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 activities regulated by both state and federal agencies, the more stringent rule must be followed.

Payment Options for Registration and Renewal

  1. Credit card payment (Visa or Master Card only) 919-527-6230
    For new registrations paying with credit card, you must submit your registration to the e-mail listed above and confirm that your information has been entered into the system before attempting to make a payment. Credit card payments are not posted immediately, please give payments 2-3 business days to post.
     
  2. Mail check payments to:
    Department of Health and Human Services
    Division of Mental Health/DD/SA Services
    Drug Control Unit
    3008 Mail Service Center
    Raleigh, North Carolina 27699-3008
    *Please add your registration number in the memo line of the check

NC-DCU Renewal Process

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The NC-DCU requires yearly registration renewal for all applications. However, the registration renewal with DEA (federal) is based on the type of the application. Please refer to DEA website for renewal application forms (224-A and 225-A) and renewal periods for different applications.

  1. To complete the NC-DCU renewal process, complete the applicable form and the Registrant Addendum of Loss, Diversion or Destruction**:

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-E: Office-Based Treatment Renewal
Form DHHS 226-F: Animal Shelter Renewal
Form DHHS 226-G: OBT-Dispensing Application for 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
**Registrant Addendum of Loss, Diversion or Destruction

  1. Please e-mail an electronic version with electronic signature, to NCCSAREG@DHHS.NC.GOV
     
  2. Once the renewal form and payment is received, your certificate will be issued and sent via e-mail

 

NC-DCU Registration Process

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All controlled substance users shall register with the North Carolina Department of Health and Human Services, NC-Drug Control Unit (NC-DCU).

  1. Complete the applicable registration form and the Applicant Addendum of Loss, Diversion or Destruction**:

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-E: Office-Based Treatment Registration
Form DHHS 224-F: Animal Shelter Registration
Form DHHS 224-G: OBT-Dispensing Application for 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
**Applicant Addendum of Loss, Diversion or Destruction

  1. Please e-mail an electronic version, with electronic signature to: NCCSAREG@DHHS.NC.GOV
     
  2. 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. What are the major elements of the controlled substances program?
  3. Where can I find a list of the controlled substances?
  4. Who oversees the controlled substances program?
  5. Is registration required for all schedules?
  6. How can I register?
  7. Do I need to renew my registration every year?
  8. What are the requirements for ordering controlled substances?
  9. Are registered facilities required to keep records on controlled substance samples?
  10. Do researchers need individual registration in one department/building?
  11. If multiple office-based treatment physicians work in the same facility, can they apply for registration as a group?
  12. Do I need to report a move, address change or change of usage?
  13. When do I need to complete a new registration?
  14. How do I store controlled substances?
  15. How do I dispose of expired/unwanted substances?
  16. How do I report breakage or spillage of controlled substances?
  17. What is the process for reporting a significant loss and/or theft of controlled substances?
  18. Could I be subject to inspection?

 

1. What are controlled substances?
Regulated under 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. Controlled substances have stimulant, depressant, or hallucinogenic effects on the higher functions of the central nervous system, and tend to promote abuse or physiological/psychological dependence.

2. What are the major elements of the controlled substances program?
Different schedules of the controlled substances, registration, registration renewal, security, inventory control and disposal process.

3. Where can I find a list of the controlled substances?

4. 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).

5. Is registration required for all schedules?
Yes. Using any of the controlled substances schedules requires registration with both state and federal administrations.

6. How can I register?

7. Do I need to renew my registration every year?
Yes. NC-DCU requires annual registration renewal. DEA registration renewal is typically every 1-3 years, based on the type of the activity (Title 21 Code of Federal Regulations (CFR) Part 1301.13)

8. 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.

9. Are registered facilities required to keep records on controlled substance samples?
The dispensing records for drug samples are under the scrutiny of the Drug Enforcement Administration and the NC Drug Control Unit. 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).

10. Do researchers need individual registration in one department/building?
For use of Schedules I and VI of controlled substances, individual registration is required without exception. If requested and granted during registration for research (schedules II–V), a representative of the department (registrant) may share substances within the department.

11. If multiple office-based treatment physicians work in the same facility, can they apply for registration as a group?
No. Each physician needs to apply as an individual to provide Buprenorphine/Suboxone. If other clinical services are provided that involve the dispensing/administering of controlled substances, an additional registration is required. The non-OBT registration can be done as a group. 

12. Do I need to report an address or ownership change, change of usage or name change?
Yes. Please notify the NC-DCU about specific reporting and forms are required by DEA for any change. These forms can be found on the DEA website (on-line forms and applications) here.

13. When do I need to complete a new registration?
Registration and authority to use controlled substances are not transferable and new registration with NC-DCU is required when there is a physical location change, change in ownership, or addition of either Schedule I or VI drug type. 

14. 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. PractitionerNon-practitioner

15. How do I dispose of expired/unwanted substances?
By contacting an NC-DCU agent at 919-733-1765 or NCCSAREG@dhhs.nc.gov and submitting form-41 to the DEA office, using a DEA registered controlled substances disposal form, or re-distributing to the original supplying/manufacturing company where the chemical was obtained.

16. How do I report breakage or spillage of controlled substances?
Breakage of controlled substances does not constitute a "loss" of controlled substances. When there is breakage, damage, spillage or some other form of destruction, any recoverable controlled substances must be disposed of according to DEA/NC-DCU requirements. If the breakage or spillage is not recoverable, the registrant must document the circumstances of the breakage in their inventory records. Two individuals who witnessed the breakage must sign the inventory records.

17. 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.

The NC Drug Control Unit advises registrants to submit a copy of the DEA Form 106 to our office at the address below. In addition, all registrants may contact their local or state law enforcement agencies. ATTN: Drug Control Unit Mail Service Center 3008 Raleigh, NC 27699

18. Could I be subject to inspection?
Yes, both federal and state administrations may inspect facilities before and after registration approval. NC-DCU performs an inspection (to ensure proper storage security) and a background check before granting registration approval. NC-DCU might also perform routine inspections of facilities 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.