Use of Controlled Substances
Controlled substances are frequently used in animal research for anesthesia, pain relief, and humane euthanasia. Increased oversight on the part of state and federal authorities has resulted in the requirement for researchers to obtain their own licenses to purchase, possess, and administer controlled substances. In Wisconsin, researchers must have a Drug Enforcement Administration (DEA) registration (federal) and a Controlled Substance Special Use Authorization (SUA) from the State of Wisconsin.
WI Dept of Regulation & Licensing (DRL) Controlled Substance SUA
- WI Controlled Substance SUA must be obtained FIRST, before applying for DEA registration.
Forms can be obtained from the WI Dept of Regulation & Licensing (WI DRL) Controlled Substances SUA. The direct link is: http://22.214.171.124/profession.asp?profid=11&locid=0
- Researchers must use Form #2184 “Application for Research, Analytical Laboratory, Industrial/Commercial Procession, Instructional Activities and Other for Controlled Substances” .
- There is no fee for employees of state institutions.
- Application forms must be printed out, completed, and mailed in hard copy.
- Researchers must have an SUA for specific drugs and amounts of drugs and are not permitted to purchase or possess more than the SUA stipulates.
- A complete WI Controlled Substances SUA application will include
- completed Form #2184
- signed checklist Form #2836
- detailed 1-page description of work and a copy of the ACUC protocol (new applications)
- clear outline of drug amounts requested, with calculations for animal dose, total doses to be delivered over 1 year, total volume and concentration of product requested for purchase or use for 1 year
- copy of the ACUC approval letter
- SUAs must be renewed annually. No renewal notice is given but the SUA will expire if not renewed 8 – 12 weeks prior to the expiration date of the current SUA.
Federal Drug Enforcement Administration (DEA) Registration
- Researchers can only apply for DEA registration once a WI SUA number has been issued.
- Researchers apply for DEA registration from the DEA Office of Diversion Control. The direct link is http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms_new.htm.
- DEA applications are better submitted online but the forms can also be printed and completed in hard copy. Do not submit both online and hard copies.
- Researchers* need to complete DEA Form #225 “Manufacturers, Import/Export, Distributors, Researchers, Dog Handlers, Labs”.
- There may not be an application fee depending on source of funding: check with your school or college
- The certifying official is usually the Associate Dean for Research in the school or college.
* Procedures differ for Practitioners (MDs, DVM, and others).
- Both the State of WI and the Federal DEA have physical security requirements but the State of WI DRL are more stringent. Compliance with WI DRL ensures compliance with the DEA.
- The security requirements from WI DRL can be found as Form #2277, “Physical Security Requirements”. The direct link http://drl.wi.gov/prof_docs_list.asp?profid=11&locid=0.
- DEA requires a complete inventory of controlled substances to be completed at least every 2 years. Consult the DEA Office of Diversion Control website for the current inventory requirements.
- An example of a controlled substance log that complies with current DEA regulations is provided on the at: Controlled Substance Usage Inventory.
- Users must keep records of all controlled substances that are administered to animals, include animal ID, dose, concentration of drug, time, date, and who administered drug.
- Records must be kept at least 2 years and be readily retrievable.
- Controlled substances must be disposed of properly. Only the DEA Special Agent in Charge can authorize for disposal of controlled substances. Researchers cannot dispose of controlled substances without DEA instructions, cannot transport the drug to an unauthorized location, and cannot transfer drugs to unauthorized persons under any circumstances.
- Complete form 41 found on the U.S. Department of Justice, Drug Enforcement Administration website. Click on Blank form and follow the printing directions.
- Sign and complete the form. Call the Hazardous Waste Specialist at x4999 to arrange a time for pick-up of the substances. (Form 41 should be available at the time of the pick up.)
- Hazardous waste personnel will submit the original form to the DEA authorities, return a copy of the form to the researcher and keep a copy on file for a record of the destruction