Controlled Substance Requirements

Contact the OES Controlled Substances Coordinator. The Controlled Substances Coordinator will set up a time to meet for the initial training.

The Controlled Substance Coordinator will help you to make sure the required information is included, such as:

1. Name and address of the investigator
2. Any current registration or license numbers
3. Qualifications including CV and a list of publications.
4. Title of research project
5. Statement of the purpose of research
6. Name of each of the controlled substances to be used, amount, and justification.
7. Source of the controlled substances
8. Detailed description of the procedures including number and species of research subjects.
9. Dosage to be administered, route, and method of administration.
10. Duration of project
11. Location where the research will be conducted
12. Outline of security parameters in place.
13. List of authorized users

1. Fill out DPH form 1026
2. Print out and mail with a check for $125 made payable to “DPH” to:
   
   

   SC DPH Bureau of Finance  P.O. Box 101106 Columbia, SC 29211

3. You will be contacted to schedule a Pre-Inspection.
4. When the registration is approved, you will receive a DPH Registration number.

1. Fill out Form 225 for “Researcher”. (Scroll Down)
2. You may qualify for a Fee Wavier.  Contact the Controlled Substance Coordinator for the Certifying Official information.

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.
• SC DPH and DEA Agents will assess and approve Storage and Security Measures during the application process.

The following documents must be maintained for two years:

1. The research protocol with the list of authorized users and the signed certification statement
2. Receipt logs and packing slips that are signed and dated of all controlled substances.
3. Initial inventory
4. Annual inventories taken on May 1st
5. Use/Administration logs
6. Dilution logs
7. Disposal forms
8. Transfer forms

Note: OES has templates available for these logs.

1. Personnel changes should be updated in the authorized user list. New personnel should sign the certification statement.
2. Changes in controlled substances (drug type, amounts, etc.) should be communicated to SC DPH/DEA to determine a path forward.

SC DPH requires an annual inventory which is due on May 1. This is SEPARATE from the annual renewal 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 DPH requires notification via the same form you send the DEA (DEA Form 106), which can be emailed to bdc@dhec.sc.gov.

Please also contact the Controlled Substance Coordinator with any concerns about drug diversion.

License holders must keep all records relating to Controlled Substance ordering, procurement, use, and inventory for two (2) 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 DPH 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 substance disposal methods must be approved by SC DPH and the DEA. Contact OES or the Controlled Substance Coordinator to schedule disposal.  To document disposing of controlled substances:

1. Contact SC DPH BEFORE DISPOSAL to let them know you are planning on disposing of controlled substances.
2. Fill out DEA Form 41 and send it to bdc@dph.sc.gov
3. Keep copies of all forms for two years with your records.