Part 1
Introduction, Background & Terms
Using Controlled Substances for Research
University of Minnesota research projects take many forms and focus on a variety of topics. Some research projects involve the use of controlled substances. When controlled substances are being used for research, everyone who works on the project must be aware of and adhere to the Federal and State regulations and University policies that govern their use. This workshop is designed as an introduction to these regulations and policies, as well as to the paperwork and record-keeping required for the use of controlled substances for research.
The objectives of this training are to provide
- an understanding of the Federal and State regulations for using controlled substances for research
- an understanding of the University of Minnesota policy for using controlled substances for research
- a detailed description of record-keeping requirements for using controlled substances for research
- a resource for researchers about the forms, instruction documents and other information available to help simplify compliance with the regulations and the University policy
Background
A controlled substance is a drug or chemical whose manufacture, possession and use are regulated by the Federal and State government. This may include illegal drugs and prescription medications. The current official list of controlled substances can be found in 21CFR §1308 http://www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm.
Controlled drugs are rated in the order of their abuse risk and placed in Schedules by the Federal Drug Enforcement Administration (DEA). The drugs with the highest abuse potential are placed in Schedule I, and those with the lowest abuse potential are in Schedule V. These schedules are commonly designated as C-I, C-II, C-III, C-IV, and C-V.
The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States. The DEA is responsible for suppressing illegal drug use and distribution by enforcing the Controlled Substances Act. The DEA requires a registration for the possession and use of controlled substances. For more information on the DEA, go to http://www.usdoj.gov/dea/index.htm.
The Minnesota Board of Pharmacy (MNBP) is the agency authorized by Minnesota statute to regulate controlled substances in the State of Minnesota. The MNBP exists to protect the public from adulterated, misbranded and illicit drugs, and from unethical or unprofessional conduct on the part of pharmacists or other licensees. The MNBP requires researchers using controlled substances to obtain an MNBP registration certificate. For more information on the MNBP go to http://www.phcybrd.state.mn.us/.
Terms used in the University policy
The University policy, Using Controlled Substances for Research, contains several unique terms that form the structure of the policy: http://www.fpd.finop.umn.edu/groups/ppd/documents/policy/controlled_substance.cfm.
For each of these terms, think about how it applies in your laboratory.
Unit: A department or other administrative structure, like a division or institute.
Location: A room or designated area where controlled substances are stored in a safe, usually in the laboratory.
Unit Registrant: A person who is appointed by the unit administrator to hold the DEA and MNBP registrations for the Unit, exercises signature authority and approves or appoints the Location Registrants for the Unit. Also referred to as the DEA registrant.
Location Registrant: A person, usually the principal investigator (PI) or lab supervisor, who obtains an MNBP registration for the (lab) Location, supervises the Authorized Users and assures compliance with the controlled substances policy and regulations at the Location.
Authorized Users: All personnel who perform one or more activities (receiving, using, disposing, etc.) with research controlled substances under supervision of a Location Registrant. Authorized Users are not required to have a specific registration. Authorized Users must receive training for lab-specific use of controlled substances.
Standard Operating Procedure
Controlled substances must be properly handled at all stages of purchase, use, storage, transfer and disposal. The University has a standard operating procedure (SOP), http://www.research.umn.edu/riop/forms/SOP.pdf, that can serve as a reference in the laboratory. We recommend that you bookmark the SOP for future reference. The SOP defines the person who is responsible for each of the activities related to using controlled substances for research.
Part 2: Registering, Purchasing, Receiving, Labeling, Storing & Securing
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