Drugs

Labeling

Below is a sortable listing of Labeling Guidances.  For more information about the Physician Labeling Rule (PLR), labeling regulations and related guidance documents, and additional labeling resources see PLR Requirements for Prescribing Information.

CategoryTitleTypeDate
Labeling Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 52KB) Final Guidance 01/18/06
Labeling Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content and Format (PDF - 117KB) Draft Guidance 08/13/14
Labeling Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 127KB) Final Guidance 01/18/06
Labeling Content and Format for Geriatric Labeling (PDF - 38KB) Final Guidance 10/01/01
Labeling Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 146KB) Final Guidance 04/05/16
Labeling Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products (PDF - 163KB) Final Guidance 03/22/10
Labeling Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (PDF - 143KB) Final Guidance 03/14/11
Labeling Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 65KB) Final Guidance 10/16/09
Labeling Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements (PDF - 527KB) Final Guidance 02/22/13
Labeling Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommended Prescribing Informtion for Health Care Providers and Patient Labeling (PDF - 458KB) Draft Guidance 11/16/05
Labeling Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice (PDF - 115KB) Draft Guidance 02/27/13
Labeling Public Availability of Labeling Changes in "Changes Being Effected" Supplements (PDF - 26KB) Draft Guidance 09/20/06
Labeling; Over-the-Counter; Small Entity Compliance Guides Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective (PDF - 123KB) Final Guidance 06/21/11
Labeling Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices (final) (PDF - 144KB) Final Guidance 06/26/09
Labeling Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 102KB) Final Guidance 10/11/11
Labeling Abuse-Deterrent Opioids — Evaluation and Labeling - Draft Draft Guidance 01/09/13
Labeling Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 91KB) Final Guidance 12/09/14
Labeling Naming of Drug Products Containing Salt Drug Substances (PDF - 210KB) Final Guidance 06/16/15
Labeling Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (PDF - 169KB) Draft Guidance 03/24/14
Labeling Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format (PDF - 208KB) Draft Guidance 12/03/14
Labeling; Small Entity Compliance Guides Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide) (PDF - 165KB) Final Guidance 06/10/15
Labeling Nonproprietary Naming of Biological Products Guidance for Industry (PDF - 111KB) Draft Guidance 08/27/15
Labeling Labeling for Biosimilar Products Guidance for Industry (PDF - 143KB) Draft Guidance 03/31/16

Page Last Updated: 04/05/2016
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