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The agency said it intends to take steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies, including Hims & Hers and other compounding pharmacies, as similar alternatives to FDA-approved drugs. This led Hims & Hers to halt sales of certain, lower-cost, non-FDA-approved, copycat versions of drugs like Wegovy and Ozempic
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503A Bulks List A legal pathway that can permit eligible traditional pharmacies to use a bulk substance under compounding conditions
They looked at two groups: Group A included over 38,000 patients who had taken GLP-1 medications at least twice
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