1. Registration Structure
The department head must appoint a Unit Registrant for the Unit. Each laboratory
in a Unit using controlled substances for research or teaching is a Location
and a Location Registrant must be designated. The Unit Registrant must obtain
a DEA registration for each University building address where controlled substances
will be used in the Unit. The Location Registrants and Unit Registrants must
also obtain MNBP registrations as described below.
Exemption: Investigators using Schedule I or some Schedule II drugs may
be exempted from the Unit-Location Registrant structure and hold an individual
DEA registration. Contact the Office of Regulatory Affairs for eligibility.
To request an exemption, complete the exemption form.
Registering:
A. MNBP registration for Unit and Location Registrants
Each Location Registrant must obtain a MNBP registration. The Unit Registrant
must obtain one MNBP registration for each DEA registration.
Complete the MNBP form: http://www.phcybrd.state.mn.us/researcher.pdf
Before a registration is issued, MNBP will conduct an inspection of the
facility to ensure that safety and security measures are in place.
B. DEA registration for the Unit Registrant:
For use of controlled substances in research, complete DEA Form 225. For
use of controlled substances in teaching, complete DEA Form 224.
Contact Office of Regulatory Affairs for assistance with DEA registration
process.
2. Purchasing
The Office of Regulatory Affairs encourages the purchase of controlled substances
from Boynton Health Service Pharmacy or the Veterinary Medical Center Pharmacy.
DEA Form 222 is required to purchase Schedule I and II drugs. If using these
schedules request Form 222 when applying for a DEA registration. When the
Unit Registrant is unavailable Power of Attorney may be used to order controlled
substances and execute DEA order forms. Power of Attorney may be granted by
Unit Registrants to the department head or senior administrator using a copy
of the DEA form available on the controlled substances website. The Power
of Attorney form must be attached to each order form and is only assigned
for specific period of time.
3. Receiving
When picking up controlled substances from the on-campus pharmacies or when
receiving in the mail, the Location Registrant or Authorized User must verify
the contents and rectify any discrepancies. Sign and date the purchase receipt
and file it with the controlled substances records. Provide a copy of the
receipt to the Unit Registrant.
4. Labeling
If controlled substances are removed from their original packaging and compounded,
diluted or combined, each new container must be labeled and tracked. The label
must include: the name of the controlled substances, the lot number, the final
concentration, the amount per container and the expiration date (not more
than 30 days after dilution date).
5. Storing and Securing
Controlled substances must be stored in a safe separate from other drugs
or materials. The safe must be bolted to an immovable object.