Controlled Substances

Date adopted: February 4, 2005

Last Review Date: September 12, 2017


I.  Policy

  1. This policy addresses the acquisition, use, record keeping, and disposal of controlled substances (narcotic and non-narcotic) regulated by the Drug Enforcement Administration (DEA).This policy is endorsed by the University of Montana (UM) Institutional Animal Care and Use Committee (IACUC). The practice and enforcement of these policies will keep all UM animal care researchers and personnel in compliance with federal, state, and local laws.

  2. All UM employees, contractors and visitors conducting research with animals are required to comply with these policies. All controlled substances on Laboratory Animal Resources (LAR) premises or dispensed by LAR at any time for any purpose are subject to regulation by LAR, the IACUC, or any other designated agent of UM.

  3. Contact the IACUC Coordinator (243-6395) for specifics related to DEA registration for the use of controlled substances in research animals at UM.

II. Procedure

  1. Responsibilities
  1.  The IACUC responsibilities include:
a.  Review animal use protocols (AUP) to ensure that researchers using controlled
      substances in animals are appropriately registered with DEA.
b.  Review AUPs to ensure appropriate clinical applications and handling
      procedures for controlled substance use in animals.
c.  As a courtesy, monitor controlled substance records twice yearly during
     facility inspections.

      2.  Principal investigators are responsible for the following items.
a.  Approved DEA registration for the use of controlled substances
b.  Order, receive, dispense, and destroy all controlled substances
c.  Have an approved AUP to conduct animal research using controlled
     substances
d.  Provide appropriate security for controlled substances
e.  Maintain records of controlled substance used in animal research at UM 
B.   Methods
1.  Controlled substances can only be used under an approved and current AUP
     that contains provisions for the use of controlled substances. Use of controlled
     substances not included in the relevant IACUC-approved AUP is not allowed.
2.  Principal investigators or their designees holding DEA licenses must file a
     photocopy of their DEA registration with the IACUC Coordinator to verify
     registration and active status.
3.   All controlled substance records are subject to inspection by LAR, IACUC, or
     other authorized review/compliance individuals without prior notice.