C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 312—INVESTIGATIONAL NEW DRUG APPLICATION › Subpart D—Responsibilities of Sponsors and Investigators

21 C.F.R. § 312.61

Control of the investigational drug

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An investigator shall administer the drug only to subjects under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator. The investigator shall not supply the investigational drug to any person not authorized under this part to receive it.

Notes of Decisions
Cited in 1 case, 2007–2007 · leading case: AstraZeneca AB v. Mylan Labs. Inc., 490 F. Supp. 2d 381 (S.D.N.Y. 2007).
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AstraZeneca AB v. Mylan Labs. Inc., 490 F. Supp. 2d 381 (S.D.N.Y. 2007). “See 21 C.F.R. § 312.61 (2005). Further, the patients who participated in the clinical trials were also carefully selected.”
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