Prescription Drug Product Labeling; Medication Guide Requirements

OMB 0910-0393

OMB 0910-0393

This information collection supports agency regulations pertaining to patient labeling for certain drug products. Specifically, regulations in 21 CFR part 208 describe requirements for Medications guides and enables the agency to determine whether the labeling for certain prescription drug products that pose a serious and significant public health concern comply with current safety regulations.

The latest form for Prescription Drug Product Labeling; Medication Guide Requirements expires 2022-10-31 and can be found here.

OMB Details

Content and Format of a Medication Guide

Federal Enterprise Architecture: Health - Consumer Health and Safety


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