Single Entity Injectable Drug Products

The FDA is requiring the removal of ratio expressions of strength from the labeling of single-entity injectable drug products (i.e., drug products that contain only one active ingredient) and replacement with the amount per unit of volume (e.g., mg/mL).

For example, Epinephrine Injection 1:1,000 will now be labeled as Epinephrine Injection 1 mg/mL. The FDA is requiring the changes to help prevent medication errors related to strength being expressed as a ratio on labeling. There have been several reports of medication errors indicating that ratio expressions are confusing to health care providers and contributed to the errors. Some of the medication errors resulted in serious adverse outcomes, including death. The United States Pharmacopeia (USP) instituted a new labeling standard in an effort to reduce medication errors related to confusion with ratio expressions.

This revision affects Epinephrine Injection, Isoproterenol Hydrochloride Injection, and Neostigmine Methylsulfate Injection.

For further details see: FDA

Posted by Dr. Tim Sandle