[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: 21CFR211.1]

[Page 140]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211_CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  211.1  Scope.


    (a) The regulations in this part contain the minimum current good 
manufacturing practice for preparation of drug products for 
administration to humans or animals.
    (b) The current good manufacturing practice regulations in this 
chapter as they pertain to drug products; in parts 600 through 680 of 
this chapter, as they pertain to drugs that are also biological products 
for human use; and in part 1271 of this chapter, as they are applicable 
to drugs that are also human cells, tissues, and cellular and tissue-
based products (HCT/Ps) and 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); supplement and do not supersede the regulations in this 
part 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, or in parts 600 through 680 of this chapter, or 
in part 1271 of this chapter, the regulation specifically applicable to 
the drug product in question shall supersede the more general.
    (c) Pending consideration of a proposed exemption, published in the 
Federal Register of September 29, 1978, the requirements in this part 
shall not be enforced for OTC drug products if the products and all 
their ingredients are ordinarily marketed and consumed as human foods, 
and which products may also fall within the legal definition of drugs by 
virtue of their intended use. Therefore, until further notice, 
regulations under part 110 of this chapter, and where applicable, parts 
113 to 129 of this chapter, shall be applied in determining whether 
these OTC drug products that are also foods are manufactured, processed, 
packed, or held under current good manufacturing practice.

[43 FR 45077, Sept. 29, 1978, as amended at 62 FR 66522, Dec. 19, 1997; 
69 FR 29828, May 25, 2004]