Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter D - DRUGS FOR HUMAN USEPart 312 - INVESTIGATIONAL NEW DRUG APPLICATION
Subpart D - RESPONSIBILITIES OF SPONSORS AND INVESTIGATORS
Section 312.59 - Disposition of unused supply of investigational drug

21 C.F.R. § 312.59

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Current through November 30, 2024
Section 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 § 312.57 .

21 C.F.R. §312.59

52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9586 , Mar. 4, 2002