The rule will amend FDA medication guide regulations to require a new form of patient labeling, Patient Medication Information, for submission to and for approval by FDA for human prescription drug products and certain blood products used, dispensed, or administered on an outpatient basis. The rule will include requirements for the development and distribution of Patient Medication Information. The rule will require clear and concisely written prescription drug product information presented in a consistent and easily understood format and is intended to help patients use their prescription drug products safely and effectively.