Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Medication Guides-- Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)." This guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the guidance addresses when FDA intends to exercise enforcement discretion regarding when a Medication Guide must be provided with a drug or biological product that is dispensed to a health care professional for administration to a patient instead of being dispensed directly to the patient for self-administration or to the patient's caregiver for administration to the patient. Second, the guidance addresses when a Medication Guide will be required as part of a REMS. The guidance is intended to answer questions that have arisen concerning these topics.