State Prescription Label Requirements in the United States

Abstract

Objective:

To determine the current legal requirements for prescription labels and to explore the usefulness of this information in determining the utility of a standardized prescription label.

Data Sources:

State prescription label regulations were requested from Board of Pharmacy executives.

Study Selection:

Label requirements for prescriptions dispensed in community, noninstitutional pharmacies were selected for review.

Data Extraction:

Data were compiled, sorted by state, and analyzed as either federally mandated or additional state requirements. Additional state requirements were divided into 16 categories and analyzed by category.

Data Synthesis:

Responses were received from all 50 states. Five states did not list all federal label requirements. Medication name was the most frequently added requirement, followed by medication strength and name of manufacturer if the medication was generic. Only in New Jersey are pharmacists allowed to add directions not included in the prescription.

Conclusions:

States were consistent in the proper use of federal prescription label requirements. However, there was little agreement on what additional information should appear on the label. Nevertheless, there appears to be consensus for the name of the medication to be on the label. There also appears to be fairly strong consensus that medication strength and quantity should appear on the label. There is little interest in expanding the current directions-for-use requirement. Finally, the results support the utility of a standardized prescription label format.