What's Going on with Compounding Pharmacies and GLP-1s?

If you watched the Super Bowl on this year, you might have seen a commercial for Hims & Hers. This digital health company touted their diagnostic testing, “microdoses” of GLP-1s, hormone treatment, and “early cancer detection through a simple blood test.”

A couple of those things have raised eyebrows—namely the cancer test, which is not approved by the Food and Drug Administration (FDA), and which medical experts are skeptical of.

The other reason that Hims & Hers has been in the headlines this week is because of a lawsuit brought against them by Novo Nordisk, makers of the GLP-1 Wegovy. They claim that the compounded version of Wegovy that Hims & Hers sells is infringing on their patent.

But what does it mean to sell a compounded version of a drug?

Compounding Pharmacies

Sometimes when a patient is prescribed a medication, they need to get a special version. Maybe they are allergic to the dye used in a drug, or maybe they can’t swallow a pill and need to take a liquid version. Traditionally, that’s where compounding pharmacies come in.

Compounding pharmacies create versions of drugs that are tailored to a patient’s specific needs. They can also step in when there are drug shortages to help meet needs that the original producer can’t.

GLP-1 Compounding

Back in 2022, when GLP-1 medications were first hitting the scene in a big way, they ended up on the FDA’s official drug shortage list. The people who needed Ozempic, Wegovy, and the like for diabetes control could not access it, nor could the growing number of people who were starting to use GLP-1s for weight loss.

Telehealth companies partnered with compounding pharmacies to start offering compounded GLP-1s on their platforms. After the original manufacturers of the drugs upped their manufacturing and were able to meet demand last year, the FDA ordered compounding pharmacies to stop selling their versions.

Many companies then pivoted, tweaking their products enough that they could claim they were different, specialized versions that they should still be able to sell. One such tweaked product is the GLP-1 pill that Hims & Hers planned to sell, and which they are now being sued over.

Why Does This Matter?

During a time when people who needed GLP-1s for their health, namely diabetics, could not access them, compounding pharmacies played an important role. But as more companies continue to sell various compounded versions of the drugs, some caution is necessary.

"I see the desperation of patients who see these companies as the only way that they can affordably access medications that will not only help them lose weight, but also lower many weight-related co-morbidities," says Mohammed Ali, MD, professor of global health and epidemiology. "I also remain cautious, because the compounded medications are not regulated by the FDA. With that comes the risk of impurities, unpredictable side effects, and potentially serious harm. These make it difficult for public health professionals and physicians to get behind these options."

Compounded drugs are not approved by the FDA, and they do not have to go through the kind of rigorous safety testing that traditional medications do. The FDA warns that compounded drugs can have quality control problems that can open up patients to serious health risks.

“In certain circumstances, compounding pharmacies provide an important pathway for patients who might otherwise face delays in treatment,” says Hui Shao, MD, associate professor of global health and health policy and management at Rollins School of Public Health. 

“However, it’s essential that patients work with licensed pharmacies operating within state and federal regulatory frameworks. GLP-1s are powerful metabolic medications, and appropriate clinical oversight, quality standards, and ongoing monitoring are critical to ensuring both safety and effectiveness."

The FDA has some tips to make sure you are buying from a safe online pharmacy, if you choose to.