21 N.C. Admin. Code 46.1616

Current through Register Vol. 39, No. 8, October 15, 2024

Section 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) auxiliary medication inventories permitted and operating in health care facilities pursuant to Rule .1414(d) of this Chapter;

(2) automated dispensing or drug supply devices permitted and operating in health care facilities pursuant to Rule .1419 of this Chapter;

(3) direct to patient systems that are not located at the home pharmacy's facility pursuant to Rule .1821 of this Chapter;

(4) facilities where drugs are dispensed only by nurse practitioners or physician assistants pursuant to Section .1700 of this Chapter;

(5) county health departments or other governmental entities providing local health services under G.S. 130A-34 where drugs are dispensed only by registered nurses and only pursuant to G.S. 90-85.34A and Section .2400 of this Chapter;

(6) county health departments or other governmental entities providing local health services under G.S. 130A-34 that engage in dispensing beyond that set out in G.S. 90-85.34A and Section .2400 of this Chapter;

(7) free clinics, as defined in G.S. 90-85.44(a)(6); or

(8) critical access hospitals, as defined in G.S. 131E-76.

(b) A pharmacist-manager for a limited service permit may designate one assistant pharmacist-manager but is not required to do so. The assistant pharmacist-manager shall be responsible for exercising all of the responsibilities of a pharmacist-manager when the assistant pharmacist-manager is present and the pharmacist-manager is not present at the location holding the limited service permit. If the pharmacist-manager chooses to designate an assistant pharmacist-manager, the pharmacist-manager shall notify the Board on the limited service permit application, if an assistant pharmacist-manager is desired at that time. If a designation is made or changed after the limited service permit application is filed, the pharmacist-manager shall notify the Board, in writing, within 15 days of any change in the designation. Notwithstanding the pharmacist-manager's designation of an assistant pharmacist-manager, the pharmacist-manager shall be responsible for ensuring the pharmacy's compliance with all statutes, rules, and standards at all times.

(c) For limited service permits, the pharmacist-manager attendance requirements set out in Rule .2502(b) of this Chapter are modified only as set forth herein:

(1) For limited service permits described in Subparagraphs (a)(1), (2) and (3) of this Rule, either the pharmacist-manager or the assistant pharmacist-manager shall perform an in-person, on-site visit at least once per calendar quarter to inspect the location holding the permit, review the operations of the location holding the permit with the persons involved in accessing them as permitted by the rules referenced in Subparagraphs (a)(1), (2), and (3) of this Rule, and ensure that the location holding the permit is operated in compliance with all applicable State and federal laws.

(2) For limited service permits described in Subparagraphs (a)(4) and (5) of this Rule, either the pharmacist-manager or the assistant pharmacist-manager shall perform an in-person, on-site visit at least once per week to inspect the location holding the permit, review the operations of the location holding the permit with the persons involved in dispensing, and ensure that the location holding the permit is operated in compliance with all applicable State and federal laws.

(3) For limited service permits described in Subparagraphs (a)(6), (7) and (8) of this Rule, either the pharmacist-manager or the assistant pharmacist-manager employed or otherwise engaged to supply pharmaceutical services may have a flexible schedule of attendance but shall be present for at least one-half of the hours the pharmacy is open or 20 hours a week, whichever is less. For the limited service permits described in Subparagraphs (a)(5) and (6) of this Rule, a licensed pharmacist shall be present when the pharmacy is open as described in Rule .2502(e) of this Chapter. For the limited service permits described in Subparagraph (a)(7) of this Rule, the location holding the limited service permit may operate in the absence of a pharmacist only as set out in Rule .1413 of this Chapter.

(4) The limited service permit holder may name a temporary pharmacist-manager or assistant pharmacist-manager for a period not to exceed 90 days from the departure date of the previous pharmacist-manager or assistant pharmacist-manager. The temporary pharmacist-manager or assistant pharmacist-manager shall accept the responsibilities of that position and shall be present as set forth in this Rule. A location holding a limited service permit may not operate for a period of more than 30 days without a pharmacist employed or otherwise engaged as a permanent or temporary pharmacist-manager who has signed the permit for that pharmacy.

(d) A person may serve as the pharmacist-manager or the assistant pharmacist-manager for multiple limited service permits, and may do so while also serving as the pharmacist-manager for a maximum of one permit other than a limited service permit. A person serving multiple limited service permit locations must fulfill all of that person's duties under State and federal law as to each location.

(e) Except as expressly set forth in this Rule, the pharmacist-manager must provide oversight and supervision as provided elsewhere in this Chapter.

21 N.C. Admin. Code 46 .1616

Authority G.S. 90-18.1(c); 90-18.2; 90-85.6; 90-85.21; 90-85.33; 90-85.34;
Eff. November 1, 2021.

Authority G.S. 90-18.1(c); 90-18.2; 90-85.6; 90-85.21; 90-85.33; 90-85.34;
Adopted by North Carolina Register Volume 36, Issue 11, December 1, 2021 effective 11/1/2021.

Amended by North Carolina Register Volume 38, Issue 07, October 2, 2023 effective 9/1/2023.