Guideline

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Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide
Internet:	http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079286.pdf
Origin/Publisher:	Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Content:	This guidance restates in plain language the legal requirements set forth in the current regulation requiring that all prescription and over-the counter (OTC) aqueous-based drug products for oral inhalation be manufactured sterile
Document Type:	Guidance