Compounding

Connecticut attorney general warns clinics over compounded tirzepatide and semaglutide

The letter puts Connecticut clinics on notice that compounded semaglutide and tirzepatide products, including oral versions and injections with added vitamins, may draw state enforcement action.

By the Semaglutides news desk·

Connecticut Attorney General William Tong warned weight loss clinics, med spas and medical practices in the state on May 21, 2025 that advertising or prescribing compounded GLP-1 weight loss medications could violate the Connecticut Unfair Trade Practices Act [1]. The letter says his office is prepared to take action against businesses and individuals that continue the conduct it describes [1].

The letter states that compounding pharmacies are no longer allowed by the FDA to make semaglutide or tirzepatide weight loss injections in bulk, because those medications are no longer on the FDA's shortage list [1]. It points to FDA-identified safety concerns, including dosing errors, compounding pharmacies' use of salt forms of semaglutide or tirzepatide, many of which are sourced from overseas manufacturers with spotty inspection records, and multiple adverse event reports, some of which required medical intervention [1].

The letter cites reporting that found three Chinese firms responsible for 20 percent of the reported imported volume of semaglutide had never been inspected as of September 2024, and that three additional Chinese firms, responsible for 44.5 percent of reported imported volume, were cited during their latest FDA inspections for current good manufacturing practice violations [1].

The letter also addresses oral products. It says the FDA has not approved any oral formulation of a GLP-1 medication to treat obesity, and that oral GLP-1 medications manufactured by compounding pharmacies "have not been shown to deliver safe or effective doses of semaglutide or tirzepatide" [1]. It says the FDA has not approved semaglutide or tirzepatide injections that contain vitamin additives, and that there are no clinical trials of such drug combinations [1]. Compounded GLP-1 medications are often inaccurately described as "generic" versions of semaglutide or tirzepatide, the letter says, but they are not approved by the FDA [1].

The letter notes that the FDA has approved GLP-1 medications only for chronic weight management in adults diagnosed with obesity, or with overweight plus a weight-related condition such as hypertension or type 2 diabetes [1]. It says these medications are not FDA-approved for cosmetic purposes [1]. Receiving the letter does not mean a provider has engaged in the conduct described, or that the office is currently investigating that provider or business, according to the letter [1].

Why it matters for patients

People in Connecticut who get compounded semaglutide or tirzepatide from a clinic or med spa are now buying from a market the state attorney general has publicly flagged. The letter states the FDA position that compounded versions are not FDA-approved, and that certain forms in particular, including compounded oral GLP-1 products and injections with added vitamins, have not been shown to deliver safe or effective doses [1]. The salt forms of semaglutide and tirzepatide the letter describes are not the same ingredient as the approved drugs, and the letter says many of those ingredients come from overseas manufacturers whose inspection records were spotty [1].

That draws a practical line between FDA-approved semaglutide and tirzepatide products, which the letter says are approved for chronic weight management in adults with obesity or overweight plus a related condition, and compounded versions sold for weight loss or cosmetic purposes [1]. The letter does not tell patients to stop any medication, does not address what compounded products cost compared with approved ones, and does not say whether insurance covers either option. It also does not say how patients who are mid-treatment on a compounded product should handle their prescriptions; that has not been reported.

What happens next

The letter does not set a deadline for clinics to change their practices, and no enforcement action against a named business has been announced [1]. It references the FDA's April 28, 2025 statement clarifying its policies for compounders as the national GLP-1 supply begins to stabilize [1]. The attorney general's office says it is prepared to take appropriate action against businesses and individuals who continue the conduct described in the letter [1].

Sources

  1. https://portal.ct.gov/-/media/ag/press_releases/2025/letter-to-wt-loss-clinics--spas-52125-final.pdf

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