Hims & Hers Betting on FDA Loophole to Keep Selling Compounded Medications -- Market Talk

Dow Jones

04/03

1317 ET - Hims & Hers is hoping to take advantage of an FDA rule to be able to keep selling compounded versions of weight-loss drugs, even after the GLP-1 shortage has ended, Needham analyst Ryan MacDonald tells WSJ. The personalization exemption rule allows companies to sell compounds if they are personalizing the treatment for a patient; for example, if the patient needs to take an oral form instead of an injection. Hims hopes it can keep offering personalized compounds, as compounded drugs make up a significant portion of its weight-loss revenue, MacDonald says. But if the FDA finds this illegal, the company may be challenged to meet revenue goals, MacDonald says. (katherine.hamilton@wsj.com)

(END) Dow Jones Newswires

April 02, 2025 13:17 ET (17:17 GMT)

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The personalization exemption rule allows companies to sell compounds if they are personalizing the treatment for a patient; for example, if the patient needs to take an oral form instead of an injection. Hims hopes it can keep offering personalized compounds, as compounded drugs make up a significant portion of its weight-loss revenue, MacDonald says. But if the FDA finds this illegal, the company may be challenged to meet revenue goals, MacDonald says. 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But if the FDA finds this illegal, the company may be challenged to meet revenue goals, MacDonald says. (katherine.hamilton@wsj.com) \n\n\n  (END) Dow Jones Newswires\n\n\n  April 02, 2025 13:17 ET (17:17 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}