Compounded GLP-1 drugs became widely available during shortages of popular medications such as Ozempic, Wegovy, Mounjaro, and Zepbound. As demand for these treatments outpaced supply, many patients turned to compounded versions prepared by pharmacies.
While compounding can help address temporary shortages and patient-specific needs, compounded drugs are not FDA-approved and are subject to different regulatory requirements than commercially manufactured medications.
As shortages have eased, the FDA has increased its scrutiny of compounded semaglutide and tirzepatide products, citing concerns about product quality, dosing errors, and misleading marketing practices.
What are GLP-1 receptor agonists?
Glucagon-like peptide-1 (GLP-1) receptor agonists stimulate insulin secretion and slow gastric emptying. They are used to control blood glucose in type 2 diabetes and, at higher doses, to promote weight loss.
Clinical guidelines from major professional societies, including the American Gastroenterological Association, the American Diabetes Association, and the Endocrine Society, recognize semaglutide, tirzepatide, and liraglutide as effective pharmacologic treatments for obesity when combined with lifestyle modifications.
In pediatric populations, guidelines suggest considering GLP-1 agents for children aged 10 years who have type 2 diabetes and obesity.
FDA-approved GLP-1 products include:
These products undergo rigorous pre-market review for safety, effectiveness and quality.
Compounded GLP-1 drugs, in contrast, are made by pharmacists or physicians for individual patients and are exempt from many federal requirements if certain conditions are met. These do not go through FDA approval and therefore carry more uncertainty around quality and clinical effectiveness.
The use of compounded GLP-1 drugs during shortages
Between 2022 and early 2025, the rapid increase in demand for semaglutide and tirzepatide outpaced manufacturing capacity. This shortage allowed compounders to legally produce “essentially a copy” of the approved drug under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Patients flocked to these cheaper, compounded versions and telehealth companies aggressively marketed them.
The FDA declared the tirzepatide shortage resolved in October 2024 and the semaglutide shortage resolved in February 2025.
The agency then gave pharmacies a grace period, 60 days for state-licensed pharmacies and 90 days for outsourcing facilities, to wind down compounding operations.
By May 2025, the grace periods for both drugs had ended. Despite this, many compounding pharmacies continued to produce and market GLP-1 formulations, prompting the FDA to take stronger action.
503A compounding for individual patients
Under section 503A of the FD&C Act, pharmacists or physicians may compound a drug only for an identified individual patient pursuant to a prescription. They must not “regularly or in inordinate amounts” make drugs that are essentially copies of FDA-approved products.
A compounded drug is considered a copy if it has the same active ingredient(s), similar strength and route of administration as the approved product.
A prescriber can only request a compounded alternative when they document a change that produces a clinically meaningful difference for a particular patient.
The FDA also cautions that combining semaglutide with other ingredients, such as vitamin B12, likely makes the compounded product essentially a copy of the approved drug when it uses the same route of administration and similar strength.
For 503A compounders, the agency currently allows up to four prescriptions per month of a compounded copy without enforcement action.
503B outsourcing facilities
Section 503B allows registered outsourcing facilities to compound medications in larger quantities but under tighter restrictions.
These facilities may not compound drugs from bulk substances unless the substance appears on the FDA’s list of ingredients for which there is a clinical need (the “503B bulks list”) or the final compounded drug appears on the national drug-shortage list.
As of June 2026, neither semaglutide nor tirzepatide appears on the bulks list or the shortage list. Thus, outsourcing facilities generally cannot legally compound these drugs.
FDA enforcement actions against compounded GLP-1 drugs
On September 16 2025, the FDA released over 55 warning letters to online sellers of compounded GLP-1 products.
The letters alleged that these sellers used language such as “generic” or “clinically proven,” named the brand products for comparison, or implied that their compounded versions contained the same active ingredient.
These statements created an “unlawful sale of unapproved and misbranded drugs,” and the FDA demanded immediate removal of the offending claims.
The enforcement campaign intensified in early 2026. On March 3 2026, the FDA published 30 warning letters addressed mainly to telehealth companies. These letters targeted marketing claims that suggested compounded GLP-1 products were equivalent to FDA-approved drugs or obscured the identity of the compounder.
Commissioner Martin Makary warned that the agency was “paying close attention” to misleading claims and would take swift action. The letters highlighted FDA’s objections to online claims implying sameness and to private-label branding that could mislead consumers.
Simultaneously, the FDA publicly endorsed a settlement between the telehealth platform Hims & Hers and Novo Nordisk.
On March 9 2026, the two companies announced that Hims & Hers would offer Novo Nordisk’s branded semaglutide products and stop marketing compounded versions, illustrating how telehealth firms may adapt to the tougher regulatory climate.
Timeline of FDA actions affecting compounded GLP-1 drugs
|
Date (approx.) |
Event |
Impact |
| 2022 | Demand for GLP-1 drugs leads to shortages of semaglutide and tirzepatide | Allowed compounders to legally produce copies under 503A/503B |
| Oct 2, 2024 | FDA declares tirzepatide shortage resolved | Grace period begins; compounders directed to cease production |
| Feb 21, 2025 | FDA declares semaglutide shortage resolved | 60-/90-day grace periods for pharmacies/outsource facilities |
| Apr 22, 2025 & May 22, 2025 | Grace periods end for semaglutide and tirzepatide | Regular compounding of copycat products becomes unlawful |
| Sept 16, 2025 | FDA issues over 55 warning letters about misleading advertising of compounded GLP-1 drugs | First large-scale enforcement action |
| Feb 6, 2026 | FDA announces intent to restrict GLP-1 APIs for non-approved compounded drugs | Signals broader crackdown on mass-marketing |
| Mar 3, 2026 | FDA releases 30 warning letters aimed at telehealth companies promoting compounded GLP-1 drugs | Emphasizes marketing claims and private-label concerns |
| Mar 9, 2026 | Novo Nordisk and Hims & Hers announce partnership, ending most marketing of compounded GLP-1s | Demonstrates industry adaptation to FDA pressure |
Safety concerns with compounded GLP-1 products
The FDA has warned that compounded GLP-1 products may present risks that are not associated with FDA-approved medications. Reported concerns include:
1. Dosing errors and variability
In July 2024, the FDA alerted healthcare providers and patients to reports of overdoses linked to compounded semaglutide.
Many patients using multi-dose vials inadvertently administered five to twenty times the intended dose due to confusion between milligrams, milliliters, and syringe units. Providers have also miscalculated doses when converting between units, leading to severe nausea and vomiting.
Reported side effects ranged from mild gastrointestinal symptoms to pancreatitis and gallstones.
2. Variability in formulation and ingredients
Unlike FDA-approved GLP-1 products, compounded formulations may use different salt forms (e.g., semaglutide sodium or acetate) or add vitamins such as cyanocobalamin.
The FDA notes that there is no evidence demonstrating that these salt forms are chemically or pharmacologically equivalent to the approved base form, and there is no legal basis for using them in compounding. The agency has also received reports of fraudulent compounded products with inaccurate labels and false pharmacy names.
3. Adverse event reporting and pharmacovigilance
A pharmacovigilance study of the FDA Adverse Event Reporting System compared adverse events reported for compounded GLP-1 receptor agonists with those for FDA-approved products.
The study found that compounded GLP-1 drugs were more likely to be associated with:
-
- abdominal pain
- nausea
- diarrhea
- gallbladder inflammation
- suicidality
Hospitalization due to adverse events was also reported more often for compounded drugs.
Researchers suggested that variability in quality and dosing might contribute to these outcomes and recommended continued monitoring and enforcement.
Bottom line
The FDA’s crackdown on compounded GLP-1 drugs reflects a deliberate effort to protect patients as supply shortages ease. While compounding is still important in individualized care during genuine shortages, it cannot substitute for the rigorous review process that ensures the safety, effectiveness, and quality of approved medications.
The wave of warning letters in 2025 and 2026, coupled with new enforcement commitments, shows that marketing “copycat” versions of GLP-1 drugs is no longer tolerated.
Patients seeking to lose weight or manage diabetes should work with their healthcare providers to obtain FDA-approved GLP-1 therapies whenever they are available.
Frequently Asked Questions
Related Articles
Sources
What are the safety concerns regarding compounded GLP-1 receptor agonists? | Drug Information Group | University of Illinois Chicago. (n.d.). https://dig.pharmacy.uic.edu/faqs/2025-2/august-2025-faqs/what-are-the-safety-concerns-regarding-compounded-glp-1-receptor-agonists/
Malkin, B. J., JD, & Siemer, E. A., JD. (2026, March 31). FDA and Novo Nordisk Warned of GLP-1 Telehealth Compounding Takedown. What’s Next? Pharmacy Times – Pharmacy Practice News and Expert Insights. https://www.pharmacytimes.com/view/fda-and-novo-nordisk-warned-of-glp-1-telehealth-compounding-take-down-what-s-next-
FDA. (2026, April 1). FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. U.S. Food And Drug Administration. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
Office of the Commissioner. (2026, March 3). FDA warns 30 telehealth companies against illegal marketing of compounded GLP-1s. U.S. Food And Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s
Chapman, M. (2026, March 9). Novo Nordisk drops its Hims & Hers patent lawsuit as Wegovy and Ozempic head to the Hims platform | AP News. AP News. https://apnews.com/article/hims-hers-novo-nordisk-wegovy-ozempic-fda-d56b8ad0737be75674bc05ffe488b948
FDA. (2024, July 26). FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products. U.S. Food And Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded
McCall KL, Mastro Dwyer KA, Casey RT, Samana TN, Sulicz EK, Tso SY, Yalanzhi ER, Piper BJ. Safety analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system. Expert Opin Drug Saf. 2026 Mar;25(3):581-588. doi: 10.1080/14740338.2025.2499670. Epub 2025 Apr 29. PMID: 40285721.
