Controlled Substances
Most research involving the use of animals requires the use of controlled substances as part of the experimental design or euthanasia protocol. Institutions that receive federal research funds, such as WesternU, are expected to adhere to the standards set forth in the Guide for the Care and Use of Laboratory Animals which states, “All those involved in animal care and use must comply with federal laws and regulations regarding human and veterinary drugs and treatments. Drug records and storage procedures should be reviewed during facility inspections.”
The IACUC has, therefore, established a written policy (IACUC Policy 2014-050) governing the acquisition, use, storage and disposal of controlled substances used in teaching or research activities involving animals at any WesternU owned or operated facility. Please take note of Section B of the Policy which restricts the use of controlled substances in research to persons registered with the DEA and authorized persons under the direct supervision of a registered investigator. This means that a Principal Investigator, or a collaborator, on a protocol that requires the use of a controlled substance, must obtain their own DEA registration. They may not piggyback on the registration of an investigator who is not a key participant in the protocol.
DEA Registrants must provide a copy of their registration to the IACUC Office. Registrants must then complete the Controlled Substances Authorized Users form. A copy of the completed form must be kept with the Registrant’s Controlled Substances Usage Log and another copy must be submitted to the Controlled Substances Program Manager at IACUCOffice@westernu.edu. A new copy of the form must be submitted to the Program Manager whenever there is a change in Authorized Users. Description of the responsibilities of the Program Manager.
All animal users listed on an IACUC-approved protocol must complete the on-line Controlled Substances training on eLearning. A user name and password is required to access this site. Newly submitted IACUC protocols that involve the use of controlled substances will not be reviewed, and active protocols could be suspended, in the absence of proof of DEA registration by the investigator and completion of the required training.
The IACUC’s standardized controlled substances usage and inventory forms are required to be used by all registered investigators who use controlled substances in research. These forms must be produced on demand by the IACUC during an inspection or by appropriate government officials. Copies of these forms may be obtained by clicking on the links below.
Inventory form for Schedule I Controlled Substances
Inventory form for Schedule II Controlled Substances
Inventory form for Schedules III, IV & V Controlled Substances
Controlled Substances Usage Log
Controlled substances that are beyond the expiration date printed on the container label by the manufacturer may not, under any circumstances, be used in animals used in teaching or research activities at WesternU. Disposal of expired or unwanted controlled substances should be returned, if possible, to the vendor from whom they were acquired. Otherwise, investigators must contact a Reverse Distributor for disposal.
A Reverse Distributor is defined as “a person or entity registered with the DEA as a reverse distributor to acquire controlled substances from another registrant for the purpose of return or destruction of controlled substances”. If returning controlled substances to the distributor from whom they were acquired is not an option, the registrant must contact one of the companies on the following list of DEA Registered Reverse Distributors or contact the DEA directly for instructions.
A DEA registrant may authorize one or more individuals to issue orders for Schedule I and II controlled substances on the Registrant’s behalf by executing a Power of Attorney form for each individual. Registrants wishing to do so must follow the instructions provided on the form. A copy of each completed form must be kept with the Registrant’s Usage Log and another copy must be submitted to the IACUC Office at IACUCOffice@westernu.edu. A registrant may revoke any power of attorney at any time by following the instructions on the form. These form must be available for inspection by the IACUC and authorized persons from appropriate regulatory agencies along with other controlled substances records.