Brazilian Clinics and the False Equivalence of Compounded GLP-1 Drugs: ANVISA should follow FDA

In September 2025, the U.S. Food and Drug Administration (FDA) issued more than 50 warning letters to compounding pharmacies and manufacturers marketing compounded versions of GLP-1 class drugs, such as semaglutide and tirzepatide. The agency was categorical in affirming that the claim disseminated by pharmacies and manufacturers - that compounded products possess the same efficacy and safety as the industrialized product - is false and misleading.

The reality is that compounded medicines do not undergo the same assessment of safety, efficacy, and quality required of FDA-approved medicines. Statements to the contrary constitute a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

As a result, the FDA established a period of 15 business days for the companies to correct the irregularities or provide justification. Failure to address the violations may result in additional enforcement action, such as product seizures or an injunction.

In Brazil, the scenario bears worrying similarities. There is a noticeable expansion of medical clinics offering packages of compounded weight-loss pens (tirzepatide/semaglutide). In many cases, the conduct of these clinics prevents patients from accessing a prescription for the original medicine, limiting them to receiving only the compounded version. There are also reports of cases where the compounded medicine is sent by the clinic directly to the patient’s residence.

The problem is aggravated when clinics improperly use the Mounjaro and Ozempictrademarks in their advertising, inducing patients to believe that they will receive the industrialized medicine or one of equal efficacy and safety.

Such practices by clinics subvert the very rationale for the existence of compounded medicines, which is to meet specific needs that industrialized medicines cannot address (such as dose adjustments, allergies to excipients, or alternative pharmaceutical forms).

In this context, medical clinics engaging in such practices not only can, but should, be held liable in the sanitary, patent, consumer protection, and competition law spheres.

Furthermore, by intermediating the contact between the consumer and compounding pharmacies, they act directly in the dispensing of medicines as if they themselves were compounding pharmacies or acted on their behalf. Thus, the prohibitions set forth in ANVISA’s (Brazilian FDA) Rule #67/2007, which governs Good Manufacturing Practices for Compounding Pharmacies, should also be applicable to these clinics.

Among other things, this resolution prohibits: (i) the public display of compounded products for the purposes of advertising, publicity, or promotion; and (ii) the indiscriminate substitution of industrialized products already available and approved by ANVISA with compounded products.

Physicians must also be mindful of violations of the Medical Code of Ethics, which expressly prohibits the exercise of medicine as a commercial activity and the obtaining of advantages through prescriptions or referrals.

Some clinics go beyond inappropriate prescribing practices with alleged administration of counterfeit medicines. Recently, a joint action by the Civil Police and the Sanitary Surveillance Agency of a São Paulo’s city, called “Cintura Fina” (Slim Waist), shut down an aesthetic clinic, arresting its owner, a nurse. The clinic offered weight-loss treatments based on standardized medical prescriptions and on-site administration of counterfeit medicines.

Although ANVISA has not yet adopted measures equivalent to those of the FDA, it has already demonstrated clear concern with the uncontrolled growth of the GLP-1 compounding market. An example is the publication of Order #97/2025, which restricted the importation of GLP-1 receptor antagonist APIs.

As of the issuance of this order on August 25, 2025, the importation of APIs obtained through biotechnological processes - such as semaglutide and liraglutide - for compounding purposes was restricted to manufacturers whose APIs have been previously reviewed by ANVISA during the product’s registration process. For APIs obtained synthetically — such as tirzepatide — importation was authorized provided that the drug medicine containing the molecule is registered in Brazil, regardless of whether a specific analysis was conducted during the registration process.

In the Technical Note that supported the publication of Order #97/2025, ANVISA stated that the routine compounding of semaglutide and tirzepatide is unfeasible from a sanitary perspective. This is because these substances are “active ingredients of high pharmaceutical complexity and high sanitary risk when compounded, particularly in sterile injectable forms, without evidence of stability, sterility, and therapeutic equivalence” (Technical Note #200/2025).

Nevertheless, although ANVISA acknowledged the identification of several irregularities in the compounding of these drugs and affirmed that inspections regarding the irregular advertising and supply of medicines have been carried out on a continuous basis, the number of medical clinics engaging in unlawful practices demonstrates that such measures have not been sufficient.

In light of the restriction on the importation of biotechnological APIs and given the lack of effective enforcement by ANVISA, which suffers from staffing shortages, it is foreseeable - and has already been observed - that clinics are directing their activities almost exclusively to tirzepatide and the situation is likely to worsen. To do so, they rely on the credibility associated with the Mounjaro trademark to induce patients to believe that the compounded product has the same efficacy as the original, thereby subverting the rationale of medical prescription and the dispensing of compounded medicines.

The FDA’s crackdown in the United States should serve as an immediate warning to Brazil: clinics and compounding pharmacies that persist in illegal practices — substituting industrialized medicines with compounded ones, improperly using registered trademarks, and engaging in irregular dispensing activities — must be held accountable.

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