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.
The FDA has promised to prevent the import of unapproved GLP-1 ingredients,
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possibly in response to a bipartisan call from congress to reduce the flow of illegal and counterfeit anti-obesity medications into the country.
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The organization has also singled out ads for compounded GLP-1 drugs as a brazen example of misleading advertising.
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And the pharmaceutical corporations that have exclusive rights to semaglutide and tirzepatide are trying to stop compounding pharmacies in court.
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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.”
