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Home » FDA Proposes to Add Five Bulk Drug Substances to Compounding List

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Pharmaceuticals / Regulatory Affairs

FDA Proposes to Add Five Bulk Drug Substances to Compounding List

Sept. 12, 2019

The FDA issued a proposed rule to include five new substances in its 503A bulk substances list for compounded drugs.

The five additions include glutaraldehyde, glycolic acid, L-citrulline, pyruvic acid, and trichloroacetic acid.

The agency selected the substances following reviews for safety and efficacy, as well as the historical use of the substance in compounded drugs.

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