Controlled Substance Requirements

Contact the OES Controlled Substance Coordinator to inform of intent ot apply for Controlled Substance License and registration.

Determine which materials you need for your research that are controlled.

1. For animal studies, all controlled substances you plan to use as part of your research procedures (even if applied by GSRC technicians) will require a license. Consider:
   • Surgical procedures = Any controlled anesthetics will require a license
   • Analgesia = If you plan to use a controlled substance for pain relief post procedures, you will need to apply for a license
   • Euthanasia = If you are using a controlled substance for routine euthanasia, you will need to apply for a license
2. If controlled substance use falls under routine vet care or emergency vet care, you do not need to apply for a controlled substance license.

The Controlled Substance Coordinator will guide you through the registration process.

• You must first register with SC DHEC.
• Once approved by DHEC, you may then apply for a DEA license.

The regulations specify the minimum security standards for controlled substances. Controlled substances must be stored in a securely locked cabinet of “substantial construction” (i.e., metal) behind two locks. The cabinet should not be easily broken into or removed. For example, a metal drug “lock box” bolted to the wall or other fixed surface.

• The US DOJ DEA Office of Diversion Control “Controlled Substances Security Manual: Security Requirements for Practitioners” has more information.

Generally, SC DHEC and the DEA will look for the following documentation:

• A Research Protocol including a list of persons authorized to use Controlled Substances
• Log of all orders and receipts of Controlled Substances under your license
• Initial and biennial inventory log
• Running use and disposition log for each container of Controlled Substances

Note: OES has templates available for these logs.

You are responsible for controlling access to, and use of, all controlled substances in your registration. You will need to list your inventory and log the “flow” of the controlled substance from acquisition to disposal.

The DEA requires an initial inventory once you have received your registration, a biennial inventory that must be kept on file, and an updated inventory if a new controlled substance is added to the license. The DEA does not require inventories to be submitted but must be available upon request or inspection.

The SC DHEC requires an annual inventory by May 1 each year, which is part of the annual report (see section on reporting).

Some good practices regarding inventory tracking:

Both SC DHEC and the DEA require notification of changes to the registration, including name of registrant (transferring would require the receiving registrant to apply for a new registration), new controlled substances added to the registration, and address changes.

In addition, both SC DHEC and the DEA require an annual renewal.

SC DHEC: You must renew by April 1 of each year. SC DHEC should send you a notification form in advance. If you do not renew on time, your registration is considered expired, and you are subject to a penalty fee of $100 in addition to a new registration fee.

DEA: The DEA registration must be renewed annually, with the renewal date a year from the original issue month. Researchers must submit renewal Form 225a and Practitioners renewal Form 224a. DEA will send only one renewal notification to the registrant. Additionally, renewal applications must be received no later than the current license expiration date. A new application must be submitted if you allow your license to expire. Late renewal applications will not be accepted by the DEA.

SC DHEC requires an annual inventory which is due on May 1. This is SEPARATE from the annual report due on April 1.

LOSS or THEFT Reporting:

The DEA requires notification within one business day of significant loss or theft, as well as contacting local police. For more information, visit the Diversion Control site.

SC DHEC requires notification via the same form you send the DEA (DEA Form 106), which can be emailed to bdc@dhec.sc.gov.

License holders must keep all records relating to Controlled Substance ordering, procurement, use, and inventory for three (3) years from the final disposition of the drug. Records for Schedule I and II Controlled Substances must be kept separately from records for Schedule III to V Controlled Substances. Completed inspection forms/materials provided to the Researcher by SC DHEC and/or the DEA for application approval must be perpetually retained with the respective active registration.

• There must be 2 physically separate files—one file for schedule I and II substance records and one file for schedule III – V substance records. These files can be stored in the same location.
• Copies of order forms (DEA Form 222) must be stored in a securely locked cabinet.
• Records must be maintained for at least 2 years.
• Records must be readily retrievable.

OES is authorized to inspect operations pertaining to controlled substances. License Holders and Authorized Users must comply with any OES inspection.

License Holders and Authorized Users must comply with any authorized federal or state agency inspections and must notify OES if a federal or state agency inspection is initiated.

Controlled substances must be dispositioned in accordance with DEA requirements and carefully documented and reported. Contact OES for controlled substance disposal.  For information on authorized means of collection/disposition visit:

• eCFR :: 21 CFR Part 1317 Subpart B -- Disposal of Controlled Substances Collected From Ultimate Users and Other Non-Registrants

SC DHEC requires the same notification of disposition, DEA Form 41 which can be sent to bdc@dhec.sc.gov.

Keep copies of these forms in your inventory records.