[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR210.2]

[Page 132-133]
 
                        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.  210.2  Applicability of current good manufacturing practice 
regulations.

    (a) The regulations in this part and in parts 211 through 226 of 
this chapter as they may pertain to a drug; in parts 600 through 680 of 
this chapter as they may pertain to a biological product for human use; 
and in part 1271 of this chapter as they are applicable to a human cell, 
tissue, or cellular or tissue-based product (HCT/P) that is a

[[Page 133]]

drug (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); shall be considered to 
supplement, not supersede, each other, unless the regulations explicitly 
provide otherwise. In the event of a conflict between applicable 
regulations in this part and in other parts of this chapter, the 
regulation specifically applicable to the drug product in question shall 
supersede the more general.
    (b) If a person engages in only some operations subject to the 
regulations in this part, in parts 211 through 226 of this chapter, in 
parts 600 through 680 of this chapter, and in part 1271 of this chapter, 
and not in others, that person need only comply with those regulations 
applicable to the operations in which he or she is engaged.

[69 FR 29828, May 25, 2004]

    Effective Date Note: At 71 FR 2462, Jan. 17, 2006, Sec.  210.2 was 
amended by adding paragraph (c), effective June 1, 2006. For the 
convenience of the user, the added text is set forth as follows:

Sec.  210.2  Applicability of current good manufacturing practice 
          regulations.

                                * * * * *

    (c) An investigational drug for use in a Phase 1 study, as defined 
in Sec.  312.21(a) of this chapter, is subject to the statutory 
requirements set forth at 21 U.S.C. 351(a)(2)(B). The production of such 
drug is exempt from compliance with the regulations in part 211 of this 
chapter. However, this exemption does not apply to an investigational 
drug for use in a Phase 1 study once the investigational drug has been 
made available for use by or for the sponsor in a Phase 2 or Phase 3 
study, as defined in Sec.  312.21(b) and (c) of this chapter, or the 
drug has been lawfully marketed. If the investigational drug has been 
made available in a Phase 2 or 3 study or the drug has been lawfully 
marketed, the drug for use in the Phase 1 study must comply with part 
211.