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At Gnosis by Lesaffre, we see this as an opportunity: creating science-based solutions for healthy weight maintenance
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
When Victoza is covered, it usually requires documentation of a type 2 diabetes diagnosis and may involve step therapy or prior authorization
Most commonly: continue the GLP-1 at the patients established dose
What type of outreach do others do
H., Noriega, L
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