MA Controlled Substances Registration (MCSR) Research Licenses

In 2023, the MCSR Research licensing system transitioned to an online licensing system which means that 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. The online licensing system will add convenience as no documents will be mailed or delivered to the MDPH, payment will be made online by credit/debit card or ACH/electronic check, and verification of a license can be done at any time. The first time a PI accesses the system they will need to create an account. PIs should save their username and password for future reference and to log into the system at any time. 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.

Background

In Massachusetts any drug used as an intervention in a research study is considered a controlled substance and is classified into Schedules I to VI or as an investigational new drug/IND. The Massachusetts law, Title 105 CMR 700.009, requires that every principal investigator (PI) who is conducting research involving any drug must be covered by a Massachusetts Controlled Substances Registration (MCSR) Research License. This means that drug research should not commence until the PI has an active MCSR Research License from the MDPH.

Until January 2020, institutions conducting drug research including BMC and BUMC could fulfill this requirement by obtaining and annually renewing institution-wide “umbrella” MCSR research licenses. There was one for the Physician in-Chief and one for the Surgeon-in-Chief and Individual PIs were apportioned either to the surgical or the medical MCSR Research License, depending upon their home department so their study was covered by the respective license until the research was completed. Hence, individual PIs did not have to apply for nor annually renew their MCSR research license. However, in late 2018, the law was amended to require that each PI 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]

*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.

The legal requirement to have an active individual MCSR Research License impacts all PIs who are conducting drug research that has an IND, whether part of a multi-center trials where the sponsor, pharmaceutical company or other PI holds the IND and for trials where the local investigator holds the IND. And when the PI applies for an individual MCSR Research License, they must list the drugs being dispensed to participants from all of their current drug studies in the application form (those with and those without an IND), as that PI will no longer be listed under the institutional/umbrella MCSR Research Licenses which are still obtained annually for drug studies that do not have an IND.

How to Apply for an Individual MCSR Research License Online

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 PI already has a MCSR Research license, a letter that contains a PIN# will be mailed to the PI’s mailing address of record and they will use that PIN# to link their MCSR license to the online account. If the MDPH did not mail the PI a letter but they have a MCSR Research license, then call the Help Desk at 617-973-0935 and they will 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 categories 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 no longer has 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 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.

    BMC/BU Medical Campus MCSR Research License Tracking System

    To ensure compliance with the amended law, the OHRA created and maintains a tracking system to monitor active and annual renewals of each BMC/BUMC umbrella and individual MCSR Research Licenses. It is also used to email PIs reminders about annual license renewals [with the online system renewal forms will no longer be mailed to PIs by the MDPH] and if their license needs to be amended (e.g. if the PI starts a new IND drug study during the license period). To ensure that there is compliance with the MA law, each PI should email: the date that their license is issued or renewed, and their license number/registration #, to the MSCR Research Licensure Administrator (damusk@bu.edu).

    Summary

    All PIs that are conducting a drug study, that has an IND with the study drugs stored in MA, need to use the fully online system to apply for, renew or amend their MSCR Research Licenses. The Investigational Pharmacy Services (IPS) cannot dispense any IND study drugs unless the PI of the study has an active MCSR Research License so it is important 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 process. 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.

    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

    • Massachusetts law: Title 105 CMR 700.009
    • https://www.mass.gov/how-to/apply-for-or-renew-a-cdtm-pharmacist-aprn-optometrist-physician-assistant-podiatrist-researcher-or-veterinarian-mcsr
    • Health Professions Licensing System User Guidehttps://www.mass.gov/info-details/health-professions-licensing-system-user-guide
    • Health Professions Licensing Portalhttps://healthprofessionlicensing.mass.gov/login-register
    • HELP Desk at helpdesk@MassMail.state.ma.us or 617-973-0935
    • DPH Check a License https://checkahealthlicense.mass.gov/
    • MCSR Licensure Administrator*: Karla Damus, PhD MSPH MN BSN RN, damusk@bu.edu, 617-358-5337