[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
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.

[66 FR 34089, May 26, 2000]

    Effective Date Note: At 66 FR 34089, May 26, 2000, Sec. 200.51 was 
added, effective May 26, 2002.

Subpart D [Reserved]