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FDA Guidance for Industry: Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide
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 ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079286.pdf
Document Type:
Guidance
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
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