Standards Proposed for Prescription Drug Labels

(FDA.gov)

The U.S. Pharmacopeial Convention (USP), a standards–setting body for prescription and over–the–counter medicines, has prepared a set of standards to guide the content, language, format, and appearance of prescription medication labels in the U.S. The draft standards are open for a 90-day public comment period.

USP says the standards, now in draft, reflect how patients read and understand medication instructions. The organization notes that the new standards are part of an effort led by the Institute of Medicine to improve health literacy in the United States. Even though they are intended to convey critical information for the safe use of medications, prescription labels can vary significantly from pharmacy to pharmacy.

According to USP, the standards were developed by a group of independent experts across the fields of pharmacy, medicine, health literacy, patient safety, human factors research, drug database software, and chain drug retail operations. The standards could be adopted by state boards of pharmacy, other governmental authorities, or included by conformity assessment bodies in state laws, regulations, or guidelines. A few states, including California and New York, recently developed their own regulations for prescription container labeling.

The standards propose that prescription drug labels printed at pharmacies:

• Feature the most important information for safe and effective understanding and use
• Emphasize instructions and other important information to patients
• Give explicit instructions
• Include purpose for use
• Improve readability
• Limit auxiliary information
• Simplify language on labels, including the elimination of Latin terms

Related: New Standard Advanced for Labeling on Injectable Medications

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