Patient Medication Information

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.

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.

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

Patient Medication Information would be stored electronically in FDA’s labeling repository at https://labels.fda.gov. PMI for blood and blood components will either be stored electronically in the FDA labeling repository (https://labels.fda.gov) or a link will be provided at https://labels.fda.gov to the site where they are stored electronically.

Comments on the Proposed Rule

The proposed rule is available for public comment for 180 days. FDA encourages comments and questions to be submitted to the docket so that the agency can fully consider all feedback.

Comments should be submitted to docket FDA-2019-N-5959 on Regulations.gov.

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: