e.the number of units of finished forms and/or commercial containers imported directly by the person (under a registration or authorization to import), including the date of, the number of units and/or commercial containers in, and the import permit or declaration number for, each importation;
f.the number of units and/or commercial containers compounded by the licensee from units in finished form received from others or imported, including:
i.the date and batch or other identifying number of each compounding;
ii.the operation performed (e.g., repackaging or relabeling);
iii.the number of units of finished form used in the compound, the number compounded and the number lost during compounding, with the causes for such losses, if known; and
iv.such other information as is necessary to account for all controlled substances used in the compounding process;
g.the number of containers distributed to other programs, including the date, the number of containers in each distribution, and the name, address and registration number of the program to which the containers were distributed;
h.the number of commercial containers exported directly by the licensee (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and
i.the number of units of finished forms and/or commercial containers destroyed in any manner by the licensee, including the reason, the date and manner of destruction.
F.Additional Recordkeeping Requirements Applicable to Drug Products Containing Gamma-Hydroxybutyric Acid. In addition to the recordkeeping requirements for dispensers and researchers provided in this Chapter, practitioners dispensing gamma-hydroxybutyric acid manufactured or distributed in accordance with federal law shall maintain and make available for inspection and copying by the board, all of the following information for each prescription:
1.name of the prescribing practitioner;
2.prescribing practitioner's federal and state registration numbers, with the expiration dates of these registrations;
3.verification that the prescribing practitioner possesses the appropriate registration to prescribe this controlled substance;
4.patient's name and address;
5.patient's insurance provider, if available.
AUTHORITY NOTE:Promulgated in accordance with R.S. 40:972.
HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2142 (October 2008).
A.Reports from Manufacturers Importing Narcotic Raw Material
1.Every manufacturer which imports or manufactures from narcotic raw material (opium, poppy straw, and concentrate of poppy straw) shall submit information which accounts for the importation and for all manufacturing operations performed between importation and the
production in bulk or finished marketable products, standardized in accordance with the U.S. Pharmacopeia, National Formulary or other recognized medical standards. Reports shall be signed by the authorized official and submitted in compliance with 21 CFR §1304.31or its successor.
2.The following information shall be submitted for each type of narcotic raw material (quantities are expressed as grams of anhydrous morphine alkaloid):
b.gains on reweighing;
e.quantity put into process;
f.losses on reweighing;
g.other dispositions; and
3.The following information shall be submitted for each narcotic raw material derivative including morphine, codeine, thebaine, oxycodone, hydrocodone, medicinal opium, manufacturing opium, crude alkaloids and other derivatives (quantities are expressed as grams of anhydrous base or anhydrous morphine alkaloid for manufacturing opium and medicinal opium):
b.gains on reweighing;
c.quantity extracted from narcotic raw material;
f.quantity returned to conversion processes for reworking;
g.quantity used for conversion;
h.quantity placed in process;
j.losses on reweighing; and
4.The following information shall be submitted for importation of each narcotic raw material:
a.import permit number;
b.date shipment arrived at the united states port of entry;
c.actual quantity shipped;
d.assay (percent) of morphine, codeine and thebaine; and
e.quantity shipped, expressed as anhydrous morphine alkaloid.
5.Upon importation of crude opium, samples will be selected and assays made by the importing manufacturer in the manner and according to the method specified in the U.S. Pharmacopoeia. Where final assay data is not determined at the time of rendering report, the report shall be made on the basis of the best data available, subject to adjustment, and the necessary adjusting entries shall be made on the next report.
6.Where factory procedure is such that partial withdrawals of opium are made from individual containers, there shall be attached to each container a stock record card on which shall be kept a complete record of all withdrawals therefrom.
7.All in-process inventories should be expressed in terms of end-products and not precursors. Once precursor material has been changed or placed into process for the
Louisiana Register Vol. 34, No. 10 October 20, 2008