Department Name:
Risk Management and Safety
Title:
Controlled Substance
Issue Date:
November 10, 1998
P.P. Number:
CS-1 (Revision #11)
Revision Date:
October 22, 2013
Page 1 of 9
Purpose: The purpose of this document is to establish the procedure for the acquisition of controlled substances. A controlled substance is a compound requiring a DEA registration number. The
Director of Risk Management & Safety (RM&S), must approve an investigator's initial order for a controlled substance and all orders thereafter. In the director's absence and after an investigator's initial approval, the director's delegated authority (Administrator) may approve orders.
Scope: This document applies to all individuals involved in the ordering, processing, and delivering of controlled substances.
Definitions: UARSC - An auxiliary organization of California State University San Marcos, University
Auxiliary and Research Services Corporation. The Office of Sponsored Projects provides professional and timely assistance to faculty and staff in their pursuit of externally funded research and sponsored programs
Responsibility: RM&S will maintain a controlled substance file. Within this general file, a subfile will exist for each investigator who has been approved to order controlled substances. Each subfile will contain the following:
- Correspondence stated in Section I.
- An original document containing the signatures of lab personnel authorized to sign for the receipt of controlled substances.
- A copy of each order for a controlled substance.
- A controlled substance requisition/approval log.
- Inventory forms noting the controlled substances ordered, the vendor, principal investigator, and the RM&S assigned control number. The inventory form is to accompany the controlled substance on delivery.
Procedure:
I. Ordering
A. The Principal Investigator provides Risk Management and Safety with a signed letter containing:
1. A description of how controlled substances will be securely maintained.
2. A list of individuals who may order controlled substances.
3. A list of individuals who may sign for receipt of controlled substances.
4. A list of individuals who may utilize controlled substances.
5. Signatures of individuals identified above.
6. An agreement to maintain an accurate inventory of the controlled substance(s)-inventory form provided by RM&S (see Appendix A).
B. The Principal Investigator, ensures that a purchase requisition (clearly indicate that the item requested is a controlled substance) is prepared. Utilize separate requisitions for each
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controlled substance. Additionally, do not order controlled substances and "noncontrolled substances" on the same requisition.
C. The Principal Investigator ensures that the signed purchase requisitions is submitted to RMS.
The requestor is responsible to provide an electronic or hard copy of the Requisition to
RM&S Administrative Assistant. As appropriate, RM&S will approve the purchase of the controlled substance. RM&S will send a copy of the approved Requisition to the AVP for
Research, Procurement or UARSC (depending on the funding source), and to the requestor
(PI or Department Administrative Assistant)
D. Orders will be delivered to Distribution Services. Upon receipt, Distribution Services must immediately contact RM&S for pickup. Distribution Services is advised to secure the package in their DEA approved locked cabinet without opening or disturbing the contents. This process follows a specific Distribution Services administrative procedure that manages the package from this point.
II. RM&S Procedure
A. Responsibility of Director or Specialist
1. Upon receipt of an order for a controlled substance, the Director, or Specialist, will verify that the requesting investigator has been previously authorized to order controlled substances. a. If this is an initial request to purchase controlled substances, the Director or Safety
Specialist will contact the investigator to ensure that the information required in item
1 of the attached Procedure for Ordering Controlled Substances (Attachment 1) is obtained. A subfile will be generated by the Safety Specialist, and the requisition will be placed in the subfile. The Safety Specialist will inform the Director of the new authorization. On receipt of the required information and approval by the RM&S
Director, follow steps 2 through 8. b. If this is not an initial request and there is not a "No Controlled Substance" hold, see items 2 through 8.
2. Enter the required information on the Controlled Substance Master Log (Appendix C).
At this point the Controlled Substance is given a RM&S control number. The number consists of the current date followed by a consecutive numbering system, e.g., current date (date requisition signed by RM&S Director or delegated authority)-01, date-02, etc.
The master log is maintained in the Controlled Substance File.
3. Complete the Investigator's Controlled Substance Requisition/ Approval Log including the RM&S control number (see Appendix B). A copy of this document will accompany the Director or Safety Specialist when they pick up the material at Distribution Services.
4. The paperwork will be provided to the Director or Delegated Authority to sign and date the RM&S portion of the Requisiton and to initial the Master Log (Appendix C).
5. Place the Investigator's Controlled Substance Requisition/Approval Log and a copy of the requisiton in the investigator's subfile.
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6. Forward a copy of the requisiton to The AVP for Research.
7. Complete the top portion of the Inventory Form and place into the investigator's subfiile.
8. If deviations from established procedures are reported, the responsible Administrator, in consort with the Director of RM&S or Delegated Authority, will determine the action to be taken--a phone call to the PI, visit to lab, referral to University Police, or future holds on orders for controlled substances.
B. Responsibility of Director or Specialist
1. On notification of a controlled substance awaiting pickup, review the appropriate investigator's subfile. It is anticipated that all packages containing controlled substances will be picked up by the RM&S Director or Specialist at the CSUSM Distribution
Services Office, report any deviations to the Director.
2. When picking up the controlled substance, verify that the material received matches the requisition. If the material received matches the requisition, sign the RM&S verification section on the Requisition/ Approval Log (see Appendix B). If there is a discrepancy, notify the Director or Delegated Authority.
3. Coordinate the delivery time with the Principal Investigator. Deliver the package and appropriate Requisition/Approval log to the laboratory and obtain an authorized signature for controlled substances (refer to copy of authorized signers sheet). Complete the
"Delivered to" section (name and room number), and leave the material and the inventory form(s) with the authorized signee.
4. Return the completed Requisition/Approval Log (Appendix B) to the principal investigator’s file (the copy of this document will be destroyed when replaced with the original, signed sheet. See section C.1.).
5. During the laboratory consultations, the Director or Specialist will review the procedures associated with controlled substances (inventory, security, etc.).
6. All deviations from established procedures shall be immediately reported to the Director or Delegated Authority.
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Issue Date: November 10, 1999
Revision # 1 Date: October 1, 2001 _____
Revisioin # 2 Date: April 20, 2002_
Revision #3 Date: October18, 2002______________
Revision #4 Date: August 5, 2003______________
Revision #5 Date: November 25, 2008__________
Revision #6 Date: December 10, 2012__________
Revision #7 Date: August 10, 2013__________
Revision #8 Date: August 26, 2013__________
Revision #9 Date: October 22, 2013__________
Prepared by: Regina Frasca, Chemical
Hygiene Officer
Prepared by: Regina Frasca______
Associate Director, RM&S
Prepared by: Regina Frasca____________
Associate Director, RM&S
Prepared by: Regina Frasca_____________
Director, RM&S
Prepared & Approved by: ______________
Regina Frasca, Director of RM&S
Prepared & Approved by: ______________
Regina Frasca, Director of RM&S
Prepared & Approved by: ______________
Regina Frasca, Director of RM&S
Prepared & Approved by: ______________
Regina Frasca, Director of RM&S
Prepared & Approved by: ______________
Regina Frasca, Director of RM&S
Prepared & Approved by: ______________
Regina Frasca, Director of RM&S
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Attachment 1
Procedure for Ordering Controlled Substances
(items requiring a DEA Registration Number)
1) Principal Investigator to provide Risk Management and Safety (RM&S) with a signed letter prior to the ordering of any material. Review letter template: a.
Describing how controlled substances will be maintained securely. b.
List of individuals who may order controlled substances. c.
List of individuals who may sign for the receipt of the controlled substance. d.
List of individuals who may utilize the controlled substance, which includes the signatures of the individuals identified above. e.
Agreement to maintain an accurate inventory of the controlled substance(s)-inventory form to be provided by RM&S.
RM&S will evaluate the method of securing the controlled substance, refer to the policy and procedure for further information and maintain this documentation in the PI’s subfile.
2) Prepare a purchase requisition (clearly indicate that the item requested is a controlled substance). Utilize separate requisitions for each controlled substance. Do not order controlled substances and noncontrolled substances on the same requisition. Forward Requisition and back up documentation (if any exists) to
RM&S. An example of what this would look like is below: a.
The Principal Investigator will supply the quote information for order to Administrative
Assistant /Coordinator (Admin) b.
The Admin enters in a requisition into CFS (Accounting Program) c.
The requesting Admin prints out the requisition and any potential back up information. d.
That hard or electronic copy is sent for signatures/authorization by the Director of RM&S or delegated authority.
3) As appropriate, RM&S will approve the purchase of the controlled substance. RM&S will forward the approved and signed purchase Requisition to the appropriate Administrative Assistant (Asst.)/Coordinator
(depending on the funding source), the AVP of Research, and the Requestor. The records will be maintained confidentially.
4) The Administrative Asst./Coordinator, UARSC or Procurement will forward the purchase order to the
Requestor or Principal Investigator. The Prinicpal Investigator or Administrative Asst./Coordinator
5) All orders for controlled substances will be delivered to Distribution Services/Receiving. A notice should be included in the address line to contact the Director RM&S for pick-up.
6) Upon receipt, Distribution Services/Receiving will contact RM&S. RM&S will pick up the controlled substance and verify that the material received matches the order. As appropriate, the controlled substance will be directly delivered to the Principal Investigator by RM&S personnel with the corresponding inventory sheet. RM&S will release custody of the package upon receiving the signature of an authorized individual.
Questions about the purchase of controlled substances should be referred to the Director of RM&S at x4502,
UARSC Grants Post Award Coordinator or the Director of Procurement.
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APPENDIX A
RISK MANAGEMENT AND SAFETY
CONTROLLED SUBSTANCE INVENTORY
Drug Name_________________________________ Vendor_____________________
Strength____________ (mg/ml) Form_____________(liq/solid) Size___________(ml, mg)
Date Describe Method of Use Quantity Used Amount
Remaining
Investigator_________________
RM&S Control #__________
Printed Name of
Authorized User
Signature of Authorized
User
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Investigator Material
APPENDIX B
RISK MANAGEMENT AND SAFETY
CONTROLLED SUBSTANCE REQUISITION/APPROVAL LOG
Quant Sz Strength Vendor DEA#
Ordered
Under
RM&S
Auth.
RM&S
Control
Number(s)
RM&S
Verification
Name (Mat.
Recd Matches
Order )
Delivered To
(Print Name)
Delivered
To
(Rm #)
Signature of
Recipient and
Date
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RM&S
Control
Number(s)
Investigator Material
APPENDIX C
RISK MANAGEMENT AND SAFETY
Quantity
MASTER LOG
Size Strength Vendor DEA#
Ordered
Under
Initials of RMS Rep
(Director or Delegated
Authority)
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APPENDIX D
RISK MANAGEMENT AND SAFETY
BIENNIAL CONTROLLED SUBSTANCE INVENTORY (21CFR 1304011 (C))
Principal Investigator (Print)_________________________________ DEA Registration number___________________________________
Date Product Package Size Quantity PI Signature Strength
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