22 Tex. Admin. Code § 291.17 - Inventory Requirements
(a) General
requirements.
(1) The pharmacist-in-charge
shall be responsible for taking all required inventories, but may delegate the
performance of the inventory to another person(s).
(2) The inventory shall be maintained in a
written, typewritten, or printed form. An inventory taken by use of an oral
recording device must be promptly transcribed.
(3) The inventory shall be kept in the
pharmacy and shall be available for inspection for two years.
(4) The inventory shall be filed separately
from all other records.
(5) The
inventory shall be in a written, typewritten, or printed form and include all
stocks of all controlled substances on hand on the date of the inventory
(including any which are out-of-date).
(6) The inventory may be taken either as of
the opening of business or as of the close of business on the inventory
date.
(7) The inventory record
shall indicate whether the inventory is taken as of the opening of business or
as of the close of business on the inventory date. If the pharmacy is open 24
hours a day, the inventory record shall indicate the time that the inventory
was taken.
(8) The person(s) taking
the inventory shall make an exact count or measure of all controlled substances
listed in Schedule II.
(9) The
person(s) taking the inventory shall make an estimated count or measure of all
controlled substances listed in Schedules III, IV, and V, unless the container
holds more than 1,000 tablets or capsules in which case, an exact count of the
contents must be made.
(10) The
inventory of Schedule II controlled substances shall be listed separately from
the inventory of Schedules III, IV, and V controlled substances.
(11) 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.
(b) Initial inventory.
(1) A new Class A, Class A-S, Class C, Class
C-S, or Class F pharmacy shall take an inventory on the opening day of
business. Such inventory shall include all stocks of all controlled substances
(including any out-of-date drugs).
(2) In the event the Class A, Class A-S,
Class C, Class C-S, or Class F pharmacy commences business with no controlled
substances on hand, the pharmacy shall record this fact as the initial
inventory.
(3) The initial
inventory shall serve as the pharmacy's inventory until the next May 1, or
until the pharmacy's regular general physical inventory date, at which time the
Class A, Class A-S, Class C, Class C-S, or Class F pharmacy shall take an
annual inventory as specified in subsection (c) of this section.
(c) Annual inventory.
(1) A Class A, Class A-S, Class C, Class C-S,
or Class F pharmacy shall take an inventory on May 1 of each year, or on the
pharmacy's regular general physical inventory date. Such inventory may be taken
within four days of the specified inventory date and shall include all stocks
of all controlled substances (including out-of-date drugs).
(2) A Class A, Class A-S, Class C, Class C-S,
or Class F pharmacy applying for renewal of a pharmacy license shall include as
a part of the pharmacy license renewal application a statement attesting that
an annual inventory has been conducted, the date of the inventory, and the name
of the person(s) taking the inventory.
(3) The person(s) taking the annual inventory
and the pharmacist-in-charge shall indicate the time the inventory was taken
(as specified in subsection (a)(7) of this section) and shall sign and date the
inventory with the date the inventory was taken. The signature of the
pharmacist-in-charge and the date of the inventory shall be notarized within
three days after the day the inventory is completed, excluding Saturdays,
Sundays, and federal holidays.
(d) Change of ownership.
(1) A Class A, Class A-S, Class C, Class C-S,
or Class F pharmacy that changes ownership shall take an inventory on the date
of the change of ownership. Such inventory shall include all stocks of all
controlled substances (including any out-of-date drugs).
(2) Such inventory shall constitute, for the
purpose of this section, the closing inventory for the seller and the initial
inventory for the buyer.
(3)
Transfer of any controlled substances listed in Schedule II shall require the
use of official DEA order forms (Form 222).
(4) The person(s) taking the inventory and
the pharmacist-in-charge shall indicate the time the inventory was taken (as
specified in subsection (a)(7) of this section) and shall sign and date the
inventory with the date the inventory was taken. The signature of the
pharmacist-in-charge and the date of the inventory shall be notarized within
three days after the day the inventory is completed, excluding Saturdays,
Sundays, and federal holidays.
(e) Closed pharmacies.
(1) The pharmacist-in-charge of a Class A,
Class A-S, Class C, Class C-S, or Class F pharmacy that ceases to operate as a
pharmacy shall forward to the board, within 10 days of the cessation of
operation, a statement attesting that an inventory of all controlled substances
on hand has been conducted, the date of closing, and a statement attesting the
manner by which the dangerous drugs and controlled substances possessed by such
pharmacy were transferred or disposed.
(2) The person(s) taking the inventory and
the pharmacist-in-charge shall indicate the time the inventory was taken (as
specified in subsection (a)(7) of this section) and shall sign and date the
inventory with the date the inventory was taken. The signature of the
pharmacist-in-charge and the date of the inventory shall be notarized within
three days after the day the inventory is completed, excluding Saturdays,
Sundays, and federal holidays.
(f) Additional requirements for Class C and
Class C-S pharmacies.
(1) Perpetual
inventory.
(A) A Class C or Class C-S
pharmacy shall maintain a perpetual inventory of all Schedule II controlled
substances.
(B) The perpetual
inventory shall be reconciled on the date of the annual inventory.
(2) Annual inventory. The
inventory of the Class C or Class C-S pharmacy shall be maintained in the
pharmacy. The inventory shall include all controlled substances located in the
pharmacy and, if applicable, all controlled substances located in other
departments within the institution. If an inventory is conducted in other
departments within the institution, the inventory of the pharmacy shall be
listed separately, as follows:
(A) the
inventory of drugs on hand in the pharmacy shall be listed separately from the
inventory of drugs on hand in the other areas of the institution; and
(B) the inventory of drugs on hand in all
other departments shall be identified by department.
(g) Change of pharmacist-in-charge
of a pharmacy.
(1) On the date of the change
of the pharmacist-in-charge of a Class A, Class A-S, Class C, Class C-S, or
Class F pharmacy, an inventory shall be taken. Such inventory shall include all
stocks of all controlled substances (including any out-of-date
drugs).
(2) This inventory shall
constitute, for the purpose of this section, the closing inventory of the
departing pharmacist-in-charge and the beginning inventory of the incoming
pharmacist-in-charge.
(3) If the
departing and the incoming pharmacists-in-charge are unable to conduct the
inventory together, a closing inventory shall be conducted by the departing
pharmacist-in-charge and a new and separate beginning inventory shall be
conducted by the incoming pharmacist-in-charge.
(4) The incoming pharmacist-in-charge shall
be responsible for notifying the board within 10 days, as specified in §
291.3 of this title (relating to
Required Notifications), that a change of pharmacist-in-charge has
occurred.
Notes
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