§ 200.51. Aqueous-based drug products for oral inhalation.
34 words·~1 min read·
/us/cfr/t21/s§ 200.51·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]