Use of Controlled Substances in Research

Legal Definitions

Controlled Substances are compounds subject to the jurisdictional control of the Drug Enforcement Agency (DEA) under Title 21, Chapter II, Parts 1300-end of the Code of Federal Regulations (CFR). (The CFR can be accessed here.) Compounds are placed in one of the following schedules (I -V) depending on their potential for abuse.

  • Schedule I - Compounds with the highest potential for abuse. Licensing for obtaining schedule I substances requires a special application. These must be obtained by individual researchers for specific projects. Examples: LSD, heroin, marijuana, and methamphetamine.
  • Schedule II - Includes the main opioids used in wildlife capture work and some of the barbiturates. Note that although carfentanil and etorphine are schedule II, DEA maintains a list of approved individuals who may obtain these potent narcotics. Therefore, having a DEA license for schedule II drugs is not enough to purchase these two drugs. Use of a scheduled II drugs necessitates the recording of each and every dose taken from a bottle. Examples: pentobarbital, carfentanil, amphetamine, morphine, and phencyclidine.
  • Schedule III - Contains several barbiturates, narcotics, as well as ketamine and Telazol. Anabolic steroids also are within this schedule. Examples: ketamine, Telazol®, some euthanasia solutions containing pentobarbital, buprenorphine, and anabolic steroids.
  • Schedule IV - Includes the benzodiazepine tranquilizers and some other opioids, primarily the agonist-antagonists. Examples: diazepam, midazolam, butorphanol, chloral hydrate, and pentazocine.
  • Schedule V - Contains a small number of narcotic drugs. Examples: cough medications containing codeine, and lomotil.

Drug Enforcement Administration Diversion Control Program

  • This website provides some excellent information including listings of all controlled substances, links to 21CFR1300-end, plus online informational documents, brochures and forms.
  • DEA Registration forms are available on this site, but contact the Office of Research Integrity for assistance prior to applying for a Research Registration.

Not all compounds given to animals are Controlled Substances. Over-the-counter or prescription drugs and other compounds may also be given to animals as part of research, teaching or testing activities. Regardless of their legal classification, all compounds given to animals, their dosage, route of delivery, etc. must be identified in an approved IACUC Assurance or prescribed by a veterinarian for therapeutic reasons.

Storage and Control

All pharmaceuticals must be stored under proper conditions. Scheduled substances will not be dispensed in any quantity unless they can be stored in a drug locker/safe with access restricted to the principle investigator, and formally designated authorized users.

Pharmaceuticals taken into the field must also be stored under appropriate conditions with restricted or limited access.

 

For questions and addtional information please contact the IACUC office at IACUC@mso.umt.edu or (406)243-6395.