Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: This rule defines requirements for the form
and maintenance of controlled substance inventories.
(1) General Requirements.
(A) Each inventory shall contain a complete
and accurate record of all controlled substances on hand on the date the
inventory was taken. Controlled substances shall be deemed to be on hand if
they are in the possession of or under the control of the registrant, including
substances returned by a customer, substances ordered by a customer but not yet
invoiced, substances stored in a warehouse on behalf of the registrant and
substances in the possession of employees of the registrant and intended for
distribution as complimentary samples.
(B) A separate inventory shall be made by a
registrant for each registered location. In the event controlled substances are
in the possession or under the control of the registrant at a location for
which s/he is not registered, the substances shall be included in the inventory
of the registered location to which they are subject to control or to which the
person possessing the substance is responsible. Each inventory for a registered
location shall be kept at the registered location.
(C) A separate inventory shall be made by a
registrant for each independent activity for which s/he is
registered.
(D) A registrant may
take an inventory either as of the opening of business or as of the close of
business on the inventory date. The registrant shall indicate on the inventory
records whether the inventory is taken as of the opening or as of the close of
business and the date the inventory is taken.
(E) An inventory must be maintained in a
permanent written, typewritten or printed form. An inventory taken by use of an
oral recording device must be transcribed promptly.
(2) Initial Inventory Date.
(A) Every person required to keep records who
is registered with the Department of Health after May 1, 1971 and who was not
registered previously shall take an inventory of all stocks of controlled
substances on hand on the date s/he first engages in the manufacture,
distribution or dispensing of controlled substances.
(B) Compliance with federal initial inventory
date requirements is deemed satisfactory. Duplicate inventories are not
required.
(3) Annual
Inventory Date. After the initial inventory is taken, the registrant shall take
a new inventory of all stocks of controlled substances on hand at least once a
year. The annual inventory may be taken on any date that is within one year of
the previous annual inventory date.
(4) Inventory Date for Newly Controlled
Substances. On the effective date of a rule by the Department of Health adding
a substance to any schedule of controlled substances, which substance was not
listed immediately prior to that date in any such schedule, every registrant
required to keep records who is manufacturing, distributing or dispensing that
substance shall take inventory of all stocks of the substance on hand. After
that, this substance shall be included in each inventory made by the
registrant.
(5) Inventories of
Manufacturers. Each registered manufacturer shall include the following
information in his/her inventory:
(A) For
each controlled substance in bulk form to be used in (or capable of use in) the
manufacture of the same or other controlled or noncontrolled substances in
finished form, the name of the substance and the total quantity of the
substance to the nearest metric unit weight consistent with unit size (except
that for inventories made in 1971, avoirdupois weights may be
utilized where metric weights are not readily available);
(B) For each controlled substance in the
process of manufacture on the inventory date the name of the substance, the
quantity of the substance in each batch, stage of manufacture, or both,
identified by the batch number or other appropriate identifying number and the
physical form which the substance is to take upon completion of the
manufacturing process (for example, granulations, tablets, capsules or
solutions), identified by the batch number or other appropriate identifying
number and if possible the finished form of the substance (for example, ten
milligram (10 mg) tablet or ten milligram (10 mg) concentration per fluid ounce
or milliliter) and the number or volume;
(C) For each controlled substance in finished
form, the name of the substance; each finished form of the substance (for
example, ten milligram (10 mg) tablet or ten milligram (10 mg) concentration
per fluid ounce or milliliter); the number of units or volume of each finished
form in each commercial container (for example, four 100 tablet bottles or
three milliliter (3 ml) vials); the number of commercial containers of each
finished form (for example, four 100 tablet bottles or six three milliliter (3
ml) vials);
(D) For each controlled
substance not included in subsections (5)(A)-(C) of this rule (for example,
damaged, defective or impure substances awaiting disposal, substances held for
quality control purposes or substances maintained for extemporaneous
compoundings), the name of the substance; the total quantity of the substance
to the nearest metric unit weight or the total number of units of finished
form; the reason for the substance being maintained by the registrant and
whether the substance is capable of use in the manufacture of any controlled
substance in finished form.
(6) Inventories of Distributors. Each
registered distributor shall include in his/her inventory the same information
required of manufacturers in subsections (5)(C) and (D) of this rule.
(7) Inventories of Dispensers and
Researchers. Each person registered to dispense or conduct research with
controlled substances and required to keep records shall include in his/her
inventory the same information required of manufacturers in subsections (5)(C)
and (D) of this rule. In determining the number of units of each finished form
of a controlled substance in a commercial container which has been opened, the
dispenser shall do as follows:
(A) If the
substance is listed in Schedule I or II, s/he shall make an exact count or
measure of the contents;
(B) If the
substance is listed in Schedule III, IV or V, s/he shall make an estimated
count or measure of the contents, unless the container holds more than 1,000
tablets or capsules in which case s/he must make an exact count of the
contents.
(8)
Inventories of Importers and Exporters. Each registered importer or exporter
shall include in his/her inventory the same information required of
manufacturers in subsections (5)(A), (C) and (D) of this rule. Each registered
importer and exporter who also is registered as a manufacturer or as a
distributor shall include in his/her inventory as an importer or exporter only
those stocks of controlled substances that actually are separated from his/her
stocks as a manufacturer or as a distributor (for example, in-transit or in
storage for shipment).
(9)
Inventories for Chemical Analysts. Each analytical laboratory registered to
conduct chemical analysis with controlled substances shall include in its
inventory the same information required of manufacturers in subsections (5)(A),
(C) and (D) of this rule as to substances which have been manufactured,
imported or received by the laboratory conducting the inventory. If less than
one kilogram (1 kg) of any controlled substance (other than a hallucinogenic
controlled substance listed in Schedule I) or less than twenty grams (20 g) of
a hallucinogenic substance listed in Schedule I (other than lysergic acid
diethylamide) or less than point five gram (0.5 g) of lysergic acid
diethylamide, is on hand at the time of inventory, those substances need not be
included in the inventory. Laboratories of the division may process up to one
hundred fifty grams (150 g) of any hallucinogenic substance in Schedule I
without regard to a need for an inventory of those substances.
*Original authority: 195.030, RSMo 1939, amended 1971,
1989, 1993, 1995, 1997, 1999 and 195.195, RSMo 1957, amended 1971, 1989,
1993.
