[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: 21CFR26.74]
[Page 277]
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 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.
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