| (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on hand on the date of the inventory (including any which are out-of-date).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(including any out-of-date drugs).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.
|
| Source Note: The provisions of this §291.17 adopted to be effective September 1, 1987, 12 TexReg 2568; amended to be effective September 30, 1993, 18 TexReg 6459; amended to be effective July 16, 1999, 24 TexReg 5196; amended to be effective June 4, 2000, 25 TexReg 4777; amended to be effective March 12, 2003, 28 TexReg 2082; amended to be effective March 10, 2011, 36 TexReg 1511; amended to be effective June 7, 2012, 37 TexReg 4046; amended to be effective December 5, 2012, 37 TexReg 9511; amended to be effective December 10, 2013, 38 TexReg 8835; amended to be effective December 6, 2015, 40 TexReg 8765; amended to be effective December 6, 2018, 43 TexReg 7772; amended to beeffective June 20, 2019, 44 TexReg 2946 |
