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21 CFR Ch. II (4–1–11 Edition) § 1304.32

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21 CFR Ch. II (4–1–11 Edition) § 1304.32 § 1304.32 21 CFR Ch. II (4–1–11 Edition) § 1304.32 Reports of manufacturers im- (d) Upon importation of coca leaves, porting coca leaves. samples will be selected and assays (a) Every manufacturer importing or made by the importing manufacturer manufacturing from raw coca leaves in accordance with recognized chem- shall submit information accounting ical procedures. These assays shall for the importation and for all manu- form the basis of accounting for such facturing operations performed be- coca leaves, which shall be accounted tween the importation and the manu- for in terms of their cocaine alkaloid content or equivalency or their total facture of bulk or finished products anhydrous coca alkaloid content. standardized in accordance with U.S. Where final assay data is not deter- Pharmacopoeia, National Formulary, mined at the time of submission, the or other recognized standards. The re- report shall be made on the basis of the ports shall be submitted quarterly on best data available, subject to adjust- company letterhead to the Drug and ment, and the necessary adjusting en- Chemical Evaluation Section, Drug En- tries shall be made on the next report. forcement Administration, on or before (e) Where factory procedure is such the 15th day of the month immediately that partial withdrawals of medicinal following the period for which it is sub- coca leaves are made from individual mitted. See the Table of DEA Mailing containers, there shall be attached to Addresses in § 1321.01 of this chapter for the container a stock record card on the current mailing address. which shall be kept a complete record (b) The following information shall of withdrawals therefrom. be submitted for raw coca leaf, ecgo- (f) All in-process inventories should nine, ecgonine for conversion or fur- be expressed in terms of end-products ther manufacture, benzoylecgonine, and not precursors. Once precursor ma- manufacturing coca extracts (list for terial has been changed or placed into tinctures and extracts; and others sep- process for the manufacture of a speci- arately), other crude alkaloids and fied end-product, it must no longer be other derivatives (quantities should be accounted for as precursor stocks reported as grams of actual quantity available for conversion or use, but involved and the cocaine alkaloid con- rather as end-product in-process inven- tent or equivalency): tories. (1) Beginning inventory; (2) Imports; [62 FR 13962, Mar. 24, 1997, as amended at 75 FR 10678, Mar. 9, 2010] (3) Gains on reweighing; (4) Quantity purchased; § 1304.33 Reports to ARCOS. (5) Quantity produced; (a) Reports generally. All reports re- (6) Other receipts; quired by this section shall be filed (7) Quantity returned to processes for with the ARCOS Unit on DEA Form reworking; 333, or on media which contains the (8) Material used in purification for data required by DEA Form 333 and sale; which is acceptable to the ARCOS (9) Material used for manufacture or Unit. See the Table of DEA Mailing Ad- production; dresses in § 1321.01 of this chapter for (10) Losses on reweighing; the current mailing address. (11) Material used for conversion; (b) Frequency of reports. Acquisition/ (12) Other dispositions and Distribution transaction reports shall (13) Ending inventory. be filed every quarter not later than (c) The following information shall the 15th day of the month succeeding be submitted for importation of coca the quarter for which it is submitted; leaves: except that a registrant may be given (1) Import permit number; permission to file more frequently (but (2) Date the shipment arrived at the not more frequently than monthly), de- United States port of entry; pending on the number of transactions (3) Actual quantity shipped; being reported each time by that reg- (4) Assay (percent) of cocaine alka- istrant. Inventories shall provide data loid and on the stocks of each reported con- (5) Total cocaine alkaloid content. trolled substance on hand as of the 78 VerDate Mar<15>2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00088 Fmt 8010 Sfmt 8010 Y:\SGML\223073.XXX 223073 erowe on DSK5CLS3C1PROD with CFR.
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