www.fdanews.com/articles/192685-fda-proposes-to-add-five-bulk-drug-substances-to-compounding-list
FDA Proposes to Add Five Bulk Drug Substances to Compounding List
September 11, 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.
