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Under section 503A, a bulk drug substance generally must satisfy one of the applicable statutory pathways, including having an applicable USP or NF monograph, being a component of an FDA-approved drug product when no applicable monograph exists, or appearing on the 503A Bulks List

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pseudomallei possesses one of the largest bacterial genomes (7.2 Mb), which is shared over two chromosomes and contains an extensive arsenal of virulence determinants, which enable it to both survive a range of harsh environments and cause a multitude of clinical presentations of disease [63]