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
The GLP-1 class of medicines is almost 20 years old
[CrossRef] [PubMed] Antioxidants 2024,13, 1228 28 of 28 145
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A Look Ahead: GLP-1 Isnt Going Away With hundreds of millions of adults eligible and adoption growing, GLP-1s influence on shopping behavior will likely persist , even among former users whove built new habits