Drugs

Small Entity Compliance Guides

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

Category	Title	Type	Date
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
Current Good Manufacturing Practices/Compliance 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