Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance Guide
This small entity compliance guide is one of a series of guidance documents prepared in accordance with section 212 of the Small Business Regulatory Fairness Act (Public Law 104- 121). The guidances are intended to explain the actions small entities are required to take to comply with rules for which the Agency prepared a final regulatory flexibility analysis.
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. FDA issued a final rule, published in the Federal Register of May 26, 2000 (65 FR 34082), in response to reports of adverse drug experiences from contaminated nonsterile inhalation drug products and recalls of these products. FDA issued the final rule after considering all comments on the proposed rule, which was published in the Federal Register of October 11, 1991 (56 FR 51354).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.