GENERAL REGULATORY OVERVIEW

The federal Controlled Substances Act (CSA) was enacted in 1970 and serves as a foundational piece of legislation aimed at controlling illegal drugs in the United States. The law classifies regulated drugs into five categories, from Schedule I (substances with no legitimate medical use in the United States and that can be addictive, e.g., LSD and heroin) to Schedule V (drugs with a clear medical use, low potential for abuse and limited psychological and physical dependence, e.g., cough medications with small amounts of codeine).

Certain campus research activities may involve the use of controlled substances, particularly in animal research where pain medication is commonly used. Use of controlled substances for research requires registering with both the federal government through the US Drug Enforcement Agency (DEA) and the State of Wisconsin through the Controlled Substances Board. Penalties for using such drugs without proper registration can be severe. The regulations strictly limit who can handle or administer the drugs and impose both physical security and inventory requirements. Some key points concerning the regulations include but are not limited to:

• The permitting process involves an individual researcher, the US DEA, and the State of Wisconsin.
• Registrants cannot transfer or share controlled substances with other registered or non-registered users. Anyone on staff using controlled substances must be listed as a user on the PI’s registration form.
• Possession of expired drugs also poses a risk to researchers since administration of expired controlled substances is prohibited.
• Disposal of controlled substances is also strictly regulated and can only be authorized by the US DEA Special Agent in Charge.

Possession or use of controlled substances without a registration is illegal.

Disposal is subject to approval by the US DEA. Registrants must contact the US DEA for authorization to destroy or otherwise properly dispose of all controlled substances.

 

REGISTRATION REQUIREMENTS & APPLICATIONS

University of Wisconsin researchers who wish to acquire and administer controlled substances must obtain both a federal DEA registration and a Controlled Substances Special Use Authorization (SUA) issued by the Wisconsin Department of Professional Services (DSPS) Controlled Substances Board. Important information concerning registration includes but is not limited to:

• The Wisconsin SUA must be obtained before applying for federal DEA registration.
• A separate registration is required for each physical building where controlled substances are administered or stored. Controlled substances and associated records cannot be moved from the DEA-registered address without approval from the US DEA.
• SUA application forms and instructions are available on the Wisconsin DSPS Controlled Substances Special Use Authorization website.
• New and renewal DEA application forms and instructions are available on the DEA Office of Diversion Control website.

ADDITIONAL RESOURCES

• Wisconsin DSPS Controlled Substances Special Use Authorization Information
• US Drug Enforcement Administration (DEA) Office of Diversion Control
• US DEA Registrant Drug Disposal Information
• US DEA Controlled Substance Schedules

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

In order to purchase, possess, and administer controlled substances for research in Wisconsin, researchers must obtain both a federal Drug Enforcement Administration (DEA) registration and a state Controlled Substances Special Use Authorization (SUA) issued by the State of Wisconsin Department of Safety & Professional Services (WI DSPS). The registration process along with required security measures, is outlined below.

State Registration:

• To Begin: Visit the WI DSPS where the relevant SUA forms can be obtained.
• New Applications: A complete SUA application for research must include:
  1. Completed Form #2184, “Application for Controlled Substances Special Use Authorization.” Read the instructions on the form carefully; Form #2275 provides additional instructions. There is no fee for employees of state institutions.
  2. Completed Form #2836, “Special Use Authorization (SUA) for Controlled Substances Checklist for Research.”
  3. A detailed one page written description of IACUC-approved study that places controlled substances use in context. (DO NOT send the entire IACUC protocol).
  4. A copy of the IACUC protocol approval letter.
  5. Print out and mail in all completed forms and materials to the address listed at the top of Form #2184.
  6. Be aware! It can take 8 to 12 weeks or more to receive a response from the CSB regarding your application.
  7. Review Form #2277, “Physical Security Requirements” and ensure there is an adequate and secure storage area in place prior to ordering controlled substances. See also: “Storage & Security Requirements” section, below.
  8. Review Form #2686, “Unauthorized Possession of Excess Amounts of Controlled Substances Important Notice.”
• Renewal Applications: SUAs must be renewed annually:
  1. 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.
  2. The SUA renewal procedure is identical to that for new applicants.
• Modifications: Registrants must amend their SUA any time there is a change in:
  1. Original authorization holder.
  2. Individuals participating in the authorized work.
  3. Amounts of drugs requested.
  4. Schedules or codes of drugs requested.
  5. See the instructions on Form #2275 to begin the SUA amendment process.

Federal Drug Enforcement Administration (DEA) Registration:

• To Begin: Researchers can apply for DEA registration once an SUA number has been given. Visit the DEA Office of Diversion Control website and obtain the appropriate forms.
• New Applications:
  1. Complete DEA Form 225, “Manufacturer, Distributor, Researcher, Analytical Laboratory, Importer, Exporter.”
  2. DEA applications are submitted online but may also be submitted through the U.S. Postal Service. Do not submit both online and paper copies.
  3. State employees are usually exempt from the DEA registration fee. The certifying official for fee-exemption status is typically the Associate Dean for Research in the school or college but can be anyone who can verify both employment status and authority to possess and administer controlled substances.
  4. The Milwaukee DEA Office may send an additional informational questionnaire before issuing a DEA registration number.
• Renewal Applications:
  1. Registration expires after one year and must be renewed annually.
  2. Use DEA Form 225a, “Manufacturer, Distributor, Researcher, Analytical Laboratory, Importer, Exporter.”
  3. DEA typically provides a reminder fir renewals.
• Modification: Registrants must amend their DEA registration any time there’s a change in:
  1. Registrant name.
  2. Registrant address.
  3. Drug schedules (i.e. a substance has been reclassified to a new schedule).
  4. Drug codes requested (i.e. substances needed. for which you have not been previously approved to obtain).
  5. Use the DEA Update Request Form to amend your DEA registration.
  6. The SUA must be amended and approved prior to amending DEA registration.

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 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 the DEA Form 222 before it is completed. This form is equivalent of a prescription pad for which you are legally responsible.
3. 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.

Storage & Security Requirements:

• As a DEA and SUA Registration holder, you are legally responsible for providing effective controls and procedures to prevent theft and diversion of controlled substances. Before obtaining any controlled substance, a secure storage area, that meets state and federal security requirements, must be set. Both the State of WI and the Federal DEA have physical security requirements but the requirements set by the State of WI DSPS are more stringent. Compliance with WI DSPS ensures compliance with the DEA.
• WI DSPS requires a wall-mounted or floor-bolted lockbox, housed in a room that is locked during non-use hours. Please, see the full list of requirements provided by the WI DSPS 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

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

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.
• Contact Campus EHS for further instructions:
  • University Safety and Assurances (uwm.edu)

 

DISCLAIMER

This publication was prepared to assist in finding resources and information for regulatory compliance. It is not intended to render legal advice.

Read full legal disclaimer