Controlled substances are any drugs or chemicals whose possession and use are regulated under the United States Controlled Substances Act (CSA). The U.S. Drug Enforcement Administration (DEA) administers the federal law. Controlled substances include anabolic steroids, chemicals used in the production or synthesis of controlled substances, and those with stimulant, depressant, or hallucinogenic effects on the central nervous system that can promote abuse or physiological/psychological dependence. Because of their potential for abuse, controlled substances have specific regulatory requirements for their acquisition, storage, use, and disposal.
The Vice Provost for Research has established this policy for the University of Massachusetts’s Boston oversight of research involving controlled substances. Due to the potential for diversion or abuse, controlled substances are subject to extensive regulation regarding their manufacture, distribution, procurement, storage, record keeping, transfer, and disposal. This policy applies to controlled substances as defined by the Controlled Substances Act of 1970.
SCOPE OF UMB POLICY ON CONTROLLED SUBSTANCES IN RESEARCH AND EDUCATION
The scope of this policy is limited to oversight for research and education involving the use of controlled substances. This includes controlled substances associated with animal research, controlled substances administered to human subjects as part of a research protocol, and in vitro or analytical research with controlled substances.
INVESTIGATOR AND ASSOCIATED PERSONNEL ROLES AND RESPONSIBILITIES
It is the responsibility of investigators and associated personnel who utilize controlled substances in a research or education setting to familiarize themselves with and comply with the regulations (see “Federal and State Regulations” below), and with all UMB requirements pertaining to controlled substances. This includes the responsibility to:
**Obtain a State of Massachusetts (SOM) license and a Drug Enforcement Administration (DEA) registration specifying the address for secure storage of the controlled substances to be used for research.
The University of Massachusetts Boston requires that, for the conduct of research activity with controlled substances, a person with a UMB faculty appointment be the one to obtain a SOM Research License and DEA Research Registration for the procurement, storage, and administration of controlled substances in their laboratory or other research location. An investigator cannot provide controlled substances to another individual UNLESS they are collaborating on the same study and are co-listed on the same protocol that governs the work the controlled substances are used for. Exceptions to these requirements will be considered on a case-by-case basis.
- Register with the UMB Controlled Substances Monitoring Program and provide timely updates following any SOM controlled substance license and DEA registration renewal or change.
- Procure all controlled substances in a manner that complies with Federal and State regulations and UMB policies.
- Store all controlled substances at a secure location matching the address listed on the State of Massachusetts licenseand DEA registration.
- Restrict access to controlled substances to a limited number of authorized personnel and maintain an authorizedpersonnel log.
- Securely maintain all records, including procurement (e.g., ordering and purchasing), formulating/reconstituting, inventory, usage/administration, and disposal records in provided controlled substance logbooks.
- Properly dispose of controlled substances in an accountable manner that renders them irretrievable when they are nolonger required for research, at their expiration, at project end, before decommissioning of laboratory, and before termination of the controlled substance license/registration.
- Keep State of Massachusetts licenses and DEA registrations up-to-date, including prior notification (and approval) of changes of address.
- Employees are required to report immediately (upon discovery) to the UMB Controlled Substance Monitors any ofthe following events: All unresolved discrepancies in inventory relating to controlled substances;
- Possible significant loss or theft/diversion of controlled substances;
- Improper removal of controlled substances from UMB premises;
- Any signs that a controlled substance may have been interfered with or tampered with (such as broken, empty or cracked containers, broken seals, or lack of efficacy*).
- Signs that a co-worker may be impaired due to self-administration of controlled substances;
- Discovery of misplaced or unsecured controlled substances; and
- Any other situations where policies and procedures relating to controlled substances may not have been followed.
9. Any theft or significant loss of unknown origin must be reported immediately to all of the following entities, in the order listed:
- UMB Department of Public Safety and Security;
- UMB Controlled Substance Monitors
- U.S. Drug Enforcement Administration (this reporting is to be facilitated by the UMB Controlled SubstanceMonitor).
- The administrator of the Massachusetts Department of Licensing and Regulatory Affairs, (this reporting is to be facilitated by the UMB Controlled Substance Monitor).
The Vice Provost for Research oversees compliance with this policy. Failure to comply with this policy may be grounds for discipline by the University, suspension or termination of the research, referral for non-compliance proceedings, and/or reporting to external licensing or public safety authorities by the University. In addition, failure to comply with the State of Massachusetts and federal controlled substances regulations may lead to administrative penalties, civil fines, revocation of state-controlled substance license and/or DEA registration, as well as criminal prosecution sought against the research registrant.
SCHEDULES OF CONTROLLED SUBSTANCES
The drugs and substances covered under the Controlled Substance Act are organized into five schedules:
Schedule I: No accepted medical use.
- Schedule I compounds are classified as illicit drugs along with their chemical precursors.
- The DEA requires a Schedule I registration application for use of these substances.
Schedules II-V: Accepted medical uses.
- Schedule II substances have a high potential for abuse with severe psychological or physical dependence.
- Schedule III-V substances have a lower potential for abuse than substances in Schedules I or II.
- The DEA requires a Schedule II-V registration application for use of these substances.
FEDERAL AND STATE REGULATIONS
U.S. Department of Justice – Drug Enforcement Administration (DEA)
- Title 21 United States Code (USC) Controlled Substance Act (CSA)
- Title 21 Code of Federal Regulations, Part 1300-1399
State of Massachusetts