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However, the presence of chronic kidney disease (CKD) has historically raised concerns about metformin use, primarily due to the risk of lactic acidosisa rare but serious complication that carries an FDA boxed warning

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Under CMS-0057-F (effective January 1, 2026), payers must respond within 7 calendar days for standard requests and 72 hours for urgent/expedited requests

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These individual findings don't mean the compounded formulation replaces prescribed treatment

Kennedy Jr., who oversees the FDA and other major health agencies as the secretary of Health and Human Services, knows this history