§200.51. Aqueous-based drug products for oral inhalation.
21 C.F.R. § 200.51
All aqueous-based drug products for oral inhalation must be manufactured to be sterile.
Manufacturers must also comply with the requirements in § 211.113(b) of this chapter.
Notes, amendments, and revision history
Amendments
[65 FR 34089, May 26, 2000]
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360e, 371, 374, 375.
Source
Source: 40 FR 13996, Mar. 27, 1975, unless otherwise noted.
Amendments
[65 FR 34089, May 26, 2000]