USA – FDA’s proprietary name guidance seeks to avoid medication errors

The US Food and Drug Administration (FDA) has issued a pair of draft guidance documents aimed at guiding the selection of proprietary names for prescription and non-prescription drugs.

The best practices set forth in the guidances are designed “to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations,” according to the guidances.

The best practices documents apply only to human drugs; the non-prescription drug naming guidance runs to 17 pages, whereas the guidance dedicated to prescription drug naming is 42 pages long and includes appendices outlining research methodology considerations for conducting misbranding review and name simulation studies. The prescription drug guidance also includes high- and low-similarity name pair lists and a checklist for moderately similar name pairs…