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Controlled Substances

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 .) 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. Contact the Office of Research Integrity for assistance prior to submitting a schedule I application. 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. At ²ÝÁñÉçÇø we provide a record sheet with each issued bottle containing a schedule II substance. 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, none of much relevance to use in research animals at ²ÝÁñÉçÇø. Examples: cough medications containing codeine, and lomotil.

• 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.

Authorizations

DEA Registrations

There are two main types of DEA Registrations at ²ÝÁñÉçÇø: practioner and research. The DEA Diversion Office in ²ÝÁñÉçÇø has determined that ²ÝÁñÉçÇø research institutes may apply for and hold Research Registrations to cover research and education related uses of Schedule II-V compounds. The research institute director is responsible for maintaining these registrations to cover the activities of their faculty, staff and students.  Practitioner registrations are those held by licensed human or animal health professionals for the conduct of their professional duties/practice.

Controlled Substances Registrations are currently held by the Institute of Arctic Biology and Institute of Marine Sciences. The Office of Research Integrity coordinates with researchers, the IACUC, and Institute Directors to insure that the authorized compound lists are kept up-to-date and to request modifications as necessary.

Researchers wishing to work with Schedule I compounds will likely have to apply for their own DEA Research Registration and should contact the Office of Research for more information as soon as possible. Schedule I Registrations require additional security measures (e.g. drug safe, alarm system, and limited access location) that will add cost to the project and thorough review and inspection by a DEA Diversion Officer which can delay approval.

Personnel Authorizations

Personnel needing access to controlled substances for animal related activities must have a PIF on file with ORI and should contact the IACUC Administrator for further application information. The ORI checks to make sure that the individual is listed on an active IACUC protocol that contains approval to use controlled substances, and if appropriate forwards the application to the appropriate institute director for review and approval. Student and staff applications must be sponsored by an authorized faculty member and complete all other ²ÝÁñÉçÇø mandated safety trainings.

Record Keeping

²ÝÁñÉçÇø Veterinary Services maintains a record of all pharmaceuticals received and dispensed. Each investigator must also maintain accurate records of the use of pharmaceuticals. These records must be made available to Veterinary Services upon request and, for controlled substances, to the DEA.

All administration of pharmaceuticals to live vertebrates must be recorded in research and animal management records. Pharmaceuticals will not be dispensed except to the PI or his/her authorized designate.

Schedule II substances require detailed record keeping. Every vial of a schedule II drug must have a record sheet (issued by Veterinary Services) where every individual dose must be recorded. The record sheets as well as any drug vials, whether empty or containing unused or expired drugs, must be returned to Veterinary Services at the end of the project.

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. The key to the drug locker must be secured at all times such that only authorized users can access it.

Pharmaceuticals taken into the field must also be stored under appropriate conditions with restricted or limited access. Contact the Office of Research Integrity or Veterinary Services for advice on obtaining a suitable portable storage container and documentation for transport.