Responsibilities of Registration/License Holders and Authorized Users
Brandeis University policies regarding Principal Investigators and other individuals who wish to register for controlled substance use may be summarized as follows:
- Principal investigators who wish to use controlled substances listed in Schedules III-V and Schedule VI must obtain both a DEA registration and a MDPH license; investigators who intend to use only Schedule VI drugs need only a MDPH license. Please contact the Controlled Substances Office for assistance in completing and submitting the appropriate applications.
- Ultimate responsibility for the proper use and documentation of controlled substances lies with the Registration/License Holder (the PI). Authorized laboratory personnel are to perform research activities involving these drugs under the supervision of the PI.
- All License Holders and authorized personnel must complete Brandeis University's Controlled Substances Training before access to controlled substances will be granted.
- Individuals who wish to use controlled substances in research under a License Holder must complete the Authorized User and Authorized Trainee Application Form and submit it to the Controlled Substance Office for review.
Authorized Users are 21 years of age or older, while Authorized Trainees are 18, 19, or 20 years of age.
Any individual who has been convicted of a felony relating to controlled substances or who has had a DEA application denied or revoked cannot have access to controlled substances.
Once the application has been approved, notification will be sent to the License Holder. The Authorized User and/or Trainee must be added to the Authorized User Log in the Controlled Substances Notebook before the user or trainee may have access to controlled substances.
- Thorough and accurate accounting of all controlled substances must be maintained from the time the substances are ordered to the time they are completely used or disposed of. The amount of drugs used to prepare working dilutions and mixtures, and the amount used in each procedure must be recorded and signed out by authorized personnel in a Controlled Substances Notebook (specifically, the Usage Logs). All drugs and the Controlled Substances Notebook must be securely locked in a cabinet of substantial construction within the laboratory; the composition of the cabinet may differ depending on whether the stored materials are classified in Schedules I-II or in Schedules III-V. The drugs cannot be transferred to any other drawer in the laboratory nor may they be transferred to another lab.
- The Controlled Substances Office will conduct an inventory of all labs in possession of controlled substances on a semi-annual basis, usually in coordination with the IACUC semi-annual review. These inventories and all usage records must be retained for two years, kept at the premises where the licensed activity is conducted and be readily available for inspections.
- The disposal of expired, damaged or otherwise unwanted controlled substances is accomplished by the transfer of these substances to the Department of Environmental Health and Safety (EH&S) at Brandeis University, and then on to a reverse distributor who is authorized to receive such materials and subsequently destroy them. The License Holder/PI or an Authorized User must contact EH&S for disposal, and the records documenting the transfer to EH&S must be maintained for a period of two years.
Andrew Finn, Director
Environmental Health and Safety