FDA Proposes 6 Bulk Drug Substances for 503A List

An FDA 12/15 final rule lists six substances the agency has evaluated and is proposing to include on a list of bulk drug substances that can be used in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. The rule also lists four substances that the agency evaluated and recommended not be included in the 503A bulks list.

The rule says FDA will use these criteria when evaluating nominated substances for inclusion on the list: the physical and chemical characterization of the substance; any safety issues raised by using the substance in compounded drug products; available evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance if such evidence exists; and historical use of the substance in compounded drug products, including information about the medical condition(s) the substance has been used to treat and any references to peer-reviewed medical literature, according to an agency statement.