eCFR Reference Browser

---

title: "21 CFR §200.51"

source: "https://www.ecfr.gov/current/title-21/section-200.51"

title_number: "21"

volume_number: "4"

chapter_number: "Unknown"

subchapter_code: "C"

subchapter_subject: "DRUGS: GENERAL"

part_code: "200"

part_subject: "GENERAL"

subpart_code: "C"

subpart_subject: "Requirements for Specific Classes of Drugs"

section_number: "200.51"

section_subject: "Aqueous-based drug products for oral inhalation."

cfr_reference: "21 CFR 200.51"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 200 to 299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§200.51 - Aqueous-based drug products for oral inhalation.