New Rule on Bulk Substances for Compounding Drugs Proposed by FDA

The FDA issued a proposed rule adding six bulk drug substances to the list of materials that can be used in compounding, while removing four substances.

In addition, the agency is proposing to use a new set of four criteria when evaluating substances for inclusion. The FDA will consider each criterion on a substance-by-substance basis, including:

• The physical and chemical characterizations of the substance,
• Any safety issues raised in using the substance in compounded drug products,
• The available evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists, and
• Historical use of the substance in compounded drug products, including information about the medical conditions the substance has been used to treat, and any references in peer-reviewed medical literature.