Purchasing, Receiving and Storing Controlled Substances

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Last Updated: January 2006

Responsible University Officer:
  • Vice President for Research

Procedure Contact:
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PROCEDURE

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.

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