North Carolina Pharmacy Law 2025

Label for Dispensed Devices

“Caution: federal law requires dispensing by or on the order of a physician”

Label for Prescription Drugs

“Caution: Federal law prohibits dispensing without prescription”

Immunizing Pharmacist

1) CPR certified from AHA or American Red Cross

2) completed a training program from CDC or ACPE

3) 3 CE hours every 2 years

4) Completed training from the immunization branch of the department of public health for enrollment in the NC Immunization Database

5) notified the Board and NC Medical Board of immunizing pharmacist status

6) follows rules stated in another statute

Mobile pharmacy

1) mobile

2) run by a nonprofit corporation

3) provides prescriptions at low or no cost to those 200% below the poverty level and does not get reimbursed

Timeline for technician hiring and registration

1) must complete a training program developed by pharmacy manager within 180 days (6 months)

2)pharmacy manager must notify Board of hire within 21 days and include

• name of pharmacy and location

• Name of pharmacy manager

• Name of pharmacy technician

• Date of hire

  —- Board must maintain a registry of pharmacy technicians with this info

3) pharmacy technician must register (and pay registration fee) with the Board within 30 days after the training program is complete and then renewed annually by paying the fee.

4) If a certified technician begins employment elsewhere (and is therefore hired as a certified pharmacy technician), they have to notify the Board within 10 days

The Board must respond to a request from a pharmacist-manager to allow a pharmacist to supervise more than two pharmacy technicians within…

60 days of the date it received the request. They respond by:

1)  Approval of the request

2) Approval of the request as amended by the Board

3) Disapproval of the request. A disapproval of a request must include a reasonable explanation of why the request was not approved

This only applies if the technicians are not certified (i.e. are still under the 180 day training program)

Board meetings should occur at least…

twice annually

The Board should keep a record of the proceedings (meetings), a register of all licensed persons, and a register of all persons to whom permits have been issued. The Board has to report this info annually, in writing, to the Governor and to the presiding officer of each house of the General Assembly.

Things the Executive Director does

1) Secretary of the Board

2) Treasurer of the Board

3) Conducts investigations concerning violations of the Pharmacy Practice Act (make investigations and prosecute)

Pharmacist License Application (with the Executive Director)

1) Applicant’s name

2) Age

3) Where you went to pharmacy school and when

4) Experience in compounding and dispensing prescriptions under the supervision of a pharmacist (APPE Hours)

A pharmacist must be granted a license if they complete the application and…

1) Have a degree from an approved pharmacy school

2) Has had up to 1 year of APPE experience (APPE experience approved by the Board, since they regulate those)

3) Has passed exams

4) Has appeared at a time and place designated by the Board and submitted to an examination as to the applicant's qualifications for being licensed. The applicant must demonstrate to the Board the physical and mental competency to practice pharmacy

5) Also must provide Board with a criminal record report

Vaccination age with parent consent for techs

7 years old

Vaccination age with parent consent for pharmacists and interns

3 years old (PREP Act- has 7 requirements that have to be met or it goes back to age 7, like technicians) (PREP Act effective date ended, have to go to link to see if it has been extended)

Vaccination age with prescription

6 years old

Age for long-acting injections (testosterone and B12)

18 (need a prescription)

After administration, the pharmacist must:

1) Maintain a record of any administration of a long-acting injectable performed by the immunizing pharmacist to the patient in a patient profile or record.

2) Within 72 hours after the administration of the long-acting injectable performed by the immunizing pharmacist to the patient, notify the prescriber regarding which medication and dosage was administered. If the long-acting injectable is in the class of psychotropic medications, the immunizing pharmacist shall notify the prescriber within 48 hours of administering the medication

3)  Within 72 hours of receipt of a specific prescription, notify the prescriber of the long-acting injectable medication if the medication was not administered. If the prescription is in the class of psychotropic medications, the immunizing pharmacist shall notify the prescriber if the medication was not administered within 48 hours of the prescription.

After administration of vaccine or immunization the pharmacist must

1) Maintain a record of any vaccine or immunization administered to the patient in a patient profile

2)  Within 72 hours after administration of the vaccine or immunization, notify any primary care provider identified by the patient. If the patient does not identify a primary care provider, the immunizing pharmacist shall direct the patient to information describing the benefits to a patient of having a primary care physician, prepared by any of the following: North Carolina Medical Board, North Carolina Academy of Family Physicians, North Carolina Medical Society, or Community Care of North Carolina.

3)  Except for influenza vaccines administered under G.S. 90-85.15B(c), access the North Carolina Immunization Registry prior to administering the vaccine or immunization and record any vaccine or immunization administered to the patient in the registry within 72 hours after the administration. In the event the registry is not operable, an immunizing pharmacist shall report as soon as reasonably possible.

An immunizing pharmacist may dispense, deliver, or administer the following medications

1) Nicotine replacement therapy that is approved by the United States Food and Drug Administration

2) Self-administered oral or transdermal contraceptives after the patient completes an assessment consistent with the CDC and Prevention’s United States Medical Eligibility Criteria (US MEC) for Contraceptive Use; however, an immunizing pharmacist shall not dispense, deliver, or administer ulipristal acetate for emergency contraception without a prescription from a prescriber licensed under this Chapter.

3)  Prenatal vitamins

4)  Post-exposure prophylaxis medications for the prevention of human immunodeficiency virus pursuant to guidelines and recommendations of the Centers for Disease Control and Prevention

5) Glucagon for the treatment of severe hypoglycemia.

If a pharmacist dispenses, delivers, or administers one of these, they must:

1)  Maintain a record of medication administered to the patient in a patient profile.

2)  Within 72 hours after administration of the medication, notify any primary care provider identified by the patient. If the patient does not identify a primary care provider, the immunizing pharmacist shall direct the patient to information describing the benefits to a patient of having a primary care provider, including information about federally qualified health centers, free clinics, and local health departments, prepared by any of the following: North Carolina Medical Board, North Carolina Academy of Family Physicians, North Carolina Medical Society, or Community Care of North Carolina.

3)  Furnish patient records to the patient upon the patient's request.

4)  Furnish patient records to the primary care provider identified by the patient upon the primary care provider's request.

5)  If the immunizing pharmacist has administered or dispensed a hormonal contraceptive to the patient, the immunizing pharmacist shall counsel the patient about preventative care, including well-woman visits, sexually transmitted infection testing information, and Pap smear testing

They should also:

1)  Comply with rules adopted by the North Carolina Medical Board and the North Carolina Board of Pharmacy governing the approval of the individual immunizing pharmacist to dispense, deliver, or administer the medications with limitations that the Boards determine to be in the best interest of patient health and safety.

2)  Have current approval from both Boards

3)  Provide the name, business address, business phone, and business fax number of the pharmacy on any communication with a prescriber.

4)  Provide the name of the immunizing pharmacist who dispenses, delivers, or administers the medication on any communication with the provider.

Prior to a pharmacy intern or technician administering a VACCINE, they must

1)  Complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique and the recognition and treatment of emergency reactions to vaccines

2)  The pharmacy technician or pharmacy intern shall have a current certificate in basic CPR

3)  The pharmacy technician shall annually complete a minimum of two hours of ACPE approved, immunization-related continuing pharmacy education.

Pharmacist License Renewal

Each license to practice pharmacy shall expire on December 31 and shall be renewed annually by filing with the Board on or after December 1 an application for license renewal furnished by the Board, accompanied by the required fee. It shall be unlawful to practice pharmacy more than 60 days after the expiration date without renewing the license. All licensees shall give the Board notice of a change of mailing address or a change of place of employment within 30 days after the change. The Board may require licensees to obtain up to 30 hours of continuing education every two years from Board-approved providers as a condition of license renewal, with a minimum of 10 hours required per year (can’t do all 30 in one year- I think the Board does annual renewal to comply with this)

License Reinstatement occurs after…

5 years

You also must appear before the Board and submit evidence that you can safely and properly practice pharmacy

Pharmacy Permits

Registration should occur annually and includes

1) Pharmacy Manager

2) All pharmacy personnel employed there

They may also identify a pharmacy permittee's designated agent that the Board shall notify of any investigation of the pharmacy or a pharmacist employed by the pharmacy. The notice shall include the specific reason for the investigation and be given prior to the initiation of any disciplinary proceedings.

All pharmacy managers should notify the Board of any change in pharmacy personnel within 30 days of the change

A mobile pharmacy shall provide the Board with the address of every location from which prescription drugs will be dispensed by the mobile pharmacy (but they don’t have to register as a pharmacy at each location)

A dispensing physician must also register annually with the Board and have a pharmacy permit. They must also register with the licensing board having jurisdiction over them

An out-of-state pharmacy that ships, mails, or delivers a dispensed drug into NC must also register annually, with the pharmacists responsible agreeing in writing to be subject to the jurisdiction of the NC BOP ($500, $200, $200)

Application For Registration With The Pharmacy Board As A Dispensing Physician

Each physician who dispenses prescription drugs, for a fee or other charge, shall annually register with the Board on the form provided by the Board, AND with the licensing board having jurisdiction over the physician. Such dispensing shall comply in all respects with the relevant laws and regulations that apply to pharmacists governing the distribution of drugs, including packaging, labeling, and record keeping. Authority and responsibility for disciplining physicians who fail to comply with the provisions of this subsection are vested in the licensing board having jurisdiction over the physician. Must pay $75 and fill out the form

Pharmacy permit exemption for in-state and out-of-state dispensing and delivery of home renal products must meet all following criteria:

1)  The dialysate or drugs have been approved or cleared by United States FDA

2)  The dialysate or drugs are lawfully held by a manufacturer or an agent of the manufacturer that is properly licensed by the North Carolina Department of Agriculture and Consumer Services as a manufacturer, or as a wholesaler, or as both, as required by G.S. 106-145.3

3)  The dialysate or drugs are held, delivered, and dispensed in their original, sealed packaging from the manufacturing facility

4)  The dialysate or drugs are delivered only by the manufacturer, or an agent of the manufacturer, and only upon receipt of a physician's order

5)  The manufacturer or an agent of the manufacturer delivers the dialysate or drugs directly to either of the following:

a. A patient with chronic kidney failure or a designee of the patient, for self-administration of the dialysis therapy.

b. A health care provider, or health care facility licensed under Chapter 122C, 131D, or 131E of the General Statutes, for administration or delivery of the dialysis therapy to a patient with chronic kidney failure

Pharmacies may ship medications for patients with renal failure to renal dialysis facilities for delivery to (i) patients who receive dialysis treatments in a Medicare certified dialysis facility or (ii) patients who self-dialyze at home, provided that all of the following criteria are met:

1)  The patient authorizes, in writing, the dialysis facility staff to act as the patient's designated agent for the purpose of receiving mailed medical packages at the dialysis facility.

2)  The pharmacy, whether in-state or out-of-state, is licensed as a pharmacy in North Carolina.

3)  The medications for home use are dispensed by the licensed pharmacist pursuant to a valid prescription order.

4)  The delivered medication packages are held in a secure location in an area not accessible to the public and delivered by the dialysis facility staff, unopened, to the patient.

5)  Medication packages are individually labeled with the patient name.

6)  The medications exclude controlled substances, as defined under G.S. 90-87.

$500

For original registration of a pharmacy

For original registration to dispense devices, deliver medical equipment, or both

Renewal and reinstatement both $200

The pharmacist in charge of a pharmacy shall report to the Board any disaster, accident, theft, or emergency which may affect the strength, purity, or labeling of drugs and devices in the pharmacy within…

10 days

A registered nurse in a local health department clinic may dispense prescription drugs and devices, other than controlled substances as defined in G.S. 90-87, under the following conditions:

1)  The registered nurse has training acceptable to the Board in the labeling and packaging of prescription drugs and devices;

2)  Dispensing by the registered nurse shall occur only at a local health department clinic;

3)  Only prescription drugs and devices contained in a formulary recommended by the Department of Health and Human Services and approved by the Board shall be dispensed;

4)  The local health department clinic shall obtain a pharmacy permit in accordance with G.S. 90-85.21;

5)  Written procedures for the storage, packaging, labeling and delivery of prescription drugs and devices shall be approved by the Board; and

6)  The pharmacist-manager, or another pharmacist at his direction, shall review dispensing records at least weekly, provide consultation where appropriate, and be responsible to the Board for all dispensing activity at the local health department clinic.

A pharmacist may accept and dispense drugs, supplies, and medical devices donated to the Program to eligible patients if all of the following requirements are met:

1)  The drug, supplies, or medical device is in the original, unopened, sealed, and tamper-evident packaging or, if packaged in single-unit doses, the single-unit dose packaging is unopened.

2)  The pharmacist has determined that the drug, supplies, or medical device is safe for redistribution.

3)  The drug has not reached its expiration date.

4)  The drug, supplies, or medical device is not adulterated or misbranded, as determined by a pharmacist.

5)  The drug, supplies, or medical device is prescribed by a practitioner for use by an eligible patient and is dispensed by a pharmacist.

Whenever a managed care company, insurance company, third-party payer, or any entity that represents a responsible party conducts an audit of the records of a pharmacy, the pharmacy has a right to all of the following:

1)  To have at least 14 days' advance notice of the initial on-site audit for each audit cycle.

2)  To have any audit that involves clinical judgment be done with a pharmacist who is licensed, and is employed or working under contract with the auditing entity.

3)  Not to have clerical or record-keeping errors, including typographical errors, scrivener's errors, and computer errors, on a required document or record, in the absence of any other evidence, deemed fraudulent. This subdivision does not prohibit recoupment of fraudulent payments.

4)  If required under the terms of the contract, to have the auditing entity provide a pharmacy, upon request, all records related to the audit in an electronic format or contained in digital media.

5)  To have the properly documented records of a hospital or any person authorized to prescribe controlled substances for the purpose of providing medical or pharmaceutical care for their patients transmitted by any means of communication in order to validate a pharmacy record with respect to a prescription or refill for a controlled substance or narcotic drug.

6)  To have a projection of an overpayment or underpayment based on either the number of patients served with a similar diagnosis or the number of similar prescription orders or refills for similar drugs. This subdivision does not prohibit recoupments of actual overpayments, unless the projection for overpayment or underpayment is part of a settlement by the pharmacy.

7)  Prior to the initiation of an audit, if the audit is conducted for an identified problem, the audit is limited to claims that are identified by prescription number.

8)  If an audit is conducted for a reason other than described in subdivision (6) of this subsection, the audit is limited to 100 selected prescriptions.

9)  If an audit reveals the necessity for a review of additional claims, to have the audit conducted on site.

Pharmacy audit continued

9)  If an audit reveals the necessity for a review of additional claims, to have the audit conducted on site.

10)  Except for audits initiated for the reason described in subdivision (6) of this subsection, to be subject to no more than one audit in one calendar year, unless fraud or misrepresentation is reasonably suspected.

5. 11)  Except for cases of Food and Drug Administration regulation or drug manufacturer safety programs, to be free of recoupments based on any of the following unless defined within the billing requirements set forth in the pharmacy provider manual not inconsistent with current North Carolina Board of Pharmacy Regulations:

   1. Documentation requirements in addition to or exceeding requirements for creating or maintaining documentation prescribed by the State Board of Pharmacy.

   2. A requirement that a pharmacy or pharmacist perform a professional duty in addition to or exceeding professional duties prescribed by the State Board of Pharmacy

      12) To be subject to recoupment only following the correction of a claim and to have recoupment limited to amounts paid in excess of amounts payable under the corrected claim.

   13)  Except for Medicare claims, to be subject to reversals of approval for drug, prescriber, or patient eligibility upon adjudication of a claim only in cases in which the pharmacy obtained the adjudication by fraud or misrepresentation of claim elements.

   14)  To be audited under the same standards and parameters as other similarly situated pharmacies audited by the same entity.

   15)  To have at least 30 days following receipt of the preliminary audit report to produce documentation to address any discrepancy found during an audit.

   16)  To have the period covered by an audit limited to 24 months from the date a claim was submitted to, or adjudicated by, a managed care company, an insurance company, a third-party payer, or any entity that represents responsible parties, unless a longer period is permitted by a federal plan under federal law.

   17)  Not to be subject to the initiation or scheduling of audits during the first five calendar days of any month due to the high volume of prescriptions filled during that time, without the express consent of the pharmacy. The pharmacy shall cooperate with the auditor to establish an alternate date should the audit fall within the days excluded.

   18)  To have the preliminary audit report delivered to the pharmacy within 120 days after conclusion of the audit.19)  To have a final audit report delivered to the pharmacy within 90 days after the end of the appeals period, as provided for in G.S. 90-85.51.

   20)  Not to have the accounting practice of extrapolation used in calculating recoupments or penalties for audits, unless otherwise required by federal requirements or federal plans.

Pharmacy audit continued

21) Not to be subject to recoupment on any portion of the reimbursement for the dispensed product of a prescription, unless otherwise provided in this subdivision:

a. Recoupment of reimbursement, or a portion of reimbursement, for the dispensed product of a prescription may be had in the following cases:
1. Fraud or other intentional and willful misrepresentation evidenced by a review of the claims data, statements, physical review, or other investigative methods.

2. Dispensing in excess of the benefit design, as established by the plan sponsor.

3. Prescriptions not filled in accordance with the prescriber's order.

4. Actual overpayment to the pharmacy.

   b. Recoupment of claims in cases set out in sub-subdivision a. of this subdivision shall

   be based on the actual financial harm to the entity or the actual underpayment or overpayment. Calculations of overpayments shall not include dispensing fees unless one of the following conditions is present:

   1. A prescription was not actually dispensed.

   2. The prescriber denied authorization.

   3. The prescription dispensed was a medication error by the pharmacy. For purposes of this subdivison, a medication error is a dispensing of the wrong drug or dispensing to the wrong patient or dispensing with the wrong directions.

   4. The identified overpayment is based solely on an extra dispensing fee.

   5.The pharmacy was noncompliant with Risk Evaluation and Mitigation Strategies (REMS) program guidelines.

   6. There was insufficient documentation, including electronically stored information, as described in this subsection.

   7. Fraud or other intentional and willful misrepresentation by the pharmacy.

      22) To have an audit based only on information obtained by the entity conducting the audit and not based on any audit report or other information gained from an audit conducted by a different auditing entity. This subdivision does not prohibit an auditing entity from using an earlier audit report prepared by that auditing entity for the same pharmacy. Except as required by State or federal law, an entity conducting an audit may have access to a pharmacy's previous audit report only if the previous report was prepared by that entity.

      23)  If the audit is conducted by a vendor or subcontractor, that entity is required to identify the responsible party on whose behalf the audit is being conducted without having this information being requested.24)  To use any prescription that complies with federal or State laws and regulations at the time of dispensing to validate a claim in connection with a prescription, prescription refill, or a change in a prescription.

You do not need a medical equipment permit if you deliver medical equipment if:

1. You have a pharmacy permit

2. You have a device permit

3. You are a pharmaceutical manufacturer registered with the FDA

4. You are a wholly owned subsidiary of one

5. You are dispensing and delivering home renal products under the above criteria (have a pharmacy permit exemption)

A pharmacist dispensing a prescription for a drug prescribed by its brand name may select any equivalent drug or interchangeable biological product which meets all of the following standards:

1) The manufacturer's name and the distributor's name, if different from the manufacturer's name, shall appear on the label of the stock package.
2) It shall be manufactured in accordance with current good manufacturing practices.
3) All oral solid dosage forms shall have a logo, or other identification mark, or the product name to identify the manufacturer or distributor.

4) The manufacturer shall have adequate provisions for drug recall.
5) The manufacturer shall have adequate provisions for return of outdated drugs, through the distributor or otherwise.