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e-CFR data is current as of February 26, 2021 |
Title 21 → Chapter I → Subchapter C → Part 200 → Subpart C → §200.51 |
Title 21: Food and Drugs
PART 200—GENERAL
Subpart C—Requirements for Specific Classes of Drugs
§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]