USP Releases First Universal Standards for Content and Appearance of Prescription Labels to Promote Patient Understanding

New United States Pharmacopeial Convention (USP) standards for a universal approach to the format, appearance, content, and instructions for medicines in containers dispensed by pharmacists have been released. “Wide variability in prescription container labels exists today across individual prescriptions, pharmacies, retail chains and states. The USP standards provide specific direction on how to organize labels in a ‘patient-centered’ manner that best reflects how most patients seek out and understand medication instructions,” as explained in a USP press release. Lack of universal standards for medication labeling can contribute to patients misunderstanding dosage instructions and can lead to medication errors.

Elements of the new USP standards, contained in General Chapter <17> Prescription Container Labeling, of the United States Pharmacopeia and the National Formulary, include:

• Emphasizing instructions and other information important to patients
• Improving readability
• Giving explicit instructions
• Including purpose for use
• Addressing limited English proficiency
• Addressing visual impairment

Descriptions of each standard including examples, as well as more information about the development of the standards is available in a USP press release (PDF). The final standard will be published in November 2012. Enforcement of the standard will be the decision of individual state boards of pharmacy, which may choose to adopt it into their regulations, notes USP. NABP member boards adopted a resolution at the 108th NABP Annual Meeting stating that the Association should support state boards of pharmacy in efforts to require a standardized prescription label. NABP also convened a task force on this issue in December 2008, and the Report of the NABP Task Force on Uniform Prescription Labeling Requirements is available for download.