Controlled Substances

Scope

Controlled Substances are drugs whose manufacture, possession and use are regulated by the Federal Drug Enforcement Administration (DEA).

At the UO, controlled substances include all Schedule II though V DEA Scheduled substances. No use of Schedule I substances is allowed.

Determine if the material you wish to use is a controlled substance by searching the DEA Alphabetical Listing.

Researchers and other employees who require the use of a controlled substance in research must apply for authorization to EHS and be approved before work with the material can begin.

Registration

Federal law requires each Registrant using Controlled Substances to possess an individual DEA registration which corresponds to one location where Controlled Substances are stored. Submit an online application through DEA's website at http://www.deadiversion.usdoj.gov/drugreg/index.html.

  • DEA Registrants using Controlled Substances for research will use Form 225.
  • DEA Registrants using Controlled Substances in teaching should be registered using Form 224.

Cass Moseley's information should be listed in the Fee Exempt section:  Cassandra Moseley, Associate Vice President for Research/Institutional Official, cmoseley@uoregon.edu, 541-346-4545

Note: UO researchers are exempt from the DEA registration fees.

Once the DEA registration certificate is received by the Registrant, the certificate should be filed in a secure location, such as a Controlled Substance logbook. In addition, the Registrant must provide a copy of the DEA registration to EHS.

Contact Hallie Hoskins, Controlled Substances Program Manager, (541) 346-3476, hallieh@uoregon.edu with any questions.

Application check list

  1. Submit an online application to DEA.  Notify Hallie Hoskins in EHS once this has been complete.
  2. Initiate paperwork for Authorized Users. See Application Forms for more information.
  3. Confirm your storage area is a securely locked, substantially constructed cabinet and cannot be carried away (at least 750 lb. or built into lab furniture). See Storage for more information.
  4. Establish a procedure for ordering and accepting deliveries of Controlled Substances. Packages cannot be dropped off in an unattended location and must be handed directly from the delivery person to an authorized user. See Handling and Transportation for more information.
  5. Review requirements for Controlled Substance ordering, use, inventory, disposal, transfer, etc. SeeRecordkeeping for more information.

Inspection

The DEA Diversion Control Officers will conduct an initial site visit prior to approving your application. They may make unannounced inspections at any time to any registration holder or applicant.

For DEA Registration application, an inspector will request a copy of your Curriculum Vitae and the applicable IACUC protocol(s) that includes details about Controlled Substances used. He or she will also inspect the storage area, inquire about your package delivery process, and request information about use logs and inventory systems.

Whether an inspection is scheduled or unannounced, the University requires the DEA Registrant and authorized users to notify EHS immediately. EHS staff will escort the inspector(s) and serve as professional experts to help answer questions or concerns about UO policies, procedures, and guidelines.

Renewals

DEA registration is valid for one year and must be renewed annually. Generally, the DEA will contact the Registrant prior to the expiration of the registration and provide instructions on submitting a renewal application.

If registration is allowed to expire, the DEA Registrant must start the registration process over again. This, unfortunately, will also put the Registrant into non-compliance with the Federal regulations.

Recordkeeping

DEA Registrants must maintain complete and accurate inventory records for all Controlled Substances.  The recordkeeping forms must be up-to-date and readily available for inspection by DEA and EHS.

All records must be kept for a minimum of two years after the last recorded date of use, order, transfer, disposal, or other recorded transaction involving the Controlled Substances.

All vendor records including orders, shipping, and receiving forms are also required to be kept for inspection purposes. A disposition log must be started for each bottle as soon as it is received.

Template forms are strongly recommended to assist in recordkeeping in accordance with DEA requirements.

Controlled Substance Disposition Log 

This form tracks the receipt and usage of a Controlled Substance under the Registrant's license.  It should also be used for any mixtures or dilutions of CSs.

Schedule III-V Controlled Substance Transfer Form 

This form documents transfer of CS ownership from one UO DEA Registrant to another UO DEA Registrant.

Controlled Substance Inventory Form 

This form documents an inventory reconciliation of all Controlled Substances in the Registrant's ownership.  It must be completed initially and at least every two years.

Storage

Secure storage is required for Controlled Substance use in research and teaching. For Controlled Substances use, a storage area must be securely locked, substantially constructed cabinet and cannot be carried away (At least 750 lb. or built into lab furniture).

Title 21, CFR Section 1301.71(a), requires that all registrants provide effective controls and procedures to guard against theft and diversion of Controlled Substances. Depending on the facility’s existing security controls and public access to the building, the DEA may determine that additional controls are needed.

EHS can advise on suitable storage conditions.

Handling and Transportation

The mailing address provided on the DEA application must be the address to which Controlled Substances are shipped; vendors will not ship to any other address.

Important: Packages cannot be dropped off in an unattended location and must be handed directly from the delivery person to an authorized user.

Packages are intentionally marked inconspicuously and will never have the Controlled Substance name on the package.

When considering procedures for handling and transportation for Controlled Substances, please identify the most appropriate shipping address so that any Controlled Substance delivery will be accepted by an authorized user or the DEA registrant.

Deliveries can never be left in an office or otherwise unattended.

Contact:  Hallie Hoskins, Controlled Substance Program Manager
541-346-3476 | hallieh@uoregon.edu