Jeffrey A. Newman
As of this week, the FDA has ordered that compound pharmacies stop selling copycat medications for weight loss including semiglutide, Ozempic, Wego,Monjaro,Zepbound and Tirzepitide. Compound pharmacies mix ingredients of a drug to create a version for specific patients. When drugs are in shortage, they mmay be compounded to help fill the gap.
Late last year, the FDA said all doses of Mounjaro and Zepbound were readily available and took the drug off its shortage list. The larger compound pharmacies aren’t allowed to produce a tirzepatide compound anymore.
Compounded drugs are always supposed to contain FDA-approved ingredients, the formulations as prepared at compounding pharmacies aren’t reviewed by the FDA for purity, safety, or effectiveness.
The global US market of compound pharmacy revenue was valued at USD 6.45 billion in 2025 and is expected to attain around USD 10.34 billion by 2033, growing at a CAGR of 10.93% during forecast period. The demand for advanced research and development facilities is increasing, which is the key factor driving the growth of the market.
These medications are designated as GLP-1’s. Glucagon-like peptide-1 receptor agonists, also known as GLP-1 drugs, are a class of medications that mimic the action of the glucagon-like peptide-1 hormone, which is involved in the regulation of blood sugar levels. These drugs can also slow gastric emptying, which contributes to weight loss. GLP-1s were first approved by FDA to treat type 2 diabetes, with more recent entrants approved to treat weight loss and an increasing number of GLP-1s receiving a label extension for the reduction of major cardiac adverse effects. GLP-1s also are being studied for many other potential indications, including chronic kidney disease, psychiatric disorders, neurodegenerative disorders and gastrointestinal disorders, among others.
While compounded GLP-1s have the same active pharmaceutical ingredient (API) as the branded versions, the products may not be identical. There are hundreds of bulk pharmaceutical manufacturers registered with FDA to manufacture the APIs in GLP-1s, but FDA does not confirm that API produced by the bulk manufacturers is identical to the API used in branded versions because it is never reviewed by the Agency. In addition, as noted above, GLP-1s compounded by 503A compounding pharmacies are not required to have directions for use. This is particularly significant because compounded GLP-1s generally come in vials, which require patients to measure out the correct dose to inject with a syringe, rather than the easier-to-use, pre-measured auto-injectors generally used for approved GLP-1s.
Jeff Newman JD MBA, represents whistleblowers nationwide relating to major tariff fraud concerning imported Chinese goods as well as Medicare and Medicaid fraud cases under the False Claims Act (Qui Tam), and SEC, IRS and FINCEN whistleblower programs. He can be reached at Jeff@JeffNewmanLaw.com or at 617-823-3217
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