No shortage of GLP-1s — or patient confusion about compounded drugs

Patient demand remains strong for GLP-1 drugs for diabetes and obesity — and so does patient confusion about compounded versions of the blockbuster drugs.

Americans for Safe and Effective Medicines (ASEM), a nonprofit advocacy organization, launched July 14 by publishing a study showing patients still have lots of questions about compounded glucagon-like peptide 1 (GLP-1) receptor agonist drugs.

“Compounding, I want to say right out the start, is extremely important in the practice of pharmacy, but it should be specific,” said Fred Mills, Pharm.D., ASEM chief policy officer. “It should be between a doctor, a patient, and the pharmacist. Very specific, not mass manufacturing to copy a me-too product.”

For nearly two years, the U.S. Food and Drug Administration (FDA) declared there was a shortage of semaglutide, the active ingredient in the antidiabetes drug Ozempic and antiobesity drug Wegovy, and tirzepatide, the active ingredient in the antidiabetes drug Mounjaro and antiobesity drug Zepbound. During that time, companies brought to market various compounded versions of the drugs.

That shortage officially is over, according to FDA. That federal declaration has not cleared up patient understanding about how the compounded drugs are regulated, according to ASEM. The organization conducted a study about physician and patient sentiment about the compounded drugs and Mills, a 50-year pharmacist and former Louisiana state senator, discussed the organization’s findings during an online news conference.

A wide gap between expectation and understanding

In May, ASEM surveyed 2,001 U.S. adults along with 405 general medicine physicians (22% primary care, 42% internal medicine, 36% family practice). The results describe what ASEM calls an “expectation gap.” A full 84% of consumers said FDA approval, independent expert review and clinical trials were extremely or very important when choosing a GLP-1 medication. That figure rises to roughly 90% among people currently using one. Yet only 17% of consumers correctly knew that compounded GLP-1 products have not received FDA approval.

The gap is most pronounced among the patients most exposed to it. Among current GLP-1 users:

• 51% mistakenly believe compounded versions have been FDA approved.
• 50% believe they've undergone the same safety and quality review as approved drugs.
• 48% believe they've gone through equivalent clinical trials.

None of that is accurate, according to ASEM’s findings, because compounded drugs, by definition, bypass FDA's premarket review for safety, effectiveness and quality.

Physicians affirm patient sentiment

Physicians are seeing the consequences directly. In the physician survey:

• 82% said they've encountered patients unaware that compounded products aren't FDA approved.
• 87% have encountered patients confused about the difference between FDA-approved and compounded medications they've seen advertised.
• 81% have treated patients who didn't know compounded products haven't been clinically tested for safety or effectiveness.

Three risks the report says are converging

The ASEM report, titled “The Shortage Is Over. The Risks Are Not: How Illegal Mass Compounding Is Undermining Patient Safety — And What Must Happen Next,” organizes its findings around three overlapping problems.

Unsafe, industrial-scale compounding

The report cites Empower Pharmacy, which describes itself as a leading 503A/503B compounder, as an example of what it calls “the personalization scam”: minor formulation tweaks, such as adding vitamins, used to preserve mass production while claiming exemptions meant for one-off compounding.

FDA inspectors cited the company in 2025 warning letters for sterile-compounding failures, including dirty production surfaces and injectable batches released despite bacterial contamination described as “too numerous to count.” Empower recalled more than 8,000 testosterone cypionate vials that year, and California regulatory filings describe patient reports of injection-site injuries, bacterial infections and anaphylaxis.

In April 2026, the family of a Texas woman filed a wrongful-death suit alleging a compounded GLP-1 product from Empower was contaminated and defectively formulated. The report cites an outside analysis finding that adverse events tied to compounded GLP-1s required hospitalization more than twice as often as those linked to FDA-approved versions.

Illicit supply chains

The report and FDA's own import-alert data point to sourcing problems upstream of the pharmacy counter. More than one in five of 48 GLP-1 active pharmaceutical ingredient (API) manufacturing sites FDA assessed were non-compliant or failed to provide required records. FDA cited the Chinese firm Harbin Jixianglong Biotech for shipping relabeled semaglutide API from unapproved suppliers and releasing tirzepatide API without validated testing methods. FDA's Import Alert 66-80 now allows the agency to detain foreign GLP-1 bulk drug substances with quality concerns at the border, though the report notes it doesn't address product already in the domestic supply chain.

Misleading marketing

FDA has sent warning letters to more than 80 compounders and telehealth companies over misleading GLP-1 advertising, including 30 telehealth firms in a single 2026 action, following more than 50 letters in 2025. An analysis cited in the report found 57% of relevant websites failed to disclose that their compounded products aren't FDA approved, while 63% advertised only that their product shares an “active ingredient” with an approved drug — language the report says implies equivalence without stating it.

What FDA itself is telling physicians and patients

Separate from ASEM's advocacy, FDA has published its own concerns about unapproved GLP-1 products, and the details give physicians concrete things to watch for. As of May 31, 2026, the agency had logged 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide. Those likely are undercounted because FDA noted that state-licensed pharmacies that aren't federally registered outsourcing facilities generally aren't required to report adverse events at all.

FDA has also flagged a number of other problems with the market for GLP-1 drugs:

• Counterfeit Ozempic is circulating
• Fraudulent compounded products labeled with pharmacies that don't exist or didn't make the product
• Dosing errors from patient self-administration and, in some cases, clinician miscalculation
• Compounders substituting salt forms such as semaglutide sodium or semaglutide acetate, which are chemically distinct from the approved active ingredient and of unknown safety
• Shipping complaints involving injectable products arriving warm or inadequately refrigerated.

Separately, FDA has stated that retatrutide and cagrilintide, two newer, unapproved GLP-1-class compounds, cannot legally be compounded at all, and has warned telehealth companies and ingredient suppliers marketing them directly to consumers.

Voices from the front line

Mills is a former executive director of the Louisiana State Board of Pharmacy. On the press call, he was careful to distinguish the compounding he practiced and once regulated. Creating narrow, patient-specific preparations done in consultation with a prescriber is different from what he called “full pharmacies” acting as unlicensed manufacturers.

Asked directly what advice physicians should give patients in the exam room, Mills described physicians as the front-line “gatekeepers” in this confusion, and drew a comparison to informed-consent conversations physicians already have around other treatment decisions, laying out the risk and the reward plainly.

He also pointed to a continuity-of-care problem: Patients obtaining GLP-1 prescriptions through telehealth platforms outside their normal physician relationship, sometimes without their primary care doctor's knowledge, complicating follow-up when something goes wrong.

In the online news conference, Mills returned to an analogy from his legislative career. Louisiana launched a consumer-education campaign called “Ask Before You Eat,” aimed at warning residents about contaminants in imported seafood. He argued patient education on compounded GLP-1s will require a similarly sustained effort.

On enforcement, he acknowledged uncertainty about FDA's capacity but suggested warning letters alone may be insufficient, floating stronger tools such as cease-and-desist orders.