Utah Admin. Code R156-17b-605 - Operating Standards - Inventory Requirements
(1) Authorized personnel shall remove
out-of-date legend drugs and controlled substances from the inventory at
regular intervals and in correlation to the beyond use date imprinted on the
label.
(2) General requirements for
inventory of a pharmacy shall include the following:
(a) the consulting pharmacist, PIC, RDPIC, or
DMPIC shall be responsible for taking required inventories, but may delegate
the performance of the inventory to another person;
(b) the inventory records shall be maintained
for a period of five years and be readily available for inspection;
(c) the inventory records shall be filed
separately from all other records;
(d) the inventory records shall be in a
written, typewritten, or printed form and include each stock of controlled
substances on hand on the date of the inventory, including any that are
out-of-date drugs and drugs in automated pharmacy systems;
(e) an inventory taken by use of a verbal
recording device shall be promptly transcribed;
(f) the inventory may be taken either as the
opening of the business or the close of business on the inventory
date;
(g) the person taking the
inventory and the consulting pharmacist, PIC, RDPIC, or DMPIC shall state the
time the inventory was taken and shall sign and date the inventory with the
date the inventory was taken;
(h)
the signature of the consulting pharmacist, PIC, RDPIC, or DMPIC and the date
of the inventory shall be documented within 72 hours or three working days of
the completed initial, annual, change of ownership and closing
inventory;
(i) the person taking
the inventory shall make an exact count or measure controlled substances listed
in Schedule I or II;
(j) the person
taking the inventory shall make an estimated count or measure of Schedule III,
I V, or V controlled substances, but if the container holds more than 1,000
tablets or capsules, an exact count of the contents shall be made;
(k) the inventory of Schedule I and II
controlled substances shall be listed separately from the inventory of Schedule
III, IV and V controlled substances; and
(l) if the pharmacy maintains a perpetual
inventory of any of the drugs required to be inventoried, the perpetual
inventory shall be reconciled on the date of the inventory.
(3) Requirements for taking the
initial controlled substances inventory shall include the following:
(a) pharmacies having stock of controlled
substances shall take an inventory, including out-of-date drugs and drugs in
automated pharmacy systems, on the opening day of business;
(b) if a pharmacy commences business with no
Schedule I or II controlled substances, the pharmacy shall record this fact as
the initial inventory and shall document Schedule I and II controlled substance
inventory separately from an inventory reporting no Schedule III, I V, and V
controlled substances;
(c) the
initial inventory shall serve as the pharmacy's inventory until the next
completed inventory as specified in Subsection (4) of this section;
and
(d) when combining two
pharmacies, each pharmacy shall:
(i) conduct a
separate closing pharmacy inventory of controlled substances on the date of
closure; and
(ii) conduct a
combined opening inventory of controlled substances for the new pharmacy before
opening.
(4)
Requirement for annual controlled substances inventory shall be within 12
months following the inventory date of each year and may be taken within four
days of the specified inventory date and shall include stocks including
out-of-date drugs and drugs in automated pharmacy systems.
(5) Requirements for a qualifying change of
ownership shall include the following:
(a) the
pharmaceutical facility shall take an inventory of legend drugs and controlled
substances including out-of-date drugs and drugs in automated pharmacy systems
on the date of the qualifying change of ownership;
(b) such inventory shall constitute the
closing inventory for the seller and the initial inventory for the buyer;
and
(c) any transfer of Schedule I
and II controlled substances shall require the use of official DEA order form
222.
(6) A pharmacy shall
maintain a perpetual inventory of Schedule II controlled substances that shall
be reconciled according to facility policy.
Notes
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