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In 2018, FDA published guidance to 503A pharmacies on what will be considered unauthorized compounding of a product that is “essentially a copy” of an FDA-approved product, with an exception available when the “prescriber documents on the prescription that the compounded drug product produces a significant difference for the identified individual patient.” Under the 2018 guidance, “FDA generally does not intend to question prescriber determinations that are documented in a prescription or notation.” To date, patient-specific GLP-1 compounding activities have often included adding supplemental ingredients to combat side effects of the GLP-1 products or customizing doses, with a significant percentage of prescriptions for customization written by telehealth prescribers
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Wissenschaftliche Studien erforschen kontinuierlich seine metabolischen Mechanismen
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