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Even with a favorable advisory committee vote, the FDA requires formal rulemaking before compounding pharmacies can act

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Each COA reports results from third-party laboratory analysis, including: High-performance liquid chromatography (HPLC) for purity, typically confirmed at 99% or higher Liquid chromatography mass spectrometry (LC-MS) for molecular identity and mass confirmation Sterility and endotoxin screening where applicable Chemical contaminant and residual solvent checks COAs are sourced from independent certified labs rather than in-house testing alone, giving researchers a verifiable record of molecular integrity for each batch