[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: 21CFR26.74]

[Page 281]
 
                        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 C--``Framework'' Provisions
 
Sec. 26.74   Preservation of regulatory authority.

    (a) Nothing in this part shall be construed to limit the authority 
of a party to determine, through its legislative, regulatory, and 
administrative measures, the level of protection it considers 
appropriate for safety; for protection of human, animal, or plant life 
or health; for the environment; for consumers; and otherwise with regard 
to risks within the scope of the applicable subpart A or B of this part.
    (b) Nothing in this part shall be construed to limit the authority 
of a regulatory authority to take all appropriate and immediate measures 
whenever it ascertains that a product may:
    (1) Compromise the health or safety of persons in its territory;
    (2) Not meet the legislative, regulatory, or administrative 
provisions within the scope of the applicable subpart A or B of this 
part; or
    (3) Otherwise fail to satisfy a requirement within the scope of the 
applicable subpart A or B of this part. Such measures may include 
withdrawing the products from the market, prohibiting their placement on 
the market, restricting their free movement, initiating a product 
recall, and preventing the recurrence of such problems, including 
through a prohibition on imports. If the regulatory authority takes such 
action, it shall inform its counterpart authority and the other party 
within 15 days of taking such action, providing its reasons.