ARIZONA HEALTH TUCSON USA

To protect patients, Arizona revisit HB 4036


By:  Dr. P. Williams 

As a doctor, I know how limited access to healthcare directly impacts patients’ options and ultimately, medical decisions. To support our community, we need real solutions, filling healthcare gaps and reducing cost barriers. What detracts from these solutions is bad actors who exploit these gaps for profit. Unfortunately, that’s exactly what we are seeing today with the emergence of counterfeit and illegally compounded GLP-1 medications.

As a safe and effective way to manage diabetes and weight-loss, FDA-approved GLP-1 medications have been in high demand over the past several years. Because of this, the FDA declared a shortage in 2022, temporarily allowing certain pharmacies and clinics to compound GLP-1 medications, a process normally reserved for patients who need customization due to allergies to inactive ingredients or other specific medical needs. Compounding uses raw active pharmaceutical ingredients (APIs) to tailor a drug to individual requirements. In early 2025, the FDA declared that the shortage was over, meaning that compounders should have stopped. However, during this time, compounding transformed into an industry with high profit potential. As such, compounders have continued.

What makes this continued compounding so dangerous? The issue is that compounded GLP-1s are not FDA-approved, despite deceptive marketing that might make consumers think they are. Without FDA approval, these compounding facilities operate without the necessary inspections and ingredient testing to protect consumers. These illicit weight loss drugs may even add ingredients that haven’t gone through clinical trials when combined with other ingredients in these medications or use ingredients from overseas facilities in China or India that don’t go through the same quality controls as FDA-approved medications do. In fact, between September 2023 and January 2025, 239 shipments of counterfeit GLP-1 ingredients entered the United States, with 82% making it into our drug supply.

Without the oversight that FDA-approved drugs receive, patients are put at risk.

The FDA is taking this concern seriously and taking action against compounders by restricting APIs intended for non-FDA-approved purposes. The agency will also combat any false claims spread by compounders that suggest that their versions are generic versions of FDA-approved GLP-1s or that they contain the exact same APIs. But federal enforcement alone cannot fully protect Arizonans from this threat, especially when deceptive ads target the communities I work with. Everyone in our state deserves to trust that the medications they take are safe.

In the face of these serious threats to public health, Arizona needs to act. This session, state Representative Michele Peña introduced HB 4036, a bill that would protect consumers by creating common-sense safety regulations and requirements to ensure the quality of ingredients and facilities compounding GLP-1s would not put patients at risk. HB 4036 would also prohibit deceptive advertising practices for these compounded GLP-1s.

Unfortunately, the bill was shot down by special interests claiming this would prohibit legitimate compounding. But what HB 4036 aims to do is ensure Arizona, through the State Board of Pharmacy, can enforce the high safety standards for medications that my patients expect and deserve.

But while the federal government is moving, so must Arizona. We cannot let illegal compounders continue to profit from the exploitation of healthcare gaps at the expense of our communities. As a medical provider, I urge the legislature to reconsider HB 4036 and the ways they can protect my patients before they are put at risk.

 

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