Title 21: Food and Drugs
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/ PART 200 - GENERAL
/ Subpart C - Requirements for Specific Classes of Drugs / § 200.51 Aqueous-based drug products for oral inhalation.
§ 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.