FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

New Rule on Bulk Substances for Compounding Drugs Proposed by FDA

Dec. 22, 2016

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.

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