DEA Registration and Renewal

Summary of DEA Registration and Approval Process

This section describes how to acquire a DEA registration, renew an existing DEA registration, obtain duplicate copies of a DEA registration, and how and when to request a modification to a DEA registration. The DEA Registration & Renewal Fact Sheet summarizes these processes.

Refer to the detailed information below for registration process, forms, fees, etc.:

  1. Go to the DEA website and access Forms 224 or 225.
    • This distinction will depend on your business activity.
  2. Follow the menu sequence: Registration → Applications → New Applications Online.
    • Form 224 – Practitioner; Mid-Level Practitioner; Pharmacy: Valid for three years with paid registration.
    • Form 225 – Researcher; Analytical Lab: Valid for one year with paid registration.
  3. Complete the online DEA Registration Form 224 or 225.
    • Once your application is submitted, a DEA Investigator will contact you. The investigator will provide you with a series of questions to complete and schedule an upcoming meeting or visit to approve your CS.
  4. Notify EH&S at ehs-cs@usc.edu of DEA appointment time and schedule a preview of storage site.
    • EH&S will assist you with the preregistration questions and requests from the DEA.
  5. To use CS in animal studies, submit protocols to the Institutional Animal Care and Use Committee (IACUC) via iStar  for approval. Principal Investigators must obtain DEA registrations which reflect CS use approved on their respective IACUC protocols.
  6. To use CS in vitro, consult with Biosafety (biosafety@usc.edu or (323) 442-2200) to see if IBC registration is required. Principal Investigators must obtain DEA registrations which reflect CS use approved on their respective IBC protocols.
  7. DEA investigator(s), DEA Registrant, and EH&S CS personnel will meet online or at the location listed on the DEA application.
  8. Following approval, a DEA registration will be granted.

Researcher and Practitioner DEA Registration for Schedule II-V Drugs

Each Principal Investigator (PI) with the intent to conduct research using controlled substances, schedule II-V, is responsible for obtaining a DEA registration prior to enrolling in the required USC EH&S Controlled Substance Use Authorization (CSUA) Program. A state controlled substance registration is not required prior to obtaining a DEA registration as California does not have a State Controlled Substance Program.

The type of DEA registration required is dependent on the nature of the business activity involving CS use. A Researcher or Practitioner DEA registration is required to conduct research at the University. Non-medical professionals (e.g. PhD scientists) must acquire a Researcher DEA registration while licensed professionals (e.g. medical doctors and veterinarians) may use their Practitioner DEA registration given the following stipulations.

  • Practitioners are permitted to use their existing DEA registration for research in a USC laboratory ONLY if the address on their DEA license matches the storage and use location of the CS used for research purposes.
  • DEA registrants that have more than one location (separate street addresses) where CS are maintained, administered and/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 the required applications online as follows:

Practitioner (MD, DO, DDS, DMD, DVM, DPM)

Researcher

Registration categories, fees and requirements may be viewed at DEA Registration. New applications are generally processed within 6 to 8 weeks. Applicants may call the DEA at 1-800-882-9539 to check on the status of their application or call their nearest DEA Field Office if they have additional questions.

Do not handle CS until your DEA registration is received and approved. Submit a copy to the CS Program Manager at ehs-cs@usc.edu when received. A copy of your most recent DEA registration must be readily available upon DEA and EH&S inspections.

Research Advisory Panel of California

Principal Investigators must independently seek authorization from the Research Advisory Panel of California (RAPC) if their research projects specifically involve the following categories:

  • Any human or non-human research using Schedule I controlled substances.
  • Academic human research using any Schedule I or Schedule II controlled substances.
  • Research for the treatment of drug addiction or abuse utilizing any drug, scheduled or not.
  • Clinical drug trial protocols evaluating or comparing any Schedule II controlled substances.

Principal Investigators with research projects that can be classified into one or more of the above categories must submit an application to RAPC. RAPC applications and submittal procedure may be viewed and obtained at Research Advisory Panel of California. Contact the CS Program Manager (ehs-cs@usc.edu) to:

  • Initiate the RAPC application.
  • Submit copies of all RAPC application materials.
  • Submit a copy of the RAPC approval.

NOTE: Do not apply to the RAPC if Schedule II CS do not adhere to the above guidelines (e.g., will be used in non-human research).

In addition to obtaining permission from the RAPC, Principal Investigators with research projects that require use of Schedule I controlled substances must also obtain a separate DEA registration for each Schedule I CS. Principal Investigators who plan to purchase, use or store Schedule I CS may not apply for or submit initial DEA registration applications online. A PDF DEA registration application must be mailed to the DEA via the US Postal Service.  Principal Investigators must abide by the protocol presented in 21 CFR 1301.18.

IACUC and Animal Use

Research that involves controlled substances used in animal studies requires oversight and protocol approval from the Institutional Animal Care and Use Program Committee (IACUC) via iStar. Principal Investigators must obtain DEA registrations which reflect CS use approved on their respective protocols. For more information please contact the Department of Animal Resources (DAR) at daradm@med.usc.edu; (323) 442-1689.

DEA Registration Renewal

Summary for DEA Registration Renewal

Registration is renewed annually for DEA registrants with a Researcher license or every three years for DEA registrants with a Practitioner license.

  1. Access the DEA Registration Renewal Login online.
  2. Complete all required fields and click the “Login” button.
  3. Complete per instructions provided by the DEA.
    • NOTE: California does not have a state controlled substance registration program. Therefore, complete section 3 as follows:
      1. State License Number – “Not Applicable”
      2. State License State – “California”
      3. State Controlled Substance Number – “Not Applicable”
      4. Expire Date – Select an expiration date after the date of your renewal registration application submittal
  4. Forward a copy of your updated DEA registration to ehs-cs@usc.edu.

If your original certificate is misplaced, illegible, or destroyed, you may obtain a Duplicate Certificate.

As of January 1, 2017, the DEA will only send out one renewal notification to DEA Registrants in accordance with Title 21, Code of Federal Regulations, Section 1301.13(e) (1). The renewal notification will be sent to the mailing address for each DEA registrant approximately 65 days prior to the expiration date. No other reminders from the DEA to renew the registration will be mailed.

In addition, the CS Program Manager (ehs-cs@usc.edu) will dispatch frequent reminders to the DEA registrant as a courtesy to ensure continued compliance.

Renewal/reinstatement of a registration by the DEA is generally a four to six week process and is contingent upon the following criteria:

  • Renewal application submitted PRIOR to expiration date. The registrant may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application.
  • Renewal application submitted AFTER expiration date. The DEA will allow the reinstatement of an expired registration for one calendar month after the expiration date. If the registration is not renewed within that calendar month, an application for a new DEA registration will be required.

Note that federal law prohibits the handling of controlled substances or List 1 chemicals for any period of time under an expired registration. It is the responsibility of the DEA Registrant to renew his/her registration prior to its expiration and provide EH&S with a copy of the renewed license.

DEA Registrants may call the DEA at 1-800-882-9539 to check on the status of their application or call their nearest DEA Field Office. Copies of renewed DEA registrations must be submitted to the CS Program Manager at ehs-cs@usc.edu.

Modifications

A DEA Registrant must request for a modification to his/her DEA registration when the following occurs:

  • Change in DEA Registrant Name.
  • Change in DEA registration address (where CS is maintained, administered and/or dispensed).
    • If the DEA Registrant relocates to a new physical location, approval by the DEA is required.
    • The CS Program Manager (ehs-cs@usc.edu) must also be contacted at least two months in advance of relocation to inspect and approve new storage location.
    • If the modification is approved, the DEA will issue a new certificate of registration.
      • The registrant should maintain the new certificate with the old certificate until expiration.
  • Change in CS schedules and/or drug codes.

A copy of the modified DEA registration must be submitted to the CS Program Manager (ehs-cs@usc.edu). NOTE: If a DEA investigator requests an in-person visit in response to a modification or DEA license renewal, notify ehs-cs@usc.edu. EH&S can assist the DEA Registrant with any preparation prior to the scheduled on-site visit and will accompany the DEA Registrant during the visit.

Duplicates

If your original certificate is misplaced, illegible, or destroyed, you may obtain a Duplicate Certificate.