21 CFR 200.51

§ 200.51 Aqueous-based drug products for oral inhalation.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 200.51, § 200.51 Aqueous-based drug products for oral inhalation, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85744
Permanent ID: ys:prov:85744@1
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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.