Each registrant shall be responsible for taking a complete and
accurate inventory of all stocks of controlled substances under the control of
the registrant pursuant to this rule. The responsible individual may delegate
the actual taking of any inventory.
Record and procedure.
Each inventory record, except the
periodic count and reconciliation required pursuant to subrule 10.18(4), shall
comply with the requirements of this subrule and shall be maintained for a
minimum of two years from the date of the inventory.
a. Each inventory shall contain a complete
and accurate record of all controlled substances on hand on the date and at the
time the inventory is taken.
Each inventory shall be maintained in a handwritten, typewritten, or
electronically printed form at the registered location. An inventory of
Schedule II controlled substances shall be maintained separately from an
inventory of all other controlled substances.
c. Controlled substances shall be deemed to
be on hand if they are in the possession of or under the control of the
registrant. Controlled substances on hand shall include prescriptions prepared
for dispensing to a patient but not yet delivered to the patient, substances
maintained in emergency medical service programs, care facility or hospice
emergency supplies, outdated or adulterated substances pending destruction, and
substances stored in a warehouse on behalf of the registrant. Controlled
substances obtained through an authorized collection program for the purpose of
disposal shall not be examined, inspected, counted, sorted, inventoried, or
d. A separate
inventory shall be made for each registered location and for each independent
activity registered except as otherwise provided under federal law.
e. The inventory shall be taken either prior
to opening or following the close of business on the inventory date, and the
inventory record shall identify either opening or close of business.
The inventory record, unless otherwise
provided under federal law, shall include the following information:
(1) The name of the substance.
(2) The strength and dosage form of the
(3) The quantity of the
substance, which shall be an exact count or measure of the substance and may
not be an estimated count or measure, except for liquid products packaged in
nonincremented containers, which may be estimated to the nearest one-fourth
(4) Information required
of authorized collection programs pursuant to federal regulations for such
signature of the person or persons responsible for taking the
(6) The date and time
(opening or closing) of the inventory.
Initial inventory. A new
registrant shall take an inventory of all stocks of controlled substances on
hand on the date the new registrant first engages in the manufacture,
distribution, storage, or dispensing of controlled substances. If the
registrant commences business or the registered activity with no controlled
substances on hand, the initial inventory shall record that fact.
Annual inventory. After
the initial inventory is taken, a registrant shall take a new inventory of all
stocks of controlled substances on hand at least annually. The annual inventory
may be taken on any date that is within 372 days after the date of the previous
Change of ownership, pharmacist in charge, or registered
a. When there is a change
in ownership or location for a registration, an inventory shall be taken of all
controlled substances in compliance with subrule 10.19(1). The inventory shall
be taken following the close of business on the last day under terminating
ownership or at the location being vacated. The inventory shall serve as the
ending inventory for the terminating owner or location being vacated, as well
as a record of the beginning inventory for the new owner or location.
When there is a change of pharmacist in
charge, including when the incoming pharmacist in charge is temporary or
interim pursuant to 657-paragraph 8.35(6)"d,"
shall be taken of all controlled substances in compliance with subrule
10.19(1). An inventory shall be taken following the close of business on the
last day of duty of the outgoing pharmacist in charge. The inventory may serve
as the beginning inventory for the incoming pharmacist in charge, unless the
incoming pharmacist in charge did not immediately assume the duties of
pharmacist in charge following the outgoing pharmacist in charge. Any lapse in
time between the outgoing pharmacist in charge and the incoming pharmacist in
charge shall cause an inventory to be taken prior to the opening of business on
the first day of duty of the incoming pharmacist in charge. An inventory count
shall not be required in the case of an interim pharmacist in charge if the
pharmacy maintains perpetual inventory logs for all controlled substances
pursuant to rule 657-10.20
registered activity. A registrant shall take an inventory of
controlled substances at the close of business the last day the registrant is
engaged in registered activities. If the registrant is selling or transferring
the remaining controlled substances to another registrant, this inventory shall
serve as the ending inventory for the registrant discontinuing business as well
as a record of additional or starting inventory for the registrant to which the
substances are transferred.
New or rescheduled controlled substances. On the effective
date of the addition of a previously noncontrolled substance to any schedule of
controlled substances or the rescheduling of a previously controlled substance
to another schedule, any registrant who possesses the newly scheduled or
rescheduled controlled substance shall take an inventory of all stocks of the
substance on hand. That inventory record shall be maintained with the most
recent controlled substances inventory record. Thereafter, the controlled
substance shall be included in the appropriate schedule of each inventory made
by the registrant.
Admin. Code r.
February 17, 2016/Volume XXXVIII, Number 17, effective
September 27, 2017/Volume XL, Number 7, effective
June 1, 2022/Volume XLIV, Number 24, effective