Controlled Substance Use in Research Procedures
(Including Chemical Precursors)

Printable Version

  1. Introduction
  2. Objectives
  3. Definitions
  4. Controlled Substance Use Authorization for Research in University Facilities
  5. Additional Authorization or Registration
  6. Acquisition of Controlled Substances and Precursor Chemicals
  7. Pick Up of Controlled Substances and Precursor Chemicals
  8. Transfer of Controlled Substances
  9. Storage of Controlled Substances and Records
  10. Recordkeeping of Controlled Substances
  11. Inspections
  12. Theft
  13. Disposal of Controlled Substances
  14. Appendices

1. Introduction:

This procedure manual describes the University of California, Irvine’s Controlled Substance Program and provides researchers with the knowledge needed to comply with applicable laws and regulations associated with the use of controlled substances and precursor chemicals in their research and instruction.  Compliance with these procedures is required of all individuals authorized to conduct chemical analysis, instructional activities, or research using controlled substances or precursor chemicals at the University of California, Irvine.

The Controlled Substance Program covers five main areas involved in the use of controlled substances in research: acquisition, storage, use requirements, recordkeeping, and disposal.  Procedures for the acquisition and disposal of precursor chemicals are covered.

Federal and state law regulates the manufacture, distribution, use, storage, and disposition of controlled substances and precursor chemicals. Controlled substances generally include narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances.  The Drug Enforcement Administration (DEA) is the agency mandated to regulate the lawful use of controlled substances and List I chemicals under federal law Title 21 Chapter 13 Code of Federal Regulations (CFR) Part 1300 to end.

The California Bureau of Narcotic Enforcement and the California State Board of Pharmacy are authorized to ensure compliance with California laws regulating controlled substances and prescription drugs, respectively.

The University of California (UC) has established policies and procedures covering the acquisition and use of controlled substances for research purposes in compliance with both state and federal laws and are found in Business and Finance Bulletin BUS-50 http://www.ucop.edu/ucophome/policies/bfb/bus50.html.

The University of California, Irvine has established Section 903-15: Guidelines On the Acquisition and Use of Controlled Substances and Precursor Chemicals for Research written in compliance with UC policy, BUS 50.  This guideline can be found at: http://www.policies.uci.edu/.

This procedure manual is not intended to provide guidance regarding the use of controlled substances by licensed healthcare personnel for non-research, clinical purposes. 

The Controlled Substance Program at UC Irvine is administered by Environmental Health & Safety (EH&S) on the university campus.

2. Objectives:

  1. To provide researchers with information needed regarding the proper use of controlled substances and precursor chemicals in their research.
  2. To provide researchers with the references to state and federal regulations and UC Irvine policies and procedures regarding controlled substances and precursor chemical use.
  3. To describe requirements of five main areas of use of controlled substances in research at UC Irvine: acquisition, storage, approved use, recordkeeping, and disposal.  Requirements apply to researchers at the UC Irvine campus, UC Irvine Medical Center, and affiliated sites.  These requirements do not pertain to facilities, labs, or buildings that are listed as inpatient or outpatient departments on the UC Irvine Medical Center’s general acute care license.
  4. To describe requirements for the acquisition and disposal of precursor chemicals used in research at UC Irvine.

3. Definitions:

3.a       Controlled Substance

A controlled substance (CS) is a substance that has a stimulant, depressant, or hallucinogenic effect on the nervous system.  Controlled substances are prescription drugs that are further classified as Schedule I-V and can only be obtained by registrants with the DEA (See 3b). The Controlled Substances Act (1970) listed substances that were controlled when the law was enacted. Since then, approximately 160 substances have been added, removed, or transferred from one schedule to another.

A general reference list of controlled substances in alphabetical order can be found at: http://www.deadiversion.usdoj.gov/schedules/orangebook/a_sched_alpha.pdf.  Federal regulations regarding schedules can be found in Section 1308 of CFR Title 21 ( 21 CFR §1308).     

Schedules of Controlled Substances:

Schedule I:      No currently accepted medical use.  Highest potential for abuse.  (e.g., GHB, heroin, marijuana).

Schedule II:     Currently accepted medical use with restrictions.  High potential for abuse with severe psychological or physical dependence. (e.g., amphetamine, methamphetamine, cocaine, codeine, morphine, meperidine, methylphenidate, pentobarbital (Nembutal)).

Schedule III:    Currently accepted medical use.  Abuse of drug may lead to moderate to low physical dependence or high psychological dependence. (e.g., Ketamine, Telazol, testosterone, pentothal.  Euthasol is a Schedule III due to pentobarbital/phenytoin mix).

Schedule IV:    Currently accepted medical use.  Low potential for abuse relative to Schedule III. (e.g., barbital, butorphanol, chloral hydrate, diazepam).

Schedule V:     Currently accepted medical use.  Low potential for abuse relative to Schedule IV (e.g., buprenorphine and Zolpidem).

3.b       DEA Registrations

The intent of DEA registration numbers is to identify and validate individuals and institutions that have been authorized by the DEA to purchase, possess, distribute or prescribe controlled substances. Controlled substances intended for research purposes acquired though drug companies or any other outside institutions must be obtained under each School’s home department DEA research registration.  (See Section 6b).

An individual practitioner’s DEA registration cannot be used to directly acquire controlled substances intended for research, instruction, and chemical analysis purposes at UC Irvine.

University hospital, clinic, and pharmacy DEA registrations only are valid for use of controlled substances at those licensed premises and will not cover research facilities or medical office buildings that are not part of the licensed hospital, clinic, or pharmacy.

Vendors and suppliers may only deliver controlled substances and precursor chemicals to the address listed on DEA registrations.  At UCI, deliveries for purchases of controlled substances and precursor chemicals are made to the Student Health Center pharmacy.

3.b.i.     Institutional Research Registration (Schedules II-V)

EH&S maintains the required institutional and/or departmental research registrations issued by the DEA covering use of Scheduled II-V controlled substances and precursor chemicals for research, instructional, and chemical analysis purposes. 

Researchers who wish to use a Schedule II controlled substance in a human subject’s protocol must have their project reviewed by the state Attorney General’s office.  This review may take several weeks to months.  A current letter of approval from the state Attorney General’s office must be provided to EH&S prior to obtaining drugs.  Contact EH&S for more information regarding this process.

3.b.ii.    Individual Research Registration (Schedule I)

EH&S maintains an institutional research registration for those individual researchers who wish to use a Schedule I controlled substance in their research.  Researchers who wish to use a Schedule I controlled substance must have their project reviewed by the state Attorney General’s office. http://caag.state.ca.us/research/.   This review may take several weeks to months. 

A current letter of approval from the state Attorney General’s office must be provided to EH&S prior to obtaining drugs via email to occhlth@uci.edu, or by Fax at (949)824-1325.

3.c        Precursor Chemicals

Precursor chemicals and List I Chemicals, in addition to legitimate uses, have the potential to be used in the manufacture of controlled substances.  State and federal laws require campus vendors to uphold stringent regulations regarding distribution of these chemicals therefore researchers must order them through the Purchasing Department as a high value requisition and must have a Controlled Substance Use Authorization on file with EH&S.  See Section 6a.

The federal list (List I Chemicals) can be found at: http://www.deadiversion.usdoj.gov/21cfr/cfr/1310/1310_02.htm.

The state of California maintains a list of precursor chemicals which includes all federal List I Chemicals plus a few additional chemicals.  The state of California precursor chemical list can be found at: http://www.ag.ca.gov/bne/pdfs/laws03.pdf

The term “precursor chemical” will be used throughout this manual and refer to both lists: List 1 Chemicals (federal list) and precursor chemicals (state of CA list).

Recordkeeping and storage requirements found in this manual on the use of controlled substances do not apply to precursor chemicals.  These chemicals are not included in the controlled substance inventory.  Disposal through the online Request for Disposal is recommended, but optional, for precursor chemicals.

3.d.      Authorized User Status

Researchers and research staff apply for authorization to use and/or pick up controlled substances including precursor chemicals for research by:

3.e.       Principal Investigator Eligibility

All Academic Staff members in the following categories are eligible to participate in the Controlled Substances Program:

Eligibility Table:

Series and Titles

Principal Investigator Eligibility (1)

Lead Researcher Eligibility

Tenure/Tenure Track
Assistant, Associate, or Professor

Yes
(includes Emeriti)

Yes
(includes Emeriti)

In-Residence
Assistant, Associate, or Professor

Lecturer - Track & SOE
Lecturer w/ Security of Employment (SOE)

Clinical "X"
Assistant, Associate, or Professor of Clinical ______ (Dept. Name)

Clinical (With Salary)
Assistant, Associate, or Clinical Professor

Yes, if salaried at 50% or more

Yes, if salaried at 50% or more. (2)

Adjunct
Assistant, Associate, or Professor

Professional Researcher
Assistant, Associate, or Professor

All other Series, Titles, Appointments

No (1)

No. (2)

(1) For exceptions, see Principal Investigator Eligibility on Sponsored Projects webpage

(2) *Petition Process All potential other series, titles, and appointments described above must have special approval from the Vice Chancellor for Research. To obtain such approval, the individual needs to secure a letter from the Department Chairperson, countersigned by the Dean, requesting approval for non-eligible employees. The approved petition should then be submitted to Environmental Health and Safety (EH&S) along with other appropriate application materials.

4. Authorization to Use CS for Research in University Facilities

EH&S will grant Authorization to those researchers who have a bona fide need to handle, use, or access controlled substances and precursor chemicals for research purposes. EH&S has this authority over all researchers to help assure maintenance of the institutional research registration(s) for UCI.  See Section 5.

The Principal Investigator is responsible for ensuring that all staff, and students using controlled substances in conjunction with their research are listed in the lead researchers CSUA application and will comply with all procedures as described in this manual.

Researchers must obtain authorization from EH&S prior to the use, purchase, or transport of controlled substances at the UC Irvine campus and UCIMC.  Controlled substances acquired under UCI ‘s institutional or departmental research registrations may not be removed, transported, or used at another location,\ unless prior written authorization is provided to the Principal Investigator by EH&S.

The Principal Investigator must complete a CSUA application and obtain authorization from EH&S to purchase precursor chemicals under UCI’s institutional or departmental research registration.  To have authorization, researchers are required to:

  1. Acknowledge their intent to comply with all laws, regulations, and university policies and procedures regarding controlled substance use in research as described in this manual.
  2. Review procedures of the Controlled Substance Program every 3 years.
  3. Submit a Controlled Substance Use Authorization (CSUA) Form for Controlled Substance Use in animals, humans and in-vitro research to EH&S. See Appendix A
  4. Complete Appendix A2 for all additional personnel working with controlled substances

Intent to comply with these laws, regulations, and university policies and procedures will be documented via submission of one’s employee or student ID number in the field located at the end of this webpage .  Documentation of each submission is automatically emailed to EH&S and to the submitting researcher for inclusion in the Principal Investigator’s file.

Submit an application with original signatures to the:
           
Controlled Substance Program Coordinator,
EH&S
Zot Code 2725
Have a question?  Call 949-824-3757 or email occhlth@uci.edu

5. Use Requirements of Controlled Substances and Precursor Chemicals

UC Irvine maintains the institutional and departmental research registration(s) with the DEA which allows researchers to use controlled substances and precursor chemicals; however, depending on your purpose and CS schedule number, state and federal regulations may require you to simultaneously obtain other authorizations or registrations when you apply for a CSUA.

Bona fide needs to handle, use, or access controlled substances for research purposes are:

  1. Animal Use: Principal Investigators must have an approved animal protocol listing the requested controlled substance.  A list of current approved protocols is maintained by EH&S through the IACUC.  Prior approval by the State Attorney General’s Office is required for the use of a Schedule I controlled substance.  (See Section 3.b.ii).

  2. Human Use: Principal Investigators must have an approved Human Subjects protocol listing the requested controlled substance. Order requisitions intended for human use must specify an approved protocol number.  Prior approval by the State Attorney General’s Office is required for use of a Schedule I or II controlled substance. (See Sections 3.b.i., ii).

  3. In-vitro Use: Principal Investigators must complete the Controlled Substance Use Authorization (CSUA) Form and complete the appropriate sections of the form.  Signature approval from the Department Chair and/or Dean or higher office is required.  See Appendix D.

6. Acquisition of Controlled Substances and Precursor Chemicals

6.a. Acquisition via Vendors

Controlled substances and precursor chemicals for the purpose of research, instruction and chemical analysis must be purchased through the Purchasing Department under UC Irvine’s institutional or the school’s departmental DEA research registration.  Order requisitions must be placed under the name of the Principal Investigator or faculty member who is an Authorized User.  A secondary name for contact purposes can be listed on the “requested by” line of the requisition.

Requisitions must be submitted via the SNAP PAL web system to create a high value requisition with PAL web, PAL, or Zeus by an authorized departmental purchasing agent for delivery to the Student Health Center Pharmacy. Procedures for using the SNAP PAL web system to purchase controlled substances are located on the Purchasing Department web site.

6.a.i. Pre-approval of Requisitions for Controlled Substances and Precursor Chemicals

All purchase requisitions for controlled substances and precursor chemicals must be pre-approved by EH&S and the DEA prior to processing by the Purchasing department.  All Principal Investigator should order their own supply of drugs.

Orders are approved if:

The order requisition is made under the name of a Principal Investigator or faculty member in the CSUA application. (See Section 4).

And one of the following:

6.b. Acquisition via Any Other Company or Institution

A controlled substance provided by a private company for research purposes must first be requisitioned through the Purchasing Department at no charge for delivery to the Student Health Center Pharmacy and must be pre-approved by EH&S (See Sections 6.a., 6.a.i.).  Drugs may not be delivered directly to researchers without EH&S and the DEA 222 form.

6.c. Precursor Chemical Acquisition Option

Researchers with their own DEA registration or California Precursor Permit can place orders with vendors for precursor chemicals under their registration for delivery to their address.

7. Pick Up of Controlled Substances and Precursor Chemicals

The delivery point of all controlled substances and precursor chemicals is the Student Health Center Pharmacy on campus.  The pharmacist accepts delivery of orders, opens and verifies order accuracy, and notifies the vendor of any missing or incorrect orders by the next business day following delivery.  The pharmacist then notifies the principal investigator or faculty member of the delivery via email.  The principal investigator is responsible for picking up orders within 3 working days.  Orders will again be counted and verified by the Pharmacy staff with the principal investigator or their designate when orders are picked up.

Principal Investigator may designate research staff who have Authorized User status to pick up deliveries from the Student Health Center Pharmacy.  The option to add a secondary name on the purchase requisition alerts the pharmacy staff to notify the designee as well as the principal investigator of delivery status.  A photo identification will be required to pick up all orders.  (See Section 6.a). 

8. Transfer of Controlled Substances

As of July 1, 2009, UCI does not allow the transfers of controlled substances between UCI principal investigators as this is no longer allowed in the Departmental DEA registration.  Please note that it is a felony to provide/posses a controlled substance that is not registered with the DEA.

In addition, researchers may not transfer controlled substances to or from other institutions and cannot be carried across state lines.  

Drugs no longer needed for research at UCI must be disposed of in accordance with UCI procedures.
(See Section 13).

9. Storage of Controlled Substances and Records

Storage of controlled substances must provide for effective prevention of theft.  Federal regulations require registrants to store controlled substances in a securely locked, and substantially constructed cabinet.  Proper storage of both drugs and usage logs is the responsibility of the Principal Investigator. 

Both the drugs and usage logs must be kept in a secure area while in use with access limited to as few individuals as possible, all of whom must be Authorized Users. (See Section 4).

To prevent theft, controlled substances should never be left unattended, inventory kept at minimum, and access provided to as few researchers as possible.

Controlled substances must be stored securely in a manner adequate for safeguarding and must be separated from other drugs, chemicals, or items. This practice will help to prevent loss by limiting access to those assigned to work with the controlled substances. It is highly recommended that access be limited to one or two individuals.  Be aware of DEA regulations that require cabinets to be firmly attached and secured to prevent possible removal.  DEA inspectors will check to see if the cabinets are bolted to a permanent structure (i.e. wall or floor) and that the interior double locked compartment is bolted to the main cabinet.  It is unacceptable to have the keys to the cabinet left in the lab, keys allowing access to the controlled substances must be in the possession of authorized individuals.

Controlled substances must not be left unattended on the countertops and/or lab benches.  Dilutions of the stock drug concentration must also be secure and never left unattended especially when disposing of that small amount left at the end of the day's work.  Controlled substances must never be used after their expiration date. 

Expired drugs must be disposed of in accordance with UCI procedures.  Periodic inspections by UCI's IACUC will look for both expired and unsecured controlled substances.

Acceptable storage

Unacceptable storage

10. Recordkeeping of Controlled Substances

10.a.     Usage Logs

The PI and his/her staff are required by federal and state law to document the use of controlled substances.  Records must include “details” from the date of order pick up from the Student Health Center Pharmacy throughout the controlled substance’s life cycle, i.e., until containers are empty or disposed of in accordance with proper disposal procedures.  (See Section 13).

Records must be kept secure in a locked area, preferably in the same secure storage with the drugs. Records must include the order invoice sheet, all Usage Logs for that order, and any disposal records.

Usage Logs must include the name of the drug, strength, amount received, name of principal investigator, and date of pick up from the Student Health Center pharmacy.  Usage Logs must indicate the amount of each use, date of use, name and signature of the Authorized User using the drug, and a balance remaining each day.  Initials can be utilized after the first time a name and signature is entered on a Usage Log.  Typically, the Usage Logs provide a legally defensible paper trail for the controlled drug while it was in the responsible PI's possession.  Without the Usage logs, there would be no record of the controlled substance proper vs. Improper use.     When you're done with a Usage log, you must submit a copy of your Usage log to the controlled substance coordinator via fax at 824-1325.

Blank Usage Logs are provided at the Student Health Center Pharmacy when orders are picked up or on the EH&S web site at https://www.ehs.uci.edu/programs/occhlth/control.html .  Other formats of the usage logs are not acceptable.  (See Appendix B).    

California law requires that all controlled substance users retain all records relating to acquisition, usage, and disposition of controlled substances for three years after disposal or terminal use.

10.b.     Inventory Log

EH&S conducts an inventory every two years as required by federal law.  Each principal investigator will be required to sign an Inventory Log acknowledging the amount of controlled substances in their possession.  The inventory takes place between May and June on even-numbered years (i.e., 2006, 2008, etc.)  Researchers will be notified by email two weeks before the completed and signed Inventory Log is due to be returned to EH&S. (See Appendix C). 

Researchers who fail to complete and return the Inventory Log by the date requested will have their Authorized User status suspended until submission of the delinquent Inventory Log.

11. Inspections

The Controlled Substance Coordinator will conduct random inspections of research labs which use controlled substances.  Included is inspection of the proper storage and recordkeeping of controlled substances.

The DEA may conduct random audits and inspections of UCI’s Controlled Substance Program. An inspection by the DEA would be conducted in coordination with EH&S.

EH&S conducts general safety inspections of all university research laboratories every two years.  The researcher’s security practices pertaining to controlled substances are included during these inspections.

The UCI Institute of Animal Care and Use Committee (“IACUC”) conducts twice yearly inspections of all laboratories approved for animal research.  This inspection includes a check of proper storage of controlled substances.

12. Theft

All employees who have knowledge of, or reasonably suspect,  theft or significant loss of controlled substances, or alteration of records indicating drug loss must immediately report such information to the Controlled Substance Coordinator at EH&S at 824-3757, the principal investigator and/or lab supervisor.  If the material is stolen or diversion is suspected EH&S will forward information to the UC Irvine Police Department.  EH&S will submit the required Theft Notification form to the DEA.

13. Disposal of Controlled Substances

To schedule a pick up of expired controlled substances or precursor chemicals no longer needed, researchers must submit the Request for Disposal found on the EH&S web site at: www.ehs.uci.edu.

The controlled substance coordinator will schedule a time to pick-up the drugs from a researcher.  The Student Health Center pharmacy will only accept controlled substances for disposal from EH&S.

Principal investigators must maintain a copy of disposal records for controlled substances along with the usage log(s) and order invoice sheet for 3 years after disposal or terminal use.  (See Section 10.a).

Empty bottles from controlled substances can be disposed of in any appropriate waste container. 

Upon permanent closure of a researcher’s lab or termination of employment, disposal of all controlled substances in accordance with University policies and procedures is required.  Controlled substances may not be transferred to another institution.  Records of disposal and all usage logs of closed labs must be forwarded to the Controlled Substance Coordinator at EH&S Zot code 2725.

Under no circumstances are controlled substances to be abandoned.  However, occasionally faculty will leave without properly disposing or transferring all controlled substances from their lab.  Sometimes faculty acquired the controlled substances before registration was required.  Under these circumstances, the school's department is responsible for the lab.  Failure to comply with the authorization, storage, security, inventory, and recordkeeping process established within the University's program exposes UCI’s departments and institutional registration to losing its registration and gravely impacting other researchers’ ability to conduct research involving controlled substances and precursor chemicals.  In these kinds of circumstance, Department Chairs must contact the Controlled Substance Coordinator to arrange for the appropriate disposal and notification to the DEA. 

Employees who violate UCI Policy and Procedures or applicable law related to controlled substances or List I chemicals will be subject to disciplinary action, up to and including termination of employment and/or referral to the appropriate law enforcement officials.

Any person who is registered with the DEA who violates record-keeping requirements or abandons controlled substances will be subject to the civil penalties outlined in the United States Code (USC): 21 USC Sec. 842. Please note that abandoning substances is equivalent to distributing a controlled substance to an unauthorized person.

http://www.usdoj.gov/dea/pubs/csa/842.htm

14. Appendices

Appendix A: Controlled Substances Use Authorization Form for Animals, Human Subject, and In-vitro
Appendix A1 (Section A1): Screening Data Sheet for Principal Investigator (PI)
Appendix A2 (Section A2): Screening Data Sheet for Authorized Personnel
Appendix B: Usage Log
Appendix C: Inventory Log
Appendix D: Flow Chart: Purchase Process


Contact Information:

Environmental Health & Safety

Karla Cornejo Controlled Substance Program Coordinator
949-824-3757
Zot Code 2725

Sheila Hedayati, Manager, Biosafety and Employee Health Programs
949-824-9888
Zot Code 2725

Student Health Center Pharmacy

John Shioya, Pharmacist
949-824-1440