[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]