Small Entity Compliance Guides

Below is a sortable listing of Small Entity Compliance Guides Guidances.

Small Entity Compliance Guides Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance Guide (PDF - 18KB) Final Guidance 11/07/01
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; 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
Pharmaceutical Quality/Manufacturing Standards (CGMP) and Small Entity Compliance Guide PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (PDF - 229KB) Final Guidance 08/04/11
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; 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
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
Small Entity Compliance Guides 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry (PDF - 82KB) Final guidance 01/17/17
Over-the-Counter; Small Entity Compliance Guides Consumer Antiseptic Wash Final Rule Questions and Answers (PDF - 92KB) Final Guidance 07/25/17

Page Last Updated: 07/25/2017
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