manufacture of a specified end-product, it shall no longer be accounted for as precursor stocks available for conversion or use, but rather as end-product in-process inventories.
B.Reports from Manufacturers Importing Coca Leaves
1.Every manufacturer importing or manufacturing from raw coca leaves shall submit information accounting for the importation and for all manufacturing operations performed between the importation and the manufacture of bulk or finished products standardized in accordance with U.S. Pharmacopoeia, National Formulary, or other recognized standards. The reports shall be submitted in compliance with 21 CFR §1304.32.
2.The following information shall be submitted for raw coca leaf, ecgonine, ecgonine for conversion or further manufacture, benzoylecgonine, manufacturing coca extracts (list for tinctures and extracts; and others separately), other crude alkaloids and other derivatives (quantities should be reported as grams of actual quantity involved and the cocaine alkaloid content or equivalency):
c.gains on reweighing;
g.quantity returned to processes for reworking;
h.material used in purification for sale;
i.material used for manufacture or production;
j.losses on reweighing;
k.material used for conversion;
l.other dispositions; and
3.The following information shall be submitted for importation of coca leaves:
a.import permit number;
b.date the shipment arrived at the United States port of entry;
c.actual quantity shipped;
d.assay (percent) of cocaine alkaloid; and
e.total cocaine alkaloid content.
4.Upon importation of coca leaves, samples will be selected and assays made by the importing manufacturer in accordance with recognized chemical procedures. These assays shall form the basis of accounting for such coca leaves, which shall be accounted for in terms of their cocaine alkaloid content or equivalency or their total anhydrous coca alkaloid content. Where final assay data is not determined at the time of submission, 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.
5.Where factory procedure is such that partial withdrawals of medicinal coca leaves are made from individual containers, there shall be attached to the container a stock record card on which shall be kept a complete record of withdrawals therefrom.
6.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 manufacture of a specified end-product, it shall no longer be accounted for as precursor stocks available for conversion or use, but rather as end-product in-process inventories.
C.Reports to ARCOS
1.Reports generally. All reports required by this Subsection shall be filed with the ARCOS Unit, PO 28293, Central Station, Washington, DC 20005 on DEA Form 333, or on media which contains the data required by DEA Form 333 and which is acceptable to the ARCOS Unit. A copy of the report shall be filed with the board.
2.Frequency of Reports. Acquisition/Distribution transaction reports shall be filed every quarter not later than the fifteenth day of the month succeeding the quarter for which it is submitted; except that a licensee may be given permission to file more frequently (but not more frequently than monthly), depending on the number of transactions being reported each time by that licensee. Inventories shall provide data on the stocks of each reported controlled substance on hand as of the close of business on December 31 of each year, indicating whether the substance is in storage or in process of manufacturing. These reports shall be filed not later than January 15 of the following year. Manufacturing transaction reports shall be filed annually for each calendar year not later than January 15 of the following year, except that a licensee may be given permission to file more frequently (but not more frequently than quarterly).
3.Persons Reporting. For controlled substances in Schedules I, II or narcotic controlled substances in Schedule III and gamma- hydroxybutyric acid drug product controlled substances in Schedule III, each person who is registered to manufacture in bulk or dosage form, or to package, repackage, label or relabel, and each person who is registered to distribute shall report acquisition/distribution transactions. In addition to reporting acquisition/distribution transactions, each person who is registered to manufacture controlled substances in bulk or dosage form shall report manufacturing transactions on controlled substances in Schedules I and II, each narcotic controlled substance listed in Schedules III, IV, and V, and on each psychotropic controlled substance listed in Schedules III and IV as identified in Paragraph 4 of this Subsection.
a.Manufacturing and acquisition/distribution transaction reports shall include data on each controlled substance listed in Schedules I and II and on each narcotic controlled substance listed in Schedule III (but not on any material, compound, mixture or preparation containing a quantity of a substance having a stimulant effect on the central nervous system, which material, compound, mixture or preparation is listed in Schedule III or on any narcotic controlled substance listed in Schedule V), and on gamma-hydroxybutyric acid drug products listed in Schedule III. Additionally, reports on manufacturing transactions shall include the following psychotropic controlled substances listed in Schedules III and IV.
Louisiana Register Vol. 34, No. 10 October 20, 2008