An Authorized Agent is an individual who has the complete trust of a DEA registrant (licensed researcher). An authorized agent with the authorization of licensed researcher may oversee the ordering and dispensing, in addition to managing the controlled substances in the absence of the licensed researcher. To minimize the risk of drug diversion, only 1-2 individuals in a laboratory should be provided the status of an authorized agent. Licensed researchers are ultimately responsible for the management of controlled substances acquired under their DEA registration or license. Only licensed researchers and respective authorized agents may have keys or combination access to the safe or locked cabinet where controlled substances are stored. Only authorized agents are permitted to know the licensed researcher’s respective registration number and order controlled substances on behalf of her/him. Authorized agents do not require a DEA background check or screening. The DEA does not specify how licensed researchers should conduct due diligence credential checks for their staff. Therefore, each licensed researcher is responsible for checking their staffs’ credentials, authorizing specific roles, and providing required training for proper handling of controlled substances.
Authorized Laboratory Personnel are research staff, including graduate students and postdoctoral scholars, working under the direct supervision of a researcher. In addition to the researcher and authorized agents, the authorized laboratory personnel (also known as daily users) may participate in using controlled substances during experiments or treatments of research animals. Authorized laboratory personnel can perform these functions but only without keys or combination access to the safe or cabinet where bulk quantities of controlled substances are stored. Licensed researchers or their authorized agent are responsible for dispensing limited quantities of controlled substances to authorized laboratory personnel for daily use and maintaining unused substances in the safe or locked cabinet for proper storage. Authorized laboratory personnel do not require a DEA background check or screening. Each licensed researcher is responsible for authorizing specific roles, and providing required training for proper handling of controlled substances.
Certificate of Registration: DEA Certificate of Registration (DEA Form 223) must be maintained and displayed at the registered location in a readily retrievable manner and must be available for DEA/IBPE inspection. An example of DEA Form 223 is shown below.
Controlled substances: controlled substances are defined as chemicals that are addictive, can be abused, and are illegal to possess. Therefore, the manufacture, possession, use and proper disposal of controlled substances (drugs or other drug products) are regulated by DEA. A complete listing of controlled substances may be viewed on the DEA website. The same information can also be found in the DEA orange book.
Controlled substance folder: the file or folder where transactions of controlled substances (e.g., receipt, use, and disposal) are recorded. Examples of typical internal forms are included in Appendix B.
CSA: the Controlled Substances Act (CSA), Title II and Title III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the legal foundation of the U.S. Government’s fight against the abuse of drugs and other substances. This law is a consolidation of numerous laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances. Also, CSA is the abbreviation for Controlled Substances Act Iowa Code chapter IC124.
Disposal: the approved method of discarding a controlled substance that is outdated, redundant, contaminated, is waste, or is no longer needed.
Disposition records: an accurate, continuous and current record used to track the purchase, use and disposal of controlled substances.
Drug Enforcement Administration (DEA): the unit within the United States Department of Justice that establishes and enforces the regulations for the handling and use of controlled substances.
IBPE: Iowa Board of Pharmacy Examiners (IBPE) authorized by the State of Iowa Administrative Code 657 to administer the controlled substances Program. The IBPE requires initial application and biennial renewal application for registration of any person engaging in animal-based research, teaching or educational projects involving the use, study or testing of controlled substances.
Licenses: There are 11 classes of licenses (registrations). The most significant classes for registration as researcher are highlighted below.
Practitioner: any individual that is registered with DEA and IBPE to practice or perform research, distribute, dispense, conduct research with respect to administering, use in teaching, or for chemical analysis of controlled substances. If a clinical practitioner wishes to do research, he/she will need to obtain a researcher license using the DEA Form 225.
Reverse Distributors: reverse distributors (third party companies) are registered with DEA as registrants. They are authorized to receive out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including unwanted bulk controlled substance samples from registered researchers. The reverse distributors dispose of controlled substances using appropriate procedures with the approval from DEA.
Registration: the formal grant of specific authority to a researcher (certificate or license) by DEA and IBPE. Researchers must “register” with DEA and IBPE for purchase and possession of controlled substances. Any researcher who handles or intends to handle controlled substances must obtain a registration issued by DEA. A unique number is assigned to each legitimate handler of controlled drugs: importer, exporter, manufacturer, distributor, hospital, pharmacy, practitioner, and researcher. This number must be made available to the supplier by the customer prior to the purchase of a controlled substance.
Registrant (see also licensed researcher): the individual that holds DEA and Iowa registrations and is responsible for ordering, storing, using, and disposing of controlled substances. This individual is fully responsible to ensure compliance with controlled substance regulations at the location where the controlled substances are held. Registrants are the only ones authorized to use controlled substances. Registrants may appoint a subordinate to manage the controlled substances and the records; however, the registrant is solely responsible for its proper recordkeeping, storage, and use. Deficiencies or discrepancies in recordkeeping are the responsibility of the registrant. Clinicians holding a clinical license must obtain a researcher license to perform non-clinical research using controlled substances.
Research: this covers any research activity (non-clinical research) that includes new product synthesis, methods development, testing, teaching, and use in animal care/procedures, etc.
(Licensed) Researcher: throughout this document, ‘licensed researcher’ refers only to the Principal Investigators (PIs) who possess a “Researcher” class license through the DEA and the IBPE.