Aqueous-based drug products for oral inhalation.
21 C.F.R. § 200.51
in effectEffective: 2024-07-01(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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026