SECTION 2800 – COMPOUNDING 21 NCAC 46 2801 COMPOUNDING

section .2800 – compounding 21 ncac 46 .2801 compounding (a) a pharmacy may dispense a compounded drug preparation to a patient only pu

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 <795>, including all
United States Pharmacopeia chapters and standards incorporated into
chapter <795> 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 <797>, including all United States Pharmacopeia
chapters and standards incorporated into chapter <797> 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 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 <795> or <797>, 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 <795> and <797>.
(j) Between January 1 and March 31 of each year, any pharmacy
permitted by the Board that has prepared, labeled, or dispensed any
compounded drug (for any patient or other person, either within or
outside North Carolina) during the immediately preceding calendar year
shall update all information regarding its services in the National
Association of Boards of Pharmacy's e-Profile Connect system at
https://dashboard.nabp.pharmacy.
(k) In addition to the requirements of this Section, the compounding
of radiopharmaceutical drug products shall comply with Section .2700
of this Chapter.
(l) United States Pharmacopeia chapters <795> or <797> 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 a free download as of the effective date
of the last amendment to this Rule.
History Note: Authority G.S. 90-85.6; 90-85.21A; 90-85.26; 90-85.32;
Eff. October 1, 1990;
Amended Eff. January 1, 2015; April 1, 2003;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive
public interest Eff. October 3, 2017;
Amended Eff. August 1, 2021.