Compounded Semaglutide: What It Was and Why It Ended

Compounded semaglutide was lawful for one reason: the drug was on FDA’s shortage list. That listing creates a narrow exception allowing compounders to prepare copies of an otherwise commercially available approved drug. When the shortage resolved, the exception went with it.

Understanding the mechanism explains why a very large market appeared and then contracted.

Why the exception exists

Compounding pharmacies prepare customised medicines for individual patients. They may not ordinarily reproduce an approved commercial product — doing so would bypass the approval system entirely.

A drug in shortage is the carve-out. While a product is listed, compounders may prepare copies, because the alternative is patients going without a medicine they need. The permission attaches to the shortage, never to the drug itself.

What compounded semaglutide was not

• Not a generic. A generic is an approved product proven bioequivalent to the reference drug. Semaglutide remains under patent; no generic exists.

• Not FDA approved. Compounded preparations are exempt from approval requirements, not approved.

• Not necessarily the same molecule. Some products used semaglutide salt forms — sodium or acetate — rather than the base semaglutide in the approved product.

• Not the same formulation. Added ingredients such as B12, and concentrations differing from the approved product, were common. Neither was in any trial.

• Not covered by manufacturer pharmacovigilance. Adverse events did not flow into the approved product’s safety monitoring.

503A versus 503B

The distinction is rarely made in marketing and represents a real difference in oversight. Neither tier produces an approved product, but a 503B facility operates under considerably more scrutiny than a 503A pharmacy.

Where things stand

The "personalised dose" argument — offering strengths that differ from approved ones to claim a genuine compounded preparation rather than a copy — is contested, and not something a buyer can adjudicate from a website.

Questions worth asking

1. Is this a 503A pharmacy or a 503B outsourcing facility?

2. Base semaglutide, or a salt form?

3. What is the concentration? It often differs from the approved product, changing every dose calculation.

4. What else is in the vial?

5. Who prescribed it, and did they see a full medical history?

See the compounded tirzepatide guide for the parallel case, the semaglutide dosage chart for the labelled schedule, and the grey market guide for the research-use-only channel.