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Unlike semaglutide and tirzepatide, retatrutide has no approved version, so the shortage exemption never applied It fails all three criteria for 503A and 503B compounding: no USP/NF monograph, not an approved drug component, not on any shortage list The FDA issued 50+ warning letters to GLP-1 compounders in September 2025, explicitly citing retatrutide violations Research-peptide vendors and "compounding pharmacies" selling retatrutide operate outside the law
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The article's table puts typical duration of coverage at twelve months, with annual reauthorization required after that
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