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 into this State.
(b) Such pharmacies shall:
(1) Maintain, in readily retrievable form, records of prescription drugs dispensed to North Carolina residents;
(2) 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;
(3) 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 affixed to each container of dispensed drugs;
(4) Comply with all USP and FDA requirements regarding the storage, packaging, and shipping of prescription medications;
(5) Develop policies governing:
(A) normal delivery protocols and times;
(B) the procedure to be followed if the patient's medication 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 an acute illness, which shall include a procedure for delivery of the medication 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 medication at the earliest possible time; and
(D) the procedure to be followed when the out-of-state pharmacy is advised that the patient's medication has not been received within the normal delivery time and that the patient is out of medication and requires interim dosage until mail prescription drugs become available;
(6) Disclose the location, names, and titles, of all principal corporate officers, if incorporated, and if unincorporated, partners, or owners of the pharmacy. Disclose the names and license numbers of all pharmacists dispensing prescription legend drugs to an ultimate user in this State, the names and, if available, license or registration numbers of all supportive personnel employed by the out-of-state pharmacy who assist such pharmacists in such dispensing. A report containing this information shall be made on an annual basis and within 30 days of each change of any principal office, pharmacist-manager of any location dispensing prescription legend drugs to an ultimate user in this State, principal corporate officer if incorporated, and if unincorporated, partner or owner of the pharmacy. A new registration shall be required for a change of ownership of an established pharmacy to a successor business entity which results in a change in the controlling interest in the pharmacy;
(7) 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. Such evidence shall consist of one of the following:
(A) a copy of the current license, permit, or registration certificate issued by the regulatory or licensing agency of the state in which the pharmacy is located; or
(B) a letter from the regulatory or licensing agency of the state in which the pharmacy is located certifying the pharmacy's compliance with the pharmacy laws of that state;
(8) Designate a resident agent in North Carolina for service of process. Any such out-of-state pharmacy that does not so designate a resident agent shall be deemed to have appointed the Secretary of State of the State of North Carolina to be its true and lawful attorney upon whom process may be served. All legal process in any action or proceeding against such pharmacy arising from shipping, mailing or delivering prescription drugs in North Carolina shall be served on the resident agent. In addition, a copy of such service of process shall be mailed to the out-of-state pharmacy by certified mail, return receipt requested, at the address of the out-of-state pharmacy as designated on the registration form filed with the Board. Any out-of-state pharmacy which does not register in this State, shall be deemed to have consented to service of process on the Secretary of State as sufficient service.
(c) The facilities and records of an out-of-state pharmacy shall be subject to inspection by the Board; provided however, the Board may accept in lieu thereof satisfactory inspection reports by the licensing entity of the state in which the pharmacy is located.
(d) An out-of-state pharmacy shall comply with the statutes and regulations of the state in which the pharmacy is located.
(e) Any person who ships, mails, or delivers prescription drugs to North Carolina residents from more than one out-of-state pharmacy shall register each pharmacy separately.
(f) Prior to original registration, a pharmacist who is an authorized representative of the pharmacy's owner must appear personally at the Board office on the first Monday of the month, the Monday before the monthly Board meeting, or such other time as scheduled with the Board's staff. Such authorized pharmacist may represent all pharmacies having the same ownership.
(g) An out-of-state pharmacy shall report to the Board information that reasonably suggests that there is a probability that a prescription drug or device dispensed from such out-of state pharmacy has caused or contributed to the death of any patient. The report shall be filed in writing on a form provided by the Board within 14 days of the pharmacy becoming aware of the death. The Board may not disclose the identity of any person or entity making the report, except when it is necessary to protect life or health of any person. No such report in possession of the Board shall be discoverable or admissible into evidence or otherwise used in any civil action involving private parties, except as otherwise required by law.
(h) The Board may, in accordance with Chapter 150B of the General Statutes, issue a letter of reprimand or suspend, restrict, revoke, or refuse to grant or renew registration to an out-of-state pharmacy if such pharmacy has:
(1) made false representations or withheld material information in connection with obtaining registration;
(2) been found guilty of or plead guilty or nolo contendere to any felony in connection with the practice of pharmacy or the distribution of drugs;
(3) made false representations in connection with the practice of pharmacy that endanger or are likely to endanger the health or safety of the public, or that defraud any person;
(4) failed to comply with this Rule;
(5) been the subject of a negligence complaint resulting from the dispensing of prescription drugs to a resident of North Carolina and based on an investigation of such complaint been found to be negligent:
(A) by the Board of Pharmacy of the state in which the pharmacy is located;
(B) by the North Carolina Board of Pharmacy if the Board of Pharmacy of the state where the pharmacy is located failed to initiate an investigation of such complaint within 45 days after referral of the complaint from the North Carolina Board of Pharmacy; or
(C) by the North Carolina Board of Pharmacy if the Board of Pharmacy of the state where the pharmacy is located initiates an investigation of such complaint within 45 days, but later advises the North Carolina Board that it will not make a determination of negligence or that it has made no determination of the issue of negligence within one year after referral of the complaint and has discontinued any active investigation or proceeding for such determination. In any disciplinary proceeding based on negligence, the standard of practice shall be that applicable in the state in which the pharmacy is located. In disciplinary proceedings pursuant to Part (h)(5)(A) of this Rule, the Board shall adopt the findings of negligence by the Board of Pharmacy of the state in which the pharmacy is located as part of the Board’s final decision without producing its own evidence of negligence.
(i) An out-of-state pharmacy shall notify the Board within five days of receipt of any order or decision by a Board of Pharmacy imposing disciplinary action on the pharmacy. Notwithstanding the provisions of Paragraph (h) of this Rule, if the permit or registration in the state where the pharmacy is located is suspended or revoked, then the pharmacy’s registration in North Carolina will be immediately suspended or revoked for the same period of time.
(j) An out-of-state pharmacy registration shall expire on December 31 of each year.
(k) The fees provided for in G.S. 90-85.21A as maximum fees which the Board is entitled to charge and collect are hereby established as the fees for each original registration and for annual renewal of each registration.
History Note: Authority G.S. 90-85.6; 90-85.21A; 90-85.26; 90-85.28; 90-85.29; 90-85.30; 90-85.32;
Eff. July 1, 1994;
Amended Eff. March 1, 2006.