USP Labeling

USP provides definitions and standards for labeling of official articles. Our standards and solutions provide guidance to ensure labels on products and prescription containers are clear and useful to healthcare practitioners and promote better patient understanding to ensure safe and appropriate use of medications.

Important Updates

  • September 1, 2023: Labeling changes for expiration date format for USP General Chapter <7> Labeling have become official.
  • July 31, 2020: USP General Chapter <7> Labeling was published with revisions to expiration date formats. A 3-year implementation period was established for the “Expiration Dates and Beyond-Use Dates” section of the chapter. 

USP General Chapter <7> Labeling

USP General Chapter <7> provides definitions and standards for labeling of official USP articles including injectable products, pharmacy bulk packages, prescription drug products, over-the-counter drug products, dietary supplements, and animal drug products. 

USP General Chapter <17> Prescription Container Labeling

USP General Chapter <17> provides guidance on organizing prescription labels in a “patient-centered” manner that reflects how most patients seek out and understand medication instructions. It includes a universal approach to the format, appearance, content, and language of instructions for medicines in containers dispensed by pharmacists.

USP General Chapter <1091> Labeling of Inactive Ingredients

USP General Chapter <1091> provides guidance for labeling of inactive ingredients in dosage forms to help promote consistency in labeling.

USP General Chapter <1121> Nomenclature

USP General Chapter <1121> provides general guidance for the nomenclature of drug products.

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