[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR210.1]

[Page 114-115]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL--Table of Contents
 
Sec. 210.1  Status of current good manufacturing practice regulations.

    (a) The regulations set forth in this part and in parts 211 through 
226 of this chapter contain the minimum current good manufacturing 
practice for methods to be used in, and the facilities or controls to be 
used for, the manufacture, processing, packing, or holding of a drug to 
assure that such drug meets the requirements of the act as to safety, 
and has the identity and strength

[[Page 115]]

and meets the quality and purity characteristics that it purports or is 
represented to possess.
    (b) The failure to comply with any regulation set forth in this part 
and in parts 211 through 226 of this chapter in the manufacture, 
processing, packing, or holding of a drug shall render such drug to be 
adulterated under section 501(a)(2)(B) of the act and such drug, as well 
as the person who is responsible for the failure to comply, shall be 
subject to regulatory action.