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First, What the 503A Bulks List Actually Is Section 503A of the Federal Food, Drug, and Cosmetic Act lets a compounded drug be exempt from certain approval, labeling, and CGMP requirements if it's compounded from a bulk drug substance that meets one of three conditions: It complies with an applicable USP or NF monograph, or It is a component of an FDA-approved drug, or It appears on the 503A Bulks List developed by FDA

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A comparative study of encapsulation of β-carotene via spray-drying and freeze-drying techniques using pullulan and whey protein isolate as wall material