Chapter 3-600: Controlled Substances & Drugs and Narcotics

The federal (21 CFR Part 1300 et seq.) and State of California (Health and Safety Code 11100 et seq.) Uniform Controlled Substances Acts require the University to have specific procedures for the acquisition and use of controlled substances, as defined in these Acts.

3-610 University Procedures for Controlled Substances – Business and Finance Bulletin Bus-50

The University procedures for the acquisition and use of controlled substances are established in Business and Finance Bulletin BUS-50, Controlled Substances Program. The purpose of this Bulletin is to implement the requirements of the federal and State Uniform Controlled Substances Acts. It sets forth the roles and responsibilities for establishing and maintaining University’s Controlled Substances Program.

In accordance with BUS-50, the Chancellor or Laboratory Director is responsible for designating, in writing, a Responsible Official to establish and oversee the campus or Laboratory program. The Responsible Official’s designee (such as personnel from Environment, Health and Safety) charged with implementing and managing the Controlled Substances Program on a day-to-day basis.

Campus and LBNL Material Managers or Purchasing Officers are responsible for procuring controlled substances, registration, order forms, and reporting requirements in compliance with the federal and State Uniform Controlled Substances Acts. (See External Requirements 3-F04 and 3-S05.) BUS-50 sets forth the procedures for the campus Material Management and the Laboratory Purchasing Office to follow in order to register for the appropriate research classifications and to apply for the acquisition and use of controlled substances. BUS-50 also sets forth the procedures for issuing orders for controlled substances, for effective controls against theft and diversion, and for maintaining records and inventories.

3-620 Responsibilities of Principal Investigators

The Principal Investigator or Department Chair initiates and signs requisitions for controlled substances. For any controlled substance on Schedule I, as defined by the Controlled Substances Acts (see External Requirements 3-F05), the research protocol describing the project must be submitted to Materiel Management with the application. At the same time, a research proposal must be submitted to the State Research Advisory Panel. (See External Requirements 3-S05.) BUS-50 outlines the applicable laws and gives the definitions of the five Schedules of Controlled Substances and procedures for Principal Investigators to follow to apply to the State Research Advisory Panel and to acquire controlled substances.

If funds to support research are being sought from any federal, State or local granting agency, the Investigator should submit the proposal prior to or with the application to the State Research Advisory Panel. (See External Requirements 3-S05 for further information on requirements of the State Research Advisory Panel.) In addition, if approval is needed from any other federal or State agency (see Section 3-630), the Investigator must apply for such approval and show evidence of it to the Materiel Manager.

Principal Investigators or laboratory employees (e.g. staff and/or students) who are authorized to possess or use Controlled Substances by the University or LBNL are responsible for complying with federal and State regulations, program requirements, and University/Laboratory policy governing the acquisition, use, storage, and disposition of controlled substances.

3-630 Requirements of Other Federal and State Agencies

Approval is required from the federal Food and Drug Administration for interstate commerce of controlled substances and for human subject studies. (See C&G Manual Chapter 18, Protection of Research Subjects.) The State Department of Justice, Office of the Attorney General, is the cognizant office if intrastate commerce is involved.