[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR56.124]



[Page 301]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 56_INSTITUTIONAL REVIEW BOARDS--Table of Contents

 

           Subpart E_Administrative Actions for Noncompliance

 

Sec.  56.124  Actions alternative or additional to disqualification.



    Disqualification of an IRB or of an institution is independent of, 

and neither in lieu of nor a precondition to, other proceedings or 

actions authorized by the act. The Food and Drug Administration may, at 

any time, through the Department of Justice institute any appropriate 

judicial proceedings (civil or criminal) and any other appropriate 

regulatory action, in addition to or in lieu of, and before, at the time 

of, or after, disqualification. The agency may also refer pertinent 

matters to another Federal, State, or local government agency for any 

action that that agency determines to be appropriate.