Controlled Substance and Precursor Chemical Program

Controlled Substances Act of 1970

Under U.S. federal drug policy, the Controlled Substances Act (CSA) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) regulates the manufacture, possession, use, importation, and distribution of certain narcotics, stimulants, hallucinogens, depressants, anabolic steroids, and other chemicals. The CSA also ranked all regulated substances into one of five categories: Schedule I through Schedule V. The ranking of a particular substance is determined based on the medical use of the substance, the means of potential abuse of the substance, as well as safety and/or dependence liability. The Drug Enforcement Agency (DEA) is responsible for implementing the CSA, and is also responsible for prosecuting violators of the CSA domestically and internationally. In order to distribute, store, handle, or order controlled substances, you must be registered with the DEA. Additionally, those registered with the DEA are responsible for maintaining accurate inventory of such substances, as well as keeping accurate records and providing adequate security over the controlled substance.

For more information regarding the requirements and responsibilities of the Controlled Substances Act, review the official documentation for the CSA both on the federal and state level:

Definitions

Precursor Chemicals

A chemical or solvent that is used in the manufacture of controlled substances which is regulated by the Drug Enforcement Administration (DEA) under the Federal Controlled Substances Act is referred to as a precursor chemical. These listed chemicals and solvents are categorized into two lists by the DEA, List I and List II. California also provides additional categorization with the DOJ precursor chemicals list. Generally, List I represents precursor reagents and List II represents solvents used in the purification and/or synthesis of controlled substances.

Controlled Substances

A drug or other chemical substance, or immediate precursor, which is regulated by the Drug Enforcement Administration (DEA) under the Federal Controlled Substances Act as well as the California Uniform Controlled Substances Act is referred to as a controlled substance. These substances and substances are categorized according to a substance's medical use, potential for abuse, and safety or dependence liability through the use of designations referred to as Schedules. The ranking systems used by the DEA go from Schedule I to Schedule V substances, with Schedule I being the most regulated substance and Schedule V being the least regulated substance. As a result, the University of San Francisco permits the use of Schedule II through Schedule V substances only, unless special permission has been granted by the DEA and the USF Environmental Health and Safety Office.

DEA Schedules I through V

Schedule I

Schedule I substances are defined by a high potential for abuse and a lack of accepted medical use in treatment within the United States. There is a lack of accepted safety for use of a schedule I substance under medical supervision.

Schedule II

Schedule II substances are defined by a high potential for abuse, but are currently used in medical treatment in the United States (or currently accepted medical use with severe restrictions). Abuse of schedule II substances may lead to severe physical or psychological dependence.

Schedule III

Schedule III substances are defined by a medium level of abuse potential and have a currently accepted medical use in treatment within the United States. Abuse of the substance may lead to moderate or low physical dependence or high psychological dependence.

Schedule IV

Schedule IV substances have a relatively low potential for abuse and have a currently accepted medical use in treatment within the United States. Abuse of these substances may lead to limited physical dependence and/or psychological dependence.

Schedule V

Schedule V substances have a low potential for abuse. These substances have a currently accepted medical use in treatment within the United States. Abuse of these substances may lead to limited physical dependence or psychological dependence.

Lists of Regulated Substances

Regulated Precursor Chemicals

Controlled Substances Lists

FAQ:

Always check the relevant lists regarding regulated substances.

Check whether chemicals are on both the precursor chemical lists and controlled substances lists before use. These regulated substances do change periodically so check regularly as to whether or not a substance you are working with has recently become regulated.

Regulated Precursor Chemicals

Controlled Substances Lists

Summary of DEA registration and approval process:

  • Complete either the DEA Form 224 or Form 225 and pay applicable fee. 
  • Notify the USF Office of Health and Safety of the DEA appointment time in order to schedule a preview of the storage site. This will assist with pre-registration audit questions and requests provided by the DEA.
  • If you are planning on using controlled substances in animal research, submit your application to the USF Office of Health and Safety for approval.
  • The DEA agent(s), DEA Registration, and EH&S personnel will meet at the location listed on the application.
  • DEA registration will be granted following the approval of submitted documentation.

DEA Registration for Schedule II-V Controlled Substances

Principal Investigators (PI) that intend on using controlled substances are responsible for obtaining an individual federal DEA registration prior use or purchase of controlled substances.

The type of DEA registration required is dependent on the intended use of the controlled substance. For example, a Researcher or Practitioner DEA registration for controlled substance use is required to conduct research at the University. Non-medical professionals, such as PhD scientists, must acquire a Researcher DEA registration while licensed professionals, such as veterinarians or medical doctors, may use their Practitioner DEA registration. Separate registration may not be required for practitioners who are already registered and engaging in research with controlled substances.

DEA registrants that have more than one location where controlled substances are maintained, administered, or dispensed must obtain a separate DEA registration for each location. If using different rooms within the same building, but only storing them at one location within the specified building, DEA registration need only reflect the storage location.

New applicants seeking a Researcher or Practitioner DEA registration must submit:

Practitioner:

Researcher:

Registration categories, fees, and requirements may be viewed at the DEA registration site. New applications are processed within 6 to 8 weeks. Do not handle controlled substances until DEA registration is received. Controlled substances may only be handled at the location indicated on the DEA registration. A copy of your DEA registration must be maintained and made readily available upon DEA and EH&S inspections. A copy of DEA registration must also be submitted to the EH&S Office.

DEA Registration Renewal

Summary of DEA registration renewal process:

  • Access the DEA Registration Renewal Form online.
  • Complete the DEA Form 224A or Form 225A depending on whether you are renewing as a practitioner or researcher.
    • Note that California does not have a state controlled substance registration program. Therefore, please indicate the following for Section 3:
      • State License Number - "Note Applicable".
      • State License State - "California".
      • State Controlled Substance Number - "Not Applicable".
  • Forward a copy of your renewed DEA registration to the USF EH&S Office.

DEA Registrants are required to submit the applications online as follows:

  • Researcher:
    • DEA Form 225A
    • Re-submitted annually
  • Practitioner
    • DEA Form 224A
    • Every 3 years

Special Cases

DEA registrants must request for modified DEA registrations when the follow occur:

  • Change in the DEA registrant's name.
  • Change in the DEA registration address.
  • Change in the controlled substance's schedule ranking and/or drug code.

Always submit the most recent version of the DEA registration to the USF EH&S Office.