Are Compounded GLP-1 Drugs Banned?

Note: Compounded drugs are not approved by the U.S. Food and Drug Administration (FDA) and may carry greater risks than FDA-approved treatments.

In fact, despite that decision, compounding pharmacies still have considerable freedom under FDA regulations to fill prescriptions for GLP-1 drugs. They can make new semaglutide and tirzepatide medications that are not officially considered copies of the brand-name drugs by significantly altering a drug's dosage, ingredients, or form.

As a result, these less-expensive weight loss drug alternatives remain available, though experts remain concerned about their safety and efficacy.

The ban on copies doesn't mean that compounders have to stop preparing GLP-1 weight loss drugs entirely.

“A clear reading of FDA guidance says that a prescriber can authorize a custom formulation of semaglutide or tirzepatide,” says Scott Brunner, the CEO of the Alliance for Pharmacy Compounding.

• A new dosage or potency
• A new drug combination, such as semaglutide mixed with vitamin B12
• A new drug form, such as a liquid or pill rather than an injection

Brunner thinks clinicians will increasingly take advantage of these exceptions: “I think we'll see more prescribers move into the customized dosage side of compounding.”

This customization has also fueled interest in microdosing GLP-1s, a technique in which patients take smaller amounts to try to achieve gradual weight loss or minimize side effects.

As a workaround for the ban, some compound pharmacies are combining semaglutide or tirzepatide with additional ingredients, such as vitamin B12 or glycine, supposedly to enhance the drug’s therapeutic effects. Compounders offering such blended products tend to claim that these extra ingredients, which are commonly used as nutritional supplements, can prevent muscle loss, improve sleep quality, or even improve weight loss results.

Some online compounding pharmacies have begun selling oral forms of semaglutide and tirzepatide, which are typically administered with an injection. These pills and liquids are not swallowed but are instead absorbed directly into the bloodstream under the tongue through what’s known as sublingual delivery.

There is one daily semaglutide pill that has been approved for the treatment of type 2 diabetes, but not weight loss, with the brand name Rybelsus. Rybelsus is not a sublingual pill, it’s a conventional pill that the user swallows.

Some online compounding pharmacies have stopped marketing GLP-1 drugs in response to the FDA's announcement, or have pivoted and joined forces with GLP-1 manufacturers, now offering only the brand name anti-obesity medications. Others have continued to supply existing customers with compounded GLP-1 drugs, but have stopped taking on new ones.

But there are still online providers prominently advertising “custom” GLP-1 formulations. At the moment, they appear to be operating entirely within the law.

What happens next is anyone's guess, says Brunner. The FDA could view the wide-scale manufacturing of custom medications as taking advantage of loopholes that ought to be closed: “I suspect the FDA never contemplated that [its guidance] would be applied the way it's being applied, given the scale of the compounded GLP-1 phenomenon,” he says.

Despite all the changes, it seems likely that compounding pharmacies will continue to offer GLP-1 drugs, at least for the foreseeable future, says Brunner: “Some patients will be able to maintain these therapies at a price point they can afford in a customized formulation.”

• The FDA ordered compounding pharmacies to stop producing and selling copies of GLP-1 injectable drugs like Ozempic, Wegovy, Mounjaro, and Zepbound, as official shortages have ended. But pharmacies can still legally create customized versions by changing dosages, ingredients, or drug forms.
• These compounded GLP-1 drugs may include custom microdose formulations, and some are marketed for off-label uses like longevity or cognitive support, though experts warn that their safety and effectiveness remain unproven.
• Some compounders are also offering new combinations, such as semaglutide with vitamin B12, and alternative delivery methods like sublingual drops. But there’s little scientific evidence supporting their benefits, and regulatory scrutiny of these practices is increasing.