On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved prescription drugs and biological products administered in an outpatient setting. The proposed rule intends to improve patient access to readable, consistent, and understandable information about his/her prescribed medications, and thus improve patient outcomes.

Under the proposed rule, the Patient Medication Information guide would create a standardized, one-page document that provides patients with timely and essential information about their medication in an easy-to-read format.

This proposed rule will be important for pharmaceutical and biologics manufacturers to follow if finalized and is open for public comment until November 27.