d.For each controlled substance not included in this Section (e.g., damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compounding) the inventories shall include:
i.the name of the substance;
ii.the total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and
iii.the reason for the substance being maintained by the licensee and whether such substance is capable of use in the manufacture of any controlled substance in finished form.
2.Inventories of Distributors. Except for reverse distributors covered in this Section, each person authorized to distribute controlled substances shall include in the inventory the same information required of manufacturers pursuant to this Section.
3. Inventories of Dispensers, Researchers, and Reverse Distributors. Each person authorized to dispense, conduct research, or act as a reverse distributor with controlled substances shall include in the inventory the same information required of manufacturers pursuant to this Section. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser, researcher, or reverse distributor shall do as follows:
a.if the substance is listed in Schedule I or II, make an exact count or measure of the contents, or
b.if the substance is listed in Schedule III, IV or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he shall make an exact count of the contents.
4.Inventories of Importers and Exporters. Each person authorized to import or export controlled substances shall include in the inventory the same information required of manufacturers pursuant to this Section. Each such person who is also registered as a manufacturer or as a distributor shall include in his inventory as an importer or exporter only those stocks of controlled substances that are actually separated from his stocks as a manufacturer or as a distributor (e.g., in transit or in storage for shipment).
5.Inventories of Chemical Analysts. Each person authorized to conduct chemical analysis with controlled substances shall include in his inventory the same information required of manufacturers pursuant to this Section as to substances which have been manufactured, imported, or received by such person. If less than 1 kilogram of any controlled substance (other than a hallucinogenic controlled substance listed in Schedule I), or less than 20 grams of a hallucinogenic substance listed in Schedule I (other than lysergic acid diethylamide), or less than 0.5 gram of lysergic acid diethylamide, is on hand at the time of inventory, that substance need not be included in the inventory. No inventory is required of known or suspected controlled substances received as evidentiary materials for analysis.
AUTHORITY NOTE:Promulgated in accordance with R.S. 40:972.
HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2141 (October 2008).
1.Every licensee required to keep records pursuant to this Section shall maintain on a current basis a complete and accurate record of each such substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him.
2.Separate records shall be maintained by a licensee for each registered location except as provided in §2731.B. In the event controlled substances are in the possession or under the control of a licensee at a location for which he is not registered, the substances shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.
3.Separate records shall be maintained by a licensee for each independent activity for which he is registered, except as provided in Subsection B of this Section.
4.In recording dates of receipt, importation, distribution, exportation, or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported, or otherwise transferred shall be used as the date of receipt or distribution of any documents of transfer (e.g., invoices or packing slips).
B.Records for Manufacturers, Distributors, Dispensers, Researchers, Importers, and Exporters
1.Records for Manufacturers. Each person authorized to manufacture controlled substances shall maintain records with the following information.
a.For each controlled substance in bulk form to be used in, or capable of use in, or being used in, the manufacture of the same or other controlled or non-controlled substances in finished form:
i.the name of the substance;
ii.the quantity manufactured in bulk form by the licensee, including the date, quantity and batch or other identifying number of each batch manufactured;
iii.the quantity received from other persons, including the date and quantity of each receipt and the name, address, and registration number of the other person from whom the substance was received;
iv.the quantity imported directly by the licensee (under a registration as an importer) for use in manufacture by him/her, including the date, quantity, and import permit or declaration number for each importation;
v.the quantity used to manufacture the same substance in finished form, including:
(a).the date and batch or other identifying number of each manufacture;
(b).the quantity used in the manufacture;
(c).the finished form (e.g., 10-milligram tablets or 10-milligram concentration per fluid ounce or milliliter);
(d).the number of units of finished form manufactured;
(e).the quantity used in quality control;
(f).the quantity lost during manufacturing and the causes therefore, if known;
(g).the total quantity of the substance contained in the finished form;
Louisiana Register Vol. 34, No. 10 October 20, 2008