Controlled Substances and Listed Chemicals
This information applies to all university faculty, affiliates, and staff, who seek to purchase or use DEA listed chemicals or Schedule I-V substances for the purposes of instruction or research on university owned or leased property, and the requirements for the acquisition and use, on university owned or leased property, of materials governed under the Code of Federal Regulations: Title 21, Part 1300 by the Drug Enforcement Agency (DEA), Office of Diversion Control, as scheduled or listed chemicals.
- Controlled substances are defined by the DEA as materials with no accepted medical use in the United States or with high potential for abuse which may lead to severe psychological or physical dependence, and they are separated into Schedules, I-V based on the severity of those factors.
- Listed chemicals, referred to as precursors, are materials necessary to produce controlled substances and are regulated at established threshold quantities to restrict illicit use.
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Purchasing of Controlled Substances or Listed Chemicals?
To purchase controlled substances for use in research faculty, affiliates, and staff are require to possess and provide both of the following:
- A valid DEA registration for the scheduled material
- A valid Virginia Board of Pharmacy registration or License to Practice Medicine
Faculty and staff can apply for these registrations by:
- Submitting a form 225 to the Office of Diversion Control, the form can be completed directly from their website; http://www.deadiversion.usdoj.gov
- Submitting an Application for Controlled Substance Registration to the Virginia Board of Pharmacy, the application can be obtained from their website; http://www.dhp.virginia.gov/pharmacy
All faculty, affiliates, and staff in possession of controlled substances on university owned or leased property must also provide electronic copies of current and renewed registrations to the Environmental Health and Safety Office for verification and record keeping while they work with or store these materials on campus.
The purchase of DEA listed chemicals requires only a signed verification of identity through the selected chemical vendor for any purchase of established threshold quantities. This form must be signed and returned before initiation of the purchase by:
- The authorized purchaser (who cannot also be the same as the contact person)
- The contact person (typically the Chair or Vice President)
DEA Registration Application Fee Exemption
Exemption from payment of the application fee is limited to federal, state or local government officials or institutions. The applicant’s superior or agency officer must certify exempt status. The signature, authority title, and telephone number of the certifying official (other than the applicant) must be provided.
Faculty and staff can apply for this exemption by:
- Obtaining the signature of the Dean of their College to verify their employment status and approval of their research.
- Obtaining the signature of another authorized university official who has the authority to verify their employment status an approval of their research.
Storage and Security Requirements
Controlled substances in use must never be left unattended at any time, and any loss or theft of materials must be reported immediately to the Office of Diversion Control by submission of form 106 directly online at their website.
All users of controlled substances must store and secure such materials in accordance with the regulations set forth in 21 CFR 1301.75, which requires at a minimum;
- Storage in a securely locked, substantially constructed cabinet,
- A location with secured access and adequate observation.
All users of listed chemicals must store and secure such materials in accordance with 21 CFR 1309.71, which requires at a minimum;
- Storage in sealed, tamper proof, containers
- Storage in locked rooms, or in areas with adequate observation.
Inventory and Records
For the purposes of inventory, controlled substances must not be transferred from their original commercial containers, and the identifying labels on such containers must be maintained and may not be removed. If the material is converted, or diluted, a new properly labeled container should be created and added to the inventory record.
All users must maintain their inventory and usage records in accordance with 21 CFR 1304, this requires complete and accurate records of all controlled substances purchased, manufactured, transferred, or wasted, as well as updated written usage logs for all materials in their possession.
- All inventory records must be updated biennially for all materials “on-hand”.
- Records for Schedule I and II materials must be kept separately from Schedule III-V records as their reporting requirements are not equivalent.
- Transfers of material between registrants must also be inventoried and recorded.
- Disposal through destruction or reverse distribution must also be recorded.
For listed chemicals, EHS Assistant may be used to maintain inventories of all materials purchased, transferred, or disposed of as hazardous waste.
Disposal of controlled substances is a strictly regulated process, therefore any faculty, affiliates, or staff seeking to dispose of their inventory stored or used on university owned or leased property must notify EHS via email to email@example.com of their intent to destroy or reverse distribute prior to making such arrangements to ensure the process and materials are properly documented.
The disposal of controlled substances is regulated by 21 CFR 1317 which permits all registrants in lawful possession of controlled substances to dispose of them by:
- Promptly destroying them by use of an approved on-site method found in 21 CFR 1317.90 and 1317.95
- Returning them via a reverse distributor
- For Schedule I and II materials request assistance for disposal from the Special Agent in Charge for the Washington Division.
- Requests for assistance can be made by completing and submitting form 41 in triplicate to the Office of Diversion Control: the form can be downloaded from their website; http://www.deadiversion.usdoj.gov
Form 41 must be maintained with your inventory records as documentation of the destruction or reverse distribution of the material. If you are not a registered user of controlled substances and require assistance with disposal, please contact the EHS office for further instructions.
Listed chemicals may be disposed of by affixing a completed hazardous waste label on the container and place it into the satellite accumulation area for the laboratory. Waste is collected from the laboratories on a weekly basis, or if needed upon request to firstname.lastname@example.org, or by calling directly to (703) 993-8448.