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Comment: Several commenters cautioned CMS to avoid defaulting to extensions in cases where broader relief is warranted and ensure reporting extensions are not disproportionately utilized in place of exceptions

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[DOI] [PubMed] [Google Scholar] 62.Chau C, Rossignol S

Do not treat 99% purity as a complete safety result Likewise, a 99% HPLC result does not establish correct fill amount, sterility, endotoxin level, residual-solvent compliance, elemental purity, or equivalence to an approved injectable product