Title 21

SECTION 200.51

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.

[65 FR 34089, May 26, 2000]