By Jeffrey A. Newman Esq.
The Food and Drug Administration has banned the sale of compounded versions of Ozempic, Wegovy, Mounjaro and Zepbound as of April 22 of this year. The FDA’s move to stop the sale of compounded versions of Ozempic, Wegovy, Mounjaro, and Zepbound is driven by three main factors: the end of the official “drug shortage” that had justified compounding in the first place, safety/quality concerns with unapproved copycat products, and enforcement of brand‑name manufacturers’ exclusive rights while their drugs remain under patent.
Compounding pharmacies were initially allowed to make semaglutide and tirzepatide copies because the brand‑name products were on the FDA’s drug shortage list starting in 2022. Once FDA determined that manufacturers (Novo Nordisk for Ozempic/Wegovy and Eli Lilly for Mounjaro/Zepbound) could meet demand, it declared the shortages “resolved” and removed these drugs from the shortage list. Under federal law, that removal largely eliminates the legal justification for routine large‑scale compounding of simple copies of these drugs. Compounded semaglutide and tirzepatide are not FDA‑approved products, and the agency does not review them for safety, effectiveness, or manufacturing quality. FDA and independent investigators identified problems including mislabeled strengths, use of different salt forms of semaglutide than in the approved drugs, and inconsistent potency in compounded versions. There were also reports and formal warnings about counterfeit or fraudulent GLP‑1 products circulating in the U.S., which raised the risk that patients could receive ineffective or unsafe injections marketed as “compounded Ozempic/Wegovy/Mounjaro/Zepbound.”
These GLP‑1 products remain on patent, so once the shortage ended, continued large‑scale compounding of straightforward “copycat” versions directly undercut the exclusive marketing rights granted to Novo Nordisk and Eli Lilly. FDA issued updated guidance and transition deadlines (March–May 2025, varying by drug and pharmacy type) requiring compounders to stop making simple copies of semaglutide and tirzepatide injections, effectively restoring those exclusivity rights. The ban is on copycat versions that are essentially duplicates of the approved products; traditional compounding for an individual patient with a specific medical need that cannot be met by a commercially available product remains permitted under narrower circumstances. Some compounders have tried to continue offering products by changing doses not available commercially or combining tirzepatide with vitamins like B12, but these strategies sit in a gray area and may still be considered illegal “copies” depending on how strictly FDA enforces its policies.
Counterfeit and other unapproved GLP‑1 weight loss drugs (fake or “copycat” Ozempic, Wegovy, Mounjaro, Zepbound, etc.) can be dangerous because their contents, dose, and quality are unknown, so they can cause both direct toxic effects and severe under‑ or overdosing. Wrong, missing, or excessive active ingredient: Testing has found products that contain no semaglutide/tirzepatide, extremely high impurity levels, or entirely different drugs, which can trigger cardiac, neurologic, or psychiatric complications and even death. Loss of blood sugar control: If you have diabetes, too little active drug can cause sustained hyperglycemia, while too much can precipitate severe hypoglycemia; both can require emergency care and lead to long‑term organ damage. Contaminated injections: Products made or repackaged outside regulated facilities may be prepared in unsanitary conditions, increasing the risk of injection‑site infections and systemic infectionMisleading labels and phantom pharmacies: FDA has documented vials labeled with fake or non‑existent compounding pharmacies, false lot/serial numbers, or claims of semaglutide that are not true, making it impossible for patients to know what they are usings.
Jeffrey Newman, JD MBA, is a whistleblower lawyer whose national firm in Boston represents whistleblowers of violations of export controls, tariff evasions, money laundering, healthcare fraud and other kinds of WB cases. The firm represents individuals both in the United States and other countries. Mr. Newman and his firm staff also represent many physicians across the country who become whistleblowers in healthcare fraud cases. Whistleblower laws in the U.S. allow individuals anywhere with information about export control violations or tariff fraud to reveal the information under The False Claims act or through the Securities and Exchange Commission’s Whistleblower Program. The Firm’s website is at www.JeffNewmanLaw.com and attorney Newman can be reached at Jeff@Jeffnewmanlaw.com or at 978-880-4758. FOR OTHER ARTICLES LIKE THIS and WHISTLEBLOWER INFO PLEASE SEE http://JeffNewmanLaw.com
