(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out-of-date legend drugs and controlled substances from the inventory at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 or persons;
(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out-of-date drugs and drugs in automated pharmacy systems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 indicate
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, unless the container holds more than 1,000
tablets or capsules in which case 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;
(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)
(i)
pharmacies having stock of controlled substances shall take an inventory,
including out-of-date drugs and drugs in automated pharamcy systems, on the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, IV, 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 prior
to 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 change of ownership shall include the following:
(a) a pharmacy that changes ownership 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
change of ownership;
(b) such
inventory shall constitute the closing inventory for the seller and the initial
inventory for the buyer; and
(c)
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.
