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June 02, 2023

FDA Proposes New Medication Guide for Patient Medication Information

On  May 30, 2023, the FDA announced a new proposed rule that requires a new document known as “Patient Medication Information” to be provided when certain drugs, biologics and blood products are dispensed or administered on an outpatient basis. The one-page document would provide essential, clear, and easy-to-understand information including product name, drug indications, safety information, common side effects and directions for use. The FDA is now  accepting comments on the proposed rule, which was published in the Federal Register on May 31, 2023. The public comment period ends on November 27, 2023. 

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