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14.4 MOUNJARO Use in Combination with Basal Insulin with or without Metformin in Adult Patients with Type 2 Diabetes Mellitus SURPASS-5 (NCT04039503) was a 40-week double-blind trial that randomized 475 adult patients with type 2 diabetes mellitus with inadequate glycemic control on insulin glargine 100 units/mL, with or without metformin, to subcutaneous MOUNJARO 5 mg, MOUNJARO 10 mg, MOUNJARO 15 mg once weekly, or placebo

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The shortage-based legal exemption that underpinned widespread compounded semaglutide availability is no longer active for either 503A pharmacies or 503B outsourcing facilities Compounded GLP-1 programs operating today must navigate a legal framework that includes restrictions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

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