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.

Latest Forms, Documents, and Supporting Material
Document
Name
Supporting Statement A
Supplementary Document
All Historical Document Collections
Approved with change
 Extension without change of a currently approved collection 2022-10-31
Approved without change
 Extension without change of a currently approved collection 2019-09-10
Approved with change
 Extension without change of a currently approved collection 2015-11-12
Approved with change
 Extension without change of a currently approved collection 2012-04-30
Approved with change
 Extension without change of a currently approved collection 2008-11-28
Approved without change
 Extension without change of a currently approved collection 2005-06-07
Approved without change
 Extension without change of a currently approved collection 2002-01-25
Approved without change
 New collection (Request for a new OMB Control Number) 1998-12-03
OMB Details

Content and Format of a Medication Guide

Federal Enterprise Architecture: Health - Consumer Health and Safety

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