[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR226.1]

[Page 171]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 226_CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  226.1  Current good manufacturing practice.


    (a) The criteria in Sec. Sec.  226.10 through 226.115, inclusive, 
shall apply in determining whether the methods used in, or the 
facilities and controls used for the manufacture, processing, packing, 
or holding of a Type A medicated article(s) conform to or are operated 
or administered in conformity with current good manufacturing practice 
to assure that a Type A medicated article(s) meets the requirements of 
the act as to safety, and has the identity and strength, and meets the 
quality and purity characteristics which it purports or is represented 
to possess, as required by section 501(a)(2)(B) of the act. The 
regulations in this part 226 permit the use of precision, automatic, 
mechanical, or electronic equipment in the production of a Type A 
medicated article(s) when adequate inspection and checking procedures or 
other quality control procedures are used to assure proper performance.
    (b) In addition to maintaining records and reports required in this 
part, Type A medicated articles requiring approved NADAs are subject to 
the requirements of Sec.  514.80 of this chapter. Similarly, Type A 
medicated articles listed in the index are subject to the requirements 
of Sec.  516.165 of this chapter.

[40 FR 14031, Mar. 27, 1975, as amended at 68 FR 15364, Mar. 31, 2003; 
72 FR 69120, Dec. 6, 2007]