A Massachusetts Controlled Substances Registration (MCSR) is required by Massachusetts General Laws Chapter 94C, section 7 in order to manufacture, distribute, prescribe, dispense, administer or possess a controlled substance.

The Drug Control Program furnishes a copy of your registration to the U.S. Drug Enforcement Administration (DEA). The DEA issues a registration number which must be used on all prescriptions for federally controlled substances (Schedules II-V) and when ordering stock of these medications for immediate treatment. During the period in which you hold only your Massachusetts Controlled Substances Registration, you may conduct approved activities only with Schedule VI controlled substances. You must obtain both your DEA number and Massachusetts number in order to conduct approved activities with controlled substances in Schedules II through V.

The following questions and answers will clarify the requirements of the registration process.

Q: Why do I need a Massachusetts Controlled Substances registration?
A:
In order to provide accountability for controlled substances, Massachusetts General Laws, Chapter 94C, section 7 and regulations of the Department of Public Health at 105 CMR 700.004 require every person who manufacturers, distributes, prescribes, administers, dispenses or possesses controlled substances to be registered with both the Department of Public Health and DEA if they utilize controlled Substances in Schedules II-V. In addition, Massachusetts law recognizes as controlled substances those prescription drugs that are not federally scheduled (Schedule VI). Practitioners who only plan to manufacture, distribute, dispense, prescribe, administer or possess Schedule VI drugs, need only obtain a Massachusetts Controlled Substances registration. Well over half of the states in the country require a state controlled substances registration in addition to a DEA registration. In these cases, the DEA will not issue a registration until the practitioner has obtained a valid state controlled substances registration.

Q: What documents must I include with my application?
A:
To ensure that your application is processed promptly, all questions on the application must be filled out in their entirety. In addition, you must include the following:

  • A check or money order in the amount of $150 made payable to the Commonwealth of Massachusetts.
  • A copy of your current practitioner license. Without this information, your application cannot be processed and it will be returned to you. The license must bear an expiration date. A letter from the Board of Registration certifying this license (known as a "verbatim copy") is also acceptable.

Q: What address should I include on my application?
A:
Your Massachusetts business address must be listed on the front of the application. Use of an out-of-state address must be accompanied with a letter of explanation. Use of your home address is not permitted unless you also maintain an office practice at that address. The business address must be a street address, not a post office box. Please be sure the address is complete (for a hospital address, for example, list the department name as well as the name of the hospital and the street address). If you wish to have the registration mailed to a different address, please note this fact on the application or in a separate letter. It is often advisable, for example, to have your registration mailed to your home if you have not yet begun work at the business address.

Q: What constitutes Amended information?
A:
Check off amended information for any change to your previously submitted application. There is no fee charged for amended information.

Q: How many MCSRs do I need?
A:
Most practitioners will need to register only their primary place of business. A second registration is only required if the practitioner stores stock or sample controlled substances at a second location as well. Therefore, working at more than one address does not necessarily require an additional registration.

Q: For which drug schedules should I request approval?
A:
Unless there is a restriction on the practitioner license, practitioners may request Schedules II through VI. Please contact us if you require additional information on these schedules.

Q: What is Schedule VI?
A:
Schedule VI drugs consists of all prescription drugs, which are not included in Schedules II -V. This is a special Massachusetts schedule (MGL 94C, 105CMR720.002).

Q: When will my MCSR expire?
A:
In most cases, the registration certificate you will receive will not show an expiration date. Until you receive a recall notice from the Department, your registration is valid as long as you maintain continuous practice in this state. This occurs approximately every three years at which time you must respond to the recall notice in order to maintain your registration.

Q: What if I have a limited license?
A:
If you are applying with a limited practitioner license, your registration will expire when the limited license expires. You must reapply to the Department with another fee payment when you receive your permanent license, and you will receive a new registration number.

Q: What if I change my business address?
A:
If you change your business address in the future, you are required to notify the Department in writing. A copy of your Massachusetts practitioner license must be included along with this notification. No fee payment is required for an address change. A revised registration will be issued showing the new address; however, your registration number will remain the same. A change of name requires the same procedure; the practitioner license must bear the new name.

Q: How long will it take to receive my MCSR?
A:
You should receive your registration within four to six weeks after DCP receives a completed and correct application package.

If you have questions, you may call the Drug Control Program at 617 983-6700. For questions about DEA requirements and applications, please go to the DEA, Office of Diversion Control web site at www.deadiversion.usdoj.gov.

 


This information is provided by the Drug Control Program within the Department of Public Health.