1. Regulations
  2. title 21
  3. chapter I-i3
  4. part 200
  5. subpart C
  6. § 200.51

View all text of Subpart C [§ 200.50 - § 200.51]

§ 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