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Substances are often placed in Category 2 due to: Insufficient human safety data Concerns about impurities or manufacturing variability Lack of clinical justification for traditional pharmacy compounding When a substance is in Category 2, traditional 503A compounding pharmacies generally should not compound it

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Compounded versions of investigational peptides like cagrilintide carry additional regulatory and quality-control uncertainties that approved medications do not, and they are not equivalent to trial-grade compounds