Section .2800 – Compounding

Link to law: http://reports.oah.state.nc.us/ncac/title 21 - occupational licensing boards and commissions/chapter 46 - pharmacy/21 ncac 46 .2801.html
Published: 2015

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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

and .

(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

this Rule.

 

History Note:        Authority G.S. 90-85.6; 90-85.32;

Eff. October 1, 1990;

Amended Eff. January 1, 2015; April 1, 2003.