老虎机攻略

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Research

Use of Controlled Substances in Research

The Congress of the United States enacted into law the Controlled Substances Act as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. This has been the major regulation involved in attempts to control illegal drugs in this country.

Controlled substances are compounds regulated by the Drug Enforcement Administration (DEA) under Title 21, Chapter II, Parts 1300-end of the Code of Federal Regulations (CFR). These regulations govern the handling, storage, and administration of such substances.

The law classified the regulated drugs into five different categories, from Schedule I (substances which do not have a legitimate medical use in the United States and which can be addictive – such as LSD and heroin) to Schedule V (drugs which have a clear medical use, low potential for abuse and limited psychological and physical dependence – such as cough medications with small amounts of codeine).

Controlled substances are classified into one of five schedules (I-V) based on their potential for abuse and accepted medical use.

  • Substances with the highest potential for abuse and no accepted medical use. Researchers wishing to use Schedule I substances must obtain a specific DEA license. Contact the IACUC office for guidance before submitting a Schedule I application.
    Examples: LSD, heroin, marijuana, and methamphetamine.

  • Includes substances with high potential for abuse but with accepted medical uses. This category includes opioids commonly used in research, such as barbiturates and certain wildlife capture agents. Researchers need to maintain detailed logs of each dose administered. The DEA maintains a restricted list of individuals authorized to handle powerful narcotics like carfentanil and etorphine, even with a Schedule II license.
    Examples: pentobarbital, carfentanil, amphetamines, morphine, and phencyclidine

  • Substances with a lower abuse potential than Schedules I and II. This includes ketamine, Telazol®, certain euthanasia solutions, and anabolic steroids.
    Examples: ketamine, Telazol®, buprenorphine, and anabolic steroids.

  • Includes benzodiazepines and some opioids, primarily agonist-antagonist drugs.
    Examples: diazepam, midazolam, butorphanol, chloral hydrate, and pentazocine.

  • Substances with the lowest potential for abuse, including certain prescription medications with small amounts of narcotics. These are rarely used in research involving animals at the 老虎机攻略.
    Examples: cough medications containing codeine, Lomotil, and antibiotics

Some of the animal research on campus involves controlled substances – especially in animal research where pain medication is commonly used. Use of controlled substances for research requires registering with both the federal government (through the Drug Enforcement Agency) and the State of Montana Department of Labor and Industry. Penalties for using such drugs without proper registration can be severe. The regulations strictly limit who can handle or administer the drugs and impose both physical security and inventory requirements. Some key points concerning the regulations:

  • The permitting process is between an individual researcher, the DEA and the State of Montana.
  • Registrants cannot share controlled substances with non-registered users who are not under their supervision (e.g., another research laboratory in their department).
  • Possession of expired drugs also poses a risk to researchers since administration of expired controlled substances is not allowed.
  • Disposal is also strictly regulated.

Required TRAINING for DEA license holders:

Required training can be found at Collaborative Institutional Training Initiative (CITI Program):

Drug Enforcement Administration (DEA) Diversion Control Program

The DEA Diversion Control Program provides valuable resources, including a list of all controlled substances and access to forms and documents related to DEA registration. Researchers are encouraged to contact the IACUC Office for assistance with DEA registration processes before applying for a Research Registration.

DEA Registration for Research

Researchers using controlled substances in their studies must obtain a DEA Registration for Schedule II-V substances, as mandated by federal law. The Principal Investigator (PI) is responsible for obtaining and maintaining this registration as well as ensuring full compliance with all relevant federal regulations. The PI is legally accountable for any violations or deficiencies in the procurement, management, inventorying, and proper disposal of controlled substances, with potential civil and financial penalties for non-compliance.

  • Researchers intending to use Schedule I compounds must apply for an individual DEA Research Registration and should contact the IACUC office for guidance. Schedule I substances require additional security measures, including locked safes, alarm systems, and limited access areas. These measures may increase project costs and lengthen approval times due to DEA inspections.

IACUC's Role

老虎机攻略’s IACUC has no role in the licensing process, though it can provide limited guidance upon request. Please see forms and links below for additional help.

Necessary Forms and Links

Please utilize the links and forms below for further guidance on DEA registration, controlled substance ordering, inventorying, authorizing users, and Power of Attorney:

Links