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The Food and Drug Administration (FDA) on Tuesday sent 30 telehealth companies warning letters about their \u201cillegal\u201d sales of compounded GLP-1s, building off increasing pressure to tamp down on the sale of these unapproved medications.<\/p>\n
According to the FDA, the companies they contacted made \u201cfalse or misleading claims\u201d about the GLP-1 products they sold on their websites, including implying \u201csameness with FDA-approved products and obscuring product sourcing.\u201d<\/p>\n
With the current state of GLP-1 availability, compounded versions of drugs like tirzepatide and semaglutide are meant to be personalized for patient-specific prescriptions. When branded drugs are not in shortage, compounding pharmacies are not permitted to mass market compounded versions of the medication.<\/p>\n
Due to the ostensibly hyper-specific nature of compounded drugs, they are not FDA-approved drugs, though compounding pharmacies are regulated by both state and federal agencies to some degree.<\/p>\n
\u201cIt\u2019s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms \u2014 and taking swift action,\u201d FDA Commissioner Marty Makary said in a statement.<\/p>\n
\u201cCompounded drugs can be important for overcoming shortages or meeting unique patient needs \u2014 but compounders should not try to compound drugs in a way that circumvents FDA\u2019s approval process,\u201d he added.<\/p>\n
Kin Meds, GoodGirlRx, WeightCare and PharmaZee were among companies targeted by FDA letters.<\/p>\n
In one such letter, FDA Deputy Director of Compliance Matt Lash stated: \u201cCompounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. As a result, these claims are false or misleading and your products are therefore misbranded.\u201d<\/p>\n
He requested the company provide written response explaining how it plans to address the violation and prevent it from happening again. Lash said such actions could include identifying the entities producing their compounded GLP-1s, providing a sample of the labeling on their product or modifying the cited violations on their platform.<\/p>\n
The agency noted this is the second batch of warning letters it has sent out regarding compounded GLP-1s since initiating a crackdown on these drugs.<\/p>\n
Though the shortages of drugs like Ozempic and Zepbound have ended, companies like Hims & Hers have continued to sell compounded versions of the drug, insisting they are no long mass-marketing the drug, but helping patients \u201caccess care personalized to their needs.\u201d<\/p>\n
The Department of Health and Human Services recently referred Hims & Hers to the Department of Justice for potential criminal violations.<\/p>\n
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