FDA Updating Label Requirements for Certain Injectables

June 23, 2017

The FDA is changing its labeling requirements for injectable drug products that contain a single active ingredient — swapping ratios of strength with amounts per unit of volume — in an effort to reduce dosage confusion and related adverse outcomes.

The revision affects injections of epinephrine, the cardiac arrhythmia drug isoproterenol hydrochloride and neostigmine methylsulfate, used to reverse the effects of anesthesia.

The agency instituted the changes following several reports of administration errors stemming from confusion over the ratios, with some of the errors resulting in serious adverse outcomes and death. Sponsors should review systems and processes that will be affected by this labeling standard, including computerized pharmacy and prescriber order entry systems, protocols, dispensing labels and labels for drug storage bins and carts, as well as in stock requisition forms. — Conor Hale

View today's stories