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120. FDA Regulations for Control of Investigational Drugs (§312.61, §312.69)

Investigational drugs may only be administered 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 to receive it.

An investigator must maintain adequate records of the disposition of the drug including the following information:

  • dates,
  • quantity, and
  • use by subjects.

If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug to the sponsor, or dispose of the unused supplies of the drug as authorized by the sponsor.

Handling of Controlled Substances

For investigational drugs subject to the Controlled Substances Act, the investigator must store the investigational drug in a securely locked, substantially constructed cabinet or enclosure to which access is limited.

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