Controlled Substances
- Controlled Substance Administration Log
- DEA Inventory Report
- SUA Form 2184 Application
- SUA Form 2836 Checklist
- SUA Form 2277 Security
- SUA Form 2686 Notice
- DEA Form 225 Application for Research
- DEA Form 225a Renewal
- DEA Form 41 Destruction
- DEA Form 106 Theft/Loss
- Lab Guide for semi-annual IACUC Inspection
- RARC Animal Program Assessment Specialists, apas@rarc.wisc.edu.
Overview
All licenses and registrations required for the use of controlled drugs are held by individual PIs, and the responsibility to obtain and renew these documents rests on the PI. RARC and UW-Madison cannot supply controlled drugs and we are not able to submit applications to state or federal agencies on behalf of PIs.
RARC supplies the information on this website as a courtesy to UW-Madison researchers, and we attempt to keep the information up to date. However, if you have problems submitting or receiving information from state or federal agencies, the best course of action will be to contact them directly.
Researchers using controlled substances must:
- have their own Special Use Authorization (SUA)* and Drug Enforcement Administration (DEA) registration per the following Institutional Policies UW-3043 section 6 (controlled substances) and UW-6066 section IX Drug Enforcement Agency (DEA) Scheduled Drugs
- understand and follow relevant state and federal laws for storage, recordkeeping, ordering and disposal
In some cases RARC veterinarians may be able to administer analgesia directly to rodents for your research project. Learn more.
(*Practitioners (e.g. licensed physicians or veterinarians) with an active DEA registration who will be working in the same building with the same substances already covered by the registration might not need an SUA. Call (800) 362-9082 for free legal clarification.)
For Complete Information
Visit the DEA Office of Diversion Control website or contact DEA directly for complete information regarding federal regulations and DEA registration.
Registration Help: (414) 336-7370; Regulatory Help: (608) 210-4334; dea.registration.help@usdoj.gov
Get answers to frequently asked questions about federal requirements on the DEA Office of Diversion Control Questions & Answers page.
Visit Wisconsin's Controlled Substance Board (CSB) website or contact CSB directly for complete information regarding state regulations and SUA registration.
(608) 266-2112; DSPSCredControlledSubstances@wi.gov
Summary of Requirements and Resources
| DEA | SUA | |
| Fees | State employees are usually exempt from DEA registration fees. Certify your fee-exemption status by talking to your associate dean for research or anybody in your school or college who can verify your employment status and authority to possess and administer controlled substances. |
No fee |
| Initial Registration |
Once your SUA number is issued, visit the DEA website to fill out and submit form 225 online (best method) or to download and mail in.
|
Visit Wisconsin's Department of Safety and Professional Services website, download form 2184, and follow the instructions for researchers. Expect eight to 12 weeks for processing. |
| Modifications |
Amend and obtain approval for your SUA prior to amending your DEA registration. Amend your DEA registration for any of the following changes:
|
Amend your SUA if you change |
| Renewals |
Registrations must be renewed annually. Use DEA form 225A to renew. The DEA typically sends a renewal reminder, but consider tracking the renewal date yourself. Allow approximately four weeks for renewal processing. |
Wisconsin does not send renewal notices, so be sure to keep track of your SUA's expiration date and renew it 12 weeks prior. The SUA renewal process is identical to the new application process. |
You are legally responsible for providing adequate and anti-theft storage for controlled substances. Although both the DEA and Wisconsin have storage requirements, Wisconsin's are more stringent. You will automatically be in compliance with the DEA if you follow Wisconsin's guidelines under form 2277, which include bolting or cementing storage boxes to the floor, if they weigh less than 750 pounds.
Standard office equipment will not meet storage requirements. Health Care Logistics, (800) 848-1633, gohcl.com, sells an approved narcotic cabinet, item 3706-01, for approximately $100-150. Contact UW Facilities Planning & Management or your building manager for mounting and associated costs.
After obtaining your required licensing, set up your own account with a vendor to order controlled substances. You must also complete DEA Form 222 when ordering schedule I and II substances. This form must be completed without errors and mailed to the vendor each time you order. When ordering from Midwest Veterinary Supply, they have provided a sample document on their website.
DEA 222 forms must be obtained by the registrant from the DEA website, additional information can be found here.
Important!
- Treat Forms 222 as if they are controlled substances, keeping both used and unused forms in a securely locked area.
- Never throw away unused DEA Forms 222. Return unwanted, defective or unused forms to DEA headquarters at the address listed in the instructions section on the back of the form.
- Follow the instructions on the back of the form VERY carefully. Vendors will return forms with even the slightest errors.
- Do NOT sign a DEA Form 222 before it is completed. This form is the equivalent of a prescription pad and you are legally responsible for its management.
- After placing an order, closely monitor its arrival. Once the shipment arrives, unpack and sign the packing slip, and put it in your lockbox as soon as possible. Maintain it in a secure area until it is in storage
Electronic records are acceptable as long as they cannot be altered or deleted and are easily separated from all other events.
| DEA | SUA | |
| Records to keep |
Inventory reports - see details below All invoices, receipts, packing slips with all of the following notation:
DEA Forms 222 - Both used and unused. Include a list of your unique form numbers along with the date each form is used, Copy 3 (blue) of executed forms should be completed in full, including number of packages received and date received, Loss/theft reports (DEA Form 106) - see details below Destruction reports (DEA Form 41) - see disposal details below |
Purchase records and receipts Disbursement, use, and disposition of each controlled substance Total weight in grams if solid, or volume and concentration if liquid, of each controlled substance on hand Documentation of any inventory or use discrepancies including investigation into such discrepancies |
| Retention | Two years | Four years after expiration of SUA |
| Location |
Keep records in a registered location, separate from all other records. Inventory and records for Schedule I and II substances, as well as DEA Forms 222, must be further retained separately from all other records. Keep one folder for schedule I and II records, one folder for Schedule III, IV and V records, and one folder for DEA Form 222 used and unused forms. |
|
| Retrieval | Records must be readily retrieval for inspection upon request | |
| SUA | DEA | |
| Include |
Name and DEA number of registrant Date of inventory Notation on whether inventory was taken at start or close of the business day List of each substance on hand including
Two signatures |
Administration logs following federal regulations (including weight in grams if solid or volume and concentration if liquid) |
| Frequency | On the date work with controlled substances begins and then every two years | Continuously |
Important!
- Once an inventory is completed it should be documented and filed away. Do not write on it again.
- Controlled substances awaiting disposal must be included in your inventory as long as they remain in your possession.
- When determining the number of units remaining in a container that has been opened: schedule I and II substances require an exact count or measurement; schedule III-V substances can be estimated unless the container holds more than 1000 tablets or capsules
Use RARC's DEA Inventory Report to capture information required for inventory records.
| DEA | SUA: All DEA requirements PLUS: | |
| Include |
Name of registrant Substance name, concentration and finished form (e.g. 10 mg/mL or 40 mg tab) Container/bottle ID (number, alphanumeric) Date of administration Use (e.g. sedation, analgesia) Number of units dispensed (e.g. 1 mL or 1 tab) and remaining substance balance Individual animal ID for USDA-covered species OR Initials of person administering
recommended: registered storage location, expiration date and lot number |
Total weight in grams if solid, or volume and concentration if liquid |
Use RARC's Controlled Substance Administration Log to capture information required for administration records.
Visit the DEA Office of Diversion Control website for regulatory information and resources.
Dispose controlled substances in a way that permanently and irreversibly alters the substance's physical or chemical state, rendering the drug nonretrievable and unusable. You may not flush substances down a drain or mix with kitty litter or coffee grounds to dispose as solid waste.
Fill out and retain DEA Form 41 for two years when you dispose a controlled substance. You are not required to submit it unless requested.
For disposal instructions, contact RARC animal program assessment specialists: apas@rarc.wisc.edu or contact DEA directly at (608) 210-4334 or dea.registration.help@usdoj.gov.
New! The product Rx Destroyer may be used to dispose of many types of controlled drugs. This product is available on ShopUW+ and vendors such as Midwest Veterinary Supply. You should continue to fill out DEA Form 41 if you use this product to dispose of controlled substances.
Storing of substances awaiting disposal
Separate expired substances from in-date and in-use drugs by placing them in a small container or plastic bag. If you have large stocks of expired or waste controlled substances, use a second lockbox to provide segregation.
Clearly label expired or waste materials with "Expired - Do Not Use in Live Animals."
Store controlled drugs awaiting disposal in the drug lockbox. You must include them in your inventory reports and count them towards your total inventory on hand while they remain in your possession.
Mail or fax a written report of theft or significant loss of your controlled substances to the DEA Milwaukee District Office within one business day of discovery.
Milwaukee District Office
4725 West Electric Ave
West Milwaukee, WI 53219-1627
Diversion phone: (414) 336-7370
Diversion fax: (414) 727-5454
Jurisdiction: Wisconsin
Then submit completed DEA Form 106 to the Milwaukee District Office and retain a copy in your records.
DEA also recommends reporting any instance of loss or theft to local police.
- Midwest Veterinary Supply
Phone: (608) 834-3504, (608) 837-5188; (800) 362-9226
Fax: (888) 372-3941
https://www.midwestvetsupply.com/products - Covetrus
Phone: (855) 724-3461 (toll-free)
Fax: (614) 659-1948
https://northamerica.covetrus.com/ - Zoetis
Phone: (888) 963-8471; (973) 660-7491 - Patterson Veterinary
Phone: (800) 225-7911; (978) 353-6000
Fax: (978) 353-6016
https://www.pattersonvet.com/
Mail completed DEA Form 222 to:
Patterson Logistics Services Inc.
Attn: Tobias Chappell
925 Carolina Pines Blvd., Suite B
Blythewood, SC 29016
