NC Controlled Substances Regulatory

Because of their potential for abuse, controlled substances have specific regulatory requirements for their acquisition, storage, security, inventory, record keeping, disposal, and importing or exporting. Rules and regulations apply to every person who manufactures, distributes, dispenses, or conducts research with any controlled substance. All controlled substances users shall fully comply with both North Carolina’s state and federal rules and regulations. For more information, see:

• DEA.gov: The Controlled Substances Act
• How COVID-19 Affects the North Carolina Controlled Substances Registration Process
• NCLeg.net: NCGS 90, Article 5
• Legal Updates

Payment Options for Registration and Renewal

Questions about the registration and renewal process should be directed to 984-236-5100

Payment Information: For all Renewal and Registration applications you must submit your application to email address: NCCSAREG@dhhs.nc.gov. Our department will then confirm receipt of the application along with instructions on how to pay.

NC Drug Control Unit Renewal Process

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NCGS 90-101 requires yearly registration renewal for all applications.

1. To renew a registration, complete the applicable form:
   • Form DHHS 226-A: Hospital Renewal
   • Form DHHS 226-B: Nursing Home Renewal
   • Form DHHS 226-C: Teaching Institution Renewal
   • Form DHHS 226-D: Clinic Renewal (incl. Animal Hospitals)
   • Form DHHS 226-F: Animal Shelter Renewal
   • Form DHHS 227-A: Manufacturer Renewal
   • Form DHHS 227-B: Distributor Renewal
   • Form DHHS 227-C: Researcher Renewal
   • Form DHHS 227-D: Analytical Laboratory Renewal
   • Form DHHS 227-E: Dog Handler Renewal
2. Please e-mail an electronic version with electronic signature, to NCCSAREG@DHHS.NC.GOV
    
3. Once the renewal form and payment is received, your certificate will be issued and sent via e-mail

NC Drug Control Unit Registration Process

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NCGS 90-101 requires that “every person who manufactures, distributes, dispenses, or conducts research with any controlled substance within this State or who proposes to engage in any of these activities shall annually register with the North Carolina Department of Health and Human Services".

1. To initially register, complete the applicable registration form:
   • Form DHHS 224-A: Hospital Registration
   • Form DHHS 224-B: Nursing Home Registration
   • Form DHHS 224-C: Teaching Institution Registration
   • Form DHHS 224-D: Clinic Registration (incl. Animal Hospitals)
   • Form DHHS 224-F: Animal Shelter Registration
   • Form DHHS 225-A: Manufacturer Registration
   • Form DHHS 225-B: Distributor Registration
   • Form DHHS 225-C: Researcher Registration
   • Form DHHS 225-D: Analytical Laboratory Registration
   • Form DHHS 225-E: Dog Handler Registration
2. Please e-mail an electronic version, with electronic signature to: NCCSAREG@dhhs.nc.gov
    
3. Once the registration form and payment is received, an inspector will contact you to coordinate an inspection

Frequently Asked Questions

1. What are controlled substances?
2. Where can I find a list of the controlled substances?
3. Who oversees the controlled substances program?
4. Is registration required for all schedules?
5. How can I register?
6. Do I need to renew my registration every year?
7. What are the requirements for ordering controlled substances?
8. Are registered facilities required to keep records on controlled substance samples?
9. Do I need to report an address, ownership or name change?
10. How do I store controlled substances?
11. How do I dispose of expired/unwanted substances?
12. What is the process for reporting a significant loss and/or theft of controlled substances?
13. Could I be subject to inspection?

1. What are controlled substances? 
   • Regulated as controlled substances are any drugs or chemical substances whose possession and use are regulated under the United States Controlled Substances Act or the North Carolina Controlled Substances Act.
2. Where can I find a list of the controlled substances?
   • DEA office of Diversion Control
   • North Carolina Controlled Substances Act
3. Who oversees the controlled substances program?
   • Both US Drug Enforcement Administration (DEA) Office of Diversion Control and the North Carolina Department of Health and Human Services, Drug Control Unit (NC-DCU).
4. Is registration required for all schedules?
   • Yes. Using any of the controlled substances schedules requires registration with both state and federal agencies.
5. How can I register? 
   • For NC-DCU registration, see above.
   • 
     For Federal registration, forms and registration guidelines can be found on DEA Office of Diversion Control website.
6. Do I need to renew my registration every year? 
   • Yes. NCGS 90-101 requires annual registration renewal.
7. What are the requirements for ordering controlled substances? 
   • Only DEA- registered individuals may order controlled substances. To order schedules I and II substances, you need to use the US DEA order form 222. Manufacturers and distributors would not accept any schedule I and II order without DEA form 222.
8. Are registered facilities required to keep records on controlled substance samples?

   • All prescription drug samples (if stocked) must be stored in locked areas at all times and any use of these samples must be documented in the patient record. These records are required to be maintained for at least two years.

     Special packaging requirements when dispensing controlled substances are listed under the following federal statutes:

     16 CFR 1700.14, (4).
     16 CFR 1700.15, (a), (b), (c).

9. Do I need to report an address, ownership or name change? 
   • Registration and authority to possess controlled substances are not transferable and new registration with NC-DCU is required when there is a physical location change, change in ownership, or name change.
10. How do I store controlled substances?
    • All controlled substances require secure and locked storage. However, security requirements are more restrictive for schedule I and II substances. There are also different security requirements for non-practitioner and practitioner users. Click below for more information:
      • Practitioner
      • Non-practitioner
11. How do I dispose of expired/unwanted substances? 
    • Please contact the Drug Control Unit via email at NCCSAREG@dhhs.nc.gov to schedule a drug destruction. In accordance with 10A NCAC 26E .0407, the destruction of a controlled substance in Schedules II-V shall be witnessed by an official authorized to enforce the Federal or the State's Controlled Substances Acts.
12. What is the process for reporting a significant loss and/or theft of controlled substances?

    • According to federal rule, the practitioner shall notify the local DEA office, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The practitioner shall also complete and submit DEA Form 106 which may be found here.

      Registrants should email a copy of the DEA Form 106 to the Drug Control Unit at NCCSAREG@dhhs.nc.gov. In addition, all registrants should contact their local or state law enforcement agencies.

13. Could I be subject to inspection? 
    • Yes, both federal and state agencies may inspect facilities before and after registration approval. NC-DCU performs an inspection to ensure proper storage, use, and documentation. Once registration is successfully completed and a registration number is assigned, you will then be eligible to register with US DEA office.