The Massachusetts Controlled Substances Registration (MCSR) research licensing system that was previously paper-based has transitioned to an online licensing system. Principal investigators (PIs) are now required to apply, renew, and amend all MCSR research licenses online through the Massachusetts Department of Public Health (MDPH) eLicensing System for all research involving controlled substances. In Massachusetts, per Title 105 CMR 700.009, this includes all prescription drug products.
Details on how this transition will be operationalized, as well as resources for PIs, can be found on the Office of Human Research Affairs webpage.
Karla Damus, PhD MSPH MN RN FAAN, who serves as BMC/BUMC’s Administrator for ClinicalTrials.gov and MCSR Research Licensure, states, “This online system is now working well and will make the process easier for PIs.” There are, however, a few issues to be aware of and for each there is an effective solution.
- For PIs renewing an existing MCSR Research License a one-time linkage of that license to the online account that the PI creates is required. This is easily done by entering the PIN# that the MDPH sent to the PI in an email entitled- ATTENTION: NEW ON-LINE MCSR APPLICATION/RENEWAL PROCESS. PIs should search their spam/junk/deleted emails for this email and if the PI did not receive this email, call the licensing HELP desk so they can look up the PI’s PIN# at 617-973-0935.
- A template of responses for some of the questions for the new and renewal license applications regarding the storage and location of the IND study drug/s is available so that the PI can just copy and paste the response to those questions as many will not know the answers without this guide.
- The only form of payment now accepted for the $150 fee is a credit or debit card or an electronic check which means the PI will need to pay and then be reimbursed by their department.
- The MDPH ended the monthly verified list of all licenses, but the PI and research administers can look up individual licenses by going to https://checkahealthlicense.mass.gov/ and the MCSR Research Licensure Administrator maintains a list of BMC/BUMC active licenses which is emailed to regulatory leaders monthly which includes Investigational Pharmacy Services (IPS).
To help promote compliance with the MA law and prevent needed licenses from expiring, PIs who need a license based on their IRB application and PIs whose license is expiring in the next 6 weeks are proactively contacted by the MCSR Research Licensure Administrator to start the application process and reminded every few weeks until the license can be verified. PIs can renew licenses up to 90 days before the expiration date and with the online system it now takes 5-10 days for a license to be issued/renewed or amended instead of the previous 2-3 weeks.
PIs and research administrators are encouraged that if they encounter any challenges using the online system or if they have any questions or need assistance to apply renew or amend an existing license, to contact the BMC/BUMC MCSR Research Licensure Administrator, Karla Damus at email@example.com, 617-358-5337.