Medication guides in outpatient settings, draft guidance

Medication Guides should be dispensed in outpatient settings, even when the drug is dispensed to a healthcare professional for administration to the patient, the first time the drug is dispensed, and if the Medication Guide is materially changed, according to a draft guidance published by the FDA. Titled “Medication Guides— Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)” the draft guidance addresses two topics pertaining to Medication Guides for drug and biological products: (1) when the FDA intends to exercise enforcement discretion regarding dispensing requirements for Medication Guides that must be distributed with a drug or biological product dispensed to a healthcare 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; and (2) when a Medication Guide will be required as part of a REMS. The draft guidance also addresses questions that have arisen concerning these topics. Written or electronic comments must be submitted by May 31, 2011. FDA Notice, ¶42,091

For more information on this and related topics, consult the CCHFDA Food, Drug and Cosmetic Law Reporter.

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