21 CFR § 312.61 Investigational New Drug Application

§ 312.61 Control of the investigational drug.

Current through Sep 8, 2026 · Read all of Part 312

⚠ 4 pending changes to Part 312

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.

← § 312.60 General responsibilities of investigators.§ 312.62 Investigator recordkeeping and record retention. →