- What is a controlled substance?
Drugs and other substances that are considered controlled substances under the Controlled Substances Act of 1970 are divided into five schedules. A listing of the substances and their schedules can be found at the U.S. Department of Justice Drug Enforcement Agency Office of Diversion Control List of Controlled Substances.
- What approvals do I need to work with controlled substances?
For conducting research on narcotic and non-narcotic controlled substances in Schedules II-IV, DEA form #225 (pdf) is submitted with the following information required:
Investigator - Name, address, institution, state license, and a qualifications statement including a curriculum vita with bibliography for each investigator in the research project.
Project - Title, statement of purpose, controlled substance name, amount needed, location of research, security statement and a technical description of the substance use.
Form #225A is used to renew this registration.
In addition to the Federal license, MCW researchers must obtain a State of Wisconsin Special Use Authorization permit. Directions can be found at the Wisconsin Department of Safety and Professional Services Checklist for Researchers (pdf). Additional information is available at their web site Controlled Substances Special Use Authorization.
- What can I do to streamline the approval process?
- Order controlled substances through MCW Purchasing. For investigators who have access to the MCW intranet site InfoScope, select “Purchasing” from the A-Z directory to visit the Accounts Payable & Purchasing Department web site.
- Ensure you have all of the requirements established before applying for State or federal licensing.
- Confer with colleagues who have applied and hold both State and Federal licenses.
- Is auditing or monitoring required?
MCW has an obligation to audit acquisition, use, record keeping, inventory, storage, transfer, and disposal of all controlled substances used in research at all MCW owned, leased, or otherwise occupied facilities per MCW Corporate Policy Use and Storage of Controlled Substances (RS.GS.020). This policy and others related to research are available on MCW’s intranet site. If you have access to InfoScope, search for keywords “research policies” and select the link Research Policies.
- What can I do to prevent problems in the laboratory?
- Secure controlled substances in an approved, limited access drug safe.
- Maintain an accurate and up to date inventory of each drug.
- Never abandon a controlled substance. The registrant who procured the controlled substance is responsible for life for that drug (unless paperwork for a transfer to another authorized registrant exists) and will be subject to penalties by State and Federal authorities.
- What training is required?
No training is required. The process of obtaining a Drug Enforcement Administration (DEA) registration identifies requirements and steps.
- What resources and optional training are available?
The Controlled Substances Coordinator is available to answer most questions and is the point of contact with the local DEA Diversion Office.
For full details, investigators who have access to the MCW intranet site should search for keywords “controlled substances” on InfoScope to view the Public Safety/Controlled Substances intranet site.
- What are the relevant policies, procedures and guidelines?
Registrants must comply with:
- Drug Enforcement Agency (DEA) Controlled Substances Act of 1970;
- All related laws in the Congressional Federal record;
- The State of Wisconsin Pharmaceutical Board;
- MCW Corporate Policy Use and Storage of Controlled Substances (RS.GS.020) Investigators who have access to MCW InfoScope can view this policy by searching for keyword “RS.GS.020”
- Whom do I contact if I have additional questions?
The Controlled Substances Coordinator is available to answer most questions and is the point of contact with the local DEA Diversion Office: