-
The use of controlled substances (Schedule I - IV) in research is highly regulated, with strict State of Michigan and federal licensing requirements and guidelines for obtaining, storing, accessing, and documenting the use/disposal of each scheduled substance.
For details, see Controlled Substances in Research.
- Annual Inventory Example Sample of a completed State of Michigan Annual Inventory
- Article 7: Controlled Substances Index of links to the controlled substance policy sections of the Public Health Code Act 368 of 1978
- Authorized Personnel Log Template (Word) to track the individuals, other than the licensee/registrant, who are authorized to handle controlled substances for research use and/or access to the storage location.
- Board of Pharmacy Controlled Substances (R 338.3101 - 338.3199q) Controlled substance policy, including definitions and schedules, from the Department of Licensing and Regulatory Affairs (LARA)
- Controlled Substance Compliance Checklist Checklist (Word) to use to prepare your laboratory and/or the controlled substance storage location for a U.S. Drug Enforcement Administration (DEA) inspection.
- Controlled Substance DEA Inventory Template Template (Word) used to perform a biennial inventory of the controlled substances currently stored at the DEA registered location.
- Controlled Substance Diluted Solution Log Log (Word) used to document the usage details for a controlled substance that has been withdrawn from its original container and mixed with a solution to dilute the concentration.
- Controlled Substance Initial & Closing Inventory Template Template (Word) used to record controlled substances at a new storage location immediately upon receipt of a DEA registration or used to list the controlled substances stored at a registered location upon the closing of that location.
- Controlled Substance Inspection Guidelines Instructions for researchers and lab staff to follow when the State of Michigan or U.S Drug Enforcement Administration (DEA) arrives for a controlled substance inspection.
- Controlled Substance Multiple Dose Log Log (Word) to document the details for each use of any controlled substance amount removed from its original container.
- Controlled Substance Research Requirements
- Controlled Substance SOM Inventory Template Template (Word) used to perform the State of Michigan (SOM) annual inventory of all controlled substances stored at the licensed location.
- Controlled Substances General Inventory Template Template (Word) used to summarize the usage of a controlled substance from the time of acquisition to the end of use (e.g., administration and/or disposal). Also called a “perpetual inventory.”
- Controlled Substances in Research
- DEA Drug Schedules I - V (21 CFR, Part 1308) External link to the federal code, 21 CFR, Chapter II, Part 1308 listing controlled substances by schedule I - V (see parts 1308.11 - 1308.15)
- DEA Form 106 - Report Theft/Loss Link to the online DEA form for use by the DEA Registrant only
- DEA Form 222 - Example Annotated PDF showing how to complete a DEA Order Form 222
- DEA Registration Application & Renewal
- DEA Research Application Instructions Guide to completing the DEA research application.
- DEA Theft/Loss Procedures & Information Link to the DEA website for additional procedural information regarding the reporting of a controlled substance theft or loss
- DEA Update Request Online form to request modifications to an existing DEA controlled substance registration. For use by the registrant only.
- Diluted Solution Log Example Sample of the information that can be found on the controlled substances Diluted Solution Log
- Dispose of Controlled Substances Printable version of the procedure (PDF).
- Dispose of Controlled Substances
- General Inventory Example Sample of a completed general inventory log
- Initial and Closing Inventory Example Sample of the type of information that could be found on a closing inventory using the Intitial & Closing Inventory template.
- Inspection Preparation
- Maintain Controlled Substance Records
- Modify a Controlled Substance License/Registration Printable version of this procedure (PDF)
- Modify a License/Registration
- Multiple Dose Log Example Sample of the information that can be found on the controlled substance Multiple Dose Log
- Online Form 225 Link to the online DEA Controlled Substance Registration Form 225, with instructions, for Schedules II - V only
- Order & Receive Controlled Substances for Research
- Order & Receive Controlled Substances for Research Printable version of the instructions (PDF)
- Report Theft/Significant Loss of Controlled Substances
- Report Theft/Significant Loss of Controlled Substances Printable version of this procedure (PDF)
- Researcher Controlled Substance Request Form Form (PDF) required to order controlled substances for research use from the Michigan Medicine B2 Pharmacy.
- Reverse Distributor Inventory Instructions Instructions to complete the Reverse Distributor Inventory List, also known as the DLD Controlled Substance Inventory List.
- Reverse Distributor Inventory List Inventory template to use when disposing of controlled substances through EHS - Hazardous Materials using U-M's contracted reverse distributor (Drug, & Laboratory, Inc. or DLD.) Also known as the DLD Controlled Substance Inventory List.
- Schedule I and II Controlled Substance Disposal Process Detailed instructions with examples of completed forms for disposing of Schedule I and II controlled substances utilizing the required reverse distributor process offered via Drug & Laboratory Disposal, Inc. (DLD) by U-M Environment, Health & Safety (EHS)
- SOM Data Request Change Form Online form from the State of Michigan (SOM) used to request modifications or updates to an existing controlled substance license. For use by the licensee only.
- SOM License Application & Renewal
- State of Michigan Application Instructions Guide to preparing State of Michigan application for controlled substances research license (Word, download)
- Title 21 Code of Federal Regulations, Part 1300-End Index listing the links to the sections of DEA policy for controlled substance registration
- Title 21 United States Code (USC) Controlled Substance Act U.S. Department of Justice - Drug Enforcement Administration (DEA) outline of the federal Controlled Substance Act
- U-M Authorized Personnel Screening Statement Form Internal attestation form (PDF) for personnel who will handle controlled substances for research purposes and/or have access to the storage location.
- U-M Policy on the Use of Controlled Substances in Research and Education Outlines the investigator and/or department roles and responsibilities when utilizing controlled substances in research at the University of Michigan (revised June 2018)
Enterprise
Enterprise
As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.
The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.
ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.
Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).
eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).
Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.