SECTION .2800 – COMPOUNDING
21 NCAC 46 .2801 COMPOUNDING
(a) A pharmacy may dispense a compounded drug preparation
to a patient only pursuant to a prescription that is valid and complies with
all requirements of the law, including 21 NCAC 46 .1801. In advance of
dispensing the compounded drug preparation, a pharmacy shall prepare the
compounded drug preparation only:
(1) upon the pharmacy's receipt of a valid
prescription order for an individual patient; or
(2) in anticipation of a prescription order
based on an established history of receiving prescription orders for the
compounded drug preparation. Any compounded drug preparation prepared in
anticipation of a prescription order shall not be dispensed until the pharmacy
receives a valid prescription order for an individual patient.
(b) Compounded drug preparations shall not be offered to
other entities for resale.
(c) A pharmacy may supply compounded drug products to
practitioners authorized by law to prescribe drugs for those practitioners to
administer to those practitioners' patients. Such compounding for office use
shall comply with applicable federal law.
(d) The preparation, labeling, and dispensing of
non-sterile compounded drug preparations shall comply with the standards
established by United States Pharmacopeia chapter , including all
United States Pharmacopeia chapters and standards incorporated into chapter
by reference and including all subsequent amendments and editions
of the same, governing both the non-sterile compounded drug preparations and
the physical and environmental conditions under which non-sterile compounded
drug preparations are prepared, labeled, and dispensed.
(e) The preparation, labeling, and dispensing of sterile
compounded preparations shall comply with standards established by United
States Pharmacopeia chapter , including all United States
Pharmacopeia chapters and standards incorporated into chapter by
reference and including all subsequent amendments and editions of the same,
governing both the sterile compounded products and the physical and
environmental conditions under which sterile compounded products are prepared,
labeled, and dispensed.
(f) A pharmacy that prepares, labels, or dispenses sterile
compounded preparations shall maintain a reference library in the pharmacy
including the current United States Pharmacopeia standards and references on
the compatibility, stability, storage, handling, and preparation of compounded
drugs. These references may be either hard copy or electronically accessible.
(g) In a pharmacy where compounded drug preparations are
prepared, labeled, or dispensed, the pharmacist-manager or the
pharmacist-manager's designated pharmacist shall be knowledgeable in the
specialized functions of preparing, labeling, and dispensing compounded drug
preparations. If the pharmacist-manager chooses to designate another
pharmacist for this purpose, the pharmacist-manager shall notify the Board on
the pharmacy's permit application and, in writing, within 15 days of any change
in the designation. Notwithstanding the pharmacist-manager's designation of
another pharmacist as knowledgeable in the specialized functions of preparing,
labeling, and dispensing compounded drug preparations, the pharmacist-manager
shall be responsible for ensuring the pharmacy's compliance with all statutes,
rules, and standards that govern such activities.
(h) In addition to complying with all recordkeeping and
labeling requirements specified or referred to by United States Pharmacopeia
chapters or , a pharmacy that prepares, labels, or
dispenses compounded drug preparations shall create and maintain a record-keeping
system that enables the pharmacy immediately upon request to identify every
compounded drug preparation prepared, labeled, or dispensed in the past three
years. This recordkeeping system may be created and maintained electronically
in compliance with 21 NCAC 46 .2508.
(i) The pharmacist-manager of a pharmacy that prepares,
labels, or dispenses compounded drug preparations shall comply with all quality
assurance requirements and standards of United States Pharmacopeia chapters
(j) In addition to the requirements of this Section, the
compounding of radiopharmaceutical drug products shall comply with Section
.2700 of this Chapter.
(k) United States Pharmacopeia chapters or
may be inspected at the offices of the Board during its normal
hours of operation. Copies also may be obtained from the U.S. Pharmacopeial
Convention (www.usp.org), as part of the "USP on Compounding: A Guide for
the Compounding Practitioner," as an electronic publication, that cost one
hundred dollars ($100.00) as of the effective date of the last amendment to
History Note: Authority G.S. 90-85.6; 90-85.32;
Eff. October 1, 1990;
Amended Eff. January 1, 2015; April 1, 2003.