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Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act | FDA

Category 2 is the designation reserved for substances the agency has identified as presenting significant safety concerns, and which may not be compounded absent an authorizing regulation

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Bile affects small intestinal bacterial population in a few ways: Bile delivers IgA antibodies (part of your immune system) to the small intestine when it is released from the gallbladder