[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.59]

[Page 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. 312.59  Disposition of unused supply of investigational drug.

    The sponsor shall assure the return of all unused supplies of the 
investigational drug from each individual investigator whose 
participation in the investigation is discontinued or terminated. The 
sponsor may authorize alternative disposition of unused supplies of the 
investigational drug provided this alternative disposition does not 
expose humans to risks from the drug. The sponsor shall maintain written 
records of any disposition of the drug in accordance with Sec. 312.57.

(Collection of information requirements approved by the Office of 
Management and Budget under control number 0910-0014)

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987]