IACUC Policies

Handling Controlled Substances

Date adopted: February 4, 2005
Last updated: February 13, 2012

This policy addresses the acquisition, use, record keeping, and disposal of controlled substances (narcotic and non-narcotic) regulated by the Drug Enforcement Administration (DEA) and any other drugs designated by the Director of Laboratory Animal Resources (DLAR). 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 and use personnel in compliance with federal, state, and local laws.

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

Policy Procedure

A.   Responsibilities

• The IACUC is responsible for the following items.
  • Establishing policies for the acquisition, use, record keeping, and disposal of controlled substances in all animal research conducted at The University of Montana
  • Reviewing animal use protocols (AUP) to ensure appropriate clinical applications and handling procedures for controlled substances are being used
  • Monitoring controlled substance records twice yearly during facility inspections
• The DLAR is responsible for the following items.
  • Ordering, receiving, dispensing, and destroying all controlled substances
  • Providing information for DEA licensing to principal investigators (PI) upon request
  • Ensuring that PIs have a current AUP and that the PIs or their designees provide evidence of a current DEA license, or provide evidence of application for a DEA license, before transferring any controlled substances
  • Monitoring controlled substance records twice yearly, during alternate quarters from the IACUC inspections
• Principal investigators wishing to use controlled substances in their research work are responsible for the following items.
  • Acquiring a DEA license for research purposes (form 225). For new applications: www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms_new.htm
  • Including the proposed use of controlled substances at appropriate doses in AUPs (www.umt.edu/iacuc/forms/aupforms.htm)
  • Providing appropriate security (anchored cabinet with a minimum of 2 separately keyed doors and limited access to keys or lock combinations) for controlled substances
  • Keeping records of controlled substance use on forms provided by DLAR at www.umt.edu/iacuc/forms/controlleddruglog.htm

B.   Procedures

• 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 forbidden.
• All controlled substance use must be pre-approved through the UM Attending Veterinarian and the DLAR.
• Principal investigators or their designees holding DEA licenses must file a photocopy of their DEA license with the DLAR to verify registration and active status.
• The PI or their designee will contact the DLAR prior to acquisitions of controlled substances. The DLAR will order the controlled substance(s) and review the plans for storage, use, record keeping, inventory, disposal, and inspection with the animal user.
• All controlled substance records are subject to inspection by LAR, IACUC, or other authorized review/compliance individuals without prior notice.
• Principal investigators or their designees with DEA licenses will return empty drug bottles to the DLAR, along with the completed drug administration record.
• PIs or their designees with DEA licenses should contact DLAR for witnessed destruction of unused or expired controlled substances. These are absorbed onto paper towels in the regular trash and discarded.
• Laboratory Animal Resources, the IACUC, or their designated agent reserves the right to refuse or suspend use of a controlled substance at any time without prior notice.
• All transfers of controlled substances between DEA license holders must be approved by DLAR.

C.   Enforcement 

• LAR/UM personnel procedures consistent with the MPEA collective bargaining agreement. Contact UM Human Resource Services, (406) 243-6766, for details.
• Any person with concerns, complaints or wishing to report a violation regarding animal care and use at The University of Montana may use the procedures posted in the LAR facilities or on the UM IACUC web site. Alternatively, contact the IACUC Chair, (406) 243-2881, or the IACUC Coordinator, (406) 243-6395.