Program: Controlled Substances Used in Research


Lead: Krystyna Kozakiewicz
Phone: (510) 643-1397
E-mail: krystyna.kozakiewicz@berkeley.edu

Team: Health & Safety
Associate Director: Brandon DeFrancisci

Description

The Federal Drug Enforcement Administration (DEA) regulates the use of controlled substances to prevent diversion and abuse. "In order for UC Berkeley to comply with DEA regulations and maintain an institutional DEA license for use of controlled substances in research, strict adherence to the Campus Controlled Substances Program is required by all researchers. Controlled Substances are categorized by the DEA into five schedules: Schedule I is characterized by the highest potential for human abuse, Schedule V the lowest. Schedule I materials such as Heroin and LSD have no currently accepted medical use and may not be obtained via the institutional DEA license. Schedule II materials, such as Pentobarbital, Cocaine, Codeine, Morphine, and Methamphetamine, are also considered high potential for abuse, but have an accepted medical use and may be used in research if restrictions are met, such as keeping the material in a locked safe and using the appropriate DEA forms. Schedule III-V materials, such as Buprenorphine, Chloral Hydrate, Ketamine, Anabolic steroids, Diazepam (Valium), and Phenobarbital, are considered to have less potential for abuse and are commonly used in research. A complete list of DEA controlled substances by schedule is available at http://www.usdoj.gov/dea/pubs/scheduling.html.


Prior to working with controlled substances (Schedules II-V) on campus, these four steps must be completed:

  1. Registration for Research Involving Controlled Substances (Word document)
  2. Criminal Background Checks at UCPD (PDF)
  3. EH&S Controlled Substances lab inspections (to schedule contact 642-3073)
  4. Completion of online training

To revise your existing Project Registration use:


Controlled Substances Program Project Registration Update Form (Word document) and forward completed form to EH&S.


Incomplete Project Registration Procedures:

  1. The Controlled Substances Program database will be checked at least monthly by EH&S for incomplete project registration information including background checks and training. Notification of any deficiencies will be sent by EH&S to the appropriate Principal Investigator. The time allowed to respond and correct the situation is 30 calendar days.

  2. If resolution does not occur after 30 calendar days, the notification will be sent to the Department Chair, Animal Care and Use Committee and the PI. The time allowed to respond and correct the deficiencies is 14 calendar days.

  3. If, after 14 days, the issue remains unresolved, EH&S will notify the appropriate Dean and the Vice Chancellor for Research.


Resources


DEA Security Requirements
Quick Guide to UCB’s Controlled Substance Program (PDF)
Approval Flow Chart (PDF)
Registration Process (PDF)
Disposal of Unwanted or Expired Controlled Substances

Background Check Documents
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