(a)In accordance with Board regulations, each pharmacy in North Carolina shall annually register with the Board on a form provided by the Board. The application shall identify the pharmacist-manager of the pharmacy and all pharmacy personnel employed in the pharmacy. All pharmacist-managers shall notify the Board of any change in pharmacy personnel within 30 days of the change. In addition to identifying the pharmacist-manager, a pharmacy may 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.
(a1) A mobile pharmacy shall register annually with the Boa
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(a) In accordance with Board regulations, each pharmacy in North Carolina shall annually register with the Board on a form provided by the Board. The application shall identify the pharmacist-manager of the pharmacy and all pharmacy personnel employed in the pharmacy. All pharmacist-managers shall notify the Board of any change in pharmacy personnel within 30 days of the change. In addition to identifying the pharmacist-manager, a pharmacy may 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.
(a1) A mobile pharmacy shall register annually with the Board in the manner prescribed in subsection (a) of this section, and the registration shall be renewed annually. A mobile pharmacy shall be considered a single pharmacy and shall not be required to pay a separate registration fee for each location but shall pay the annual registration fee prescribed in G.S. 90-85.24. A mobile pharmacy shall provide the Board with the address of every location from which prescription drugs will be dispensed by the mobile pharmacy.
(b) 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. The form provided by the Board under this subsection shall be as follows:
Application For Registration
With The Pharmacy Board
As A Dispensing Physician
1. 2.
Name and Address of Dispensing Affix Dispensing Label Here
Physician
3. Physician's North Carolina License Number ______________________________
4. Are you currently practicing in a professional association registered with the North Carolina Medical Board?
______ Yes ______ No. If yes, enter the name and registration number of the professional corporation:
______________________________________________________________________
______________________________________________________________________
5. I certify that the information is correct and complete.
________________________ _________________
Signature Date
(1927, c. 28, s. 1; 1953, c. 183, s. 2; 1981 (Reg. Sess., 1982), c. 1188, s. 1; 1987, c. 687; 1995, c. 94, s. 25; 1999-246, s. 2; 2001-375, s. 3; 2005-427, s. 1.)
§ 90-85.21A. Applicability to out-of-state operations.
(a) Any pharmacy operating outside the State which ships, mails, or delivers in any manner a dispensed legend drug into this State shall annually register with the Board on a form provided by the Board. In order to satisfy the registration requirements of this subsection, a pharmacy shall certify that the pharmacy employs a pharmacist who is responsible for dispensing, shipping, mailing, or delivering dispensed legend drugs into this State or in a state approved by the Board and has met requirements for licensure equivalent to the requirements for licensure in this State. In order for the pharmacy's certification of the pharmacists to be valid, a pharmacist shall agree in writing, on a form approved by the Board, to be subject to the jurisdiction of the Board, the provisions of this Article, and the rules adopted by the Board. If the Board revokes this certification, the pharmacy shall no longer have authority to dispense, ship, mail, or deliver in any manner a dispensed legend drug into this State.
(b) Any pharmacy subject to this section shall at all times maintain a valid unexpired license, permit, or registration necessary to conduct such pharmacy in compliance with the laws of the state in which such pharmacy is located. No pharmacy operating outside the State may ship, mail, or deliver in any manner a dispensed legend drug into this State unless such drug is lawfully dispensed by a licensed pharmacist in the state where the pharmacy is located.
(c) The Board shall be entitled to charge and collect not more than five hundred dollars ($500.00) for original registration of a pharmacy under this section, and for renewal thereof, not more than two hundred dollars ($200.00), and for reinstatement thereof, not more than two hundred dollars ($200.00).
(d) The Board may deny a nonresident pharmacy registration upon a determination that the pharmacy has a record of being formally disciplined in its home state for violations that relate to the compounding or dispensing of legend drugs and presents a threat to the public health and safety.
(e) Except as otherwise provided in this subsection, the Board may adopt rules to protect the public health and safety that are necessary to implement this section. Notwithstanding G.S. 90-85.6, the Board shall not adopt rules pertaining to the shipment, mailing, or other manner of delivery of dispensed legend drugs by pharmacies required to register under this section that are more restrictive than federal statutes or regulations governing the delivery of prescription medications by mail or common carrier. A pharmacy required to register under this section shall comply with rules adopted pursuant to this section.
(f) The Board may deny, revoke, or suspend a nonresident pharmacy registration for failure to comply with any requirement of this section. (1993, c. 455, s. 1; 1998-212, s. 12.3B(b); 2004-199, s. 25; 2005-402, s. 3.)
§ 90-85.21B. Unlawful practice of pharmacy.
It shall be unlawful for any person, firm, or corporation not licensed or registered under the provisions of this Article to:
(1) Use in a trade name, sign, letter, or advertisement any term, including "drug", "pharmacy", "prescription drugs", "prescription", "Rx", or "apothecary", that would imply that the person, firm, or corporation is licensed or registered to practice pharmacy in this State.
(2) Hold himself or herself out to others as a person, firm, or corporation licensed or registered to practice pharmacy in this State. (2003-284, s. 10.8D.)
§ 90-85.21C. Pharmacy permit exemption for dispensing and delivery of home renal products.
Each location or facility within or outside this State from which dialysate or drugs necessary to perform home renal dialysis are dispensed and delivered to a patient in this State is exempt from the pharmacy permit requirements established by G.S. 90-85.21 and G.S. 90-8.21A, provided that all the following criteria are met:
(1) The dialysate or drugs have been approved or cleared by United States Food and Drug Administration.
(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. (2015-28, s. 1.)
§ 90-85.21D. Dialysis facilities as designated agents to receive home medications for patients with renal failure.
Pharmacies may ship medications for home use by 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. (2015-28, s. 1.)