Registration with the Massachusetts Department of Public Health’s Drug Control Program is required if you are going to use a Controlled Substance, Schedule I – VI, as defined under 105 Code of Massachusetts Regulations 700.002 (A-F). The registration fee is $150, and the license must be renewed annually. The registration fee is subject to change. Therefore, to prevent any delays, check with the Massachusetts Department of Public Health’s Drug Control Program for the current fee. The approximate turn around time for the registration process is between two and four weeks. Licenses are not granted automatically with the payment of the fee. In general, the applicant must be able to demonstrate a need for the Controlled Substance to conduct their business. Additionally, an applicant must demonstrate an internal control system that will account for usage control, secure access (storage under lock & key in the case of narcotics) and personnel training. Applicants’ facilities are subject to inspection by authorities. There are further requirements that must be fulfilled before licensure is permitted, and licenses can be suspended or revoked from a facility.

The Massachusetts Department of Public Health’s Drug Control Program is also the licensing authority for the possession of hypodermic needles. A license is required for both the possession with intent to use and the possession with intent to sell hypodermic needles. The rules and regulations governing the possession of hypodermic needles can be found in the General Laws of the Commonwealth of Massachusetts under Part I (Administration of the Government), Title XV (Regulation of Trade), Chapter 94C (Controlled Substances Act), Section 27 (Instruments for Administering Controlled Substances by Injection). These rules and regulations stipulate the applicant must be able to demonstrate a need for hypodermic needles to conduct their business. The licensing fee is $60.00 for a new license or annual renewal. The application is two pages, and it may require supporting documentation be simultaneously submitted. The application turn-around time is estimated to be 10 working days.

In the process of registering with the Massachusetts Department of Public Health’s Drug Control Program for using a Scheduled I – VI Controlled Substance for research purposes, it may not be necessary to apply for a Hypodermic Needle license. The agency most likely will assume you will be using hypodermic needles. However, this does not apply if you are a facility that is seeking to sell or distribute hypodermic needles in your business operations. Additionally, as time progresses and operations expand, a Hypodermic Needle License may be required in addition to your Controlled Substance registration. You should check with the Massachusetts Department of Public Health’s Drug Control upon annual renewal of your Controlled Substance registration for guidance.

Controlled Substance Registration

Hypodermic Needle License

305 South Street, 2nd Floor
Jamaica Plain, MA 02130
Telephone (617) 983-6717
Fax (617) 524-8062

Yes. In general, any prescription drug is classified as a Controlled Substance, and any drug without an abuse potential is classified as a Schedule VI Controlled Substance.

2) Are research technicians that are using Controlled Substances for bench-top research purposes and not dispensing Controlled Substances required to be listed in registration application?

Yes, they should be listed in Section 13 of the Application for Massachusetts Controlled Substances Registration to Use Controlled Substances and Investigational New Drugs in Research in Accordance with the Controlled Substances Act, M.G.L. Chapter 94C.

3) Am I required to register at the federal level with the United States Department of Justice’s Drug Enforcement Agency in addition to registering with the Commonwealth of Massachusetts Department of Public Health?

Registration with the United States Department of Justice’s Drug Enforcement Agency will be required of Principle Investigators who are not medical practitioners. A medical practitioner will hold one of the following degrees: Medical Doctor (M.D.), Doctor of Medical Dentistry (D.M.D.), Doctorate in Dental Surgery (D.D.S.), Doctor Veterinarian Medicine (D.V.M.), Veterinarian Medical Doctor (V.D.M.), Doctor of Osteopathy (D.O.) or Doctorate of Podiatric Medicine (D.P.M.).

4) As a start-up company, can I order a Controlled Substance, Schedule I – VI, from a vendor without registering with the Massachusetts Department of Public Health, Division of Food and Drugs, Drug Control Program?

No

5) How do I know when I have successfully been registered to possess a Controlled Substance in the state of Massachusetts?

You will receive a Certificate of Registration from the Massachusetts Department of Public Health, Division of Food and Drugs, Drug Control Program.

6) Am I required to get a license if I am not going to use the hypodermic needles with Controlled Substances?

Yes

7) Am I required to get a license if I am not going to use the hypodermic needles on human subjects?

Yes. This Hypodermic Needle License will specify that use on human subjects is not permitted.

8) Can I purchase a hypodermic needle for research purposes from a vendor without being licensed to possess hypodermic needles?

No; the vendor is supposed to ask for copy of your license.

9) Should I permit another business to give my business hypodermic needles without my business possessing a hypodermic needle license?

No

10) May my business manufacture hypodermic needles and sell or distribute them without a license?

No

United States Department of Justice, Drug Enforcement Agency Drug Scheduling
(Schedule VI Agents are not listed here but are understood to be all other prescription pharmaceuticals and investigational new drugs.)

Applications for Controlled Substances for various Occupations and Facilities

Application for License to Sell and/or Obtain Hypodermic Needles

Code of Massachusetts Regulations regarding Controlled Substances

Massachusetts General Law governing the use, sale and distribution of hypodermic needles