Current through April 3, 2024
(1) The pharmacist in charge or the person(s)
designated by the pharmacist in charge shall be responsible for, at a minimum,
the following:
(a) Procurement, storage,
compounding, labeling, repackaging, dispensing, and distribution of all drugs
and devices and related materials necessary in compounding and dispensing
compounded drug products;
(b)
Establishment of policies and procedures for the compounding and dispensing of
compounded drug products;
(c)
Documentation of competency in proper techniques of all pharmacists, pharmacy
interns and pharmacy technicians. The proper technique of each person
compounding and dispensing compounded drug products shall be observed and
evaluated as satisfactory during orientation and training pursuant to standards
established by USP chapters 795, 797, 800, and/or 825, pursuant to the
compounding pharmacy's site practice, including all USP chapters and standards
incorporated into chapters by reference and including all subsequent amendments
and editions of the same, governing both the compounded drug products and the
physical and environmental conditions under which compounded drug products are
prepared, labeled, and dispensed or whenever unacceptable techniques are
observed or detected;
(d)
Establishment of a quality assurance program.
(2) All pharmacists, pharmacy interns and
pharmacy technicians as defined in 1140-02-.02 responsible for compounding or
dispensing compounded drug products shall:
(a)
Obtain practical and/or academic training in the compounding and dispensing of
compounded drug products;
(b)
Complete education pursuant to the standards established by USP chapters 795,
797, 800, and/or 825, pursuant to the compounding pharmacy's site practice,
including all USP chapters and standards incorporated into chapters by
reference and including all subsequent amendments and editions of the same,
governing both the compounded drug products and the physical and environmental
conditions under which compounded drug products are prepared, labeled, and
dispensed; and
(c) Maintain, in the
pharmacy practice site, documentation of completion of the required initial and
subsequent training and competency evaluations for (2) years. A written record
of initial and subsequent training and competency evaluations shall be
maintained in the pharmacy practice site. These records shall contain the
following information:
1. Name of the person
receiving the training or evaluation;
2. Date(s) of the training or
evaluation;
3. General description
of the topics covered; and
4.
Signature of the person receiving the training or evaluation and the pharmacist
in charge or the person(s) designated by the pharmacist in charge. The person
receiving the training may not self-evaluate.
(d) Use proper technique in all drug product
compounding as defined by the pharmacy practice site's policies and procedures
and in compliance with standards established by USP chapters 795, 797, 800,
and/or 825, pursuant to the compounding pharmacy's site practice, including all
USP chapters and standards incorporated into chapters by reference and
including all subsequent amendments and editions of the same, governing both
the compounded drug products and the physical and environmental conditions
under which compounded drug products are prepared, labeled, and
dispensed.
(3) The
pharmacist in charge shall be assisted by such additional pharmacists, pharmacy
interns, pharmacy technicians as defined by 1140-02-.02 and supportive
personnel necessary to operate the pharmacy practice site competently and
safely and to provide services in a timely and appropriate manner.
(4) All pharmacists, pharmacy interns and
pharmacy technicians must be qualified at least annually through an appropriate
combination of specific training and experience to operate or manipulate any
item of equipment, apparatus, or device to which such pharmacists, interns and
technicians will be assigned to use to compound and dispense compounded drug
products.
(5) Upon request, the
Board may waive selected portions of these requirements so long as any waiver
granted is consistent with the Board's authority under Tenn. Code Ann. Title
63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.
Authority: T.C.A. §§
63-10-216,
63-10-308, and 63-10-310.
