Controlled Substance Regulation
Controlled substances are regulated by the Commonwealth of Massachusetts under Massachusetts General Laws and regulations 105 CMR 700. 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
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.
Last Revised 8/17/10