Use and Disposal of Controlled Substances Used in Research
CU Boulder Campus Guidelines on Controlled Substance Use and Disposal in Research and Teaching
What is a Controlled Substance? In the context of this policy, a controlled substance is as defined by the US Department of Justice Drug Enforcement Agency (DEA), Office of Diversion. Specifically, a controlled substance is a drug or other substance, or immediate precursor, included in Schedules I, II, III, IV, or V; these schedules can be found at http://www.deadiversion.usdoj.gov/schedules/schedules.htm.
Background
It may be necessary to use controlled substances in certain research and teaching activities on the CU Boulder campus. Controlled substances are identified in the schedules contained within the "Controlled Substances Inventory List," published by the U.S. Drug Enforcement Administration (DEA; see http://www.deadiversion.usdoj.gov/index.html). When conducting research or teaching with controlled substances, all University employees who are engaged in these activities must:
- comply with applicable federal and state laws and regulations regarding their use;
- possess any necessary US DEA and State of CO registrations;
- adhere to controlled substance storage, inventory maintenance, and disposal requirements;
- comply with reporting and record keeping requirements;
in accordance with Title 21, Code of Federal Regulations (CFR), Parts 1300-1308 (http://www.deadiversion.usdoj.gov/21cfr/cfr/index.html).
Procedures and Guidelines for Engaging in Research and Teaching Activities that Involve Controlled Substances
General overview: The use of controlled substances in research and teaching activities MUST conform to the rules and regulations set forth by the US DEA, Office of Diversion Control. In cases where local rules and regulations appear to be in conflict with DEA rules and regulations, the most stringent rules should be followed (as long as compliance with Federal DEA Diversion rules and regulations are being followed).
To conduct research or teaching that requires the use of controlled substances, you must be appropriately registered with the US DEA (see below). Your work must receive prior approval from campus regulatory committees. As a DEA registrant, you are personally responsible for the proper security, record keeping and reporting, and use and disposal of the controlled substances that you are authorized to use in your work. Anyone who works closely with the controlled substances in your laboratory is subject to a criminal background check. Furthermore, as a DEA registrant, you are required to inquire if any of those personnel have been convicted of any drug related offense or felonies. Personnel who answer in the affirmative cannot work with or in close proximity to controlled substances without prior clearance from a local DEA field office.
Below are the general guidelines for becoming eligible to work with controlled substances in your research and/or teaching at CU Boulder.
1. Registration
Anyone intending to use controlled substances for research or teaching must be registered with DEA. Researchers should use the DEA Form 225. There is an on-line registration option http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms_new.htm, and a paper registration option http://www.deadiversion.usdoj.gov/drugreg/reg_apps/pdf_apps.htm. (At this time, the State of Colorado no longer issues state registration numbers to university researchers. For this reason, the paper DEA registration option must be used since the currently designed DEA on-line process cannot be completed without the input of a valid State registration number). Be sure to use Form 225. For the “Select One Business Activity” option, select “Researcher.” CU personnel are considered State personnel, and are not required to pay the registration fee. You will have to acquire verification from an institutional official to receive a fee waiver (verification can be obtained through your Dean’s office, usually a divisional Dean, Dean of Research, etc). This signature must be provided in Section 6 of Form 225.
2. Prior Approval and Conduct of Research/Teaching Involving 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. For research involving controlled substances, the approving bodies are typically the CU Boulder Institutional Animal Care and Use Committee (IACUC) or Human Research Committee (HRC). Question regarding the proper approval authority should be directed to the Office of the Associate Vice Chancellor for Research (303-492-2889).
- 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.
- All personnel who work closely with controlled substances in your lab are subject to a criminal background check. As the DEA registrant, you are required to ask those personnel if they have ever been convicted of a drug-related offense, or a felony of any sort. If any of your personnel make such a disclosure, you are required to contact your local DEA field agent in order to determine if personnel participation in your activities involving controlled substances is allowable.
3. Use/Disposition Records, Labeling, and Controlled Substance Inventory (see CFR 1304.03(a))
Use/Disposition Records: The registrant must carefully and thoroughly document all actions taken with the controlled substance, which includes receiving, using, diluting/combining, transferring or disposing of expired and waste controlled substances. Record the use of controlled substances on disposition records. Use records must be maintained in 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 registant’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 substance used in research can be clearly reconciled with the amounts of controlled substances that were acquired by a registrant.
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.
Controlled Substance Inventory (see CFR 1304.11): 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 so that a quantitative history of controlled substance use in research can credibly and easily account for drug use. Every two years, registered users must complete an inventory to compare the actual count of controlled substances to the amount in the written disposition records. More frequent inventories are recommended for laboratories using schedule II drugs, higher volumes, multiple controlled substances or those labs with many authorized users. (see http://www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_11.htm)
4. Maintaining Registrations
Researchers must renew their DEA registrations annually. The renewal process is described at http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms.htm.
5. Storage and Security of Controlled Substances (see CFR 1307.21) and Order Forms (see CFR 1305)
Controlled substances and order forms must be stored in a sturdily constructed, locked cabinet separate from other drugs or materials. 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 the sake of enhanced security, he/she must receive prior approval from the local DEA Diversion Control Field Office (http://www.deadiversion.usdoj.gov/drugreg/offices/denver.htm).
6. Disposing of Controlled Substances (see CFR 1307.21)
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 effected through the use of ‘reverse distributor’. A ‘reverse distributor’ is a DEA registered entity that is legally allowed to handle controlled substance disposal. The CU System has established a reverse distributorship for the disposal of controlled substances. On the CU Boulder campus, the point of contact for the disposal of controlled substances is Mark Lapham, the Hazardous Materials Program Manager (303-492-8531; mark.lapham@colorado.edu). 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 Hazardous Materials Program Manager will be able to provide guidance in this regard.
7. Reporting Theft or Loss of Controlled Substances
If you suspect a theft, immediately notify the CU Police Department (303-492-6666) and the local DEA Field Office (http://www.deadiversion.usdoj.gov/drugreg/offices/denver.htm). 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. The form is available at https://www.deadiversion.usdoj.gov/webforms/dtlLogin.jsp.
If a container of a controlled substance is inadvertently broken or damaged, document this in the disposition record and have a witness sign and date it, if possible. Complete a DEA Form 41 (http://www.deadiversion.usdoj.gov/21cfr_reports/surrend/index.html) for the amount of 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.
8. Retaining Records
Controlled substance records must be maintained for at least 5 years.
9. Other
Questions regarding the use of controlled substances in animal research should be directed to Dr. Albert Petkus (Albert.Petkus@colorado.edu). For inquiries regarding the use of controlled substances in human research, contact Dr. Claire Dunne (Claire.Dunne@colorado.edu). If you have other questions, contact Stein Sture, Vice Chancellor for Research (303-492-2890; Stein.Sture@colorado.edu).