corner with the letter "C" no less than 1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for non-controlled substances. However, if a pharmacy employs an ADP system or other electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived.
C.Records of Authorized Central Fill Pharmacies and Client Pharmacies
1.Every pharmacy that utilizes the services of a central fill pharmacy shall keep a record of all central fill pharmacies, including name, address and DEA number, which are authorized to fill prescriptions on its behalf. The pharmacy shall also verify the registration for each central fill pharmacy authorized to fill prescriptions on its behalf. These records shall be made available upon request for inspection by the board.
2.Every central fill pharmacy shall keep a record of all pharmacies, including name, address and DEA number, for which it is authorized to fill prescriptions. The central fill pharmacy shall also verify the registration for all pharmacies for which it is authorized to fill prescriptions. These records shall be made available upon request for inspection by the board.
AUTHORITY NOTE:Promulgated in accordance with R.S. 40:972.
HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2139 (October 2008).
A.General Requirements. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. An inventory taken by use of an oral recording device shall be promptly transcribed. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the licensee, including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the licensee, and substances in the possession of employees of the licensee and intended for distribution as complimentary samples. A separate inventory shall be made for each registered location and each independent activity registered, except as provided in this Section. In the event controlled substances in the possession or under the control of the licensee are stored at a location for which 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. The inventory may be taken either as of opening of business or as of the close of business on the inventory date and that option shall be indicated on the inventory.
B.Initial Inventory Date. Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with this Section as applicable. In the event a person commences business with no controlled
substances on hand, he shall record this fact as the initial inventory.
C.Biennial Inventory Date. After the initial inventory is taken, the licensee shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.
a.Pharmacies shall take a new inventory of all stocks of controlled substances on hand every year; the annual inventory may be taken on any date which is within one year of the previous annual inventory date.
b.Pharmacies shall take a new inventory on the following occasions:
i.arrival of a new pharmacist-in-charge;
ii.discovery of any substantial loss, disappearance, or theft of controlled substances;
iii.departure of a pharmacist-in-charge; and
iv.permanent closure of a pharmacy.
D.Inventories of Manufacturers, Distributors, Dispensers, Researchers, Importers, Exporters, and Chemical Analysts. Each person registered or authorized to manufacture, distribute, dispense, import, export, conduct research or chemical analysis with controlled substances and required to keep records shall include in the inventory the information listed below.
1.Inventories of Manufacturers. Each person authorized to manufacture controlled substances shall include the following information in the 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, the inventory shall include:
i.the name of the substance; and
ii.the total quantity of the substance to the nearest metric unit weight consistent with unit size.
b.For each controlled substance in the process of manufacture on the inventory date, the inventory shall include:
i.the name of the substance;
ii.the quantity of the substance in each batch and/or stage of manufacture, identified by the batch number or other appropriate identifying number; and
iii.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 or volume thereof.
c.For each controlled substance in finished form the inventory shall include:
i.the name of the substance;
ii.each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);
iii.the number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
iv.the number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials).
Louisiana Register Vol. 34, No. 10 October 20, 2008