[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]
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