DEA Controlled Substances

All research and/or teaching activities involving the use of Controlled Substances must have prior written approval from the appropriate campus regulatory bodies.

• The approving bodies are typically the CU Boulder Institutional Animal Care and Use Committee (IACUC) or Institutional Review Board (IRB). 

Once prior approval is obtained, anyone intending to use Controlled Substances for research or teaching must register with the DEA using DEA Form 225. 

• At CU Boulder, the DEA Registrant is typically the PI or Project Lead. A DEA Registrant is any person who is registered with the DEA in accordance with the Controlled Substances Act.
• Use the CU Boulder Instructions for Form 225 to fill out your form accurately.

Tips For Completing Initial Registration Form

• Be sure to use Form 225 for initial registration.
• For the “Select One Business Activity” option, select “Researcher.”
• CU personnel are State employees and are not required to pay the registration fee. Check the "exempt" box and indicate the following as the certifying institutional official:  Dr. Jon Reuter, Associate Vice Chancellor of Research Integrity, 99 UCB, 303-735-5809. 
• The State of Colorado no longer issues state licenses to researchers, thus unless you have a license to prescribe, leave Section 3 (State Licenses) blank. The second entry in Section 3 should also be left blank, since the State of Colorado does not issue State Controlled Substance Licenses.

Once the research/teaching activity has been approved, the DEA Registrant shall purchase Controlled Substances from licensed vendors using his/her own registration number.

• The registrant shall not purchase Controlled Substances for other personnel or for use in other activities that have not received prior approval.
• At least two people must verify receipt of the Controlled Substances
• Regional DEA offices can also supply forms and information concerning the type of registration required for a particular substance for research use.

Ordering Controlled Substances: Schedules I-II

• For Controlled Substances listed in Schedules I and II, researchers must either request a DEA Form 222 or use the DEA’s electronic ordering system (CSOS-Controlled Substances Ordering System). Using CSOS is recommended.
• Incorrectly filled out Form 222 must be voided and kept as part of the recordkeeping requirements.
• Form 222 cannot be pre-signed.

Ordering Controlled Substances: Schedules III-IV

• For Controlled Substances listed in Schedules III-V, the DEA registrant (PI or project lead) can order directly from vendors. 
• Most researchers on campus use MWI Animal Health: (800-896-8873) mwiapplicationprocessing@mwianimalhealth.com

Ordering Buprenorphine-SR/ER

• For Buprenorphine-SR (sustained release), also known as Buprenorphine-ER (extended release), researchers must order through the University Veterinarian (Sara.Hashway@colorado.edu). 

An Authorized User is any person who is authorized by a DEA Registrant (PI or Project Lead) to handle Controlled Substances under that Registrant’s DEA registration.

• Any person who works closely with Controlled Substances in your lab must complete and sign the DEA Authorized User Screening Certification, and complete a criminal background check if they did not do so as part of being hired as an employee of the University of Colorado Boulder.   
• Additionally, all current employees are required to self-disclose any post-employment criminal convictions or felony charges filed against them that occur on or after their date of hire, within three business days of the conviction or felony charge to the Human Resources Background Check Coordinator.
• If any of your personnel make such a disclosure, you are required to contact your local DEA field agent to determine if they are still eligible to serve as an Authorized User.

Once a license is acquired, it is critical that an initial inventory is conducted and recorded so that the use of Controlled Substances can be accounted for from the time of their acquisition. 

• Record keeping must be conducted in such a way that a quantitative history of Controlled Substance use in research can credibly and easily account for drug use.
• Every two years, Registrants must complete an inventory to compare the actual count of Controlled Substances to the amount in the written use records. Use the DEA Biennial Controlled Substance Inventory Form.
• More frequent inventories are recommended for laboratories using Schedule II Substances, higher volumes, multiple Controlled Substances or those labs with many Authorized Users.

The Registrant must document all actions taken with the Controlled Substance, including receiving, using, diluting/combining, transferring or disposing of expired and wasted Controlled Substances. 

• Record the use of Controlled Substances in the recommended Use Record form.
• Use records must be maintained in a way that clearly reflects when and how much of a particular Controlled Substance was introduced into a Registrant’s laboratory. 
• Once a Controlled Substance is introduced into a Registrant’s laboratory, the specific dates and times of use, as well as the identity of the personnel who used the Controlled Substance, must be clearly documented at the time of use (retrospective record keeping is not allowable). 
• It is critical that records be kept so that the amounts of Controlled Substances used in research can be clearly reconciled with the amounts of Controlled Substances that were acquired by a Registrant.

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.

Controlled Substances and order forms must be stored in a sturdily constructed, locked cabinet separate from other drugs or materials. 

Storage

• In general, DEA regulations call for the storage of Controlled Substances and order forms in the same venue. 
• If a Registrant should choose to store order forms in a separate place for enhanced security, they must receive prior approval from the Denver DEA Diversion Control Field Office (1-800-326-6900).
• Controlled Substance containers must be in good condition, labeled, and not expired.
• Storage must be at the registration location.
• Schedule I and II Controlled Substances must be stored separately from Schedule III, IV, and V Controlled Substances.
• Non-controlled substances cannot be stored with Controlled Substances without approval from the DEA.
• Sharing locked cabinets with multiple Registrants needs to be approved by the DEA.

Transportation

• A Registrant can transport material (within university boundaries) from the storage location for use at a different location from the address on the DEA registration. 
• Transportation can only take place during business hours.
• Controlled Substances can only be transported by the Registrant or an Authorized User.
• When at a different location, the Controlled Substance cannot be left unattended.
• Controlled Substances must be returned, secured, and stored at the registered location by the end of day.
• Controlled Substance must not be in the Registrant or Authorized User’s possession while off duty.

Security

• A double secured system must be in place.
• Common hallway badge access doors do not qualify as security.
• Storage cabinets must be non-transportable and substantially constructed. Cabinets must be secured to the floor or wall by facilities.

Controlled Substances that are outdated, surplus, or contaminated must be disposed of according to federal regulations and DEA policy. 

• Disposal of Controlled Substances must be conducted using a Reverse Distributor. A Reverse Distributor is a DEA registered entity that is legally allowed to handle Controlled Substance disposal. 
• On the CU Boulder campus, disposal is handled by the Department of Environmental Health & Safety (EH&S); the point of contact for the disposal of controlled substances is Chris Quattrociocchi, EH&S Hazardous Materials Program Manager. 
• Depending on the origins of the Controlled Substances (e.g. expired with a current license, spent materials, materials abandoned without a known Registrant, etc.), different types of paperwork may be required to initiate and complete the disposal process. The CU Boulder Hazardous Materials Program Manager will be able to provide guidance in this regard.

If you suspect a theft of Controlled Substances, immediately notify the CU Police Department (303-492-6666) and the local DEA Field Office (720-895-4040). 

• In addition, the DEA requires that theft or loss of Controlled Substances be reported on DEA Form 106 Report of Theft or Loss of Controlled Substances.
• If a container of a Controlled Substance is inadvertently broken or damaged, document this in the Use Record and have a witness sign and date it, if possible. 
• Complete a DEA Form 41 for the Substance lost and write “unintentional destruction” on the form. Signatures of the person who broke the bottle, the witness and the Registrant are required on Form 41. Mail the original to the DEA and file a copy with your Controlled Substance records.

DEA Registrants (PI or Project Lead) must renew their DEA Registrations annually. 

• The DEA sends electronic renewal reminders to the email address listed on the registration.

Periodically, DEA will make unannounced inspections. 

• In compliance with the Controlled Substance Act, the DEA is authorized to audit any registered Controlled Substance storage location and laboratories with controlled substance use. 
• Use the DEA Inspection Preparation Guidelines to ensure your lab is ready for an inspection.