New USP Medication Labeling Standards

The U.S. Pharmacopeial Convention (USP) released a universal approach to the format, appearance, content, and language of instructions for medicines in containers dispensed by pharmacists. For the first time, 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.

The new standards were developed from an Institute of Medicine (IOM)-led initiative to improve health literacy, which is defined as the degree to which people can obtain, process and understand the basic health information and services they need to make appropriate health decisions.

Elements of the new USP standards, of the United States Pharmacopeia and the National Formulary include:

  • Emphasize instructions and other information important to patients
  • Improve readability with optimized typography
  • Give explicit instructions separating the dose itself from the timing of each dose
  • Include purpose for use unless a patient prefers that it not appear
  • Address limited English proficiency by utilizing high-quality translation processes when possible
  • Address visual impairment by providing alternative access

The USP issued a draft of this standard for public review and comment by all interested stakeholders—including healthcare practitioners, retailers, software vendors, consumers and others—in December 2011. 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.

For more information call (800) 227-8772 or visit http://uspgo.to/prescription-container-labeling.