FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1”
FDA: concerns with unapproved GLP-1 drugs used for weight loss · read Sep 3

Dosing errors put people in hospital

Patients and clinicians miscalculated compounded doses; some took more than the label allows.

“FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products. These dosing errors resulted from patients measuring and self-administering incorrect doses of the drug, and in some cases, health care professionals miscalculating doses of the drug. Additionally, the agency has received adverse event reports that may be related to patients prescribed compounded semaglutide or tirzepatide products in doses beyond what is in the FDA-approved drug label.”
FDA: dosing concerns with compounded semaglutide and tirzepatide · read Sep 3

Fake labels, warm boxes, old vials

Labels naming pharmacies that do not exist, shipments that arrive warm, vials used past 28 days.

“FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In some cases, the compounding pharmacies identified on the labels of the products do not exist. In other cases, the labels”
FDA: fraudulent compounded GLP-1 drugs, storage and multi-dose vials · read Sep 3

Who inspects the pharmacy

503B outsourcing facilities are FDA-inspected; 503A pharmacies are overseen by state boards.

“Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.”
FDA: Compounding and the FDA: Questions and Answers · read Sep 3

The full FDA list, item by item: is compounded semaglutide safe?

Six checks before you pay anyone

Refrigerated on arrival

Warm box: do not use it

FDA recommends not using any injectable GLP-1 that arrives warm or with too little ice.

A real, named pharmacy

Check the license

FDA has seen labels naming pharmacies that do not exist. Look the pharmacy up with your state board of pharmacy.

Units, not guesses

Measure the dose right

Dosing errors are the most reported harm. Convert mg to syringe units from your own vial's label.

Dose converter →

28 days, then discard

Even if some is left

FDA: discard a multi-dose vial 28 days after first use, whatever the compounder's label says.

A prescription first

No exam, no sale

Compounded drugs are for patients a clinician has assessed. A seller that skips that step is a red flag.

Who oversees it

503A or 503B?

Ask which: 503B outsourcing facilities are inspected by FDA and held to manufacturing standards; 503A pharmacies are not.

Check it yourself