University Safety and Assurances

Use of Controlled Substances


"WI Dept of Safety and Professional Services forms"

 

DEA Form 106      DEA Form 222      DEA Form 225

Controlled substances are pharmaceuticals or chemicals strictly regulated under the Controlled Substances Act (CSA). They are placed into schedules based on their medical use, relative abuse potential, dependence liability, and concern for safety. The U.S. Drug Enforcement Administration (DEA) recognizes five drug schedules:

Schedule I (C-I)
Substances in this category have the highest potential for abuse and no accepted medical use in the U.S. Examples include heroin and certain fentanyl analogs. 

Schedule II (C-II)
Substances in this category have accepted medical use in the U.S., but have a high potential for abuse with severe risk for psychological or physical dependence. Examples include cocaine and pentobarbital.

Schedule III (C-III)
Substances in this category have an abuse potential that is less than those listed as Schedule I and II, and have accepted medical use in the U.S. Examples include ketamine and buprenorphine.

Schedule IV (C-IV)
Substances in this category have an abuse potential that is less than those listed as Schedule I,II,III, and have accepted medical use in the U.S. Examples include phenobarbital and diazepam (valium).

Schedule V (C-V)
Substances in this category have an abuse potential that is less than those listed as Schedule I,II,III, and IV, and have accepted medical use in the U.S. Examples include Codeine and Robitussin.

 
A comprehensive list of substances and which schedule they fall under can be found on the Office of Diversion Control website.
 

Registering to obtain controlled substances

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 both a Drug Enforcement Administration (DEA) registration (federal) and a Controlled Substance Special Use Authorization (SUA) issued by the State of Wisconsin Controlled Substances Board. Wisconsin Controlled Substances SUA must be obtained FIRST, before applying for DEA registration.

  • SUA forms can be obtained from the WI Dept of Safety and Professional Services (WI DSPS)
  • 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 as a hard copy.
  • Form #2275 provides instructions for filing a new application or amendment. Form #2275 outlines the physical security requirements for storage of controlled substances.
  • A complete WI Controlled Substances SUA application will include:
    1. Completed form #2184
    2. Signed Checklist Form #2836 (you must mail the initiated checklist back to DSPS)
    3. Detailed 1-page layman's description of IACUC approved study that placed drug use in the context (do not send the entire IACUC protocol)
    4. Copy of the IACUC approval letter
  • SUA's must be renewed annually. No renewal notice is given by the WI DSPS but the SUA will expire if not renewed 8-12 weeks prior to the expiration date of the current SUA. The application procedure for SUA renewals is identical to that for initial applications.

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.
  • 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".
  • State employees are usually exempt from the DEA registration fee. The certifying official for fee-exemption status is typically the Dean for Research in the school or college.
  • The Milwaukee DEA Office may send an additional informational questionnaire prior to issuing a DEA registration number.
  • DEA Registration for Research lasts 1 year. The DEA typically provides a reminder to renew.

Ordering Controlled Substances

Once you have obtained proper registration, you must set up your own account with a vendor that dispenses the substance you need. Common Vendors:

 

Midwest Veterinary Supply
Phone: 1-608-837-5188; 1-800-362-9226
Fax: 1-888-372-3941
5374 Maly Road, Route 1
Sun Prairie, WI 53590
www.midwestvet.net

Butler Schein Animal Health
Phone: 1-888-691-2724
Fax: 800-456-0377
Butler Schein Animal Health Corporate Office
400 Metro Place N.
Dublin, OH 43017
www.butlerschein.com

 

Schedule I and II substances require a special form (DEA Form 222) for obtainment. DEA Form 222 may be ordered with your initial DEA Application or through the Office of Diversion Control.

You may also order the form by calling the DEA Registration Headquarters Unit at 1-800-882-9539 or the Milwaukee District Office at (414) 336-7370

As the DEA Registrant, you are responsible for securing both used and unused DEA Forms 222 in a locked area. Make a list of your unique form numbers, along with the date each form is used.

Tips for filling out the form:

  1. Follow the instructions on the back of the form VERY carefully. If the form has even the slightest error, the vendor may send it back to you.
  2. Do NOT sign a DEA Form 222 before it is completed. This form is the equivalent of a prescription pad for which you are legally responsible.
See an example of a completed DEA Form 222.

 

*NOTE: In space "E" of Form 222  where it says "Veterinarian's Signature", this should read "Registrant's Signature." The person holding the DEA Registration or their registered designee must sign the form.


Security Requirements

As a DEA Registration holder, you are legally responsible for providing effective controls and procedures to help prevent theft and diversion of controlled substances.


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 DSPS ensures compliance with the DEA.

WI DRL requires a wall-mounted or floor-bolted lockbox. Locked drawers or cabinetry are NOT adequate. The Wisconsin Department of Regulation and Licensing provides a list of requirements on Form #2277, "Physical Security Requirements."

An approved (small) double locking cabinet can be ordered through Health Care Logistics, 1-800-848-1633, or www.healthcarelogistics.com, item #3707-01: slim line narcotic cabinet for $125.00.

In an instance of loss or theft of your controlled substances, notify the Milwaukee District Office immediately, and promptly submit DEA Form 106, which can be found on the Office of Diversion Control website.

Milwaukee District Office
4725 West Electric Ave
West Milwaukee, WI 53219-1627
Diversion Number: (414) 336-7370
Diversion Fax: (414) 727-5454
Jurisdiction: Wisconsin


Record Keeping

DEA requires a complete inventory of controlled substances to be completed at least every two years. Consult the DEA Office of Diversion Control for the current inventory requirements.

The Wisconsin Controlled Substance Board requires that users keep detailed records of each controlled substance on hand including its use, disposition, and total weight in grams. Users should also include animal ID, dose, concentration of drug, time, date, and person administering drug.

To capture required information for records, users should refer to the controlled substance log template.

The Wisconsin Controlled Substance Board also requires retention of purchase records (including receipts), and any documentation related to discrepancies in inventory and use (including investigation of such discrepancies).

All records must be kept for four years after expiration of the SUA and must be readily retrievable.


Disposal

  • 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 instructions.
  • 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.