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FDA Guidance for Industry: Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide


Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; ;

Document Type:
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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