Current through Register Vol. 38, No. 18, March 15, 2024
(a) Applications
for pharmacy permits, whether original or renewal, shall be made upon forms
provided by the Board. The Board shall not issue any original or annual renewal
pharmacy permit until the Board is satisfied that:
(1) The pharmacist-manager is sure that at
all times adequate qualified personnel have been secured by the management of
the store to properly render pharmaceutical service in the manner prescribed by
law.
(2) The pharmacy posts in a
location conspicuous to the public the specific hours that a pharmacist is on
duty in the pharmacy. This requirement does not apply to hospitals, nursing
homes, and similar institutions subject to the provisions of Section .1400 of
this Chapter.
(3) The
pharmacist-manager shall be responsible for obtaining and maintaining equipment
in the pharmacy adequate to meet the pharmaceutical care needs of the
pharmacy's patients.
(4) The
pharmacist-manager shall be responsible for obtaining and maintaining a
reference library in the pharmacy. The library shall include current
references, either hard copy or electronically accessible, covering:
(A) State and federal statutes and rules
relating to the practice of pharmacy and the legal distribution of
drugs;
(B) Drug interactions,
adverse effects, therapeutic use, dosing and toxicology;
(C) Patient-oriented reference materials for
counseling in proper drug usage as specified in
21 NCAC
46 .2504;
(D) Equivalent drug products as defined in
G.S.
90-85.27; and
(E) Any reference materials otherwise
required by state or federal law, including any otherwise required in these
Rules.
(5) The pharmacy
is equipped with sanitary appliances including lavatory facilities with hot and
cold running water; is well lighted; and is kept in a clean, orderly, and
sanitary condition.
(6) All
prescription medications are labeled in accordance with
G.S.
106-134 and
106-134.1.
(b) In addition to the requirements for
issuance and renewal of a pharmacy permit imposed by statute and rules of the
Board, a permit shall not be issued or renewed to any person to operate a
pharmacy wherein the prescriptions of medical practitioners are compounded or
dispensed and distributed when such distribution is effected by mail and the
practitioner-pharmacist-patient relationship does not exist, until the Board is
satisfied that:
(1) The pharmacy maintains
records of prescriptions compounded or dispensed and distributed in manner that
is readily retrievable;
(2) During
the pharmacy's regular hours of operation but not less than six days per week,
for a minimum of forty hours per week, a toll-free telephone service is
provided to facilitate communication between patients and a pharmacist at the
pharmacy who has access to the patient's records. This toll-free number must be
disclosed on the label affixed to each container of dispensed drugs;
(3) The pharmacy complies with all lawful
orders, directions, and requests for information from the Boards of pharmacy of
all states in which it is licensed and all states into which it distributes
prescription drugs;
(4) The
pharmacy complies with all United States Pharmacopeia and Food and Drug
Administration requirements regarding the storage, packaging, and shipping of
prescription medications. The pharmacist-manager and all other pharmacists
employed in the pharmacies permitted pursuant to this Paragraph shall be
subject to all Federal and State statutes and regulations concerning the
dispensing of prescription medications including
21 NCAC
46 .1801 and
46 .1805 and
21 CFR
1306.01,
1306.05, and
1306.21.
(c) The Board shall not issue an original or
renewal permit to any person to operate a drugstore or pharmacy as a department
in or a part of any other business serving the general public (except
hospitals, nursing homes, and similar institutions subject to the provisions of
Section .1400 of this Chapter) unless such pharmacy facility:
(1) is physically separated from such other
business;
(2) is separately
identified to the public both as to name and any advertising;
(3) completes all transactions relative to
such pharmacy within the registered facility; and
(4) meets the same requirements for
registration as all other pharmacies.
(d) In addition to all of the other
requirements for issuance and renewal of a pharmacy permit imposed by statute
and rules of the Board, the Board shall not issue any original or annual
renewal pharmacy permit to any Internet pharmacy until the Board is satisfied
that:
(1) The Internet pharmacy is certified
by the National Association of Boards of Pharmacy under its Digital Pharmacy
Accreditation program;
(2) The
Internet pharmacy has certified the percentage of its annual business conducted
via the Internet on a form provided by the Board, when it applies for permit or
renewal; and
(3) The Internet
pharmacy has provided the Board with the names, addresses, social security
numbers, phone numbers, facsimile numbers, email addresses, and titles of all
principal corporate officers of the Internet pharmacy; the names, addresses,
social security numbers, phone numbers, facsimile numbers, email addresses, and
titles of all principal officers of any company, partnership, association, or
other business entity holding any ownership interest in the Internet pharmacy;
the names, addresses, social security numbers, phone numbers, facsimile
numbers, email addresses, and titles of any individual holding any ownership
interest in the Internet pharmacy.
This Paragraph does not relieve an out-of-state pharmacy from
compliance with all provisions of
21 NCAC
46 .1607 governing out-of-state
pharmacies.
(e)
Permits to operate pharmacies, whether original or renewal, shall be issued to
the pharmacist-manager of such pharmacy pursuant to a joint application of the
owner and pharmacist-manager for the conduct and management of said pharmacy.
The issuance of said permit shall not be complete and the permit shall not be
valid until it has been countersigned by the pharmacist-manager as represented
in the application. The permit so issued is valid only so long as the
pharmacist-manager to whom it was issued assumes the duties and
responsibilities of pharmacist-manager. Permits may be reissued at any time to
a successor pharmacist-manager pursuant to the proper amendment of the
application for the permit.
(f)
Upon application, the Board may issue and renew separate permits for pharmacies
operating at one location. Records for each permitted pharmacy must be
maintained separately. Prior to issuance of an original permit, each pharmacy
shall submit a plan to the Board that shall assure accountability for the
actions of each pharmacy at the location.
Authority
G.S.
90-85.6;
90-85.21;
132-1.10;
Eff. April
1, 1983;
Amended Eff. November 1, 2012; April 1, 2007; April 1,
2003; April 1, 1999; October 29, 1998; July 1, 1996; September 1, 1995; May 1,
1989; August 1, 1988; March 1, 1984;
Pursuant to
G.S.
150B-21.3A, rule is necessary without
substantive public interest Eff. October 3, 2017;
Amended Eff. May
1, 2020.