A. What Are Controlled Substances?
Controlled substances are defined by the federal Drug Enforcement Administration (DEA) and the Massachusetts Department of Public Health (DPH). Copies of the regulations and schedules referenced are available from the Environmental Health and Safety Office and on the Internet at the addresses listed below.
- 21 CFR 1308.00: Schedules I through V.
- 105 CMR 700.001: Controlled substance means a drug, substance, or immediate precursor in a schedule or class referred to in M.G.L. c94C or 105 CMR 700.000: DEA Schedules I - V, and Massachusetts Schedule VI which includes all other prescription drugs.
Both DEA and DPH regulations also list "excluded" nonnarcotic substances, which are exempt from regulation. The federal list is much more extensive than the state, with the result that certain substances are exempt from federal requirements but not from state. DEA lists "exempt chemical preparations" which are exempt when intended for laboratory, industrial, educational, or special research purposes and not for general administration to a human being or other animal. DPH regulations also include "excepted compounds" which are exempt from requirements of Schedule I through V but still subject to Schedule VI requirements.
B. Registration Requirements
Each faculty member wishing to purchase or use any controlled substance must obtain registrations in her/his name from both DEA and DPH. Certain substances that are exempt from DEA requirements but not DPH will only require a DPH registration. You cannot purchase any controlled substance until you are issued registration numbers. A faculty member, awaiting action on submitted registration applications, may use controlled substances under the registration of a registered faculty member if the registered faculty member agrees to supervise use, and the Director of Environmental Health and Safety and the Dean of Faculty approve the arrangement.
Copies of registration/renewal applications and registrations including appended research protocols should be sent to the Office of the Dean of the Faculty and the Office of Environmental Health and Safety where they are kept on file.
C. Controlled Substance Security
Both the DEA, 21 CFR 1301.71, and DPH, 105 CMR 700.005, establish requirements for security of controlled substances. The requirements are summarized here, the regulations should be referred to for additional details.
Physical Security from Theft
Controlled substances must be stored in a “securely locked, substantially constructed cabinet”. This cabinet must be located in a room that is locked when not occupied. If using a keyed lock, the key(s) must be under the direct control of the registered faculty member.
Personnel Security Requirements
No person who has had an application denied or registration revoked may work with controlled substances. Each non-registered faculty, staff, or student working under the supervision of the registered faculty member, who is provided controlled substances for use when the registered faculty member is not present, must sign a statement provided by Human Resources. The statement asks questions regarding criminal and drug use history, and allows the College to perform a criminal record check, as required by the DEA. The registered faculty member must supply the names of such individuals to the Director of Environmental Health and Safety who will forward the names to the Director of Human Resources. Work with controlled substances cannot begin until the registrant is notified that the individual is approved for work.
Security Upon Receipt
All shipments of controlled substances should be delivered directly to the registrant or to the Department Office and held in a secure location for pick-up by the registered faculty member.
Report of Theft or Loss
Report of loss or theft must be made to both the DEA and DPH by telephone upon discovery, and by mail on form DEA 106 within 7 days.
D. Records And Inventories
The Director of Environmental Health and Safety will keep a list of all registered faculty members, and of all other faculty, staff, and students approved to use controlled substances under the supervision of the registered faculty member.
The DEA and DPH require that certain records be kept by the registered faculty member. All records must be maintained for at least two years and must be kept separately from all other records (e.g., in a separate log or file). Records include:
- records of receipt, date and amount dispensed, consumptive use, and disposal, and
- an initial inventory of all controlled substances on-hand and biennial inventories on the day of the year on which the initial inventory was completed, or on a fixed inventory date that does not vary by more than six months from the biennial date, thereafter.
E. Disposal Of Controlled Substances
Controlled substances that need to be disposed of must be handled in accordance with the requirements of the DEA, 21 CFR 1307.21, which specifies procedures for obtaining approval from the DEA for destruction of the controlled substance or shipment to a pharmaceutical processing facility.
F. Institutional Oversight
The “Mount Holyoke College Policy on Alcohol and Drug-Free Environment,” was developed in part as a requirement of the Drug-Free Schools and Communities Act of 1989 and the Drug-Free Workplace Act of 1988. The policy prohibits the unlawful distribution, possession or use of controlled substances and alcohol by any member of the College community on College property or at any College-sponsored function.
In support of the policy, the College has adopted procedures for the institutional oversight of the use of controlled substances in teaching and research. The procedures are designed to accomplish the following goals: 1) assure the safety and well-being of faculty, staff and students who may use controlled substances in laboratory courses or in research projects; 2) afford additional legal protection to the College and the holders of licenses for the use of controlled substances in the unlikely event that substance abuse by faculty, staff, or students authorized by the licensee to use controlled substances should occur; and 3) comply fully with the letter and spirit of the College Policy on Alcohol and Drug-Free Environment.
The Director Environmental Health and Safety conducts an annual audit of the use of controlled substances in teaching and research. The audit will consist of 1) an inspection of the safe or locked cabinet containing the controlled substances, 2) a review of the records pertaining to the acquisition, inventory, use, and disposal of controlled substances (including those obtained without cost from, for example, federal laboratories or other investigators) and 3) a discussion of the procedures for the oversight of non-licensed personnel (other faculty, staff, students) authorized by the licensee to use controlled substances in teaching or research.
A record of the audit is kept in the files of the Office of Environmental Health and Safety along with any comments on that record from the licensee. Copies of these records are provided to the licensee and to the Dean of the Faculty and Vice President for Academic Affairs.
In addition, the registered faculty member must comply with Mount Holyoke College policies and procedures regarding animal care and welfare and protection of human subjects.