91´ÎÔª

Policy on the Use of Controlled Substances in Research

Number: IACUC-POL-010 

Responsible Office: Office of Research and Creative Scholarship (ORCS) 

Applies to: Principal Investigators Conducting Animal Research or All animal research and teaching protocols involving live vertebrate animals 

1. Purpose 

The 91´ÎÔª is committed to ensuring the lawful and responsible use of Controlled Substances in animal research. This policy establishes requirements for the acquisition, storage, use, recordkeeping, and disposal of narcotic and non-narcotic Controlled Substances regulated by the Drug Enforcement Administration (DEA). 

The purpose of this policy is to ensure that all Controlled Substances used in research are handled in full compliance with federal, state, and local regulations—including DEA requirements—and applicable institutional policies. The policy is designed to prevent diversion, promote researcher accountability, protect animal welfare, and safeguard the University and its personnel from regulatory or legal violations. 

2. Policy  

This policy is endorsed by the Institutional Animal Care and Use Committee (IACUC) and applies to all faculty, staff, students, contractors, visitors, and research personnel who acquire, possess, store, use, administer, or dispose of Controlled Substances for IACUC-approved research. Controlled Substances may only be used for approved scientific or medical research and only to the extent permitted by the researcher’s DEA registration and Montana Dangerous Drug Researcher (DDR) license. 

All Controlled Substances located on Laboratory Animal Resources (LAR) premises or dispensed by LAR are subject to oversight by LAR, the IACUC, or other designated University officials. Compliance with this policy is mandatory for all individuals involved in animal research at UM. 

3. Definitions 

• Controlled Substance: Any drug or substance listed under Schedules I–V of the Controlled Substances Act. 
• DEA Registrant: The individual holding a DEA registration and DDR license. 
• Authorized Agent (AA): A trusted individual designated by the DEA registrant to order, dispense, and manage Controlled Substances in the registrant’s absence. AAs may have key or combination access to storage. 
• Authorized Individual (AI): Personnel authorized to administer Controlled Substances for research purposes but who may not access storage areas or order Controlled Substances.  

4. Registration and Licensing Requirements 

1. Researchers must obtain: 
   • A Montana Dangerous Drug Researcher (DDR) License, prior to applying for 
   • A DEA Registration (DEA Form 225). 
2. Copies of both licenses must be provided to the IACUC Manager. 
3. Only the DEA registrant may permit AAs and AIs to access or administer Controlled Substances. 
4. Registrations and licenses must be kept current and renewed as required. 

5. Training  

All personnel involved in the acquisition, handling, storage, use, or disposal of Controlled Substances must complete required training prior to beginning work and as assigned thereafter. The 91´ÎÔª provides this training through the Collaborative Institutional Training Initiative (CITI Program).  

Required training includes the course titled “Controlled Substances in Higher Ed Research Settings.”  

Information on how to access the CITI Program and required courses is available through the University’s designated training resources. Completion records must be maintained as part of compliance documentation and provided upon request to the IACUC, LAR, or other authorized University officials. 

6. Responsibilities 

The DEA registrant is solely responsible for: 

• Ensuring compliance with federal and state regulations. 
• Securing and managing Controlled Substances. 
• Maintaining an updated list of AAs and AIs. 
• Ensuring personnel are trained in proper handling and documentation. 
• Maintaining accurate purchase, use, and inventory records. 
• Conducting biennial inventories. 
• Ensuring proper disposal. 
• Reporting loss, theft, or unauthorized use. 
• Have an approved AUP to conduct animal research using controlled substances 

Violations—intentional or unintentional—may result in civil and criminal penalties and are the sole responsibility of the DEA registrant. 

The IACUC is responsible for:  

• Review animal use protocols (AUP) to ensure that researchers using controlled substances in animals are appropriately registered with DEA and State of Montana. 
• Review AUPs to ensure appropriate clinical applications and handling procedures for controlled substance use in animals. 
• As a courtesy, monitor controlled substance records twice yearly during facility inspections.  

7. Procedures  

Storage and Security 

• Controlled Substances must be stored only at the location listed on the DEA registration.
• Storage must be in a locked, substantially constructed safe or cabinet that meets DEA security standards. 
• Access must be restricted to the DEA registrant and designated AAs. 
• Controlled Substances must remain secured except during active use and must never be left unattended. 
• Changes to storage location must be reported to and approved by the DEA. 

Purchasing 

• Only the DEA registrant or an AA with Power of Attorney may order Controlled Substances. 
• Purchases must require: 
  • Proof of research need, 
  • Storage location, 
  • DEA and DDR license numbers. 
• Schedule I & II substances require DEA Form 222. 
• Stock quantities must be kept to the minimum needed for research. 

Recordkeeping and Inventory 

• A bound usage log must be maintained for each Controlled Substance. 
• Records must document: 
  • Receipt 
  • Use 
  • Distribution 
  • Disposal 
• Logs must be retained for at least two years after use or disposal. 
• A complete biennial inventory is required and must be signed by the DEA registrant and a witness. 
• Quarterly self-checks are strongly recommended. 

Reporting Loss, Theft, or Unauthorized Use 

• Any suspected or confirmed loss, theft, or unauthorized use must be reported: 
  • Immediately to UM Campus Police, and 
  • To the DEA within one business day using DEA Form 106. 
• Spills or breakage must be documented but do not require DEA reporting if witnessed and fully accounted for. 

Controlled Substances of Unknown Origin 

If Controlled Substances are found with no known ownership: 

1. Notify the IACUC Manager or Attending Veterinarian. 
2. Secure the material in an approved storage area. 
3. The University will notify DEA and dispose of the substances upon approval. 

Disposal 

• Controlled Substances may not be disposed of in trash, drains, or by dilution.
• Disposal must occur through: 
  • Manufacturer return, or 
  • A DEA-approved reverse distributor. 
• Expired but recoverable substances must be labeled “Expired – Not for Use in Animals” and stored securely until disposal. 

8. Resources 

• IACUC Manager 
• Attending Veterinarian 
• Laboratory Animal Resources 
• DEA Office of Diversion Control 
• Montana Department of Labor and Industry 

9. References  

1. UM Guidance on the Use of Controlled Substances in Research  
2. UM Controlled Substances in Research Website   
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10. Review, Approval and Version History  

Review and approval version history for this policy

Version	Date	Description of Changes	Approved By
1.0	February 4 2005	Initial policy creation	IACUC
2.0	September 12, 2017	Review	Heivilin
3.0	November 26, 2025	Review and rewrite	Hicks