Drug Accountability

Abstract

Research on pharmaceutical products imposes special obligations for their proper storage and dispensation consistent with FDA regulations (21 CFR Part 312). The PI has the obligation to maintain an inventory of the receipt and disposition of the products under study, including doc-umentation of any returns to the sponsor, or destruction of supplies at a study’s conclusion. The PI also is expected to assume responsibility for the activities of any of the physicians listed as collaborators on the FDA 1572/3 form who will be dispensing study medication under his direction. It is the PI’s responsibility to assure that staff members are thoroughly oriented to the importance of documenting drug-related transactions and to the protocol criteria for dosing eligibility. This section will address the regulatory requirements governing supply disposition and describe mechanisms that can be employed to eliminate many common dispensing errors.