North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .1600 - LICENSES AND PERMITS › Section 46 .1607 - OUT-OF-STATE PHARMACIES

Current through Register Vol. 39, No. 2, July 15, 2024
(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 into this State.
(b) An out-of-state pharmacy may not ship,
				mail, or deliver in any manner even a single dispensed legend drug, device, or
				piece of medical equipment into this State until it receives a permit from the
				Board. All unpermitted dispensing must be disclosed on any permit application,
				and any permit applicant must update any application within 24 hours of any
				dispensing into this State that occurs while a permit application is pending.
				The Board may deny a permit based on that dispensing or on a failure to
				disclose it.
(c) In addition to the
				requirements contained in
				G.S.
				85-21A, these pharmacies shall:
(1) supply all information requested by the
				Board in carrying out the Board's responsibilities under the statutes and rules
				pertaining to out-of-state pharmacies;
(2) during the pharmacy's regular hours of
				operation but not less than six days per week, for a minimum of 40 hours per
				week, provide a toll-free telephone service to facilitate communication between
				patients and pharmacists at the pharmacy who have access to the patient's
				records. This toll-free number must be disclosed on the label for each
				dispensed drug, device, or piece of medical equipment;
(3) comply with all USP and FDA requirements
				regarding the storage, packaging, and shipping of drugs, devices, and medical
				equipment;
(4) develop policies
				governing:
(A) normal delivery protocols and
				times;
(B) the procedure to be
				followed if the patient's drug, device, or medical equipment is not available
				at the out-of-state pharmacy, or if delivery will be delayed beyond the normal
				delivery time;
(C) the procedure to
				be followed upon receipt of a prescription for a condition that requires
				treatment before the drug, device, or medical equipment would be delivered in
				the normal delivery time, which shall include a procedure for delivery of the
				drug, device, or medical equipment to the patient from the out-of-state
				pharmacy at the earliest possible time (such as courier delivery), or an
				alternative that assures the patient the opportunity to obtain the drug,
				device, or medical equipment at the earliest possible time; and
(D) the procedure to be followed when the
				out-of-state pharmacy is advised that the patient's drug, device, or medical
				equipment has not been received within the normal delivery time and that the
				patient is out of the drug, device, or medical equipment and requires interim
				dosage until the pharmacy can provide the drug, device, or medical
				equipment;
(5) disclose
				the location, names, and titles, of all officers and direct and indirect owners
				of the pharmacy. Disclose the names and license numbers of all pharmacists
				dispensing drugs, devices, or medical equipment to an ultimate user in this
				State, the names and, if available, license or registration numbers of all
				pharmacy personnel employed by the out-of-state pharmacy who assist pharmacists
				in dispensing. The pharmacist-manager for the out-of-state permit issued by
				this Board must be the same person as the pharmacist-manager (whether called a
				pharmacist-manager, a person-in-charge or otherwise) of the pharmacy on the
				permit issued by the pharmacy's home state. A report containing this
				information shall be made on an annual basis and within 30 days of each change
				of any pharmacist-manager, officer, or owner (whether direct or indirect) of
				the pharmacy. A new permit shall be required under the circumstances set out in
				Rule .1603 of this Section, and a new permit must be secured before any legend
				drugs, devices, or medical equipment may be dispensed into the State of North
				Carolina following any of the enumerated changes in circumstances. The existing
				permit becomes void upon one of the events in Rule .1603, and any dispensing
				into the State of North Carolina following one of those events is unlawful and
				grounds for denial of a new permit;
(6) submit evidence of possession of a valid
				license, permit, or registration as a pharmacy in compliance with the laws of
				the state in which the pharmacy is located;
(7) designate a registered office and
				registered agent in North Carolina for service of process pursuant to Article 4
				of Chapter 55D of the North Carolina General Statutes. The Board may serve or
				deliver any notice or other document provided for under the Pharmacy Practice
				Act or these Rules on that registered agent. The Board may further serve or
				deliver any notice or other document provided for under the Pharmacy Practice
				Act or these Rules on the Secretary of State when the Secretary of State
				becomes an agent of the entity pursuant to Article 4 of Chapter 55D of the
				North Carolina General Statutes; and
(8) notify the Board within five days of
				receipt of any order or decision by a Board of Pharmacy or other state or
				federal agency imposing discipline of any sort on the pharmacy, or receipt of
				any warning letter from the Food and Drug Administration.