Definition

FDA-required patient labeling that provides information about drug risks to help patients use medicines safely.

Example

The Medication Guide for an antidepressant includes the boxed warning about suicidality in young adults, symptoms to watch for, and when to contact a healthcare provider.

Regulatory source

21 CFR 208

Common mistakes

Not ensuring medication guides are distributed with each prescription as required.

Inspector question

How do you ensure medication guides reach patients? How do you monitor distribution?

Related terms