New York State Prescription Medicine Labeling Requirements

Prescription Medicine Labeling Standards

• Section 6830 of the Education Law mandates standardized patient-centered data elements for all prescription medicines dispensed in the state.
• Critical elements required on prescription labels include:
  • Patient name
  • Directions for use, structured in complete sentences
  • Drug name and strength

Important Elements

• Important elements that must be included on labels are:
  • Pharmacy's name, address, and telephone number
  • Patient’s address
  • Prescriber’s name
  • Date when the prescription was filled or refilled
  • Prescription number or a unique identifier for the prescription

Label Formatting Requirements

• All prescription drug labels must feature both critical and important elements.
• Critical elements must be:
  • Emphasized using color highlights, bold typography, or both
  • Printed in a minimum font size of 12 points
• Important elements must:
  • Not be highlighted or bolded
  • Remain legible without undermining the emphasis on critical elements