Controlled Substances Policy

This policy establishes the guidelines for the authorization, procurement, storage, control, annual inventory and disposal of all Controlled Substances, Listed Chemicals, and Industrial Hemp for research and educational purposes. Environmental Health & Safety (EHS) is the designated Controlled Substances Program Administrator overseeing the day-to-day activities of the program.

A controlled substance is a drug or chemical whose manufacture, possession, and use are regulated by the U.S. federal government and require Drug Enforcement Agency (DEA) registration. All campus employees must comply with the following Federal and State regulations regarding controlled substances:

• Title 21 United States Code (USC) Controlled Substances Act
  • https://www.deadiversion.usdoj.gov/21cfr/21usc/801.htm
• Title 21 Code of Federal Regulations, Part 1300 to end
  • https://www.deadiversion.usdoj.gov/21cfr/cfr/2100cfrt.htm
• California Health and Safety Code (HSC) Division 10, Section 11000-11651, California Uniform Controlled Substances Act
  • https://leginfo.legislature.ca.gov/faces/codes_displayexpandedbranch.xhtml?tocCode=HSC&division=10.&title=&part=&chapter=&article=
• California Food and Agricultural Code (FAC) Division 24, Section 81002-81006, Industrial Hemp
  • https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=81002.&lawCode=FAC

Controlled Substance – A substance that has a stimulant, depressant, or hallucinogenic effect on the nervous system (e.g., cocaine hydrochloride, fentanyl citrate, oxycodone hydrochloride, cannabis, etc.). Controlled substances are further classified as Schedule I, II, III, IV, or V and can only be obtained by registrants with the DEA.  Possession and/or use is regulated under the Federal Controlled Substances Act and the California Uniform Controlled Substances Act.

Listed Chemical – Chemicals that are regulated by federal and/or state law that may be used to manufacture controlled substances and were established by Public Law 103-200, the Domestic Chemical Diversion Control Act of 1993.

Principal Investigator – A Principal Investigator (PI) includes Professors, Associate Professors, Assistant Professors, Instructors, and Veterinarians who are assigned space for research or teaching activities. In the context of this program, the PI is also the individual that holds the DEA license (registrant).

Authorized Personnel – Authorized personnel are faculty, students, staff, or visiting scholars who have a need to handle or access-controlled substances for department-approved projects at CSUDH. For security purposes, the number of Authorized Personnel shall be kept to a minimum. To become an authorized person, an individual must have no prior history with controlled substances abuse or diversion.  The PI is responsible for assigning the privileges of Authorized Personnel and completing the Authorization to Access Controlled Substances form included in Attachment 1.

Industrial Hemp – A crop that is limited to types of the plant Cannabis sativa L. having no more than 0.3% tetrahydrocannabinol (THC) contained in the dried flowering tops, whether growing or not; the seeds of the plant; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin produced therefrom.

Marijuana-Related Research – Research that involves the growth, production, procurement, possession, distribution, administering, or use of marijuana. It does not refer to observational research or other research (e.g., policy research) for which a researcher does not grow, produce, procure, possess, distribute, or administer marijuana.  As defined in the federal Controlled Substances Act the term marijuana (or “marihuana”) means: “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.”

The Controlled Substances Program Administrator (or the Administrator’s delegated authority) is responsible for the following:

• Oversee and enforce the Controlled Substances Program policy.
• Conduct initial assessment of new controlled substances program participant storage location(s).
• Maintain current PI DEA registration on file.

PIs are responsible for the following:

• Maintain a current DEA license and adhere to all federal and state requirements pertaining to controlled substances.
• Oversee the purchase and receipt of controlled substances.
• Maintain an up to date and accurate usage log/inventory.
• Assign privileges to Authorized Personnel as needed.
• Supervise their facility and Authorized Personnel in compliance with this program policy.

Authorized personnel are individuals designated by the PI to access and work with controlled substances under their particular DEA License.   Authorized personnel must:

• Use controlled substances exclusively for the purpose stated in the DEA License.
• Maintain a secure storage location for controlled substances at all times.
• Return controlled substances to the secure storage location when not in use.
• Record dispensation of any controlled substances in the log sheet.
• Properly dispose of controlled substances.

Clinical professionals working in Student Health Services are responsible for obtaining clinical DEA registration to dispense controlled substances to patients. Clinical use of controlled substances is not included in this program.

Each individual PI is responsible for applying and registering with the DEA to purchase, store, and use controlled substances for research or educational purposes. PI’s must provide EHS with electronic copies of all registration application forms and a copy of the approved registration (license). If the registration is no longer needed, the PI shall provide in writing to the DEA a request to discontinue use of their registration and provide a copy of this request to EHS.

The PI is responsible for notifying the DEA and EHS of any changes that may impact the registration such as a change in storage location, research process, or the type/amount of controlled substances used.

The PI licensed by the DEA is responsible for initiating a purchase request for controlled substances by following both their department’s purchasing policy as well as adhering to DEA requirements. If there is a conflict between the two, the PI shall contact EHS for resolution. A DEA Form 222 must  be completed for Schedule I and II purchases. Controlled substances for non-patient purposes cannot be purchased with a medical doctor’s clinical DEA registration.

All shipments of controlled substances shall be delivered to the registered address established with the DEA. Only the licensed PI may receive controlled substances unless prior authorization has been granted by the DEA for others to serve as authorized receivers. Upon receipt of a delivery of controlled substances, the PI or authorized receiver must immediately open the package to verify the accuracy of its contents versus the purchase order. Any discrepancy or damage to the package should be brought to the attention of the shipper and corrected. Shipments should be immediately logged in the Controlled Substances Use/Inventory Log (provided here as Attachment 1) and secured.

After controlled substances have been received at the location designated on the DEA license, they must not be moved to another location without prior DEA approval.

Each PI shall have appropriate locked storage and control measures as required by the DEA and pre-approved by EHS. Contact EHS to arrange for an assessment of any new controlled substances storage location prior to purchasing controlled substances. Controlled substances shall be stored as follows:

• Storage unit shall be secure enough to show forced entry
• Storage unit shall be bolted or cemented in place (floor or wall) or weigh more than 750 pounds
• Storage unit shall be equipped with a padlock, pin-tumbler, or combination lock
• If a padlock, pin-tumbler, or combination lock is used, a hasp shall be installed so that there is no access to the mounting screws or bolts when the door is closed, and the lock is fastened
• Corridor storage of controlled substances is prohibited
• Hinges shall be installed so as to prevent access to mounting screws or bolts when the door is closed
• The combination or key shall at all times remain in the physical custody of the licensed PI and/or their Authorized Personnel

Storage unit shall contain only controlled substances and corresponding use logs. No other chemicals or supplies shall be stored in the controlled substances storage area.

Controlled Substances Use/Inventory Logs for Schedules I and II must be filed separately than those for Schedules III through V. Controlled Substances Use/Inventory Logs must be kept in a secure location either inside the approved controlled substances storage area or in close proximity and its location noted inside the storage area. All controlled substance dispensations from its original container shall be recorded on the Controlled Substance Use/Inventory Log. The actual amount of controlled substances remaining in the drawer must equal the documented remaining amount in the logbook at all times.

Any breakage of containers shall be noted on the corresponding Controlled Substance Use/Inventory Log, initialed by the individual responsible for the breakage, and co-signed by the PI. Receipts of controlled substances shall be noted on the Controlled Substance Use/Inventory Log. Use Logs and disposal documents shall be maintained by the PI in the controlled substance binder and shall be available upon request by the DEA or EHS.

Controlled substances shall not be transferred from the original containers for storage and/or inventory purposes. Access to controlled substances shall be denied to any individual who has had a personal application for registration with the DEA denied or revoked. The PI shall maintain a current list in the laboratory of those individuals authorized to access controlled substances using the form included in Attachment 1.

Department Chairs are responsible for notifying EHS prior to PI arrival on campus with controlled substances.  Additionally, the Department Chair must notify EHS when a PI authorized to experiment with controlled substances passes away or separates from the University.

Controlled substances shall not be transferred, shipped, or removed from the registration location except for in cases of disposal, return to supplier, or by prior agreement with the DEA.

Theft or significant loss of controlled substances or alteration of records indicating drug loss must be immediately reported to the University Police, EHS, and the Department Chair. The PI also must notify the Field Division Office of the DEA of any theft or significant loss immediately upon discovery and complete DEA Form 106 regarding such theft or loss. Thefts must be reported whether or not the controlled substances are subsequently recovered, and/or the responsible parties are identified, and action is taken against them.

Individual PIs should examine both the nature and scale of their research and the external environment in which their research is conducted to determine whether unexplained losses of controlled substances are “significant”. When in doubt, PIs should err on the side of caution in alerting the DEA of thefts and losses of controlled substances.

The DEA requires an inventory be conducted and documented every two years. PIs must declare their inventory status even if there is zero controlled substances in stock when biennial inventory is taken. The completed Controlled Substances Use/Inventory Logs can be used to document that the inventory has been completed.

The DEA may and often does perform unannounced inspections to view the current Controlled Substances Use/Inventory Logs, storage method and procedure, and other aspects of the program.

To make arrangements for disposal of controlled substances in any manner other than the dispensation or use for which they were procured, the PI must contact the DEA. In some cases, the DEA will pick up the controlled substance and dispose of it or request that the campus work with a DEA-approved vendor. Once the disposal has been completed, the respective Controlled Substances Use/Inventory Logs must be updated to reflect the disposal and retained for a minimum of three years by the PI. Empty vials can be disposed of in the same manner as any other chemical bottle of similar construction.  

Disposal must be arranged when:

• A project has been closed or terminated and controlled substances are still in supply
• A DEA registration has expired, and a renewal has not been submitted
• A PI determines that the controlled substance is no longer required
• A PI maintaining controlled substances separates from University employment
• A PI maintaining controlled substances dies

Marijuana is categorized as a Schedule I drug by the DEA. This means that federal regulations do not permit the use, production, processing, sale or growth of marijuana, except for medical or research use conducted under special licensing requirements established by the DEA, usually involving National Institute on Drug Abuse (NIDA) as the source of the marijuana and Food and Drug Administration (FDA) for approval for use of marijuana with humans. While the current U.S. Department of Justice (DOJ) has indicated that it will not focus its prosecutorial resources on the sale or use of medical marijuana in states where a well-regulated legal framework has been established, NO exemption from the federal law has been granted to any state.

Before applying for and before accepting research funding or gifts that comes directly from individuals or entities (e.g., companies, associations) whose funding is derived from the marijuana industry (for example, from a professional association of marijuana growers legally licensed in the state of California) PIs must contact EHS to obtain approval. In evaluating PI requests to accept funding or gifts/donations from such sources, a significant consideration is the requirement to comply with laws on money laundering and the aiding/abetting of illegal activities. EHS may engage campus or CSU general counsel for review.

The Federal Controlled Substances Act excludes from the definition of marijuana certain parts of the Cannabis sativa L. plant, such the mature stalks of the plant, fiber produced from such stalks, and sterilized seeds incapable of germination. Industrial Hemp is derived from the same Cannabis sativa plant as psychoactive marijuana, but unlike psychoactive marijuana, Industrial Hemp has traditionally been used for manufacturing purposes rather than for psychoactive or therapeutic effects. A DEA license would not be required in order to receive extracted DNA samples of cannabis plants for the purpose of analyses such as genetic sequencing or other genomic research.

At this time research on industrial hemp is restricted to that which does not require the handling or cultivation of the plant. CSUDH prohibits the growing or cultivating of cannabis for research purposes, by employees and students.