MA Controlled Substances Registration (MCSR) Research Licenses

Background

In Massachusetts any drug used as an intervention in a research study is considered a controlled substance. Each study drug is classified into Schedules I to VI or as an investigational new drug (IND) under an Investigational New Drug application.  Massachusetts law, Title 105 CMR 700.009, requires that every principal investigator (PI) who is conducting research involving one of more drugs must be covered by a Massachusetts Controlled Substances Registration (MCSR) Research License.

Beginning in 2018, this MA law requires that each PI has to obtain their own individual MCSR Research License if both of these conditions are met:

  1. the drug research involves an investigational new drug (IND) [no matter who holds the IND- whether the PI, another PI, the sponsor, or a pharmaceutical company], and
  2. the IND drug is stored at a site in MA*[e.g. in the BMC Investigational Pharmacy Services/IPS, in Radiology, in the research office, or even at another institution.

*Note If the IND drug is sent directly to participants and not stored in MA, the PI does not have to obtain an individual MCSR Research License.

This is an annual license and must be renewed each year that the study drug is being dispensed to participants. For study drugs that meet the criteria for IND exemption, this MA law also allows institutions conducting drug research to fulfill this requirement by obtaining and annually renewing institution-wide “umbrella” MCSR research licenses. Therefore, PIs that only conduct research with study drugs under IND exemptions can be covered under the appropriate institutional umbrella license. The only exception to the use of the “umbrella license” is that the PI of any study using a Schedule I, II or III drug will also need to obtain an individual MCSR Research License, even if the use of the drug meets the criteria for IND exemption.

BMC/BU Medical Campus MCSR Research License Compliance System

Compliance with the MA law begins with the PI accurately completing the ‘Drugs or Biological Agents Information’ section in the IRB application.  Particular attention needs to be paid to the two recently added fields for: 1) drug schedule, and 2) the drug storage location.  The Office of Human Research Affairs (OHRA) also maintains a tracking system to monitor active and annual renewals of each BMC/BUMC umbrella and individual MCSR Research Licenses. PIs are emailed reminders about annual license renewals and if their license needs to be amended (e.g. if the PI starts a new IND drug study during the license period – see below for more detailed information about requirements for amending an active license).

How to Apply for an Individual MCSR Research License

PIs who are required to have a MCSR Research license must apply, renew, and amend all licenses online through the Massachusetts Department of Public Health (MDPH) eLicensing System. Instructions on how to do this are summarized below with step by step instructions also provided at this MDPH website.

  1. Create an account The first time a PI uses the online system to apply for a new MCSR Research License, renew an existing license for another year, or amend an existing license they will need to create an account. To create an account:
    • go to https://HealthProfessionLicensing.mass.gov and select ‘create an account’
    • fill in the required fields and create a password [at least 10 characters with a lower and upper case character and a number]
    • verify the email address by entering the verification code that will be emailed to the PI

An account will be created and in the future the PI can just ‘log in’ to use the system with their username and password. Consult the Health Professions Licensing System User Guide  to reset the password, update profile information, and read notifications.

  1. Link any previous professional license to the created account
    • Log into the system and select the “Link License to My Account” button and provide information for the subsequent screens that will appear.

If the system requests a PIN#, the PI should  call the Help Desk at 617-973-0935 as they can look up the PIN#.  Linking any previous license with the created account will only need to be done once.

New License: If the PI needs to apply for a new, individual MCSR Research License for IND-related research, they will need to gather the following items to answer the questions and enter the information into the online application form:

  • Massachusetts Board of Registration License Number
  • DEA Federal Controlled Substance Registration Number (if possessed)
  • Business Address (Under the applicable law and regulations, the address used for the MCSR license must be the PI’s principal place of business or professional practice).
  • Primary telephone number
  • Primary email address
  • Social Security number (Required by M.G.L. c. 30A, s. 13A)
  • The names of all study IND/s being dispensed and the names and schedules for all non-IND drugs being dispensed in the PI’s current research studies

Contact the MCSR Licensure Administrator/damusk@bu.edu  for a template with suggested responses that the PI can copy and paste to the provide information about:

    • The source of the IND/s
    • The purpose of the IND/s
    • How the IND/s will be secured
    • The exact location of the IND/s
    • Constructions of storage area
    • Accountability system

The PI will also have to attest to having access to the IRB approval letter and to the form 1572 for the IND study drug/s but the PI does not have to upload these documents during the application process.

In addition to completing the application form online, an application fee of $150 payable by credit or debit card or an electronic check will need to be entered online.

Renewal License: MCSR Research Licenses expire in 12 months and need to be renewed annually. In the online system the license can be renewed up to 90 days before the expiration date. To renew an individual MCSR Research License for IND-related research, the PI must gather the same items listed above, log into their created account and follow the instructions, upload required attachments, and submit payment for the renewal fee of $150. The PI will receive an email renewal notice per their MCSR’s renewal cycle with guidance on renewing the MCSR Research License in the online licensing system.

Amended License: If a PI starts another drug study with an IND while their license is current, they need to amend their license as soon as possible.  A license can be amended as many times as needed during the year. The license does not need to be amended if the PI starts a non-IND drug study during the license period. Instead that non-IND study drug/s can be added to the annual renewal application when submitted. To amend a license the same process is followed for a new or renewal license except there is no fee to amend the license.

Processing may take between 5-10 business days from the receipt of the completed application to issuing a new, renewal, or amended MCSR Research License. If a PI or system user encounters a problem or has any questions they can email MCSR@Massmail.State.MA.US  or during weekdays from 9a to 5p they can contact the eLicensing Support Help Desk at 617-973-0935 or the MCSR Board at 617-973-0949.  They can also contact the BMC/BUMC MCSR Research Licensure Administrator, Karla Damus at damusk@bu.edu or at 617 358 5337.

Summary

At BMC/BUMC, every PI conducting a study with a drug(s) has to be covered by a MCSR Research License. If the drug is not an IND nor Schedule I-III, they will usually be covered by the appropriate institutional umbrella license. However, if the study drug is used under an IND and it is stored in MA, or if the study drug is Schedule I, II, or III, then the PI must obtain an individual MCSR Research license.  Although uncommon, it is also possible that a PI may need more than one MCSR License which should be discussed with the BMC/BUMC MCSR Research Licensure Administrator.

The Investigational Pharmacy Services (IPS) cannot dispense any IND study drugs unless the PI of the study has an active MCSR Research License, and therefore it is imperative to apply for and renew the licenses before the expiration date through the online licensing system. A MCSR Research License can be renewed up to 90 days before the expiration date and should be renewed at least 3 weeks before the expiration date as it takes 5-10 days for the renewal license to be issued by the MDPH. There are many resources to assist PIs with the licensing, renewal and amendment processes. Investigators are encouraged to contact the BMC/BUMC MCSR Research Licensure Administrator or the MDPH Help Desk if they need assistance.

 Assistance and Training

The Health Professions Licensing System User Guide provides detailed step by step instructions for the online MDPH Health Professions Licensing System. Several tutorials have also been created to assist online system users.

The PI should check with their department or section/division research administrator for reimbursement of the $150 application fee required for new and renewal license applications. There is no fee to amend a license when needed.

For any MCSR Research License questions, assistance with the application process, or to schedule an individual or group MCSR training at BMC/BUMC, please contact the MCSR Research Licensure Administrator Karla Damus (damusk@bu.edu, 617-358-5337).

Resources

updated 6/4/2025