CONTROLLED SUBSTANCES FREQUENTLY ASKED QUESTIONS
HUMAN SUBJECT RESEARCH – IND
RCR training is required of all trainees, postdoctoral fellows, students and career-development recipients supported by training grants (e.g., T32, F32, all K-awards) identified in the NIH notice dated November 24, 2009; and NSF training and research grant supported students and postdoctoral fellows as identified in the Federal Register notice dated August 20, 2009.
Any human subject research project or study involving a research drug must have a Researcher MCSR. A research drug is defined as an Investigational New Drug (IND) or the investigational use of a scheduled drug in a research study or program where the drug is administered or dispensed. If the drug is covered by an Investigational New Drug application, it is considered an investigational new drug. A scheduled drug/ controlled substance includes narcotics and all prescription drugs. A research drug includes all drugs that are part of a specific research protocol and not just the specific research drug(s) being studied.
The PI of a protocol using an IND must hold the Researcher MCSR for the protocol.
Any IND used in a human subject research project or study in Massachusetts must be covered by a Researcher MCSR. It does not matter whether you, a sponsor/funder, or the primary site investigator or third party holds the IND.
Yes. Within Massachusetts, each IND used in a human subject research project or study at a Massachusetts site must be covered by a Researcher MCSR specific to that site. If you are the PI of the protocol at your hospital, you must have a Researcher MCSR that covers every IND used in the protocol. If you are PI on multiple protocols, you are not required to hold a separate MCSR for each project or study. You may include multiple INDs on the same MCSR.
No. Only the PI is required to hold the registration for an IND used on a particular protocol at a specific site. On the application, the PI lists all individuals (i.e., authorized users) who will have access to the controlled substance. The identified individuals will be authorized to use that substance for the protocols included on the registration.
Only individuals conducting research under the protocol at the PI’s institution may be included on the PI’s Researcher MCSR application. Investigators at other institutions in Massachusetts conducting the same research with the same investigational new drug must obtain their own Researcher MCSR. Investigators outside of Massachusetts should consult their institutions to see what is required by their home state.
A single Researcher MCSR application may include multiple research projects or studies and multiple research drugs (both scheduled drugs and investigational new drugs) if the research drugs included in the application are all stored in one location and all required information for each protocol is included in the application.
- Completed and signed Application
- IRB approval letter for each protocol
- Statement of Investigator, Form FDA 1572
- Fee
If your Researcher MCSR expires while DPH is still processing the application for renewal, the covered individuals can still administer/dispense the investigational new drug pending receipt of the renewal certificate, as long as the renewal application was filed prior to the expiration date of the previous registration and you have documentation of the submission.
HUMAN SUBJECT RESEARCH – SCHEDULED DRUGS AND CONTROLLED SUBSTANCES
RCR training is required of all trainees, postdoctoral fellows, students and career-development recipients supported by training grants (e.g., T32, F32, all K-awards) identified in the NIH notice dated November 24, 2009; and NSF training and research grant supported students and postdoctoral fellows as identified in the Federal Register notice dated August 20, 2009.
Any human subject research project or study involving a research drug. A research drug is an investigational new drug (IND) or the investigational use of any scheduled drug in a research study or program where it will be administered or dispensed. If the drug you are using in your study is covered by an investigational new drug application, then you are using an IND. A scheduled drug/ controlled substance includes narcotics and all prescription drugs. A research drug includes all drugs that are part of a specific research protocol and not just the specific research drug(s) being studied.
The PI or the PI’s direct supervisor, department chair or chief academic officer can hold the Researcher MCSR for Schedules II-VI. All Schedule I MCSRs must be held by the PI. If the research drugs are stored at your hospital’s Clinical Research Pharmacy, the research drug can be included on the Department Head’s registration. If the research drugs are stored elsewhere, then the PI must hold the registration.
A Researcher MCSR can cover multiple research projects or studies and multiple research drugs (both scheduled drugs and investigational new drugs) in a single application if the research drugs included in that application are all stored in one location and all required information for each protocol is included in the application.
- Completed and signed Application
- IRB approval letter for each protocol
- Fee
If your Researcher MCSR expires while DPH is still processing the application for renewal, the covered individuals can still administer/dispense the research drug pending receipt of the renewal certificate, as long as the renewal application was filed prior to the expiration date of the previous registration, and you have documentation of the submission.
ANIMAL RESEARCH
RCR training is required of all trainees, postdoctoral fellows, students and career-development recipients supported by training grants (e.g., T32, F32, all K-awards) identified in the NIH notice dated November 24, 2009; and NSF training and research grant supported students and postdoctoral fellows as identified in the Federal Register notice dated August 20, 2009.
Any animal research project or study involving any research drug. A research drug is the investigational use of a scheduled drug (controlled substance) in a research study or program where it will be administered or dispensed. A research drug includes all drugs used in the research protocol and not just the specific drug(s) being researched.
If the drugs are stored in the same location, the PI or head of the laboratory can hold the Researcher MCSR covering all research in the laboratory.
A Researcher MCSR may include multiple research projects or studies in a single application if the drugs included in that application are all stored in one location and all required information for each study is included in the application. For instance, the PI’s Researcher MCSR may include all protocols for their laboratory that include all scheduled drugs stored in one location.
- Completed and signed Application
- DEA Researcher Registration (except for Schedule VI drugs)
- IACUC approval letter for each protocol
- Fee
If your Researcher MCSR expires while DPH is still processing the application for renewal, the covered individuals can still administer/dispense the scheduled drug pending receipt of the renewal certificate, as long as the renewal application was filed prior to the expiration date of the previous registration, and you have documentation of the submission.
No, not unless you are an authorized user under that registrant, and it is for a protocol that is approved as part of that registration.
No, only one registration is allowed per controlled substances cabinet.
Scheduled VI drugs are not covered by the DEA; they are covered by DPH. They should be stored “in such a manner as to obstruct the theft or diversion of these substances” (247 CMR 6.02(6)(c)).