Controlled Substances

Use of controlled substances (CS) and listed chemicals is regulated by federal and state law. Lists of Controlled Substances can be found on the U.S. Department of Justice DEA's web site and in Massachusetts General Laws Part 1, Title XV, Chap. 94C, section 31. Controlled substances on Schedules I and II include addictive street drugs like heroin and cocaine as well as pentobarbital and are the most strictly regulated. Schedule III compounds include some stimulants and depressants, pain killers, and many anesthetics and analgesics. Schedule IV substances include stimulants and depressants with lower abuse potential. Schedule V lists therapeutic drug mixtures containing very limited quantities of Controlled Substances. Each CS has a specific drug code. Schedule VI Controlled Substances under Massachusetts law include all prescription drugs. A registration requirement has been waived in Massachusetts for purchases of hypodermic needles and syringes.

An investigator must obtain both a DEA registration (DEA license) number and a Massachusetts Department of Public Health Controlled Substances Registration (MA license) number in order to acquire, make, possess or use a Controlled Substance in Massachusetts. The DEA Form requires a Massachusetts DPH registration number so you will need to complete state registration procedure first.

DEA Practioner's Guide

Delivery and Storage

Shipments of controlled substances must be delivered directly to the registrant for storage at the address listed on the registration. Both the DEA, 21 CFR 1301.71, and DPH, 105 CMR 700.005, establish requirements for security of controlled substances. Refer to the regulations for details but note that controlled substances must be stored in a “securely locked, substantially constructed cabinet” located in a room that is locked when not occupied. A controlled substance must be stored at the storage location on the registrations which must be amended before the storage location can be changed. However, it is legal to transport a CS to a different location for use provided the use is within the scope of the licensee's employment, and provided left-over CS is returned promptly to the registered storage location after use.

Personnel Security Requirements

In addition to the screening that is part of licensing and registration for licensees, other users working with controlled substances under the authorization of a license holder must be screened. At a minimum, the authorized user must answer two specific written questions (CFR 1301.90) and a record of the answers must be kept by the licensee.

Record Keeping

Each license holder must maintain an active inventory log that includes: initial inventory, biennial inventory, daily use logs, receipt/disposal records. 21 CFR §1304 requires that records for Schedules I and II controlled substances be maintained separately from all other records, and that records for Schedules III, IV and V substances be maintained either separately from other records, or in such form that the information required is readily retrievable.

Disposal

It is illegal to dispose of a CS in the trash or down a sink. When you have no further legitimate use or need for a CS, or if a CS purchased for use with animals has expired, contact EH&S (5-2682) or the Office of Research Compliance (5-0668) to arrange for safe and legal disposal. When destruction is complete you will receive a copy of the destruction records.

Loss or Theft

You are responsible for reporting significant loss, theft or diversion of a CS under your registration immediately to the MA DEA office (888 272-5174), to the UMass Office of Compliance, and to the UMass Police Department so that a formal investigation can be started. DEA Form 106: Theft or Loss of Controlled Substances (available to license holders) must be used to report the loss or theft to the DEA. The DEA website has guidance on using Form 106. The DEA stresses that minor inventory discrepancies not attributable to theft need not be reported to DEA. However, DEA considers a continuing pattern of loss of small quantities significant.

List 1 Chemicals

Precursor chemicals and List I Chemicals are chemicals that, in addition to legitimate uses, have the potential to be used in the manufacture of controlled substances. While it is necessary to have a MA and DEA registration to order precursor chemicals, storage, tracking inventory, and disposal requirements once the item has been purchased are less stringent. State and federal laws require vendors to comply with the regulations regarding distribution of these chemicals.

Procurement of Controlled Substances - Exerpt from Massachusetts System Purchasing Manual

Controlled substances are regulated by the Commonwealth of Massachusetts under Massachusetts General Laws and regulations 105 CMR 700(link is external). Any researcher who purchases one or more controlled substances referenced in the law including hypodermic syringes and/or needles or prescription drugs must be licensed. See the following university policy "Purchase of Controlled Substances Including Hypodermic Syringes and Needles" for licensing and purchasing requirements.

Excerpt from University of Massachusetts System Purchasing Manual

Date: 07/01/94

Page: 2.24.1 Amherst

Subject: Purchase of Controlled Substances, Including Hypodermic Syringes & Needles

Pursuant to Massachusetts General Laws, Chapter 94C, Section 27, and Commonwealth of Massachusetts Regulations 105 CMR 700, any researcher instructor who purchases one or more controlled substances as referenced in the law, including, but not necessarily limited to, hypodermic syringes and/or needles* or prescription drugs, for any purpose from any vendor, must be licensed by the Commonwealth of Massachusetts, Department of Public Health.
(Note: Under the law, hypodermic syringes and needles are a Schedule VI Controlled Substance. In addition, only state hospitals are exempt from paying the licensing fee.)*
- If the intended purpose of the purchase does not involve the administration of prescription drugs, the appropriate license is the one entitled, "Application for License to Obtain, Receive or Purchase Hypodermic Syringes, Needles or any Instrument Adapted for the Administration of Controlled Substances by Injection."*
- If the intended purpose of the purchase involved prescription drugs, no matter how administered, the appropriate license is the one entitled, "Application for Registration under the Controlled Substances Act."
Furthermore, each researcher/instructor who so purchases a controlled substance shall maintain a perpetual inventory, in a bound ledger (not loose leaf), consisting of the purchase order number, the name of the licensed researcher/instructor, the purchase order date, the quantity received, the quantity and date issued, and the intended purpose. Said ledger shall be maintained in the department office and shall be provided to state inspectors upon request.
Blanket and Term Contract orders shall not be used to order controlled substances. Only line-term specific purchase orders are appropriate. Each such purchase order shall reference the researcher/instructor's registration number, as issued by the Commonwealth of Massachusetts, Department of Public Health.
Application forms may be obtained from, and questions should be referred to, the Division of Food and Drugs, at the address and telephone number listed below. The name of our current contact is Ann O'Brien.
License fees may be paid out of non-appropriated (non-state) department funds. Purchase Orders/Requests should be addressed as follows:
Commonwealth of Massachusetts
Dept. of Public Health, Div. of Food and Drugs
Controlled Substances, Registration Program
305 South Street
Jamaica Plains, MA 02130
Vendor Code: V 997 035 052 0; Object Code 3560
Telephone: (617) 983-6717
Contact: Ann O'Brien
The completed application form should be attached to the purchase order and processed through the Procurement Department.
Controlled substances shall be kept in a locked, secured location.
The end users shall dispose of all controlled substances in accordance with the law.

* Please note that this portion of the University of Massachusetts Purchasing Manual is under revision. On September 18, 2006 Massachusetts enacted a law which made it legal for anyone over the age of 18 to purchase needles and syringes. For more details see the Purchase and Sale of Needles and Syringes(link is external).Guidance

Controlled Substances

Excerpt from University of Massachusetts System Purchasing Manual

Date: 07/01/94

Page: 2.24.1 Amherst

Subject: Purchase of Controlled Substances, Including Hypodermic Syringes & Needles

Research Administration and Compliance

Research and Engagement

Excerpt from University of Massachusetts System Purchasing Manual

Date: 07/01/94

Page: 2.24.1 Amherst

Subject: Purchase of Controlled Substances, Including Hypodermic Syringes & Needles

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