Current through Register Vol. 48, No. 9, September 27, 2024
Each registered manufacturer shall include the following
information in his or 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 non-controlled substances in finished form:
(1) The name of the substance; and
(2) 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:
(1) The name of the substance;
(2) The quantity of the substance in each
batch and/or state of manufacture, identified by the batch number of other
appropriate identifying number;
(3)
The physical form which the substance is to take upon completion of the
manufacturing process (e.g., granulations, tablets, capsules, or solutions),
identified by the batch number or other appropriate identifying number, and if
possible the finished form of the substance (e.g., 10-milligram tablet or
10-milligram concentration per fluid ounce or milliliter) and the number of
volume thereof.
(c) For
each controlled substance in finished form:
(1) The name of the substance;
(2) Each finished form of the substance (e.g.
10-milligram tablet or 10-milligram concentration per fluid ounce or
milliliter);
(3) The number of
units or volume of each finished form in each commercial container (e.g.
100-tablet bottle or 3-milliliter vial); and
(4) The number of commercial containers of
each such finished form (e.g., four 100-tablet bottles or six 3-milliliter
vials).
(d) For each
controlled substance not included in paragraphs (a), (b), or (c) of this
section (e.g., damaged, defective or impure substances awaiting disposal,
substances held for quality control purposes, or substances maintained for
extemporaneous compounding):
(1) The name of
the substance;
(2) The total
quantity of the substance to the nearest metric unit weight or the total number
of units of finished form; and
(3)
The reason for the substance being maintained by the registrant and whether
such substance is capable of use in the manufacture of any controlled substance
in finished form.
