CONTROLLED SUBSTANCES REGISTRATION
Any individual who plans to or is using Schedule I-V Controlled Substances in non-human research must obtain a researcher registration from both the Department of Public Health (Massachusetts Controlled Substance Registration (MCSR)) and the US Drug Enforcement Administration (DEA). A researcher registration is required in addition to any clinical registrations you may hold. Separate registrations are required for Schedule I and Schedule II-V Controlled Substances.
Additionally, the state of Massachusetts recognizes prescription drugs that are not federally scheduled (Schedule VI) as controlled substances. Researchers who only plan to or are using Schedule VI drugs only need to get an MCSR (and not a DEA number).
UPDATED REGISTRATION REQUIREMENTS
Registrations for both the DPH and DEA are submitted online. In addition, applicants are now required to submit copies of the IRB or IACUC approval letters(s) for INDs and scheduled drugs, as applicable. PIs will be required to submit Form FDA 1572 with the Researchers MCSR application for each IND.
Researcher registrations must be renewed annually. Researchers are responsible for ensuring that DPH and DEA researcher registrations are updated and current. The registrant will also be required to register in the MGB Controlled Substance system, iLog.
Registrants will receive automated emails regarding their approvals with a copy of the DEA certificate. If you did not receive the email, you may obtain a duplicate here.
Contact Research Compliance if you require assistance with state or federal registration applications, are applying for Schedule I controlled substances, need help determining the schedule designation of a controlled substance, or have any questions about security, storage, and access to controlled substances. Research Compliance must be present for all DEA interviews.
AUTHORIZED USERS
The Registrant has ultimate responsibility for ensuring proper acquisition, use, storage, and accountability of controlled substances; however, the Registrant may authorize members of his or her laboratory to work with controlled substances by including those individuals on their DPH and DEA registration applications. An Authorized User must have a reporting relationship, funding relationship, or have a protocol in common with the Registrant. For purposes of DEA and DPH Compliance, Authorized Users must be documented on the Authorized Users Log in the Controlled Substances Accountability Logbook. All Authorized Users must be a current Mass General Brigham institution employee or sponsored staff with a valid institution badge.