UNIVERSITY of WISCONSIN–MADISON
COMPLIANCE MY UW MAP
RARC link
IACUC Overview
CALS IACUC
LSVC IACUC
SMPH IACUC
SVM IACUC
Meeting Calendar
Semiannual Inspections
Training
Pathology
Pharmacy
Program Assessment
Rodent Analgesia
Rodent Quarantine
Veterinary Care
Equipment Lending
Protocol Overview
What All PIs Need to Know
ARROW
ARROW Tips
Request Grant Congruence
Submit
Comply
Amend
Renew, Update
Terminate
RARC Documents and Forms
Animal Transfer
Animal Transport
Facilities
Inspections
Species

Policies Overview
Animal User Requirements
Policies by Committee
My Profile
Login Contacts

Controlled Substances

Related Information Forms Contacts

Overview

Researchers using controlled substances must

UW-Madison and RARC do not have an umbrella registration covering investigators and cannot order or distribute controlled substances for your research. In some cases RARC veterinarians may be able to administer analgesia directly to rodents for your research project. Learn more.

(*Practitioners 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

  SUA DEA
Fees No fee

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.

Initial Registration

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.

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.


The Milwaukee DEA office sometimes sends researchers a questionnaire prior to issuing DEA registration numbers.

Modifications

Amend your SUA if you change

  • Original authorization holder
  • Individual participating in the authorized work
  • Drug amounts (SUAs may be revoked for unauthorized possession of excess amounts. Read form 2686 for more information.)
  • Drug codes or schedules
  • See form 2184 for instructions.

 

Amend and obtain approval for your SUA prior to amending your DEA registration. Amend your DEA registration for any of the following changes:

  • Registrant name
  • Registrant address
  • Drug schedules (i.e., reclassification of a substance to a new schedule)
  • Drug codes (i.e, you need approval for a previously unapproved substance)

Amend on the DEA website.

Renewals

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.

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.

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. Complete DEA form 222 for schedule I and II substances. Request the form in one of two ways:

Log into the DEA website with your DEA number and request.

Or, for a large quantity of Form 222 (minimum 100 books), mail or fax a request with DEA number, plus registrant's name and address.

Fax: (202) 307-8485

Drug Enforcement Administration
Diversion Control Division
ATTN: Chief - Registration Unit, Attn: Registration Section/DRR
P.O. Box 2639 Springfield, VA 22152-2639

Important!

  • Treat forms 222 as if they are controlled substances, keeping both used and unused forms in a securely locked area.
  • Never throw away unexecuted 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, put it in your lockbox as soon as possible. Maintain it in a secure area until it is in storage
Registrants are responsible for knowing Wisconsin's and the DEA's separate recordkeeping and inventory requirements. Get complete details on the Office of Diversion Control website and via Wisconsin Legislative Documents Chapter CSB 3, "Special Use Authorization."

Electronic records are acceptable as long as they cannot be altered or deleted and are easily separated from all other events.

  SUA DEA
Records to keep

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

inventory reports - see details below

all invoices, receipts, packing slips with all of the following notation:

  • name, address & DEA number of registrant AND supplier
  • date items were received
  • drug names, strengths, forms and quantities
  • recipient's initials

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,

administration/dispensing logs - see details below

loss/theft reports (DEA Form 106) - see details below

destruction reports (DEA Form 41) - see disposal details below

Retention Four years after expiration of SUA Two years
Location

Keep records in a registered location, separate from all other records. Inventory and records for Schedule I and II substance, 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

administration logs following federal regulations (including weight in grams if solid or volume and concentration if liquid)

name and DEA number of registrant

date of inventory

notation on whether inventory was taken at start or close of business

list of each substance on hand including

  • drug name
  • finished form (e.g. 10 mg/mL)
  • number of units or volume per container (e.g. 100 mL vial)
  • total number of containers

two signatures

Frequency continuously on the date work with controlled substances begins and then every two years

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.

  SUA DEA
Include

disbursement

use

disposition

total weight in grams if solid, or volume and concentration if liquid

name of registrant

date of administration

substance name and finished form (e.g. 10 mg/mL or 40 mg tab)

number of units dispensed (e.g. 1 mL or 1 tab)

animal ID and building address of animal housing

initials of person administering

notation of any waste or loss in needle hub

  • Be sure to include insignificant loss (e.g. a minor spill or substance remaining in a vial that cannot be further utilized).
  • Provide an estimation for needle hub loss that is accurate as possible. The average needle hub may waste anywhere from 0.02 mL to 0.1mL of solution, depending on the needle type and size.

the initials of a second person who witnessed waste whenever possible

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.

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.

 

jump to top button
Internet Explorer is not compatible with this website.

Please use Edge, Firefox, Safari, Chrome or Opera.