[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.4]

[Page 248-249]
 
                        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 REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE 
PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents
 
      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'')

[[Page 249]]

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]