Drugs

Over-the-Counter

Below is a sortable table listing the Over-the-Counter Guidances

CategoryTitleTypeDate
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; 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 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 - 160KB) Final Guidance 04/10/13
Over-the-Counter; Small Entity Compliance Guide Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide) Final Guidance. Updated for 508 compliance 11/14/12
Over-the-counter Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide Final Guidance 12/05/12
Compliance; Over-the-Counter Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions (PDF - 78KB) Draft Guidance 11/26/14
Pharmaceutical Quality/CGMP; Compliance; Over-the-Counter Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — (PDF - 173KB) Final Guidance 11/16/15
Over-The-Counter Over-the-Counter Sunscreens: Safety and Effectiveness Data Guidance for Industry (PDF - 420KB) Draft Guridance 11/20/15
Over-The-Counter Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry (PDF - 107KB) Draft Guidance 11/20/15
Over-the-Counter Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process (PDF - 100KB) Draft Guidance 11/20/15
Over-The-Counter Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act (PDF - 124KB) Draft Guidance 11/20/15
Drug Safety Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen (PDF - 82KB) Final Guidance 08/04/15
Pharmaceutical Quality/CGMP; Compliance; Over-the-Counter Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — (PDF - 173KB) Final Guidance 11/16/15

Page Last Updated: 01/19/2016
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