[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR200.51]
[Page 7]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 200 GENERAL--Table of Contents
Subpart C Requirements for Specific Classes of Drugs
Sec. 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 Sec.
211.113(b) of this chapter.
[65 FR 34089, May 26, 2000]
Subpart D [Reserved]
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