50-State Healthcare and Pharmaceutical Licensing Compliance Guide
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North Carolina Healthcare and Pharmaceutical Licensing

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Licensing requirements for North Carolina healthcare and pharmaceutical companies and individuals.

This page provides an overview of healthcare and pharmaceutical industry licensing in North Carolina for individuals and businesses. You will find state requirements, application fees, filing instructions, and more. For assistance with licensing, please contact us to learn about our software and managed license services.

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Company Licenses

North Carolina Healthcare and Pharmaceutical Company Licenses

North Carolina Controlled Substance Registration - Analytical Laboratory

Agency:North Carolina Department of Health and Human Services - Drug Control Unit

Initial Registration

Form:

Form DHHS 225-D: Analytical Laboratory Registration

Agency Fee:

$100

Registration Renewal

Form:

Form DHHS 227-D: Analytical Laboratory Renewal

Agency Fee:

$100

Due:

Annually

North Carolina Controlled Substance Registration - Animal Shelter

Agency:North Carolina Department of Health and Human Services - Drug Control Unit

Initial Registration

Form:

Form DHHS 224-F: Animal Shelter Registration

Agency Fee:

$150

Registration Renewal

Form:

Form DHHS 226-F: Animal Shelter Renewal

Agency Fee:

$150

Due:

Annually

North Carolina Controlled Substance Registration - Clinic

Agency:North Carolina Department of Health and Human Services - Drug Control Unit

Initial Registration

Form:

Form DHHS 224-D: Clinic Registration (incl. Animal Hospitals)

Agency Fee:

$125

Registration Renewal

Form:

Form DHHS 226-D: Clinic Renewal (incl. Animal Hospitals)

Agency Fee:

$125

Due:

Annually

North Carolina Controlled Substance Registration - Distributor

Agency:North Carolina Department of Health and Human Services - Drug Control Unit

Initial Registration

Form:

Form DHHS 225-B: Distributor Registration

Agency Fee:

$500

Registration Renewal

Form:

Form DHHS 227-B: Distributor Renewal

Agency Fee:

$500

Due:

Annually

North Carolina Controlled Substance Registration - Dog Handler

Agency:North Carolina Department of Health and Human Services - Drug Control Unit

Initial Registration

Form:

Form DHHS 225-E: Dog Handler Registration

Agency Fee:

$150

Registration Renewal

Form:

Form DHHS 227-E: Dog Handler Renewal

Agency Fee:

$150

Due:

Annually

North Carolina Controlled Substance Registration - Hospital

Agency:North Carolina Department of Health and Human Services - Drug Control Unit

Initial Registration

Form:

Form DHHS 224-A: Hospital Registration

Agency Fee:

$300

Registration Renewal

Form:

Form DHHS 226-A: Hospital Renewal

Agency Fee:

$300

Due:

Annually

North Carolina Controlled Substance Registration - Manufacturer

Agency:North Carolina Department of Health and Human Services - Drug Control Unit

Initial Registration

Form:

Form DHHS 225-A: Manufacturer Registration

Agency Fee:

$600

Registration Renewal

Form:

Form DHHS 227-A: Manufacturer Renewal

Agency Fee:

$600

Due:

Annually

North Carolina Controlled Substance Registration - Nursing Home

Agency:North Carolina Department of Health and Human Services - Drug Control Unit

Initial Registration

Form:

Form DHHS 224-B: Nursing Home Registration

Agency Fee:

$100

Registration Renewal

Form:

Form DHHS 226-B: Nursing Home Renewal

Agency Fee:

$100

Due:

Annually

North Carolina Controlled Substance Registration - Teaching Institution

Agency:North Carolina Department of Health and Human Services - Drug Control Unit

Initial Registration

Form:

Form DHHS 224-C: Teaching Institution Registration

Agency Fee:

$100

Registration Renewal

Form:

Form DHHS 226-C: Teaching Institution Renewal

Agency Fee:

$100

Due:

Annually

North Carolina Device and Medical Equipment Dispensing Permit

Agency:North Carolina Board of Pharmacy

Initial Registration

Filing Method:

Online

Agency Fee:

$500

Registration Renewal

Filing Method:

Online

Agency Fee:

$200

Due:

Annually by December 31.

North Carolina Distributor (In-State) License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$700

Registration Renewal

Form:

Renewal Application

Agency Fee:

$700

Due:

Annually by December 31.

North Carolina In-State Pharmacy Permit

Agency:North Carolina Board of Pharmacy

Initial Registration

Filing Method:

Online

Agency Fee:

$500

Registration Renewal

Filing Method:

Online

Agency Fee:

$200

Due:

Annually by December 31.

North Carolina Manufacturer License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$1,000

Registration Renewal

Form:

Renewal Application

Agency Fee:

$1,000

Due:

Annually by December 31.

North Carolina Medical Gas Distributor (In-State) License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$700

Registration Renewal

Form:

Renewal Application

Agency Fee:

$700

Due:

Annually by December 31.

North Carolina Medical Gas Supplier (Out-of-State) License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$700

Registration Renewal

Form:

Renewal Application

Agency Fee:

$700

Due:

Annually by December 31.

North Carolina Medical Gases Manufacturer License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$1,000

Registration Renewal

Form:

Renewal Application

Agency Fee:

$1,000

Due:

Annually by December 31.

North Carolina Out-of-State Pharmacy Permit

Agency:North Carolina Board of Pharmacy

Initial Registration

Filing Method:

Online

Agency Fee:

$500

Turnaround:

6 weeks 

Notes:
  • When the application is approved, you must appear before the board in a preliminary permit meeting .
    • Permits are issued to the pharmacist manager who must be present at the time of issuance for clarification of any matters in question
  • - If the dispensing of controlled substances anticipated, a DEA Registration is also necessary
  •  
Required Attachments:
  • Photographs as instructed below (Colored photographs. No black and white.)
    • A photograph or photographs of the actual existing exterior of the building in which the pharmacy is currently located, including identifiable parts of the adjacent building(s), if any.
    • Signage of or on the exterior of the Pharmacy.
    • Interior photograph(s) of the prescription area of the pharmacy as viewed by a customer/inspector as well as a photograph(s) of the dispensing/processing area of the pharmacy.
    • A photograph(s) of and/or assurance that all required equipment is present. It should include equipment in the pharmacy adequate to meet the pharmaceutical care needs of the patient as well as the pharmacy services that are pharmacy is providing.
    • Photograph(s) of the compounding area with adequate equipment present (if compounding this is required).
  • Copy of Current License (permit) or Letter from Regulatory Agency
  • Current Operational Inspection Report
    • . USP Compounding Compliance Inspection report is required if compounding.
    • The Board will accept a compliant inspection from the State Board in which you are permitted. As well as a NABP VPP Inspection if applicable. If the inspection report shows non-compliance, documentation from that corrective action has been taken and is acceptable from either the State Board or NABP
  • Verification or assurance of Reference Material
    • Online References are acceptable. A photograph of the reference library required by Board regulation clearly showing titles of publications on hand or assurance that references are available online
  • Completed Label, (not a blank label)
    • The label should be an example of what is placed on a patient’s bottle with all the required label information.
    • Dispensing pharmacist’s initials only are NOT acceptable. See FAQ- Pharmacist FAQ on Board’s website: Prescription Labeling 
  • Secretary of State or Registered Agent Information:
  •  

Registration Renewal

Filing Method:

Online

Agency Fee:

$200

Due:

Annually by December 31.

North Carolina Outsourcing Facility License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$1,000

Registration Renewal

Form:

Renewal Application

Agency Fee:

$1,000

Due:

Annually by December 31.

North Carolina Pseudoephedrine Only License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$700

Registration Renewal

Form:

Renewal Application

Agency Fee:

$700

Due:

Annually by December 31.

North Carolina Re-packager License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$1,000

Registration Renewal

Form:

Renewal Application

Agency Fee:

$1,000

Due:

Annually by December 31.

North Carolina Reverse Distributor Only License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$700

Registration Renewal

Form:

Renewal Application

Agency Fee:

$700

Due:

Annually by December 31.

North Carolina Third Party Logistic Provider Only License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$700

Registration Renewal

Form:

Renewal Application

Agency Fee:

$700

Due:

Annually by December 31.

North Carolina Virtual Manufacturer License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$1,000

Turnaround:

6 weeks

Registration Renewal

Form:

Renewal Application

Agency Fee:

$1,000

Due:

Annually by December 31.

North Carolina Wholesaler (Out-of-State) License

Agency:North Carolina Department of Agriculture and Consumer Services - Food and Drug Protection Division - Drug Program

Initial Registration

Form:

New Registration Application

Agency Fee:

$700

Registration Renewal

Form:

Renewal Application

Agency Fee:

$700

Due:

Annually by December 31.

Individual Licenses

North Carolina Individual Healthcare and Pharmaceutical Licenses

North Carolina Clinical Pharmacist Practitioner License

Agency:North Carolina Board of Pharmacy

Initial Registration

Filing Method:

Online

Agency Fee:

$100

Registration Renewal

Filing Method:

Online

Agency Fee:

$135

Due:

Annually by December 31.

North Carolina Controlled Substance Registration - Researcher

Agency:North Carolina Department of Health and Human Services - Drug Control Unit

Initial Registration

Form:

Form DHHS 225-C: Researcher Registration

Agency Fee:

$125

Registration Renewal

Form:

Form DHHS 227-C: Researcher Renewal

Agency Fee:

$125

Due:

Annually

North Carolina Dispensing Physician Registration

Agency:North Carolina Board of Pharmacy

Initial Registration

Filing Method:

Online

Agency Fee:

$75

Registration Renewal

Filing Method:

Online

Agency Fee:

$75

Due:

Annually by December 31.

North Carolina Nurse Practitioner Registration

Agency:North Carolina Board of Pharmacy

Initial Registration

Filing Method:

Online

Agency Fee:

$75

Registration Renewal

Filing Method:

Online

Agency Fee:

$75

Due:

Annually by December 31.

North Carolina Pharmacist License

Agency:North Carolina Board of Pharmacy

Initial Registration

Filing Method:

Online

Agency Fee:

$100

Registration Renewal

Filing Method:

Online

Agency Fee:

$135

Due:

Annually by December 31.

North Carolina Pharmacy Technician Registration

Agency:North Carolina Board of Pharmacy

Initial Registration

Filing Method:

Online

Agency Fee:

$30

Registration Renewal

Filing Method:

Online

Agency Fee:

$30

Due:

Annually by December 31.

North Carolina Physician Assistant Registration

Agency:North Carolina Board of Pharmacy

Initial Registration

Filing Method:

Online

Agency Fee:

$75

Registration Renewal

Filing Method:

Online

Agency Fee:

$75

Due:

Annually by December 31.

Learn about healthcare and pharmaceutical licensing in other states:

Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho
Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri
Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania
Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming

Controlled Substance Registration - In addition to a pharmacy license, controlled substance registration registration is required in many states for pharmacies that distribute controlled substances.

NABP (National Association of Boards of Pharmacy) - Host a variety of programs and resources relating to pharmacist and pharmacy licensure and examination.

Pharmacist in Charge - A licensed pharmacist designated by a pharmacy to act as the party responsible for compliance with regulations.

VPP (Verified Pharmacy Program) - A program run by NABP that allows state boards to share information and more easily register out-of-state pharmacies.

Accreditation Council for Pharmacy Education (ACPE)

Drug Enforcement Administration (DEA) - Office of Diversion Control

National Alliance of State Pharmacy Associations (NASPA)

National Association of Boards of Pharmacy (NABP)

Revised April 03, 2019. Complete data last reviewed April 03, 2019.
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