GroundRules
21 CFR 200.51: Aqueous-based drug products for oral inhalation.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER C—DRUGS: GENERAL
- PART 200—GENERAL
- Subpart C—Requirements for Specific Classes of Drugs
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON