U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Laws, Acts, and Rules
  5. FDA’s Labeling Resources for Human Prescription Drugs
  6. Patient Medication Information (PMI)
  1. FDA’s Labeling Resources for Human Prescription Drugs

Patient Medication Information (PMI)

Background

FDA is proposing to amend its human prescription drug labeling regulations to require a new type of Medication Guide—"Patient Medication Information” (PMI)—for prescription drug products used, dispensed, or administered on an outpatient basis, including blood and blood components transfused in an outpatient setting. 

PMI will:

  • Improve public health by providing patients with clear, concise, accessible, and useful patient information.
  • Ensure that essential information for patients to use their prescription drug products safely and effectively is provided in a patient friendly manner.
  • Consist of a single page document with standard content and formatting to make it easier for patients to access important information on drug products.
  • Expand patient choice to include an electronic option to receive patient medication information in addition to the physical paper format. 

FDA recognizes the importance of providing written information to patients about their prescription drug products. Evidence suggests that such information can help patients use their prescription drug products safely and effectively, which may reduce preventable adverse drug reactions and improve health outcomes. The layout and format of PMI is based on the prototypes that were developed through public meetings with interested parties through an iterative process. Prototypes were tested against each other and current medication guides to determine patient comprehension and retention.  

PMI will highlight essential information that patients need to know about the prescription drug product, including basic directions on how to use the product. PMI will be an FDA-approved, one-page document that follows standardized format and content requirements. FDA-approved PMI will be given to patients with their prescription drug products to help them use their prescription drug products safely and effectively. 


PMI Development Past Events

Comments on the Proposed Rule

FDA requested public comment on the entirety of the proposed rule, and specifically for certain elements, including, but not limited to:

  • Whether the proposed format and content requirements support the accessibility of PMI for all intended users, including patients with limited health literacy.
  • Actions applicants and other organizations might take to make PMI accessible to individuals with limited English proficiency.
  • PMI requirements for which waivers could be requested and the criteria that FDA might consider when evaluating such requests.

The comment period on the proposed rule closed on November 27, 2023. FDA is in the process of reviewing the comments for consideration in issuing a final rule.


Contact Information

For questions related to the proposed rule:
Toll Free
(855) 543-3784, or 
(301) 796-3400
Email: druginfo@fda.hhs.gov, or CDEROMP@fda.hhs.gov

Related Information


PMI Example for a Hypothetical Drug Product

The example below for a hypothetical product was created during the development of the proposed rule and may not represent requirements of a final rule, if issued.

Rheutopia Patient Medication Information
 
Back to Top