CFR /  Title 21  /  Part 200  /  Sec. 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 Sec. 211.113(b) of this chapter. [65 FR 34089, May 26, 2000] Subpart D [Reserved]