[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: 21CFR211.1]

[Page 117-118]
 
                        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, and in parts 600 through 680 
of this chapter, as they pertain to biological products for human use, 
shall be considered to supplement, not supersede, the regulations in 
this part unless the regulations explicitly provide otherwise. In the 
event it is impossible to comply with applicable regulations both in 
this part and in other parts of this chapter or in parts 600 through 680 
of this chapter, the regulation specifically applicable to the drug 
product in question shall supersede the regulation in this part.
    (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

[[Page 118]]

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]