[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: 21CFR210.1]

[Page 137]
 
                        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 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.
    (c) Owners and operators of establishments engaged in the recovery, 
donor screening, testing (including donor testing), processing, storage, 
labeling, packaging, or distribution of human cells, tissues, and 
cellular and tissue-based products (HCT/Ps), as defined in Sec.  
1271.3(d) of this chapter, that are drugs (subject to review under an 
application submitted under section 505 of the act or under a biological 
product license application under section 351 of the Public Health 
Service Act), are subject to the donor-eligibility and applicable 
current good tissue practice procedures set forth in part 1271 subparts 
C and D of this chapter, in addition to the regulations in this part and 
in parts 211 through 226 of this chapter. Failure to comply with any 
applicable regulation set forth in this part, in parts 211 through 226 
of this chapter, in part 1271 subpart C of this chapter, or in part 1271 
subpart D of this chapter with respect to the manufacture, processing, 
packing or holding of a drug, renders an HCT/P adulterated under section 
501(a)(2)(B) of the act. Such HCT/P, as well as the person who is 
responsible for the failure to comply, is subject to regulatory action.

[43 FR 45076, Sept, 29, 1978, as amended at 69 FR 29828, May 25, 2004]