This information concerning controlled substances and precursors is based upon campus policy and Drug Enforcement Administration (DEA) and Department of Justice (DOJ) regulations. 

If there is an information conflict with current policy, please note that policy supersedes the information on this site.

Contents:

• Determining if a Drug is a Controlled Substance
• Ordering Controlled Substances
• Receiving Controlled Substances
• Returning/Cancelling Controlled Substances
• What Is a Precursor?
• Precursor Purchasing Process
• AggieBuy and Controlled Substances/Precursors
• Import Certification Requirements

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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 DEA provides searchable online controlled substance schedules. You can also refer to medical reference manuals, such as:

• Prescribers' Digital Reference
• Daily Med

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

Drug purchases MUST be pharmaceutical grade as part of veterinary care or live animal research.

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Ordering Controlled Substances

All orders for controlled substances must be processed on a KFS Requisition (REQS), citing an appropriate commodity code by controlled substance name. Each line item must state:

1. Name of the drug (generic name preferred)
2. Strength of the drug
3. Size of the drug or quantity in pack
4. Form of the drug

Additionally, the Notes tab on your REQS must state the following elements, ensuring that the bracket [area] contains the appropriate numeral and/or statement.

• This substance is subject to the U.S. Drug Enforcement Administration (DEA) Comprehensive Drug Abuse Prevention and Control Act of 1970.
• This is a schedule [I, II, or III to V] controlled substance. 
• The substance is pharmaceutical grade for live animal research, but can be non-pharmaceutical grade for analytical use.
• The substance will be used [for/to: state general purpose or manner of use and specify if for research, teaching, or analytical].
• Approved authorized custodian is [principal investigator].
• Approved user is [user requesting order or responsible person to pick up/receive].
• Approved storage site is [approved storage location].

If you are unable to locate an appropriate commodity code for the controlled substance you are purchasing, you can use one of the following codes:

• 51000001: Schedule I drugs
• 51000002: Schedule II drugs
• 51000003: Schedule III drugs
• 51000004: Schedule IV drugs
• 51000005: Schedule V drugs

Ordering Multiple Items on One Requisition

• Multiple items with the same schedule can be combined on one Requisition.
• Items identified as Controlled Substances (CS) are NOT to be combined on the same Requisition with non-controlled items. 
• Schedule III, IV, and V drugs can be combined on one requisition.   
• Schedules I and II drugs are NOT to be combined on one requisition.

Document Routing

You must ad hoc route the REQS document 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 department head/designee must be electronically attached to the Requisition.

Requisitions citing controlled substance commodity codes will automatically route to Safety Services for review and approval before routing to Procurement & Contracting Services for final review and approval.

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Receiving Controlled Substances

Only the following staff may receive controlled substances:

• Authorized Central Receiving staff
• Authorized custodian, as specified on the approved Requisition and final PO
• Someone listed on the Controlled Substances Receipt Authorization list (CSRA) as a "temporary receiver" (only pre-authorized users can access/view the list)

To add or delete names from the CSRA list, review and follow the information on the UC Davis Safety Services website. Determine who the temporary receivers are for your department (only pre-authorized users can access/view the list).

The Process

1. After the Requisition routes to Supply Chain Management, the assigned buyer ensures that the correct DEA license delivery address is stated on the Requisition.
2. The buyer checks stock availability with the supplier, and, if needed, changes supplier information, and places order with the supplier. The buyer emails a notification to Receiving unit and department PI and/or User that the order was placed. 
3. Upon arrival of order, Receiving unit takes possession and confirms packing slip against item(s) received. 
4. Receiving unit initiates a Controlled Substance Delivery Record and contacts department PI and/or User to arrange for pick up, or other authorized arrangement. Receiving unit secures order at storage site until transfer is made to authorized department personnel.
5. Every time the order is transferred, contents must be verified by both authorized parties. In addition, an authorized recipient must sign and note any discrepancy on the Controlled Substance Delivery Record each time the order changes hands.
6. The authorized custodian, as the ultimate receiver of the controlled substances, must complete the log in process on the Safety Services Online Controlled Substance Usage Log System no later than 7 days upon receipt and ensure all usage of the logs are kept up-to-date. Usage entries should be completed by the end of the same business day. 
7. The signed Controlled Substance Delivery Record should be sent to the department business office as proof of receipt and for uploading to the related KFS Purchase Order for record keeping.  

Delivery Troubleshooting

If a controlled substance is delivered directly to your department in error, immediately contact Central Receiving to notify them that the delivery bypassed the intended delivery address. 

All controlled substance deliveries are opened and verified for accuracy by Receiving personnel. If discrepancy or damage is found, Receiving personnel will contact assigned buyer for assistance to resolve. Procurement and Contracting Services will work with Receiving personnel, PI/User, and supplier to ensure 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.  (a) Department can immediately contact supplier to cancel, then notify buyer via email of confirmed cancellation.  (b) Department can immediately contact buyer by email/phone and ask to cancel order.  Buyer will contact supplier and determine if the order can be cancelled or notify Receiving personnel to refuse order. 
• If supplier returns the DEA Form 222 (Schedule I & II), Receiving personnel will immediately notify buyer and forward the form to buyer’s attention.  Buyer’s action will depend on reason provided by supplier.  (a) If due to incorrect completion or date expiration (good for 60 days from date of issue) buyer will replace with new form and send to supplier.  Buyer initiates KFS PO amendment with updated form information.  (b) If due to no stock or cancellation, buyer marks "Void" on form and attaches a PDF file to related KFS PO document.  Buyer notifies department contacts by email of order cancellation and either (i) requests department to initiate voiding of PO or (ii) buyer initiates PO void.  Reason for cancellation along with written proof of cancellation must be provided.
• If PO has been PAID and CLOSED, an amendment should be initiated by the department indicating the order was cancelled and not received.  As necessary, department processes KFS Vendor Credit Memo if payment has already been cashed by the supplier.
• If needed, buyer creates a void PO and sends to the supplier.
• Buyer checks the Safety Services Online Controlled Substance Usage Log System to ensure database reflects update.
• Form 222s are uploaded to KFS PO and saved in Procurement and Contracting Services.

Return of product, no replacement

• The department user determines the controlled substance is not needed.  (a) User requests Return Authorization (RA) from the supplier and provides details of return to buyer.  Buyer ensures User understands the controlled substance must be taken back to Receiving and hand delivered to Receiving personnel. The buyer contacts Receiving personnel of return details provided by user. (b) User contacts buyer to request return of controlled substance. Buyer obtains details of request and contacts supplier for RA.  Buyer instructs user to bring the controlled substance to Receiving personnel with note siting RA/waybill reference. Buyer notifies Receiving personnel and department business office of return request.   
• If the PO is not already paid and closed, the department should initiate a Void Order on KFS PO and add a note on the KFS document,  clearly explaining the reason for cancellation.  The department is to provide the supplier with the contact name of the departmental staff who authorized the return. If the supplier provides a RA number, the department user is to include the RA information in the Notes tab on the KFS PO.
• If KFS Purchase Order (PO) had paid and closed, an amendment should be done to open PO, with a note indicating the order was cancelled and not received. As necessary, a KFS Vendor Credit Memo should be processed if payment has already been cashed.
• When the amendment request reaches the appropriate buyer, the buyer works with the supplier and department to ensure arrangements were completed for return.
• For Schedule I or II, the buyer makes request to supplier for a Form 222. Supplier is "procuring" the substance back from the university. This form is required prior to return process.
• Buyer notifies the department when PO amendment is approved. Department makes arrangement for Safety Services approved drop off at Central Receiving to pick up the substance. The delivery driver retrieves the drug from the 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 supplier of the return and the RA# (if a number was provided by the supplier).
• 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 a copy sent to the 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 a final copy of the CSR form sent to Procurement and Contracting Services.
• If product replacement is an exact exchange and IS a Schedule I or II, the 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 UC Davis 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 a 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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What is a Precursor?

While not DEA controlled substances themselves, precursors are chemicals that can be used to manufacture a controlled substance. Precursor chemicals are used at UC Davis in the course of legitimate research that can also potentially be used in the illicit production of controlled substances. One mission of the DEA and the CA DOJ is to disrupt the illicit production of controlled substances by preventing diversion of precursor chemicals.

There are two Federal DEA lists, List I and List II, which differ by import/export/sales reporting thresholds.

There is also a California list of precursor chemicals that includes the DEA List I Chemicals listed in the link referenced above, plus additional chemicals. California law requires the university to purchase these chemicals from in-state suppliers. Examples include ephedrine hydrochloride, Propionic anhydride, piperidine, and pyrrolidine. 

Labs wishing to purchase a chemical on the California precursor list should purchase it through AggieBuy Spectrum Chemical, as Spectrum Chemical has the required State of California licenses to sell these precursors. Spectrum is the only company that produces/synthesizes these compounds in the state of CA. The precursors cannot be purchased in another state and then shipped over state lines.

In addition to the listed precursors, California Health and Safety Code 11107 requires the regulation of purchases of laboratory glassware, apparatus, chemical reagents or solvent over $100, so these orders may also fall into the “precursor” category.

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Precursor Purchasing Process

Spectrum Chemical and other California suppliers providing Precursor Chemicals require the lab to complete a Spectrum QAF481 form (or other supplier provided form) and a “Letter of Intended Use” on department letterhead. The DEA requires a holding period of 21 days after a supplier is in receipt of the completed form and letter when ordering California precursor chemical, so plan accordingly.

Orders through Spectrum Chemical or Sigma.

Log in to AggieBuy.

1. In the Supplier Showcases, under the Lab Essentials section, click on the Spectrum Chemical tile, and enter the desired chemical, and click the search icon.
2. Complete the shopping process in AggieBuy.
3. After the Requisition has been approved, and a Purchase Order has been submitted to Spectrum Chemical, the AggieBuy Requester will receive an email message from Spectrum Chemical asking for completion of the Spectrum Form QAF481. 
   • This form should be completed by the Principal Investigator (PI) or researcher who will be using the chemical.  The form must be hand signed by the PI or researcher, as well as by the appropriate business manager or fiscal officer. 
   • The form must be emailed/faxed to the address/number provided on the form.  Once the form has been accepted by Spectrum Chemical, it is good for one calendar year, meaning that additional purchases of that chemical from Spectrum Chemical will not require the completion of the form until after the one-year period has passed.
   • Wet signatures are required.
4. Two scanned forms of ID are required, along with the completed form in step 4; these forms of ID can be a valid CA-issued driver's license and the UC Federal Tax ID. These two forms of ID should be emailed or faxed with the form and letter to the contact information provided on the form.
5. In addition to completion of the Spectrum Form QAF481, a "Letter of Intended Use" for the chemical must also be completed and documented on department letterhead stationery, hand signed and dated by the same staff who signed the Spectrum Form QAF481.  The letter must be emailed/faxed to the address/number provided on the Spectrum Form QAF481.  The letter must specify:
   • the name of the chemicals being purchased
   • the intended use for the chemicals
   • how long the quantity on this order is expected to last
   • how the chemicals will be stored at your facility when not in use

NOTE: If the desired precursor chemical is not found in the AggieBuy catalog, contact the AggieBuy Help Desk at ab-help@ucdavis.edu to assist you in locating the item.  If not found, other sources can be used, but the manufacturer must be California-based.  A KFS Requisition can be created to purchase the precursor, but this method requires considerably more time and is generally not recommended.

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AggieBuy and Controlled Substances/Precursors

Some AggieBuy catalogs may contain items that are DEA-defined controlled substances; attempting to purchase these items in the supplier’s punch-out catalog will result in an error message indicating that the item cannot be purchased.  As mentioned above, precursor chemicals that could be used to make controlled substances are available for purchase in AggieBuy.

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Import Certification Requirements

The United States Federal Government has specific documentation requirements for chemicals being imported from outside of the US, as part of the Toxic Substances Control Act (TSCA).  The TSCA requires the completion of a form identifying what is being imported, from where it is being imported, and the purpose of the imported item (e.g., research and development).

If your department is ordering chemicals from a supplier outside of the US, and a TSCA certification form is being requested, please contact chem-safety@ucdavis.edu with the name of the Principal Investigator (PI) who will be using the chemicals. The Chemical Safety team will then follow up with the PI to ensure they can comply with the requirements that make up the TSCA certification.