Due to their potential for misuse and abuse, items listed by the U.S. Department of Justice, Drug Enforcement Administration (DEA), scheduled drugs (controlled substances) are subject to special procurement, storage, use and disposal requirements. The University takes this responsibility seriously and has developed the Controlled Substances in Research UOP (University Operating Procedure). It is the responsibility of individual researchers and other staff using these materials to obtain appropriate registrations and licenses.
Controlled Substances Committee
The UVM Controlled Substances Committee (CSC) was organized to:
- Establish and review policies and procedures on all matters relating to the purchase, storage, usage, and disposal of controlled substances by members of the University Research community;
- Review and authorize UVM researchers to purchase and use controlled substances;
- Develop standards for monitoring compliance and responding to non-compliance with regulations and/or institutional procedures; and
- If necessary, terminate a user’s authority to use controlled substances at UVM.
The DEA's Diversion Control Division mission is to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial and scientific needs. The DEA is a law enforcement agency, with the ability to assess civil and criminal penalties.
The DEA accomplishes its mission by requiring that any person proposing to use controlled substances in research must first be registered with the DEA. All registrants must renew their registration on an annual basis. At each time point, paperwork is required, and a background check is run by the DEA.
The DEA makes periodic unannounced inspections of registered controlled substance storage locations. Reports of loss or theft may result in a DEA inspection or visit. Background checks may be conducted by the DEA as part of the inspection.
The Controlled Substances Act (CSA) Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain narcotics, stimulants, depressants, hallucinogens, anabolic steroids and other chemicals is regulated.
Controlled substances are divided into five schedules, based on:
- Whether they have a currently accepted medical use in the United States,
- Their relative abuse potential, and
- Safety and likelihood of causing dependence when abused.
Schedule I: No currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.
Schedule II: High potential for abuse which may lead to severe psychological or physical dependence.
Schedule III: Potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.
Schedule IV: Low potential for abuse relative to substances in Schedule III.
Schedule V: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.
Each investigator who orders, handles, or stores controlled substances must be registered with the DEA and approved by the UVM CSC prior to performing these functions. Registrants must also:
- Maintain accurate inventories and records of controlled substances for a minimum of 2 years;
- Designate Authorized Users: An Authorized User is a member of the research team who has completed appropriate training, and is approved to handle controlled substances in the laboratory;
- Ensure that controlled substances are stored in a manner that prevents their theft or misuse;
- Supervise use of controlled substances in the lab;
- Ensure the appropriate disposal of controlled substances;
- Comply with DEA and UVM reporting requirements;
- Renew registrations annually; and
- Administer the "Questionnaire for Access to Controlled Substances for Research Purposes" to all Authorized Users (questionnaire can be found below in the Forms section)
Security & Storage Requirements
Each registrant and authorized user will have their background checked by DEA before being approved to handle controlled substances.
Controlled substances must be stored in a way that prevents their theft or misuse.
- Controlled substances must be stored at the location specified in the registration, in a double-locked, substantially constructed cabinet that is fixed in place.
- Registrants must institute a key access procedure and keep the key in a secure key safe or a locked drawer.
- Registrants must ensure that only authorized users have access to controlled substances.
- The storage area must remain locked when not in use.
- No bicycle locks, clasp locks, or any other locking structure that can be easily cut off the cabinet may be used.
Reporting Theft or Loss
All employees and students are required to report diversion of controlled substances. Any suspected theft, loss, or diversion must be immediately reported to:
- UVM Police Services at (802)656-3473 or firstname.lastname@example.org,
- UVM Office of Compliance Services at (802) 656-3086 or at email@example.com, and
- Area DEA Field Division Office must be notified in writing within one business day of discovery of loss or theft. Completion and submission of the DEA Form 106, "Report of Theft or Loss of Controlled Substances" is also required.
Follow the Anonymous Reporting procedures if you want your identity to be protected.
Breakage, spills, or other witnessed controlled substance losses do not need to be reported as lost. This type of loss must be documented by the registrant and witness on the inventory record.
Controlled substances that can be recovered after a spill, but cannot be used because of contamination (such as tablets), must be disposed of in accordance with disposal procedures.
Methods of Disposal
A registrant may dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples, by either of the following methods.
- The DEA Registrant can personally administer the drug to an animal carcass, or the University Veterinarian can administer the drug to an animal carcass while the DEA Registrant is present.
- Transferring them to a registrant who is authorized to receive such materials (contact the local DEA field office for a list of authorized “reverse distributors”). Risk Management and Safety can also help coordinate this with UVM's hazardous waste contractor.
Documentation of the disposal is required. Registrants are required to complete the online “Registrant Record for Controlled Substances Destroyed”, Form DEA- 41, to notify the DEA of controlled substance destruction.
If an unregistered controlled substance must be disposed of, please contact firstname.lastname@example.org.
Forms and Guidance
- Information Needed for Registration [MS Word]
- Example Controlled Substance Log [MS Word]
- Example Controlled Substance Inventory Form [MS Word]
- Use of Controlled Substances in Research Flow [PDF]
- Purchase Order Requirements [PDF]
- DEA Unannounced Inspection [PDF]
- Instructions and Questionnaire for Access to Controlled Substances for Research Purposes by Non-DEA Registration Holders
- Pharmacy Permit Waiver [PDF]