C.F.R. » Title 21 » 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

21 C.F.R. § 200.51

Aqueous-based drug products for oral inhalation

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(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]