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Over-the-Counter
Below is a sortable table listing the Over-the-Counter Guidances
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Category
Title
Type
Date
Over-the-Counter
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16).
(PDF - 294KB)
Final Guidance
05/01/84
Over-the-Counter
General Guidelines for OTC Combination Products
(PDF - 270KB)
Final Guidance
11/01/78
Over-the-Counter
Label Comprehension Studies for Nonprescription Drug Products
(PDF - 148KB)
Final Guidance
08/03/10
Over-the-Counter
Labeling OTC Human Drug Products -- Questions and Answers
(PDF - 599KB)
Final Guidance
01/02/09
Over-the-Counter
Labeling OTC Human Drug Products -Submitting Requests for Exemptions and Deferrals
(PDF - 34KB)
Draft Guidance
12/19/00
Over-the-Counter; Small Entity Compliance Guides
Labeling OTC Human Drug Products; Small Entity Compliance Guide
(PDF - 270KB)
Final Guidance
05/12/09
Over-the-Counter
Labeling OTC Human Drug Products Updating Labeling in ANDAs
(PDF - 32KB)
Draft Guidance
02/21/01
Over-the-Counter
Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs
(PDF - 30KB)
Final Guidance
10/01/02
Over-the-Counter
Labeling OTC Human Drug Products Using a Column Format
(PDF - 57KB)
Final Guidance
12/01/00
Over-the-Counter; Small Entity Compliance Guides
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide
(PDF - 176KB)
Final Guidance
08/17/10
Over-the-Counter
Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
(PDF - 298KB)
Final Guidance
07/13/09
Over-the-Counter
Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers
(PDF - 83KB)
Final Guidance
08/13/09
Over-the-Counter
Time and Extent Applications for Nonprescription Drug Products
(PDF - 241KB)
Final Guidance
09/28/11
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
Over-the-Counter
Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731)
(PDF - 583KB)
Final Guidance
10/01/78
Over-the-Counter
Self-Selection Studies for Nonprescription Drug Products
(PDF - 151KB)
Draft Guidance
09/16/11
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