Revised
Campus Policy Number: 850-35
Policy Topic: Procurement, Use, and Disposal of Controlled Substances
Listed Chemicals, and Chemical Precursors
Policy Owner: Environmental Health and Safety
Effective Date: 07/01/2010
A. Introduction and Overview
This policy provides guidance to UCR faculty and staff regarding the general program requirements for the use of controlled substances, listed chemicals, and precursor chemicals that are used in campus research and teaching activities. The above policy does not apply to controlled substances dispensed by a practitioner to a patient in the course of professional practice as authorized by his/her license, or to the UCR Campus Pharmacy. Medical practitioners are required to maintain appropriate state and federal licensure with respect to dispensing controlled substances.
In addition to controlled substances, the DEA and State of California regulate chemicals that may be used in the production of these substances.
The Drug Enforcement Administration (DEA) maintains 2 lists of these chemicals, while the State of California maintains a list of “Precursor Chemicals”. The California Precursor Chemicals include the DEA Listed chemicals, as well as additional chemicals. Requirements for the procurement and use of these chemicals are less restrictive than for controlled substances.
B. Background and Related References
The Drug Enforcement Administration (DEA), a division of the United States Department of Justice, has established stringent restrictions on the procurement, handling, use and storage of drugs and related compounds (controlled substances). The University of California Controlled Substance Program Best Practices Guide (BUS 50) is the guidance document for all University of California campuses on how to assure compliance with federal and state regulations. All University locations are expected to implement the program using the BUS-50 or an equally effective procedure. A Responsible Official is designated by the Chancellor for oversight of the controlled substances program. The Responsible Official designates a Program Administrator who is responsible for management of the program on a day to day basis. Refer to the Delegations of Authority website: Delegations of Authority website to view the Delegation of Authority for the UCR Controlled Substances Program.
References:
· 10 CFR Title 21, Food and Drug Act 1300-1316
· California Health and Safety Code 11100-11700
· University of California Controlled Substance Program Best Practices Guide (BUS 50)
C. Definitions
Authorized Person - Principal Investigators and research staff who have successfully completed the authorization process for controlled use and/or pickup
Biennial Inventory - Detailed inventory of all controlled substances present at UCR on a specified date and time conducted every two years at the direction of the Program Administrator
Controlled Substances - Narcotic and non-narcotic drugs under the jurisdiction of the Federal
Controlled Substances Act and the California Uniform Controlled Substances Act
DEA - Federal agency responsible for enforcing the controlled substance laws and regulations
Environmental Health and Safety (EH&S) - Administrative unit that manages the campus EH&S programs
Listed Chemicals - Under federal law, any List I or List II Chemical that can be used in manufacturing a controlled substance
Materiel Manager - Individual delegated authority and responsibility for the procurement of controlled substances, listed chemicals, and precursor chemicals in compliance with DEA registration and the campus Controlled Substance Program
Precursor Chemicals - Any chemical that can be used to create a controlled substance including, but not limited to catalysts, direct precursors, or crucial ingredients used in the production of controlled substances
Program Administrator - Individual delegated authority and operational responsibility for the campus Controlled Substance Program
Research Advisory Panel of California - Function of the California Attorney General’s office, which must review and authorize proposed research projects involving certain opioid, stimulant, and hallucinogenic drugs classified as Schedule I and Schedule II Controlled Substances
Responsible Official – Individual delegated authority and responsibility for oversight of the campus Controlled Substance Program
Schedule of Controlled Substances - Classifications of narcotics and dangerous drums, ranked according to their potential for abuse and other relevant factors, as denoted by roman numerals I through V.
· Schedule I - No currently accepted medical use. Highest potential for abuse.
· Schedule II - Currently accepted medical use with restrictions. High potential for abuse with server psychological or physical dependence.
· Schedule III -Currently accepted medical use. Abuse of drug may lead to moderate to low physical dependence or high psychological dependence.
· Schedule IV - Currently accepted medical use. Low potential for abuse relative to Schedule III.
· Schedule V - Currently accepted medical use. Low potential for abuse relative to Schedule IV.
Usage Log - Form used by the Authorized Person to track controlled substance use
D. Policy
Primary Investigators wishing to use controlled substances, listed chemicals, and/or chemical precursors must complete a Controlled Substance Use Application (CSUA), undergo a criminal background check, and complete an on-line training class. Final approval to use controlled substances will be given by UCR Environmental Health and Safety. Controlled substance orders will be handled through UCR Materiel Management. Controlled substance deliveries and disposal will be handled by UCR Environmental Health and Safety.
E. Procedures (Roles and Responsibilities)
Chancellor
The Chancellor is responsible for providing resources to effectively administer a Controlled Substance Program and to designate in writing, a Responsible Official to establish and oversee the program
Responsible Official
· Establish and oversee the Controlled Substances Program in accordance with DEA guidelines
· Sign all DEA registrations on behalf of the UC Regents; and
· As appropriate, grant a Power of Attorney to managers to enable them to obtain and execute order forms for controlled substances. The Responsible Official my designate one or more individuals to implement and manage the program.
Program Administrator
The Responsible Official’s designee charged with implementing and managing the Controlled Substances Program on a day-to-day basis.
Material Manager
Responsible for procuring controlled substances, listed and precursor chemicals in compliance with DEA registrations and the UCR Controlled Substances Program.
Authorized Individuals
A Principal Investigator or laboratory member authorized to possess or use Controlled Substances by the University are responsible for understanding their responsibilities within the program and complying with DEA regulations, and campus program requirements regarding the purchase, use, storage, and disposal of controlled substances.
F. Frequently Asked Questions
1. How do I know if I need to fill out a Controlled Substance Use Authorization?
2. How do I complete the controlled substance training?
3. Where can I find the Controlled Substance Use Authorization Form and the other forms?
5. What type/kind of background check is required for access to controlled substances? Can and should faculty, staff (represented), staff (unrepresented), students, and volunteers be treated consistently?
Answers to the aforementioned questions may be found on the EH&S Website/Controlled substances http://www.ehs.ucr.edu/controlledsubstances/
G. References and Resources
H. Feedback
For questions or comments on this policy, please contact the Director of EH&S at (951)-827-5528, or UCRpolicy@ucr.edu.