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MA Controlled Substances Research Licenses

MA Controlled Substances Registration (MCSR) Research Licenses

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 (MCSRResearch License. This means that drug research should not commence until a MCSR Research License is obtained from the Massachusetts Department of Public Health (MDPH). In Massachusetts any drug used as an intervention in a research study is considered a controlled substance and are classified into Schedules I to VI or an investigational new drug/IND.

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 the 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 [ie 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.

Compliance with this major change in the MCSR Research License process became effective in January 2020. This requirement 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 all of their current drug studies in Q10 of the application form (those with and those without an IND), as that PI will no longer be listed under the institutional umbrella MCSR Research License.

BMC/BUMC continues to annually obtain two institutional/umbrella licenses for all the drug studies that do not have an IND. Therefore, if a PI is conducting a drug study, no matter how many non-IND drugs are being dispensed that are stored in a MA site, that PI does not have to apply for and annually renew an individual MCSR Research License. Instead the PI’s study/ies and all the non-IND study drugs being dispensed will continue to be listed under the appropriate institutional/umbrella MCSR Research License which is done by the MCSR Research License Administrator. The BMC/BUMC Office of Human Research Affairs appointed a MCSR Research Licensure Administrator Karla Damus (damusk@bu.edu; 617-358-5337) to assist the institution and all PIs conducting IND drug studies in complying with the amended law.

How to Apply for an Individual MCSR Research License

New License: If a PI needs to apply for a new individual MCSR Research License for IND-related research, the PI must gather and mail the following items to the MDPH:

·        MCSR research application form

·        Check or money order for $150 made out to “Commonwealth of Massachusetts”

·        A copy of an IRB approval letter for each human research study 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

Renewal License: MCSR Research Licenses expire in 12 months and need to be renewed annually. If a PI needs to renew their individual MCSR Research License for IND-related research, the PI must gather and mail to the MDPH the same items listed above. In the application form they will check ‘renewal’ instead of ‘new’.

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/ies can be added to the renewal application when submitted. To amend a license the same items listed above are submitted, except the ‘amend’ option is checked and there is no fee for the amendment [ie you do not submit a check with the packet].

A template application form is available to facilitate applications [new, renewal and amended] where the research drugs are kept in the BMC Investigational Pharmacy. If the research drugs are kept at a different MA site, contact the MSCR Research Licensure Administrator for assistance. 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.

It takes the MDPH 2-3 weeks to issue a new or renewal license so the packet should be mailed to the MDPH about a month before the license is needed or for a renewal is going to expire. Currently the MDPH requires that all new, renewal, and amended applications be submitted by mail; there is no electronic option at this time.

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 and annual renewals of each BMC/BUMC umbrella and individual MCSR Research License.  It will also be used to email PIs reminders about annual license renewals and if their license needs to be amended [eg the PI starts a new IND drug study during the license period). A copy of each MCSR research license obtained whether new, renewal or amended should be emailed to the MSCR Research Licensure Administrator.

Summary

The revised Massachusetts law (105 Mass. Reg. 700.009) requires that a MCSR Research License be obtained to conduct any drug studies/research and PIs conducting drug studies with an IND [no matter who holds the IND] must obtain and annually renew their own MCSR Research License.  PIs and research administrators should be aware of these 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 the MSCR Licensure Administrator or their research administrator and who will assist them with the new, renewal and if needed amendment process.

Please contact the MCSR Research Licensure Administrator Karla Damus (damusk@bu.edu; 617-358-5337)

Resources

Massachusetts law: Title 105 CMR 700.009

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

Application template for MCSR Research License [new, renewal, amend]

MCSR Licensure Administrator: Karla Damus, PhD MSPH MN RN, damusk@bu.edu, 617-358-5337