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Controlled Substances

The information concerning controlled substances is based upon campus policy. Policy supersedes the information on this site, in case of any conflict in information.

Contents:


Determining if a Drug is a Controlled Substance

The United States Drug Enforcement Administration and the State of California Board of Pharmacy strictly regulate controlled substances. The Drug Enforcement Administration provides searchable online controlled substance schedules. You can also refer to medical reference manuals, such as:

If you are unable to use either of the above to determine if a substance is controlled, contact a member of the Procurement Team.

Note: Anyone ordering, delivering, receiving and using controlled substances must have completed training and/or background checks as required by campus policy.


Ordering Controlled Substances

All orders for controlled substances must be processed on a KFS Requisition (REQS), citing an appropriate commodity code. The PR line item(s) must include a full description of the item requested: quantity, size of package, and name of drug. Additionally, the REQS must include a statement with the following elements:

  • That the substance requested is subject to the Comprehensive Drug Abuse Prevention and Control Act of 1970.
  • The number of the Federal Schedule of Controlled Substances to which it is assigned.
  • The purpose and/or manner of planned use and if it is to be used for teaching, research or clinical applications.
  • The name of the authorized custodian (typically the principal investigator).
  • Whether or not the substance is pharmaceutical grade (required if substance is for animal use).
  • The final delivery and storage location.

A sample statement satisfying the above conditions would resemble the following:

"This material is subject to the Comprehensive Drug Abuse Prevention & Control Act of 1970 (Controlled Substances Act) and is a Schedule II substance. The authorized custodian is Jonathan Doe. The substance is pharmaceutical grade and will be used to anesthetize dogs in research on heart disease. The authorized custodian's approved storage site is Building Y, Room X."

Note: Schedule III, IV, and V substances may be included on the same Requisition; Schedules I & II may be included on a single Requisition, but may not be included with the other schedules. No other product may be included with scheduled substance(s)on a Requisition.

Ad hoc route the Requisition in KFS to the approving department head or authorized designee for approval. If the department head/designee is not a KFS user, a signed document from the approver must be electronically attached to the Requisition. Requisitions citing controlled substance commodity codes will automatically special conditions route to Safety Services for approval.

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Receiving Controlled Substances

Only the following may receive controlled substances:

To add or delete names from the CSRA list, review and follow the information on the UC Davis Safety Services website. To find out who the temporary receivers are for your department, click here.

The Process

All controlled substances are to be delivered to Central Receiving. They will take possession of the drugs and initiate a Controlled Substance Delivery Record, which will follow the shipment to the authorized storage site. Every time the shipment is transferred to another person it must be opened, and the contents verified by both parties. In addition, an authorized recipient must sign and note any discrepancy or damage on the Controlled Substance Delivery Record each time the drug changes hands.

The ordering department will receive a copy of the purchase order from Procurement and Contracting Services and must complete the area stamped in red. The authorized custodian designated in the description area of the requisition must, as the ultimate receiver of the substance, sign the copy and will be the last to sign the Controlled Substance Delivery Record. Both of the signed documents must be returned to Procurement and Contracting Services within 15 calendar days of receipt of the controlled substance.

Note: If the required documentation is not returned to Procurement and Contracting Services within 15 calendar days of delivery of the controlled substance, a notice of negligence will be sent to the authorized custodian with a copy to the department head and Safety Services. If the information is not returned within fifteen additional calendar days, the Procurement and Contracting Services department will no longer place orders for the authorized custodian in question and will send another letter to the authorized custodian, department head, the appropriate Deans' office, and Safety Services. The Purchasing Controlled Substance Database will be annotated, and all authorized controlled substance buyers and managers will be notified.

Delivery Troubleshooting

If a controlled substance is delivered directly to your department by the supplier, contact Central Receiving to notify them that the delivery bypassed them. Also, add a note to your copy of the Purchase Order that the delivery bypassed Central Receiving and was made directly to your department.

All controlled substance deliveries are opened and verified for accuracy at the Central Receiving department. If there is a discrepancy or damage, Central Receiving will contact Procurement and Contracting Services for product return arrangements. Procurement and Contracting Services will work with the department and the supplier to ensure that the most appropriate action is taken.

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Returning/Cancelling Controlled Substances

Cancellation Prior to Shipment

  • The department determines the substance is not needed and calls supplier to cancel. Department immediately notifies buyer via email.
  • If substance is a Schedule I or II, the DEA Form 222 is returned by the supplier to Procurement and Contracting Services and is marked "Void" by the buyer.
  • If KFS Purchase Order (PO) has not already been paid for and closed, the department should click the Void Order button at the bottom of the PO; a screen shot of the Void Order screen should be sent to the supplier.
  • If KFS Purchase Order (PO) has been paid for and closed, an amendment should be done to the PO, with a note added indicating that the order was canceled and not received. As necessary, a KFS Vendor Credit Memo should be processed if the payment has already been cashed by the vendor.
  • A Procurement and Contracting Services Department off-line (Access) change order is processed by the buyer with copy sent to supplier.
  • Procurement and Contracting Services reviews the change order prior to filing the file copy and updates the controlled substances database accordingly.
  • Procurement and Contracting Services staff keeps voided Form 222 on file.

Return of product, no replacement

  • The department determines the substance is not needed and requests Return Authorization (RA) from the supplier.
  • If the PO is not already paid and closed, the department should click the Void Order button at the bottom of the PO and include notes in the document clearly explaining why the cancellation and providing the contact name of the person who authorized the return on behalf of the supplier. If an RA number was provided by the supplier, department must also include that in the notes.
  • If KFS Purchase Order (PO) has been paid for and closed, an amendment should be done to the PO, with a note added indicating that the order was canceled and not received. As necessary, a KFS Vendor Credit Memo should be processed if the payment has already been cashed by the vendor.
  • When the amendment request reaches the appropriate buyer, the buyer works with the supplier and the department to make arrangements for the return. If the substance is a Schedule I or II, the buyer requests that the supplier provide a new, completed DEA Form 222 less the "Purchaser's Copy 3". (Essentially, the supplier is "procuring" the substance back from the University.)
  • Buyer notifies the department when the PO amendment is approved. If Schedule I or II, CO approval will happen after the supplier's 222 has been received. Department then arranges for Central Receiving to pick up the substance. The delivery driver retrieves the drug from end-user department utilizing a Controlled Substance Return (CSR) form. The driver will sign one copy and leave with the department for their records. The other copy will return to Central Receiving with the substance.
  • The delivery driver returns the drug to Central Storehouse, and obtains a signature (dual verification) on the copy of the CSR from the receiving staff as an acknowledgment that the drug was received at Central Receiving and returned to storage.
  • The CSR is kept with the drug under lock and key.
  • Central Receiving staff notifies the vendor of the return and the RA# (if a number was provided by the vendor).
  • The supplier retrieves the drug and signs the CSR for proof of receipt.
  • A copy of the CSR is maintained at Central Receiving and attached to the original delivery record. In addition, a copy is sent to Procurement and Contracting Services.
  • A Procurement and Contracting Services department off-line (Access) change order is processed by the buyer with copy sent to supplier. If Schedule I or II, buyer clips the Form 222 to the "file" copy of the change order and provides it to the appropriate Contracting Services Staff.
  • Procurement and Contracting Services staff review the change order prior to filing the file copy and updates the controlled substances database accordingly.
  • Procurement and Contracting Services staff keep Form 222 "Supplier's Copy 1" on file with the original Form 222 that was used to order the substance and marks "void" on the 222 that was used for ordering.
  • Procurement and Contracting Services staff send Form 222 "DEA Copy 2" to DEA.

Return of product for replacement

  • If product replacement is an exact exchange AND is NOT a Schedule I or II, the department may work directly with the supplier to obtain return authorization and arrange with Central Storehouse for the return. Steps identified above will be followed by Central Storehouse with final copy of CSR form sent to Procurement and Contracting Services.
  • If product replacement is an exact exchange and IS a Schedule I or II, department must work with Procurement and Contracting Services to obtain the 222 form from the supplier for the return as well as completing a new 222 form for UCD to obtain the replacement. Buyer will process an amendment to the KFS Purchase Order (PO) to reference the replacement 222 form number. Buyer clips the supplier's 222 form (for return) to the "file" copy of the amended order and provides it to the appropriate Contracting Services Staff. Buyer mails the new 222 form (for replacement) to the supplier along with supplier copy of the amended PO.
  • Procurement and Contracting Services Staff reviews the change order prior to filing the file copy and updates the controlled substances database accordingly.

    For the supplier's 222 (for return of substance) Procurement and Contracting Services Staff keeps Form 222 "Supplier's Copy 1" on file with the original Form 222 that was used to order the substance and marks "void" on the 222 that was used for ordering. Procurement and Contracting Services Staff sends form 222 "DEA Copy 2" to DEA.

NOTE: If product replacement is NOT an exact exchange, the return would be handled as noted under Cancellations with return of product above. The purchase of replacement would be handled on a new Requisition in KFS.

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