Controlled Substances

Controlled Substances Defined:

Chemicals and compounds regulated by the Federal (DEA) and by the State of California DOJ laws.  Controlled Substances: Psychotropic drugs and precursors regulated under the Federal Controlled Substances Act and the California Uniform Controlled Substances Act.

The DEA maintains lists of controlled substances at https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf

In order for UC Berkeley to comply with DEA regulations and to maintain an institutional DEA license, strict adherence to the Campus Controlled Substances Policy is required by all researchers.  Prior to working with Controlled Substances, Researchers must be registered with and approved by the EH&S, see EH&S webpage for instructions (link is external).

Orders for Schedule controlled substances (Schedule 2, 2N, 3, 3N, 4 and 5) need prior approval from EH&S(link is external).  The DEA website contains a complete list (List I Chemicals) of precursors.(link is external)  The State of California maintains a list of precursor chemicals(link is external) that includes all federal List I Chemicals plus a few additional chemicals.

Examples of Controlled Substances:

  • Scheduled Drugs
  • CA Precursors
  • CA Regulated

The following controlled substances are commonly used for research in campus laboratories:

  • Anabolic steroids
  • Buprenorphine
  • Chloral Hydrate
  • Cocaine
  • Codeine
  • Diazepam (Valium)
  • Ketamine
  • Phenobarbital

 

How to order Controlled Substances:

  1. Scheduled drugs that are to be used on animals must be requested to be ordered through the Office of Laboratory Animal Care (OLAC).  Scheduled drugs are delivered to OLAC and must be picked up by the requesting PI.
  2. Departments may order Schedule drugs, List 1, List 2, California Pre-Cursors and California Regulated that are not to be used on animals, directly in BearBuy.  Note that the “ship to” address for all scheduled drugs, regardless of use, must be delivered to OLAC and be picked up by the requesting PI from OLAC.
  3. The preferred ordering method would be through Bear Buy Catalogs.  If the substance isn’t offered in the catalog then proceed to step 4.  BearBuy contracted suppliers are Spectrum Chemicals, Fisher Scientific, VWR, and Sigma Aldrich.
  4. If the Supplier isn’t listed above then verify the Supplier has been set up in Bear Buy by Vendoring.  Please note for California Precursors, Suppliers must have a warehouse in State of California.  Once the Supplier has been set up in Bear Buy, use the following Form:  “Non-Catalog”. 
  5. The department should attach the following Required PO Documents to the Form as directed in BearBuy:
    1. Intended Use Statement is required for List 1, List 2, California Regulated, and California Precursor items.

                                                               i.      Statement must not mention any confidential research.

                                                             ii.      Statement must include the wet signature of the lab’s PI and date.

                                                           iii.      An Intended Use Statement is not required for Scheduled drugs.

  1. Requisition Description should include specific identification details:

                                                               i.      Lot Specifics

                                                             ii.      Required Lot Expiration Date Information

  1.  “Controlled Substance” must be checked at the Line Level.
  2. California precursor orders are cleared by the State DOJ Sacramento Office and will incur 21 days waiting period.
  3. Do not mix controlled substance items with non-controlled items.  Non-controlled items should be on a separate PO.
  4. The PI and all individuals in the lab who will be handling/using Scheduled drugs must be authorized for that substance and unit of measure in the EH&S Controlled Substance database at https://jwas.ehs.berkeley.edu/ctrlsub/.  Work with EH&S (Krystyna Kozakiewicz) to gain authorization.
  5. The DEA Form 222 is required for Scheduled 2 and 2N controlled substances and will be completed by the Controlled Substance authorized Buyer.

 

Relevant Policy/Procedures:

BFB-BUS50 – Controlled Substances (link is external), Research Policy (link is external), and EH&S website for Controlled Substances (link is external).

 

Additional Resources:

Controlled Substances workflow process map.

 

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