North Carolina Administrative Code

21 NCAC 46 .1604 WHEN NEW PERMIT NOT REQUIRED (a) A new pharmacy, device or medical equipment permit is not required in the following situations: (1) the permit holder is a publicly-traded corporation and continues to hold the permit; or (2) the permit holder is a corporation whi…

21 NCAC 46 .1605 CHARGE FOR VERIFICATION FOR REINSTATEMENT History Note: Authority G.S. 90-85.6; 90-85.17; 90-85.21; 90-85.22; 150B-19(5)(e); Eff. September 1, 1993; Amended Eff. February 1. 2006; September 1, 1995; Expired Eff. November 1, 2017 pursuant to G.S. 150B-21.3A.

21 ncac 46 .1606 NORTH CAROLINA-SPECIFIC EDUCATION FOR PERMIT APPLICANTS Prior to issuance of any original pharmacy permit or device and medical equipment permit, the pharmacist-manager for the applicant pharmacy or the person in charge of the facility applying for the device and…

21 NCAC 46 .1607 OUT-OF-STATE PHARMACIES (a) In order to protect the public health and safety and implement G.S. 90-85.21A, the following provisions apply to out-of-state pharmacies that ship, mail, or deliver in any manner a dispensed legend drug, device, or medical equipment in…

21 NCAC 46 .1608 DEVICE AND MEDICAL EQUIPMENT PERMITS (a) Applications for device and medical equipment permits, whether original or renewal, shall be made upon forms provided by the Board. The Board shall not issue any original or annual renewal device and medical equipment perm…

21 NCAC 46 .1609 PERMIT RENEWAL Permits issued by the Board expire on December 31 and become invalid 60 days following expiration. History Note: Authority G.S. 90-85.6; 90-85.21; Eff. September 1, 1995; Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public int…

21 NCAC 46 .1610 REINSTATEMENT OF FORFEITED LICENSING PRIVILEGES An individual whose licensing privileges have been forfeited pursuant to G.S. 15A-1331, shall immediately surrender to the Board office his or her permit or license, current renewal certificate, and wallet card. In …

21 NCAC 46 .1611 FEE FOR SUBMITTAL OF DISHONORED AND RETURNED CHECK History Note: Authority G.S. 25-3-506; Eff. September 1, 1995; Amended Eff. February 1, 2006; Expired Eff. November 1, 2017 pursuant to G.S. 150B-21.3A.

21 NCAC 46 .1612 REINSTATEMENT OF LICENSES AND PERMITS (a) All licenses and registrations issued to individuals that are not renewed by March 1 of the succeeding year, lapse and are subject to the maximum reinstatement and renewal fees set out in G.S. 90-85.24 in order to be rein…

21 NCAC 46 .1613 EXTENSION PERIOD FOR CERTAIN MEMBERS OF THE ARMED FORCES (a) Definitions: (1) "Eligible licensee" means a pharmacist who holds a license in good standing from the Board of Pharmacy, who serves the armed forces of the United States, and who is eligible for an exte…

21 NCAC 46 .1614 SUSPENSION OF AUTHORITY TO EXPEND FUNDS In the event that the Board's authority to expend funds is suspended pursuant to G.S. 93B-2(d), the Board shall continue to issue and renew licenses, registrations and permits and collect all fees set forth in G.S. 90-85.24…

21 NCAC 46 .1615 E-PROFILE NUMBER REQUIRED FOR LICENSE, PERMIT, OR REGISTRATION (a) As part of the application for issuance or renewal of any in-state or out-of-state pharmacy permit, device and medical equipment permit, license to practice pharmacy, pharmacy intern registration,…

21 NCAC 46 .1616 LIMITED SERVICE PERMITS (a) The following pharmacy practice locations are eligible to apply for "limited service permits," which are pharmacy locations whose operations are modified by the provisions set forth in Paragraphs (b), (c), and (d) of this Rule: (1) aux…

21 NCAC 46 .1703 DRUGS TO BE DISPENSED (a) The nurse practitioner may dispense any and all drugs that the nurse practitioner is authorized by law to prescribe. (b) The physician assistant may dispense any and all drugs that the physician assistant is authorized by law to prescrib…

21 NCAC 46 .1706 RETROSPECTIVE REVIEW AND CONSULTATION During the weekly in-person, on-site visit required by Rule .1616(c)(2) of this Chapter, if not more frequently, the pharmacist-manager or assistant pharmacist-manager shall retrospectively perform a drug regimen review of al…

SECTION .1800 - PRESCRIPTIONS 21 NCAC 46 .1801 EXERCISE OF PROFESSIONAL JUDGMENT IN FILLING PRESCRIPTIONS (a) A pharmacist or device and medical equipment dispenser shall have a right to refuse to fill or refill a prescription order if doing so would be contrary to his or her pro…

21 NCAC 46 .1802 PRESCRIPTION REFILLS (a) Authorization for prescription refills is presumed to be within the prescribed dosage or normal therapeutic use. Refilling prescriptions more frequently than the prescribed dosage would require, or refilling prescriptions in significant e…

21 NCAC 46 .1803 PRESCRIPTION RECORDS All records pertaining to the filling and refilling of prescriptions shall be available to designated employees of the Board during normal business hours. History Note: Authority G.S. 90-85.6; 90-85.32; 90-85.36; Eff. April 1, 1983; Pursuant …

21 ncac 46 .1804 PRESCRIPTION: RECEIVING AND DISPENSING (a) In order to assure that the practitioner-pharmacist-patient relationship exists and to promote the safe and secure distribution of drugs and devices from a pharmacy, prescription orders may be received for filling and re…

21 NCAC 46 .1805 DISPENSING DRUGS WITHOUT A PRESCRIPTION The dispensing of or any delivery of a prescription drug, including the surrender of control or possession in any manner which results in a delivery of a prescription drug, without a valid prescription order is unlawful. Re…

21 NCAC 46 .1806 TRANSFER OF PRESCRIPTION INFORMATION (a) The transfer of original prescription information for the purpose of refill dispensing is permissible between pharmacies subject to the following requirements: (1) the transfer is communicated directly from either a pharma…

21 NCAC 46 .1807 FACSIMILE TRANSMISSION OF PRESCRIPTION ORDERS History Note: Authority G.S. 90-85.6(a); 90-85.32; Eff. October 1, 1990; Amended Eff. September 1, 1995; Repealed Eff. March 1, 2004.

21 NCAC 46 .1808 REPACKAGED PHARMACEUTICALS History Note: Authority G.S. 90-85.6(a); 90-85.32; Eff. December 1, 1991; Expired Eff. November 1, 2017 pursuant to G.S. 150B-21.3A.

21 NCAC 46 .1809 EMERGENCY PRESCRIPTION REFILLS In the event a pharmacist or device and medical equipment permit holder receives a request for a prescription refill and the pharmacist or permit holder is unable to obtain refill authorization from the prescriber, the pharmacist or…

21 NCAC 46 .1810 COMPOUNDING History Note: Authority G.S. 90-85.6; 90-85.32; Eff. September 1, 1995; Amended Eff. August 1, 1998; Repealed Eff. January 1, 2015.

21 NCAC 46 .1811 EXCESSIVE DISPENSING OF PRESCRIPTION DRUGS Pharmacists shall not dispense and permit holders shall not allow a pharmacist to dispense prescription drugs at such a rate per hour or per day as to pose a danger to the public health or safety. History Note: Authority…

21 NCAC 46 .1812 CHANGES IN PRESCRIPTION ORDERS A permit holder or registrant requesting a change from the prescription drug originally prescribed to a different prescription drug shall disclose to the prescriber at the time of the request any business relationship between the pe…

21 NCAC 46 .1813 TRANsMISSION OF PRESCRIPTION ORDERS (a) Prescription orders may be transmitted by using a facsimile machine ("FAX") or by other electronic transmission from a prescriber to a pharmacy. "Electronic transmission" means transmission of the digital representation of …

21 ncac 46 .1814 AUTOMATED DISPENSING OR DRUG SUPPLY DEVICES (Recodified to 21 NCAC 46 .1419 Effective May 1, 2021)

21 NCAC 46 .1815 EMERGENCY PRESCRIPTION REFILL DUE TO INTERRUPTION OF MEDICAL SERVICES In the event a pharmacist or device and medical equipment permit holder receives a request for a prescription refill and the pharmacist or permit holder is unable to readily obtain refill autho…

21 NCAC 46 .1816 CENTRALIZED pharmacy services (a) This Rule sets out the requirements under which pharmacies may engage in "centralized pharmacy services," which consist of both centralized prescription filling services and remote medication order processing services, as defined…

21 ncac 46 .1817 PROOF OF IDENTIFICATION (a) As a precondition to filling any prescription or dispensing any drug, a pharmacist or person acting at the direction of a pharmacist may demand, inspect and record proof of identification, including valid photographic identification, f…

21 ncac 46 .1818 PRESCRIPTION LABELS Prescription labels shall list at a minimum the generic name of the drug, even if the generic drug is unavailable to dispense or even if the substitution of a generic drug is not authorized. History Note: Authority G.S. 90-85.6; 90-85.32; Eff.…

21 NCAC 46 .1819 COVID-19 DRUG PRESERVATION RULE History Note: Authority G.S. 90-85.6; 90-85.26; 90-85.32; Emergency Adoption Eff. April 1, 2020; Temporary Adoption Eff. June 26, 2020; Eff. February 1, 2021; Repealed Eff. March 1, 2023.

21 NCAC 46 .1820 CODE OF ETHICS All pharmacists must comply with the American Pharmacist Association Code of Ethics, which is hereby incorporated by reference, along with all subsequent amendments or editions. A copy of the Code of Ethics is available free of charge on the Board'…

21 NCAC 46 .1821 DIRECT-TO-PATIENT DELIVERY SYSTEMS (a) This Rule sets out the requirements under which pharmacies may utilize "direct-to-patient" or ("DTP") delivery systems for dispensing in the State of North Carolina. (b) Definitions. (1) "Direct to patient system" or "DTP sy…

SECTION .1900 - FORMS 21 NCAC 46 .1901 DEFINITION For use in the discharge of the statutory duties of the Board, it has adopted certain official forms which are described in this Section. Forms referred to in this Chapter are those forms described in this Section, and are availab…

21 NCAC 46 .1904 RENEWAL OF PHARMACIST'S LICENSE The form for application for renewal of a pharmacist's license is entitled "Pharmacist License Annual Renewal Notice," and must be completed and returned to the Board yearly for those individuals who desire to continue their licens…

21 NCAC 46 .1905 REPLACEMENT OF CERTIFICATES The form for application for replacement of certificates is entitled "Order for Certificate of Registration." In addition to the ordinary identification information, this form requires the completion of an affidavit describing the loss…

21 NCAC 46 .1906 RECIPROCITY DATA QUESTIONNAIRE The form for application to initiate reciprocity procedures is entitled "Reciprocity Data Questionnaire" and begins the process of reciprocating a pharmacist's license to North Carolina from another state. Along with the usual ident…

21 NCAC 46 .1907 APPLICATION FOR RECIPROCITY Following receipt from the applicant for reciprocity of the Data Questionnaire, the form for application for reciprocity, entitled "Preliminary Application for Reciprocal Licensure," will be mailed to the applicant by the Board to faci…

21 NCAC 46 .1908 REGISTRATION FOR PRACTICAL PHARMACY TRAINING The form for registration for practical pharmacy training is entitled "Application for Registration in Pharmacy Training Program." This form must be completed by individuals at the beginning of the training necessary t…

21 NCAC 46 .1909 PRACTICAL PHARMACY EXPERIENCE The form for certification of experience in North Carolina is entitled "Practical Pharmacy Experience Affidavit," and is used to certify training in North Carolina. This form requires information necessary to certify the hours comple…

21 NCAC 46 .1910 CERTIFICATE OF EXPERIENCE OUTSIDE NORTH CAROLINA History Note: Authority G.S. 90-85.6; 90-85.15; Eff. April 1, 1983; Amended Eff. May 1, 1989; Repealed Eff. July 1, 1996.

21 NCAC 46 .1911 CERTIFICATE OF GRADUATION History Note: Authority G.S. 90-85.6; 90-85.15; Eff. April 1, 1983; Amended Eff. May 1, 1989; Expired Eff. November 1, 2017 pursuant to G.S. 150B-21.3A.

SECTION .2000 - ADMINISTRATIVE PROVISIONS 21 NCAC 46 .2001 FILING AND SERVICE (a) Parties shall file all papers provided for in this Section with the Board, either before service or within five days after service. The Board shall consider a paper to be filed when the Board actual…

21 ncac 46 .2004 REQUEST FOR HEARING (a) A person aggrieved by a Board administrative action who has not received a notice of hearing from the Board may file a request for a hearing. (b) The request for hearing shall contain the following information: (1) the petitioner's name an…

21 NCAC 46 .2005 GRANTING OR DENYING HEARING REQUEST (a) The Board shall grant a request for a hearing if it determines that the petitioner is a "person aggrieved" within the meaning of G.S. 150B-2(6). The Board shall provide notice of the time and place for the hearing. If the p…

21 NCAC 46 .2006 NOTICE OF HEARING (a) Before imposing final discipline under G.S. 90-85.38 on a person who holds a license, registration, permit, or other privilege issued by the Board, the Board shall file and serve a notice of hearing pursuant to G.S. 150B-38(b). (b) A party w…

21 NCAC 46 .2007 WHO SHALL HEAR CONTESTED CASES (a) A majority of the Board shall conduct all hearings, as set forth in G.S. 150B-40(b), except as provided in G.S. 150B-40(e). (b) The Board President shall be the presiding officer at any hearing, unless the President is disqualif…