[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.58]

[Page 84-85]
 
                        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

[[Page 85]]

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.