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Key approved indications include: Type 2 diabetes mellitus management (Mounjaro) Chronic weight management in obesity or overweight with comorbidities (Zepbound) Use as adjunct to lifestyle modification (diet and exercise) It is critical to recognize that tirzepatide has no FDA approval for the treatment, prevention, or management of autoimmune diseases

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The 4 or fewer prescriptions per month exemption: The FDA has stated it does not intend to take action against compounders compounding products essentially copying FDA-approved drugs in inordinate amounts, where the compounder fills four or fewer prescriptions per month for that specific compounded product