Mandatory Massachusetts Controlled Substances Registration (MCSR) Research License for ALL Drug Studies

January 2020 Issue

Author(s):

  • Karla Damus, PhD, MSPH, MN, RN, FAAN
    Administrator, BMC/BUMC ClinicalTrials.gov and MCSR Licensure

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Introduction

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 a MCSR research license is obtained from the Massachusetts Department of Public Health (MDPH).  

Until January 2020, institutions conducting drug research like BMC and BU Medical Campus (BUMC) could fulfill this requirement by submitting an annual institution-wide “umbrella” MCSR research license application to the MDPH.  This has been done at BMC/BUMC where each year, two institutional umbrella licenses have been obtained: one for the Physician in-Chief and one for the Surgeon-in-Chief.  Individual PIs were apportioned either to the surgical or the medical license, depending upon their home department, and 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 if the drug research involves an investigational new drug (IND), then each local PI has to obtain an individual MCSR research license, which requires completing and submitting their own MCSR application.  Compliance with this major change in the MCSR license process became effective in January 2020.  This new requirement will impact all PIs who are conducting drug research that has an IND, both for multi-center trials where the sponsor holds the IND and for trials where the local investigator holds the IND.  The BMC/BUMC Office of Human Research Affairs has appointed MCSR Licensure Administrator Karla Damus (damusk@bu.edu; 617-358-7382) to assist the institution in complying with the new law.

 

What will Change?

For PIs who are conducting one or more drug studies and none of the studies has an IND, the licensing process will not change.  The institution will continue to apply for and renew the institutional umbrella MCSR research license; and they and their drug study/ies will be listed in that application and covered by that umbrella license.

In contrast, for PIs who are conducting any study that has an IND, the application and renewal process will change.  Each of those PIs will need to apply for an individual MCSR research license, and their license will cover all the drug studies that the PI is conducting – even those that do not have an IND.  Those PIs and their studies will no longer be listed under the institutional umbrella MCSR license, and the annual renewal will need to be done by the PI.

Another change is that the MCSR Licensure Administrator will amend the institutional umbrella MCSR research licenses twice a year to add new non-IND studies that are IRB-approved, and to remove those studies that have been completed. 

A final change is that there will be a third institutional umbrella MCSR license for drug studies in the Goldman School of Dental Medicine which will be obtained, amended twice a year, and annually renewed by the Dental School.  The new Dental School umbrella MCSR license only covers PIs whose drug studies do not have an IND.  PIs in the Dental School who are conducting any study that has an IND, will be required to obtain an individual MCSR research license; and those PIs and their studies will not be listed on the umbrella Dental School MCSR research license.

 

When will changes occur?

Ongoing studies with an IND:  Since 2020 is a year of transition when the amended law is enacted, some of the changes will go into effect when the current umbrella licenses expire (i.e., in May 2020 for the Physician-in-Chief’s license, and August 2020 for the Surgeon-in-Chief’s license).  Therefore, if a PI has at least one ongoing drug study with an IND, they will need to apply for an individual MCSR research license before those respective expiration dates so that their research can continue without interruption as they will no longer be listed on the next umbrella license. Those PIs will be contacted a few months before the expiration dates by the MCSR Licensure Administrator, who will assist them with the individual MCSR research license application. 

New studies with an IND:   Effective now (January 2020), any new drug study with an IND will require an individual MCSR research license.  The PI should as soon as possible contact the MSCR Licensure Administrator, who will assist them with the individual MCSR research license application.

 

How to Apply for an Individual MCSR Research License

To apply for an individual MCSR research license for IND-related research, the PI must gather and submit the following items to the MDPH:

  • MCSR research application form
  • Check for $150 made out to “Commonwealth of Massachusetts”
  • A copy of an IRB approval letter for all human research that involves a drug (both IND and non-IND studies)
  • A copy of an FDA Form 1572 for all human research that involves an IND
  • A copy of the PI’s current DEA Researcher Registration if applying for Schedules II-V.  If a new DEA Researcher Registration application is needed for a Schedule I drug, the DEA Boston office should be contacted at (617) 557-2100

A researcher may include multiple research projects or studies in a single application, listing all INDs and any other drug studies that the PI is conducting. A template application form is available to facilitate applications where the research drugs are kept in the BMC Investigational Pharmacy (contact your research administrator or the MSCR Licensure Administrator).  The PI should check with their department or section/division research administrator for reimbursement of the $150 application and annual renewal fee.

 

BMC/BU Medical Campus MCSR Research License Tracking System

To ensure compliance with the amended law, the MCSR Licensure Administrator has created a tracking system to monitor applications, amendments, and annual renewals of each BMC/BUMC umbrella and individual MCSR research licenses.  It will also be used to email PIs reminders about annual license renewals and any amendments.  A copy of each MCSR research license must be emailed to the MSCR Licensure Administrator.

 

Summary

The Massachusetts law that requires a MCSR research license to be obtained in order to conduct any drug studies/research has recently changed. PIs and research administrators should be aware of the changes which mainly impact drug research with an IND. Effective January 2020, if a PI is conducting any drug study that has an IND, then they will need to obtain an individual MCSR research license, which may take 2 to 3 weeks to process after the application is received by the MDPH. If the PI only conducts drug research that does not have an IND, then the institutional umbrella MCSR research license will cover the research as it has done in the past. To facilitate these changes, PIs should contact their research administrator and the MSCR Licensure Administrator who will assist them with the application, amendment, and renewal process..

 

Resources

MCSR Licensure Administrator: Karla Damus, PhD MSPH MN RN, damusk@bu.edu, 617-358-7382

MCSR website for license application: https://www.mass.gov/how-to/apply-for-or-renew-a-podiatrist-optometrist-researcher-or-veterinarian-mcsr

Massachusetts law: Title 105 CMR 700.009 

Template application form: http://www.bumc.bu.edu/irb/files/2020/01/MCSR-Application-Template.doc

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