FDA Proposed Rule on “Patient Medication Information” Guide

The U.S. Food and Drug Administration (FDA) “is proposing to amend its human prescription drug labeling regulations to require a new type of Medication Guide – ‘Patient Medication Information’ – for prescription drug products used, dispensed, or administered on an outpatient basis, including blood and blood components transfused in an outpatient setting.” [Proposed Rule at 88 Fed. Reg. 35694 (May 31, 2023).]  Helping to fight health care misinformation and to improve public health, the “Patient Medication Information” (PMI) guide will “highlight essential information that patients need to know about the prescription drug product, including basic directions on how to use the product,” and “be an FDA-approved, one-page document that follows standardized format and content requirements.”  The FDA also proposes to store PMI in its Online Label Repository (OLR); PMI for blood and blood components will be stored in the OLR or the OLR will provide a link to the site where they are stored.  Electronic and written comments on the proposed rule will be received through November 27, 2023.  For more information, see 88 Fed. Reg. 35694 (May 31, 2023).