Category: Controlled Substances
Number: SOP-004-CS
Date of Last Review: October 2023
Next Review Date: October 2024

Printable PDF: VTH DEA Registrant Controlled Substance Inventory Transfer SOP-004-CS

Purpose/ Applicability:

To describe the process for transferring the VTH controlled drug inventory from one DEA Registrant to another (i.e., when a new hospital director is appointed)

Scope:

This process applies to the VTH controlled substance inventory. This does not apply to MDVC.

Associated Policy: VTH DEA Registrant Responsibilities Policy

Definition(s):

• 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 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 the Medical District Veterinary Clinic (MDVC).
• VTH Controlled Substance Surveillance Program Manager: The person working within the Veterinary Teaching Hospital (VTH) who is responsible for implementing the oversight program for all clinical controlled substance activities, including students on rotation.

Applicable Regulations:

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."
• 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 distributor 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."

Procedure:

As soon as the new VTH Hospital Director has been identified, the following steps must occur.

Incoming Hospital Director

1. Obtain IL State Veterinary License
   1. Once obtained, provide a copy to the VTH Controlled Substance Surveillance Program Manager.
2. Obtain IL State Controlled Substance Registration at the VTH address (1008 W. Hazelwood Dr. Urbana, IL 61802)
   1. Once obtained, provide a copy to the VTH Controlled Substance Surveillance Program Manager.
3. Obtain DEA License at the VTH address after IL CS Registration is received.
   1. Once obtained, provide a copy to the VTH Controlled Substance Surveillance Program Manager.
   2. Order DEA Forms 222 for the VTH address once DEA License is received.
4. Obtain IL State Controlled Substance Registration at the VMSC address (2100 Goodwin Ave. Urbana, IL 61801)
   1. Once obtained, provide a copy to the VTH Controlled Substance Surveillance Program Manager.
5. Obtain DEA License at the VMSC address after IL CS Registration is received.
   1. Once obtained, provide a copy to the VTH Controlled Substance Surveillance Program Manager.
   2. Order DEA Forms 222 for the VMSC address once DEA License is received.
      
      

Incoming Hospital Director, Outgoing Hospital Director, and VTH Controlled Substance Surveillance Manager

1. Set date and time for complete controlled substance inventory and drug transfer.
   1. All three individuals must be present and involved in the inventory and drug transfer.

Outgoing Hospital Director

1. Notify IDFPR and DEA contacts of upcoming hospital director change. Include date of role change, date planned for controlled substance inventory and drug transfer, and name and contact information for incoming hospital director.
   1. Address any outstanding questions/concerns of IDFPR and DEA contacts.

VTH Controlled Substance Surveillance Program Manager

1. File copies of all five licenses for the Incoming Hospital Director.
2. Identify all sources of controlled substances (wholesalers, drug companies, pharmacies, etc.).
   1. Reach out to contacts at each source as request paperwork necessary for changing the DEA and veterinary license used to order drugs.
   2. Complete the necessary paperwork with the Incoming Hospital Director’s licenses. *When submitting, ensure that orders will continue to be processed under the Outgoing Hospital Director’s license until inventory transfer occurs.
3. Complete DEA Power of Attorney forms for each full time staff pharmacist to sign DEA Forms 222.
4. Complete CSOS registration process to create an account under the Incoming Hospital Director’s VTH DEA License (1008 W. Hazelwood Dr.)
   1. Incoming Hospital Director will be the registrant.
   2. VTH Controlled Substance Surveillance Manager will be the coordinator.

The Gantt chart below provides a visual of which tasks described above can be completed concurrently.

Controlled Substance Inventory and Drug Transfer

Pre-Inventory Preparation

1. Stock up on all controlled substances prior to the inventory. Implement a controlled substance ordering cutoff date at least 1 week prior to the inventory date to ensure that there are no outstanding controlled substance orders.
2. After the controlled substance ordering cutoff date has passed, notify all companies from which controlled substances are obtained to cancel/inactivate the DEA license associated with the outgoing hospital director.
3. Dispose of all expired or otherwise unusable controlled substances.
4. Return all DEA Forms 222 with the outgoing hospital director’s license information to them for return to the DEA.
5. Complete full cycle counts of all controlled substances within the VTH to ensure quantities on hand are accurate. Address all identified discrepancies.
6. Ensure inventory forms reflect the current controlled substances stocked at each address.
7. Close out all controlled substance files and label with the outgoing hospital director’s information. Create new files for the incoming hospital director.
8. Remove DEA suffixes from HIS user accounts that no longer need them. Compile a list of those users that will need updated suffixes after the switch.
9. Prepare invoice templates for transferring CIII-V controlled substance inventory.
10. Ensure sufficient DEA Forms 222 are on hand for both addresses for transferring CII controlled substance inventory.

Inventory

1. At the predetermined date/time, the outgoing and incoming hospital directors and the VTH Controlled Substance Surveillance Program Manager will meet to conduct the inventory of all controlled substances.
2. Separate inventories will be completed for controlled substances located at the VTH (1008 W. Hazelwood Dr.) and VMSC (2100 Goodwin Ave.).
3. Inventory will be conducted in an organized manner with exact counts/draws of all controlled substance open bottles/vials.
4. All three roles must be present and actively participating in the inventory and sign the completed inventory testifying to its accuracy.
5. The completed inventory for each location will serve as the ending inventory for the outgoing hospital director and the opening inventory for the incoming hospital director.

Controlled Substance Transfer

1. At the completion of the inventory, the controlled substances on hand will be transferred from the outgoing hospital director to the incoming hospital director.
2. VTH and VMSC controlled substance transfers will need to be completed on separate documents.
   1. CII drugs must be transferred utilizing DEA Forms 222 that are completed and sent to the DEA as described on the back of the forms.
   2. CIII-V drugs must be transferred “by invoice” utilizing templates that have been internally created.

Immediately Post-Inventory

1. Switch DEA suffixes to the incoming hospital director’s DEA licenses.
   1. Use the VMSC DEA license for clinicians practicing primarily at VMSC.
   2. Use the VTH DEA license for all other VTH clinicians.
2. Within one business day, notify all pharmacies which have been provided a list of suffixes, that the previously provided suffixes are invalid, and new ones have been issued.
3. Monitor all controlled substance orders for the next couple of months to ensure they are being placed with the correct DEA license. Promptly address any identified issues.