21 CFR 200.51 - Aqueous-based drug products for oral inhalation.

Regulations last checked for updates: Feb 11, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

§ 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]

authority: 21 U.S.C. 321,331,351,352,353,355,358,360e,371,374,375

source: 40 FR 13996, Mar. 27, 1975, unless otherwise noted.

cite as: 21 CFR 200.51