Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
All TitlesTitle 21Chapter IPart 200Subpart C - Subpart C—Requirements for Specific Classes of Drugs
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
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