Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)

• Date: May 12, 2011
• Source: http://www.fda.gov

This guidance is intended to address two topics pertaining to Medication Guides for drug and biological products. This guidance applies when FDA intends to exercise enforcement discretion regarding when a Medication Guide must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient4 instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient. The guidance also clarified when a Medication Guide will be required as part of a risk evaluation and mitigation strategy (REMS).

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