CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER C—DRUGS: GENERAL (parts 200 to 299) > PART 200—GENERAL > SUBPART C—Requirements for Specific Classes of Drugs (§200.50 to §200.51) > 200.51—Aqueous-based drug products for oral inhalation.

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.

Code of Federal Regulations

[65 FR 34089, May 26, 2000]