[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.58]

[Page 77]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 312_INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
        Subpart D_Responsibilities of Sponsors and Investigators
 
Sec.  312.58  Inspection of sponsor's records and reports.

    (a) FDA inspection. A sponsor shall upon request from any properly 
authorized officer or employee of the Food and Drug Administration, at 
reasonable times, permit such officer or employee to have access to and 
copy and verify any records and reports relating to a clinical 
investigation conducted under this part. Upon written request by FDA, 
the sponsor shall submit the records or reports (or copies of them) to 
FDA. The sponsor shall discontinue shipments of the drug to any 
investigator who has failed to maintain or make available records or 
reports of the investigation as required by this part.
    (b) Controlled substances. If an investigational new drug is a 
substance listed in any schedule of the Controlled Substances Act (21 
U.S.C. 801; 21 CFR part 1308), records concerning shipment, delivery, 
receipt, and disposition of the drug, which are required to be kept 
under this part or other applicable parts of this chapter shall, upon 
the request of a properly authorized employee of the Drug Enforcement 
Administration of the U.S. Department of Justice, be made available by 
the investigator or sponsor to whom the request is made, for inspection 
and copying. In addition, the sponsor shall assure that adequate 
precautions are taken, including storage of the investigational drug in 
a securely locked, substantially constructed cabinet, or other securely 
locked, substantially constructed enclosure, access to which is limited, 
to prevent theft or diversion of the substance into illegal channels of 
distribution.