21 C.F.R. § 200.51

Aqueous-based drug products for oral inhalation.

Last amended: 2016Year: 2026Length: 34 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 200.51 (2026)

(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]
Cross-references to the CFR
211.113
21 C.F.R. § 200.51: Aqueous-based drug products for oral inhalation. | Justis AI