Controlled Substances

The following guidance represents RARC's understanding of current state and federal controlled substance regulations. Please note that this guidance is provided as reference only! Registrants are responsible for knowing and understanding their obligations under state and federal laws.



State and Federal Regulatory Information

What Are Controlled Substances?

Controlled Substances and RARC

Registration Requirements

Storage & Security Requirements

Recordkeeping Requirements

Ordering Controlled Substances

Disposal of Controlled Substances



STATE AND FEDERAL REGULATORY INFORMATION

Visit the Drug Enforcement Administration (DEA), Office of Diversion Control website or contact DEA directly for information regarding federal regulations:

(608) 210-4334

DEA.Registration.Help@usdoj.gov

View federal regulations:

Title 21 Code of Federal Regulations

Title 21 U.S. Code (USC) Controlled Substance Act

Visit the Wisconsin Department of Safety and Professional Services (WI DSPS), Controlled Substance Board (CSB) website for information regarding state regulations.

View state regulations:

Wisconsin Administrative Code - CSB


WHAT ARE CONTROLLED SUBSTANCES?

Controlled substances are pharmaceuticals or chemicals strictly regulated under the Controlled Substance 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 separate drug schedules. A comprehensive list of substances and which schedule they fall under can be found on the Office of Diversion Control website.

At UW-Madison, researchers are often required to administer controlled substances for the purpose of anesthesia, analgesia, or euthanasia.


CONTROLLED SUBSTANCES AND RARC

Current regulations require researchers to obtain their own registrations to purchase, possess, and administer controlled substances. RARC cannot sell or distribute controlled substances for your research.

  • In some cases, RARC veterinary staff may be able to directly administer analgesia to rodents for your research project. Visit the Rodent Analgesia Service page for information.
  • RARC provides an Anesthesia and Analgesia Formulary for information regarding commonly used anesthetics and analgesics.
  • You may also contact your RARC veterinarian for consultation regarding drug types, dosages, routes of administration, formulations, commercial products, and other medical issues. See the "RARC login" at the top of the page and log in with your NetID to see the full list of RARC veterinarians.
  • RARC provides one-on-one assistance with state and federal registration procedures, and management of controlled substances and required records. Contact Sarah Johnson-Schlueter for assistance: apas@rarc.wisc.edu, 608-263-4861.

REGISTRATION REQUIREMENTS*

In Wisconsin, researchers who want to obtain and administer controlled substances must have both a federal Drug Enforcement Administration (DEA) registration and a Controlled Substance Special Use Authorization (SUA) issued by the State of Wisconsin Controlled Substances Board (CSB). The SUA must be obtained BEFORE applying for 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 your DEA registered address without approval from DEA.

*NOTE: State of Wisconsin Licensed Practitioners, (e.g. MDs, DVMs etc.) who already hold an approved DEA registration, may conduct research and instructional activities with the controlled substances for which the DEA registration was granted if:

  1. the practitioner license is current and active and,
  2. the research is conducted in the same location (building) that is listed as the registered address on the DEA registration and,
  3. the substances to be used for research are already authorized on the current approved DEA registration.

If any of the above specifications are not met, an SUA must be obtained and a separate DEA registration may also be required.
Contact the DEA directly for information: (608) 210-4334; DEA.Registration.Help@usdoj.gov.


State Registration

  • Visit the WI Dept of Safety and Professional Services (WI DSPS) to obtain the relevant SUA Application Form for beginning the registration process.
  • 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.
      • 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 substance use in context.
      • Do not send the entire IACUC protocol.
    4. A copy of the IACUC approval letter.
      • This can be sent directly to WI DSPS by the protocol managers in the RARC IACUC Office upon email request from PI on protocol.
  • Print out and mail all completed forms and materials to the address listed at the top of Form #2184.
    • Be aware! It can take eight to 12 weeks or more to receive a response from the CSB regarding your application.
  • Review Form #2277, "Physical Security Requirements" and ensure there is adequate and secure storage area in place prior to ordering controlled substances. See also: "Storage & Security Requirements" section, below.
  • Review Form #2686, "Unauthorized Possession of Excess Amounts of Controlled Substances Important Notice."
  • Renewal Applications: SUAs must be renewed annually.
    • The WI DSPS does not send a renewal notice, but the SUA will expire if not renewed eight to 12 weeks prior to the expiration date of the current SUA.
    • The SUA renewal procedure is identical to that for initial applications.
  • Modifications to SUA: Registrants must amend their SUA any time there is a change in:
    • original authorization holder
    • individuals participating in the authorized work
    • amounts of drugs requested
    • schedules or codes of drugs requested

See the instructions on Form #2184 to begin the SUA amendment process.


Federal Registration

  • Researchers can apply for DEA registration once a SUA number has been issued.
  • New applications: Visit the DEA Office of Diversion Control website and complete
    DEA Form #225, "Manufacturer, Distributor, Researcher, Analytical Laboratory, Importer, Exporter," to begin the process for a new application.
    • DEA applications are better submitted online, but a paper version may also be submitted through the U.S. Postal Service. Do not submit both an online and paper copy.
    • 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.
    • The Milwaukee DEA Office may send an additional informational questionnaire prior to issuing a DEA registration number.
  • Renewal applications: DEA registration expires after 1 year and must be renewed annually
    • The DEA typically provides a reminder to renew.
    • Use DEA Form #225a, "Manufacturer, Distributor, Researcher, Analytical Laboratory, Importer, Exporter" for renewal applications.
  • Modifications to registration: Registrants must amend their DEA registration any time there is a change in:
    • registrant name
    • registrant address
    • drug schedules (i.e. a substance has been reclassified to a new schedule)
    • drug codes requested (i.e. substances need, for which you have not previously been approved to obtain)

Use the DEA Update Request Form to amend your DEA registration. Note: The SUA must be amended and approved prior to amending DEA registration.


STORAGE & SECURITY REQUIREMENTS

As a DEA and SUA registration holder, you are legally responsible for providing effective controls and procedures to help prevent theft and diversion of controlled substances. Before obtaining any controlled substance, you must establish a secure storage area that meets state and federal security requirements. RARC recommends that you limit storage access to only those individuals who absolutely need it.

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 nonuse hours. Locked drawers or cabinetry are NOT adequate. 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, item #3707-01: slim line narcotic cabinet for ~ $150.00. Contact FP&M or your building manager for mounting and associated costs.


RECORDKEEPING REQUIREMENTS

The State of WI DSPS and the Federal DEA have set separate recordkeeping and inventory requirements for researchers. The following guidance represents RARC's understanding of current state and federal regulations. Please note that this guidance is provided as reference only! Registrants are responsible for knowing and understanding their obligations under state and federal laws.

To capture information for inventory and administration records, users should refer to RARC's DEA Controlled Substance Inventory Report and Controlled Substance Administration Log.


Requirements at a Glance*


State of WI (SUA Registrants)
Federal (DEA Registrants)
Records required to be kept
  1. Purchase records and receipts
  2. Disbursement, use, and disposition of each controlled substance
  3. Total weight in grams if solid, or volume and concentration if liquid, of each controlled substance on hand
  4. Documentation of any inventory or use discrepancies including any investigations into such discrepancies
  1. Accurate inventory reports
  2. Invoices, receipts, and packing slips with notation of
    • name, address & DEA number of Registrant AND Supplier
    • date items were received
    • drug names, strengths, forms and quantities
    • recipient's initials
  3. DEA Form 222 - both unused forms and used forms completed in full**
  4. Administration/Dispensing Logs
  5. Loss/theft reports (DEA Form 106)
  6. Destruction and disposal reports (DEA Form 41)
When to take inventory
Continuously
On the date work with controlled substances begins (initial inventory) then every two years (biennial inventory) and on the effective date a substance becomes controlled by DEA (newly controlled substances inventory)
What the inventory must include Follow federal regulations for administration logs and include substance weight in grams if solid, or volume and concentration if liquid
  1. Name and DEA number of Registrant
  2. Date of inventory
  3. Notation of whether inventory was taken at opening or close of business
  4. 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 (e.g. 4 vials)
  5. Two (2) signatures
What administration/dispensing log must include
  1. Disbursement
  2. Use
  3. Disposition
  4. Total weight in grams if solid, or volume and concentration if liquid
  1. Name of Registrant
  2. Date of administration
  3. Substance name and finished form (e.g. 10 mg/mL or 40 mg tab)
  4. Number of units dispensed (e.g. 1 mL or 1 tab)
  5. Animal ID & building address of animal housing
  6. Initials of person administering
  7. Notation of any waste or loss in needle hub
  8. Initials of a second person witnessing any waste
Where to keep the records
Registered location
Registered location
** NOTE: Inventory and records of Schedule I and II substances and DEA form 222 must be maintained separately from all other records.
Retention time
4 years after expiration of SUA
2 years
Availability requirements
Copies of original records must be readily retrievable upon request
All records must be readily retrievable for inspection by the DEA upon request

*Please find additional details that represent RARC's understanding of current state and federal regulations in the narrative below.


Federal Requirements

All federally required records must be:

  1. complete and accurate
  2. readily retrievable for inspection and copying by the DEA upon request
  3. maintained at the registered location
  4. maintained for two years
  5. maintained separately from all other records (i.e. controlled substance records must not be comingled with records of non controlled substances)
  6. a. Schedule I & II records must be further maintained separately from Schedule III-V records.
    i. RARC recommends that registrants keep one folder for schedule I & II records, one folder for Schedule III, IV & V records, and one folder for DEA Form 222 used and unused forms.
    ii. DEA recommends treating DEA Form 222 as if it is a controlled substance.

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

Records required by the DEA are summarized below.
For details of all federal requirements, see "Title 21 Code of Federal Regulations," on the Office of Diversion Control website.

1. Inventory Reports

The DEA requires a physical inventory of controlled substances to be completed on the date the registrant first engages in business with controlled substance(s) (initial inventory), then at a minimum of every two years thereafter (biennial inventory). In addition, an inventory must be taken on the effective date that the substance you're using becomes controlled by DEA (newly controlled substances inventory).

Inventory must include the name and DEA registration number of Registrant, the date inventory was taken, a notation of whether the inventory was taken at the opening or close of business and a list of each controlled substance in your possession including: drug name, finished form (e.g. 10 mg tablet or 10 mg/mL), number of units or volume per container** (e.g. 100 tab bottle or 3mL vial), total number of containers (e.g. 4 bottles or 3 vials). The inventory should also include two signatures, one of the person taking the inventory and the other of a witness. Refer to RARC's DEA Controlled Substance Inventory Report to help capture the required information.

Once an inventory is completed it should be documented and filed away. Do not write on it again.

Please note: 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, schedules I and II controlled substances require an exact count or measurement. For schedules III-V substances, an estimated count or measure may be used unless the container holds more than 1000 tablets or capsules.

2. Invoices, Receipts, and Packing Slips

The DEA requires registrants to keep all financial and shipping records (i.e., invoices, packing slips). These records must include: the name, address and DEA registration number of both the Registrant AND the supplier, a notation of the date received, the drug name, strength, form, and quantities received, and the recipient’s initials.

If your financial and shipping records comprise a packing slip, invoice, and/or a receipt log, each document must contain all of the required information, including the date received and verification of all items received.

3. DEA Form 222

As the DEA Registrant, you are responsible for securing both used and unused DEA Forms 222 in a locked area. Copy 3 (blue) of each executed DEA Form 222 must be retained and completed in full, including the number of packages received and date received.

DEA Form 222 records must be maintained separately from all other records of the registrant. 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.

4. Administration/Dispensing Logs

The DEA requires the use of controlled substances to be logged including: date, substance name, finished form (e.g.*i.e., 10 g tablet or 10 mg/mL), number of units or volume dispensed, patient address and name (i.e., animal ID and address where animals are housed), the name or initials of the person administering the substance, and the name of the Registrant. Logs must also include a notation of any drug waste or insignificant loss (e.g. a minor spill or substance remaining in a vial that cannot be further utilized), including waste in the hub*** of the needle. Providing a witness to waste that is lost in the needle hub is not required but is strongly recommended whenever possible. Refer to RARC's Controlled Substance Administration Log to help capture the required information.

***When determining the amount of solution lost in the hub of a needle, users should provide an estimation 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.

5. Loss or Theft Reports

You must provide a written report of any instance of theft or significant loss of your controlled substances to the DEA Milwaukee District Office within one business day of discovery. Send your report via mail or fax using the contact information below. You must also complete and submit DEA Form 106 to the Milwaukee District Office and retain a copy in your records.

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

DEA also recommends reporting any instance of loss or theft to local police.

6. Destruction and Disposal Reports

Report all authorized destruction of controlled substances on DEA Form #41 and retain it in your controlled substance records. Instructions for proper destruction can be found on the RARC Pharmacy Services website under Expired Materials.

State Requirements

The WI DSPS Controlled Substance Board requires that registrants keep detailed records of each controlled substance on hand including its disbursement, use, disposition, and and total weight in grams if solid, or volume and concentration if liquid. Registrants must also retain purchase records (including receipts), and any documentation related to discrepancies in inventory and use (including investigation of such discrepancies).

All state required records must be kept for 4 years after expiration of the SUA and must be readily retrievable upon request.

Full details of state requirements can be found on the WI DSPS Controlled Substance Board website and are outlined in Chapter CSB 3 of Wisconsin Legislative Documents.

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.

NOTE: After placing an order, closely monitor its arrival. Once the shipment arrives keep it in your possession or maintain it in a secure area until it can be transported to your lock box for proper storage. Transfer the shipment to proper storage as soon as possible.

Following is a list of commonly used controlled-substance vendors. The ordering process for schedule I and II substances differs from substances III–V:

Schedule III–V substances can be ordered directly from vendors using their standard ordering procedures.

Schedule I and II substances require a special form (DEA Form 222) for obtainment. Paper versions of DEA Form 222 may be ordered with your initial DEA Application or through the Office of Diversion Control. DEA Forms 222 can also be submitted electronically by enrolling in the Controlled Substance Ordering System (CSOS) program.

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 DEA Form 222:

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.

Visit the DEA Office of Diversion Control Questions & Answers page for more information.

Commonly Used Controlled-Substance 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
Regional Contact: Sue Lavigne 1-608-834-3504

Henry Schein Animal Health
Phone: 1-855-724-3461 (toll-free)
Fax: 1-614-659-1948
400 Metro Place North
Dublin, OH 43017
www.henryscheinvet.com

Zoetis
Phone: 1-888-963-8471; 1-973-660-7491
5 Giralda Farms
Madison, NJ 07940
Call for ordering information

Patterson Veterinary
Phone: 1-800-225-7911; 1-978-353-6000
Fax: 1-978-353-6016
137 Barnum Road
Devens, MA 01434
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


DISPOSAL OF CONTROLLED SUBSTANCES

Instructions for proper destruction can be found on the RARC Pharmacy Services website under Expired Materials.

Questions

If you have questions or would like additional information, contact Sarah Johnson-Schlueter: apas@rarc.wisc.edu, 608-263-4861.