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Part 2
Registering, Purchasing, Receiving, Labeling, Storing & Securing

Registering for Controlled Substances

The DEA requires a registration for different types of activities when using controlled substances, e.g., research, teaching, clinical practice and other activities. Under the University of Minnesota policy, a practitioners’ DEA registration cannot be used to purchase controlled substances used for research.

Unit Registrants and Location Registrants must go to "Registrations and Responsibilities" to understand the Unit and Location structure, registration process, roles and responsibilities.

Authorized Users do not need a specific registration.

Everyone performing any research activity with controlled substances must sign the Authorized Users Signature Log. The Authorized Users Signature Log is one of the documents required by the University policy that must be kept up-to-date and filed in the research controlled substances records. 

Authorized Users Signature Log

Online Version of Form

The Authorized User Signature Log, like all controlled substance records, must be kept for a minimum of three years. When a person departs the laboratory, note the date the person left on the form. If there is high turnover in the lab, you may need to start a new log, but remember to keep the original document with your controlled substance records.

Purchasing Controlled Substances

The DEA and the University policy have specific procedures to be followed when purchasing controlled substances:

• The Unit Registrant must be aware of all purchases of controlled substances. Ensure this by providing an initialed and dated copy of the purchase receipt to the Unit Registrant.
• File the purchase receipt with the Location controlled substances records.
• Purchasing controlled substances from centralized sources is highly recommended for those on the Twin Cities campus.  On the Minneapolis campus, Boynton Pharmacy will obtain, and often stocks, the controlled substances commonly used in animal research. In St. Paul, the Veterinary Medical Center Pharmacy can supply most controlled drugs. For more information on purchasing controlled substances from these pharmacies, see the controlled substances website, http://www.research.umn.edu/riop/controlsubst.htm#purchasing.
• To pick up controlled substances, both campus pharmacies require a copy of the DEA registration, the Authorized Users Signature Log and photo identification.

The purchase of C-I and C-II substances require completion of a DEA Form 222.

After the DEA has approved your use of C-I or C-II controlled substances, they will send you the DEA Forms 222. After initial approval, you may request additional Forms 222 online from the DEA website.

Receiving Controlled Substances

When picking up controlled substances from the pharmacy, or if controlled substances are shipped to the lab, ensure that the controlled substances are processed as soon as possible, by:

• Recording receipt of substances in the disposition record
• Locking controlled substances in the safe immediately

In addition, ensure that the purchase records meet the DEA regulations by:

• Initialing and dating purchase receipt
• Providing a copy for Unit Registrant’s records
• Filing the purchase records with laboratory controlled substances records

Labeling Controlled Substances

All containers of controlled substances must be properly labeled. If the laboratory re-packages, compounds or dilutes controlled substances, appropriately label the re-packaged, compounded or diluted substance and store it in the safe.

The label on diluted or combined controlled substances that will be stored at least overnight in the safe must include the following information:

• Name of controlled substance
• Final concentration of controlled substance
• Volume per container
• Expiration date no more than 30 days after dilution

Storing and Securing Controlled Substances

Controlled substances must be stored securely, according to the University policy and DEA regulations. The following points highlight the requirements:

• Store controlled substances in a locked safe bolted to immovable object.
• Store controlled substances separately from other drugs and materials.
• Limit access to the safe.
• For expired drugs, mark the container “Expired” and segregate in the safe.
• Store the slurry bottle with contaminated waste controlled substances in the safe.
• Store controlled substances requiring cold storage in a refrigerator or freezer with a locked door.

Part 2: Knowledge Check