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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter C - Drugs: General |
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Part 200 - General |
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Subpart C - Requirements for Specific Classes of Drugs |
§ 200.51 - Aqueous-based drug products for oral inhalation.
Latest version.
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§ 200.51 Aqueous-based drug products for oral inhalation.
(a) All aqueous-based drug products for oral inhalation must be manufactured to be sterile.
(b) Manufacturers must also comply with the requirements in § 211.113(b) of this chapter.
[65 FR 34089, May 26, 2000]