(1) The responsible pharmacy manager or their designee is responsible for the storage, distribution, and control of approved investigational drugs used in an institutional facility. The pharmacy shall be responsible for maintaining and providing information on approved investigational drugs.

(2) Under the explicit direction of the authorized principal investigator, coinvestigator(s), or per study protocol requirements, investigational drugs must be properly labeled and stored for use. An appropriate medical staff committee, institution review board, or equivalent committee, shall approve the use of such drugs.