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Training Fact Sheet - Controlled Substances Standard
Drug Enforcement Administration (DEA)
Regulation:
University Policies
2.1.4, 2.1.4.2, 2.1.4.1
21 CFR 1300
State Statutes, Chapter 6800
Who is covered?
In conducting research and teaching activities with controlled substances, University authorized departments, units, and employees must comply with federal regulations and state laws regarding their uses, including registration with DEA and Minnesota Board of Pharmacy (MNBP), storage requirements, inventory maintenance, and substance disposal. This policy does not apply to controlled substances dispensed by a practitioner to a patient in the course of professional practice as authorized by his/her license.
Program Requirements:
- Departments shall designate unit registrants, and unit registrants shall designate location registrants.The unit registrant purchases or authorizes purchases and disposal of controlled substances for location registrants within the department or unit.
- Unit registrants must possess DEA and MNBP registration and must also register with DEHS.
- Location registrants must possess a MNBP registration and maintain an accurate authorized user list.
- Departments, units, and employees must take appropriate storage and security measures to prevent theft of controlled substances used in research when procuring, using, and disposing of them.
- Persons having custody of controlled substances shall dispose of them according to federal regulations. If there is any difficulty in disposing of controlled substances, or if you have questions about disposal, contact Greg Casura at 612-626-5338, or the Thompson Center for Environmental Management at 612-626-1604.
Record keeping:
Accurate disposition records must be maintained; separate records are required for Schedules I and II substances and shall be maintained for three years. Any inventory discrepancy must be reported to the police and DEHS.
The registrant shall conduct an annual inventory and reconciliation as part of a self-audit. A copy of the completed self-audit must be submitted to the Department of Environmental Health and Safety (DEHS) prior to registration renewal. The disposition records or log will be reviewed by DEHS and the Office of Regulatory Affairs when it conducts a periodic on-site review of controlled substances as required by DEA and MNBP.
Contact name and number:
For further information, call Greg Casura, safety specialist & ergonomist, Environmental Health and Safety, at 612-626-5338 or e-mail:
casur001@tc.umn.edu