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As background, the Food and Drug Act in sec 503A provides that bulk drug substances that either 1) lack a USP or NF monograph, or 2) are not components of FDA-approved drug products, cannot be used in compounding unless they appear on a list created under Section 503A

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When Nimzyme was first reported, fluorine-labeled lactose-immobilized substrates ( m / z 1074.30) were incubated with lysates from E