[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.4]

[Page 248]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
   PART 26_MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE 
 
      Subpart A_Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices
 
Sec.  26.4  Product coverage.

    (a) The provisions of this subpart will apply to medicinal products 
for human or animal use, intermediates and starting materials (as 
referred to in the European Community (EC)) and to drugs for human or 
animal use, biological products for human use, and active pharmaceutical 
ingredients (as referred to in the United States), only to the extent 
they are regulated by the authorities of both parties as listed in 
Appendix B of this subpart.
    (b) Human blood, human plasma, human tissues and organs, and 
veterinary immunologicals (under 9 CFR 101.2, ``veterinary 
immunologicals'' are referred to as ``veterinary biologicals'') are 
excluded from the scope of this subpart. Human plasma derivatives (such 
as immunoglobulins and albumin), investigational medicinal products/new 
drugs, human radiopharmaceuticals, and medicinal gases are also excluded 
during the transition phase; their situation will be reconsidered at the 
end of the transition period. Products regulated by the Food and Drug 
Administration's Center for Biologics Evaluation and Research or Center 
for Drug Evaluation and Research as devices are not covered under this 
subpart.
    (c) Appendix C of this subpart contains an indicative list of 
products covered by this subpart.

[63 FR 60141, Nov. 6, 1998, as amended at 70 FR 14980, Mar. 24, 2005]