(1) A policy and
procedure manual related to drug product compounding shall be available for
inspection at the pharmacy practice site. The manual shall include policies and
procedures for compounding pursuant to USP standards, and shall, at a minimum,
include:
(a) Security;
(b) Equipment;
(c) Sanitation;
(d) Reference materials;
(e) Prescription drug and device and related
material storage;
(f) Prescription
drug and device and related material compounding and dispensing;
(g) Prescription drug and device and related
material labeling and relabeling;
(h) Prescription drug and device and related
material destruction and returns;
(i) Dispensing of compounded drug
products;
(j) Record
keeping;
(k) Quality
assurance;
(l) Quality
control;
(m) Duties for
pharmacist(s), pharmacy intern(s), pharmacy technician(s) and supportive
personnel;
(n) Public safety
relative to harmful compounded drug products, including the active notification
of patients if they may be affected by a product found to have a defect or an
out-of-specification result including any recall policy and
procedures;
(o) Attire;
(p) Pharmacist, pharmacy intern, and pharmacy
technician training;
(q) Compliance
with 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
(r) Response to adverse events,
outbreaks, and other public health threats associated with products compounded,
dispensed, manufactured, propagated, distributed, or otherwise processed at the
facility, including procedures for the rapid compilation and dissemination of
records to appropriate authorities.
(2) Any licensed facility which engages in
drug product compounding shall conduct an annual review of its policy and
procedure manual, and shall update its policy and procedure manual as
necessary.
(3) Failure by any
licensee or registrant to comply with its policy and procedure manual, or any
part of this rule shall be considered a violation of a duly promulgated rule of
the Board of Pharmacy and may be considered dishonorable, immoral, unethical or
unprofessional conduct within the meaning of T.C.A. §
63-10-305(6).
