New USP Standards Guide Prescription Container Labels

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New US Pharmacopeial Convention (USP) standards provide a universal approach to organizing labels for prescription containers dispensed by US pharmacists in an effort to improve patient understanding.

The US Pharmacopeial Convention (USP) released standards that, for the first time, provide a universal approach to organizing labels for prescription containers dispensed by pharmacists. The new standards aim to eliminate the variability that currently exists between pharmacies across the US and improve patient understanding of medication instructions by giving direction for optimal format, appearance, content, and language.

“Lack of universal standards for labeling on dispensed prescription containers is a root cause for patient misunderstanding, nonadherence, and medication errors,” said Joanne G. Schwartzberg, MD, director of aging and community health for the American Medical Association and a member of the USP Nomenclature, Safety, and Labeling Expert Committee, which was responsible for the new standard, in an Oct. 9, 2012, press release. “With an aging and increasingly diverse population, and people utilizing a growing number of medications, the risks are more pronounced today than ever,” said Schwartzberg. The USP standards will promote patient understanding of medication instructions, she notes.

The standards explain how to create labels that reflect how most patients seek out and understand instructions. The standards include detailed instructions for how to:


  • Emphasize instructions and information important to patients

  • Improve readability

  • Give explicit instructions

  • Include purpose for use

  • Address limited English proficiency

  • Address visual impairment.

The final version of the standard will be published in November 2012, and will incorporate changes based on feedback on the draft version, which was released for public comment in December 2011. The boards of pharmacy in individual states may choose to adopt the standard into their regulations. The National Association of Boards of Pharmacy passed a resolution in May 2012 supporting state boards in requiring a standardized label.