VTH DEA Registrant Responsibilities Policy

Implementation Date: 10/2023

Date of Last Revision: 10/1/2023

Next Review Due: 10/2024

 

Reviewed by VetMed Controlled Substance Surveillance Program Manager & VTH Director: 10/2023

Reviewed by VTH Board: N/A

 

Reviewed by Legal Counsel: N/A

Reviewed by Biosecurity Subcommittee: N/A

Subject to modification by the VTH Director without approval.

Printable PDF: VTH DEA Registrant Responsibilities Policy

Intent and Scope: 

To describe the responsibilities of the person holding the DEA registration for the controlled substances within the VTH. These responsibilities apply to the DEA Registrant (Hospital Director) for the VTH. This does not apply to MDVC.

Policy

The VTH Hospital Director serves as the DEA Registrant for all controlled substances used within the VTH. The Hospital Director will work closely with the VetMed Controlled Substance Surveillance Program Manager to ensure the security of all controlled substances within the VTH, the integrity of controlled substance recordkeeping, and compliance with all Federal and State Controlled Substance Acts and best practices.

To achieve the above, the VTH Hospital Director must maintain the following licenses active and in good standing.

• Illinois State Veterinary License
• Illinois State Controlled Substance Registration at the VTH address (1008 W. Hazelwood Dr. Urbana, IL 61802)
• Illinois State Controlled Substance Registration at the VMSC address (2100 Goodwin Ave. Urbana, IL 61801)
• DEA License at the VTH address (1008 W. Hazelwood Dr. Urbana, IL 61802)
• DEA License at the VMSC address (2100 Goodwin Ave. Urbana, IL 61801)

The VTH Hospital Director must have on hand sufficient DEA Form 222s for conducting the necessary transfer of controlled substances between the VTH and VMSC. The VetMed Controlled Substance Surveillance Program Manager is responsible for notifying the VTH Hospital Director when more DEA Form 222s need to be ordered for either registration.

Twice yearly, the VTH Hospital Director and VetMed Controlled Substance Surveillance Program Manager must coordinate with the local DEA and IDFPR field agents to conduct a review of all active practitioner DEA licenses with a UIUC address to ensure that all active license holders are currently working in a capacity with UIUC that makes the practitioner license and associated address appropriate.

The VetMed Controlled Substance Surveillance Program Manager will review all resolved discrepancies on a monthly basis and notify the VTH Hospital Director of any concerning trends. When the VetMed Controlled Substance Surveillance Program Manager determines there is need to report a potential theft/loss of controlled substances, they will engage with the VTH Hospital Director to discuss and coordinate submitting an initial email notification and the DEA Form 106 if necessary. This is done is accordance with POL-001-CS and SOP-001-CS (Notifying the DEA Registrant of Controlled Substance Questions and Concerns).

When a new Hospital Director will be assuming the role, a formal closing inventory and transfer of drugs by DEA Form 222/invoice is required. This inventory must be completed at “Close of Business” which for the VTH means after the Medication Dispensary has closed and during a time when treatment needs are expected to be minimal (e.g., 9pm at night). Drug ordering must be timed so that there are no unreceived controlled substance orders under the outgoing registrant. The inventory must include an exact count of each controlled substance (CII-V) throughout the VTH. The inventory must be completed by the Outgoing Registrant, the Incoming Registrant, and the VetMed Controlled Substance Surveillance Program Manager with all three participants signing the inventory documentation. Once the inventory has been completed, the final totals of each drug at each registered address must be transferred by DEA Form 222 (CIIs) and by invoice (CIII-Vs) from the outgoing registrant to the incoming registrant. This will require the incoming registrant have sufficient DEA Form 222s for both addresses.

Once the inventory transfer has occurred, all future controlled substance orders and transfers from the VTH to VMSC must be completed using the new registrant’s DEA license. This requires switching all drug ordering accounts to the incoming Hospital Director’s licenses and setting up CSOS with the incoming Hospital Director’s VTH DEA license. The VetMed Controlled Substance Surveillance Manager will serve as the CSOS coordinator, and the Hospital Director will be the registrant.

The outgoing registrant is responsible for returning all unused DEA Forms 222 to the DEA Registration Section.

Guidelines

• The VTH Hospital Director is the license holder for all drug ordering within the VTH. Therefore, the responsibility for remaining legally compliant with all controlled substance requirements ultimately falls to the Hospital Director. This risk is mitigated by close oversight and proactive management on the part of the VetMed Controlled Substance Surveillance Program Manager.
• The VetMed Controlled Substance Surveillance Program Manager is responsible for monitoring all controlled substance use within the VTH and utilizing good judgement to determine when involving the Hospital Director is necessary.
• The VetMed Controlled Substance Surveillance Program Manager will work closely with the Pharmacist in Charge and will have final authority on decisions related to responsibilities outlined in this policy.

Associated SOP: SOP-004-CS VTH DEA Registrant Responsibilities

Definitions (if applicable)

• Controlled Substance: A drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of Title 21 USC Controlled Substances Act. This term does not include distilled spirits, wine, malt beverages, or tobacco.
• Controlled Substance Ordering System (CSOS): The system which allows for secure electronic transmission of controlled substance orders without the supporting paper DEA Order Form 222.
• DEA Form 106: The DEA form used for reporting theft or loss of a controlled substance. This form must be completed online.
• DEA Form 222: The paper DEA form used for ordering CI and CII drugs. This is used when CSOS is not used.
• DEA Registrant: The DEA license holder under whom controlled substances are purchased by the Medication Dispensary for VTH use.
• Drug Enforcement Agency (DEA): The Federal and State Agency responsible for overseeing the Controlled Substance Act (CSA) and affiliated rules.
• Illinois Department of Financial and Professional Regulation (IDFPR): The Illinois state government code department that through its operational components oversees the regulation and licensure of various licensed professions and is charged with enforcing standards of professional practice and protecting the rights of Illinois residents in their transactions with regulated industries.
• Veterinary Teaching Hospital (VTH): The collective clinical services of the Large Animal Clinic, Midwest Equine, the Small Animal Clinic, and the Veterinary Medicine South Clinic. This does not include Medical District Veterinary Clinic (MDVC).
• VetMed Controlled Substance Surveillance Program Manager: The person working within the College of Veterinary Medicine (CVM) who is responsible for implementing the oversight program for all clinical activities including students on rotation.

Regulations (if applicable)

Federal

• 1301.12 (a) Separate registrations for separate locations: "A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person."
• 1301.76 (b) Other security controls for practitioners: “The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft…”
• 1301.91 Employee responsibility to report drug diversion: “…an employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information toa responsible security official of the employer… A failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area.”
• 1301.92 Illicit activities by employees: “…employees who possess, sell, use or divert controlled substances will subject themselves not only to State or Federal prosecution for any illicit activity, but shall also immediately become the subject of independent action regarding their continue employment…”
• 1304.03 and 1305.04 (b) DEA Form 222 Requirement: "Either a DEA Form 222 or its electronic equivalent…is required for each distribution of a Schedule I or II controlled substance…" "An order for Schedule I or II controlled substances may be executed only on behalf of the registrant named on the order and only if his or her registration for the substances being purchased has not expired or been revoked or suspended."
• 1304.11 (a) Inventory general requirements: "Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, ordered by a customer but not yet invoiced...A separate inventory shall be made for each registered location...The inventory may be taken either as of opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory."
• 1304.11 (b) Initial inventory date: "Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances."
• 1304.11 (e) (6) (i-ii) Inventories of dispensers and researchers: "Each person registered or authorized to dispense or conduct research with controlled substances shall include in the inventory for each controlled substance in finished form the name of the substance; each finished form of the substance; the number of units or volume of each finished form in each commercial container; and the number of commercial containers of each such finished form. In determining the number of units of each finished form of a controlled substance in a commercial container that has been opened, the dispenser or researcher shall do as follows: If the substance is listed in Schedules I or II, make an exact count or measure of the contents; or If the substance is listed in Schedule III, IV, or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents. For each controlled substance that is damaged, defective awaiting disposal, held for quality control purposes or maintained for extemporaneous compounding, the inventories shall include the name of the substance; the total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and the reason for the substance being maintained by the registrant."
• 1304.12 (a, b, d, e) Procedure for filling DEA Forms 222: "A purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. The copy retained by the purchaser may be in paper or electronic form. A supplier may fill the order, if possible and the supplier desires to do so, and must record on the original DEA Form 222 its DEA registration number (if not previously entered by the purchaser) and the number of commercial or bulk containers furnished on each item and the date on which containers are shipped to the purchaser. The supplier must retain the original DEA Form 222 for the supplier's files. Any supplier who is not required to report to ARCOS (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail or email. The copy must be forwarded at the close of the month during which the order is filled. The purchaser must record on its copy of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser."
• 1305.05 (a) Power of Attorney: A registrant may authorize one or more individuals…to issue orders for Schedule I and II controlled substances on the registrant's behalf by executing a power of attorney for each such individual, if the power of attorney is retained in the files, with executed Forms 222 where applicable, for the same period as any order bearing the signature of the attorney. The power of attorney must be available for inspection together with other records."
• 1305.06 (a) (c) Persons entitled to fill CII orders: "An order for Schedule I and II controlled substances, whether on a DEA Form 222 or an electronic order, may be filled only by a person registered with the DEA as a manufacturer or distrubotr of controlled substances…except for the following. A person registered with DEA to dispense the substances, or to export the substances, if he/she is discontinuing business or if his/her registration is expiring without reregistration, may dispose of any Schedule I or II controlled substances in his/her possession with a DEA Form 222 or an electronic order. A person registered to dispense Schedule II substances may distribute the substances to another dispenser with either a DEA Form 222 or an electronic order only in the circumstances described in 1307.11."
• 1305.11(a) Obtaining DEA Forms 222: "DEA Forms 222 are issued in mailing envelopes containing a predetermined number of forms based on the business activity of the registrant, each form consisting of one single-sheet. A limit, which is based on the business activity of the registrant, will be imposed on the number of DEA Forms 222 that will be furnished upon a requisition for order forms."
• 1305.12 (a-d) Executing DEA Forms 222: "A purchaser must prepare and execute a DEA Form 222 by use of a typewriter, computer printer, pen, or indelible pencil. Only one item may be entered on each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance. The number of lines completed must be noted on that form at the bottom of the form, in the space provided. The name and address of the supplier from whom the controlled substances are being ordered must be entered on the form. Only one supplier may be listed on any form. The supplier's DEA registration number may be entered by the purchaser or the supplier. Each DEA Form 222 must be signed and dated by a person authorized to sign an application for registration or a person granted power of attorney to sign a Form 222. The name of the purchaser, if different from the individual signing the DEA Form 222, must also be inserted in the signature space."
• 1305.18 Return of unused DEA Forms 222: "If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser's registration) or is suspended or revoked, the purchaser must return all unused DEA Forms 222 to the Registration Section."
• 1307.11 (a)(1)(i-iv) Distribution by dispenser to another practitioner: "A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to another practitioner for the purpose of general dispensing by the practitioner to patients provided that, the practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance; the distribution is recorded in accordance with 1304.22(c), an order form is used as required in 1305, and the total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year."

State

• 720 ILCS 570/302 (d) Separate registration for separate locations: "A separate registration is required at each place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances, or purchases, stores, or administers euthanasia drugs. Persons are required to obtain a separate registration for each place of business or professional practice where controlled substances are located or stored. A separate registration is not required for every location at which a controlled substance may be prescribed."