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Finally, the applicant stated that, under the regulation at 419.66(a), CMS makes a pass-through payment for a medical device that meets the requirements in paragraph (b) of that section and that is described by a category of devices established by CMS under the criteria in paragraph (c) of that section, and that, further, according to 419.66(g), the pass-through period begins on the first date on which pass-through payment is made
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The report notes the presence of counterfeit Ozempic, the use of non-FDA-approved ingredients such as retatrutide or cagrilintide, and products bypassing regulations by being labeled as not for human consumption. As of July 2024 the most recently issued report the FDA had received over 1,000 reports of adverse events related to compounded semaglutide and compounded tirzepatide