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. 

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 1301.90and 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.

Transfer

A researcher with an active DEA license may transfer small amounts of their CS inventory to another licensed researcher.  The transfer must be recorded in both licencee's records and include: Name, address, DEA and MA license #s of receiver; name, address, DEA and MA license numbers of the supplier; name, concentration, quantity and Lot # of the CS transferred; transfer date.  A DEA 222 order form must also be completed for transferring Schedule I or II agents.  The receiver submits copies 1 and 2 of Form 222 to the supplier, the supplier submits copy 2 to the DEA, and the receiver completes copy 3.

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/State of Massachusetts Requirements

DEA Practioner's Guide