Recommendations for Regulators and Standards Setters to Prevent Medication Errors Associated with the Label, Labeling, and Packaging of Pharmaceutical (Drug) Products and Related Devices

These recommendations primarily apply to the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP):

The Council encourages the FDA to maintain an error prevention analysis program that results in consistent and effective regulatory review of drug product labeling and packaging to minimize error-prone aspects of design.

The Council recommends that the FDA discourage pharmaceutical manufacturers from printing company logos and company names on product labels that are larger than the type size of the drug name.

The Council recommends that regulators and standards setters promote the use of innovative labeling to aid practitioners in distinguishing between drug products.

The Council encourages the printing of the drug name (brand and generic) and the strength on both sides of injectables and IV bags, containers, and overwraps. For large volume parenterals and IV piggybacks (minibags), the name of the drug should be readable in both the upright and inverted positions.

The Council encourages USP and FDA to examine the feasibility and advisability of using tactile cues in container design to differentiate drug products (e.g., for injectable drug products where mix-ups can result in significant harm to patients). Such cues may be in the design of the container, itself, or embedded in the label.

The Council supports the recommendations of the USP-FDA Advisory Panel on Simplification of Injection Labeling. Furthermore, the Council encourages the USP and FDA to consider expansion of the concepts of simplification to apply to the packaging and labeling of other pharmaceutical dosage forms.

The Council encourages USP and FDA to take an active role in alerting health care professionals about proposed FDA regulations and USP standards, respectively, that are available for public comment.

The Council encourages collaboration among regulators, standards-setters, pharmaceutical manufacturers, health care organizations, health care professionals, and patients to facilitate design of packaging and labeling of drug products to help minimize errors.

Actions/Decisions are those of the Council as a whole and may not reflect the views/positions of individual member organizations.

May 12, 1997
February 27, 2007