[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.3]

[Page 252]
 
                        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. 26.3   Scope.

    (a) The provisions of this subpart shall apply to pharmaceutical 
inspections carried out in the United States and Member States of the 
European Community (EC) before products are marketed (hereafter referred 
to as ``preapproval inspections'') as well as during their marketing 
(hereafter referred to as ``postapproval inspections'').
    (b) Appendix A of this subpart names the laws, regulations, and 
administrative provisions governing these inspections and the good 
manufacturing practices (GMP's) requirements.
    (c) Appendix B of this subpart lists the authorities participating 
in activities under this subpart.
    (d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of subpart 
C of this part do not apply to this subpart.