Published online 16 November 2024
The shortage-based legal exemption that underpinned widespread compounded semaglutide availability is no longer active for either 503A pharmacies or 503B outsourcing facilities Compounded GLP-1 programs operating today must navigate a legal framework that includes restrictions on compounding drugs that are commercially available drugs - meaning the compounding pharmacy's specific formulation, documentation, and prescriber individualization process matters for legal compliance The FDA still permits compounding under 503A for individual patient-specific prescriptions that involve a prescriber-documented "significant difference" from the commercially available product - but that requires specific clinical justification, not just a standard intake form Availability of specific compounded GLP-1 formulations may be affected by FDA enforcement actions, pharmacy-specific compliance status, and ongoing regulatory developments in this space None of this means compounded GLP-1 programs are operating illegally
2022;34(9):1234e12479
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The talk clearly left an impression, because immediately afterward, while they were sharing a meal, Jastreboff remembers Winfrey turning to her and saying, "You should write a book, and I will help you." "In that moment I thought, 'Well, this is going to help millions of people,'" Jastreboff said
While once viewed as primarily drugs for treating diabetes, these therapies are now finding new markets, but putting new pressures and challenges for the healthcare system and pharmaceutical companies
