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Drug Enforcement Administration, Justice § 1304.32

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Drug Enforcement Administration, Justice § 1304.32 Drug Enforcement Administration, Justice § 1304.32 shall be signed by the authorized offi- (e) Upon importation of crude opium, cial and submitted quarterly on com- samples will be selected and assays pany letterhead to the Drug and Chem- made by the importing manufacturer ical Evaluation Section, Drug Enforce- in the manner and according to the ment Administration, on or before the method specified in the U.S. Pharma- 15th day of the month immediately fol- copoeia. Where final assay data is not lowing the period for which it is sub- determined at the time of rendering re- mitted. See the Table of DEA Mailing port, the report shall be made on the Addresses in § 1321.01 of this chapter for basis of the best data available, subject the current mailing address. to adjustment, and the necessary ad- (b) The following information shall justing entries shall be made on the be submitted for each type of narcotic next report. raw material (quantities are expressed (f) Where factory procedure is such as grams of anhydrous morphine alka- that partial withdrawals of opium are loid): made from individual containers, there (1) Beginning inventory; shall be attached to each container a (2) Gains on reweighing; stock record card on which shall be (3) Imports; kept a complete record of all with- (4) Other receipts; drawals therefrom. (5) Quantity put into process; (g) All in-process inventories should (6) Losses on reweighing; be expressed in terms of end-products (7) Other dispositions and and not precursors. Once precursor ma- (8) Ending inventory. terial has been changed or placed into (c) The following information shall process for the manufacture of a speci- be submitted for each narcotic raw ma- fied end-product, it must no longer be terial derivative including morphine, accounted for as precursor stocks codeine, thebaine, oxycodone, available for conversion or use, but hydrocodone, medicinal opium, manu- rather as end-product in-process inven- facturing opium, crude alkaloids and tories. other derivatives (quantities are ex- pressed as grams of anhydrous base or [62 FR 13961, Mar. 24, 1997, as amended at 75 anhydrous morphine alkaloid for man- FR 10677, Mar. 9, 2010] ufacturing opium and medicinal opium): § 1304.32 Reports of manufacturers im- porting coca leaves. (1) Beginning inventory; (2) Gains on reweighing; (a) Every manufacturer importing or (3) Quantity extracted from narcotic manufacturing from raw coca leaves raw material; shall submit information accounting (4) Quantity produced/manufactured/ for the importation and for all manu- synthesized; facturing operations performed be- (5) Quantity sold; tween the importation and the manu- (6) Quantity returned to conversion facture of bulk or finished products processes for reworking; standardized in accordance with U.S. (7) Quantity used for conversion; Pharmacopoeia, National Formulary, (8) Quantity placed in process; or other recognized standards. The re- (9) Other dispositions; ports shall be submitted quarterly on (10) Losses on reweighing and company letterhead to the Drug and (11) Ending inventory. Chemical Evaluation Section, Drug En- (d) The following information shall forcement Administration, on or before be submitted for importation of each the 15th day of the month immediately narcotic raw material: following the period for which it is sub- (1) Import permit number; mitted. See the Table of DEA Mailing (2) Date shipment arrived at the Addresses in § 1321.01 of this chapter for United States port of entry; the current mailing address. (3) Actual quantity shipped; (b) The following information shall (4) Assay (percent) of morphine, co- be submitted for raw coca leaf, ecgo- deine and thebaine and nine, ecgonine for conversion or fur- (5) Quantity shipped, expressed as an- ther manufacture, benzoylecgonine, hydrous morphine alkaloid. manufacturing coca extracts (list for 77 VerDate Mar<15>2010 13:51 May 02, 2013 Jkt 229076 PO 00000 Frm 00087 Fmt 8010 Sfmt 8010 Y:\SGML\229076.XXX 229076 pmangrum on DSK3VPTVN1PROD with CFR § 1304.33 21 CFR Ch. II (4–1–13 Edition) 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; (6) Other receipts; (a) Reports generally. All reports re- (7) Quantity returned to processes for quired by this section shall be filed reworking; with the ARCOS Unit on DEA Form (8) Material used in purification for 333, or on media which contains the sale; data required by DEA Form 333 and (9) Material used for manufacture or which is acceptable to the ARCOS production; Unit. See the Table of DEA Mailing Ad- (10) Losses on reweighing; dresses in § 1321.01 of this chapter for (11) Material used for conversion; the current mailing address. (12) Other dispositions and (b) Frequency of reports. Acquisition/ (13) Ending inventory. Distribution transaction reports shall (c) The following information shall be filed every quarter not later than be submitted for importation of coca the 15th day of the month succeeding leaves: the quarter for which it is submitted; (1) Import permit number; except that a registrant may be given (2) Date the shipment arrived at the permission to file more frequently (but United States port of entry; not more frequently than monthly), de- (3) Actual quantity shipped; pending on the number of transactions (4) Assay (percent) of cocaine alka- being reported each time by that reg- loid and istrant. Inventories shall provide data (5) Total cocaine alkaloid content. on the stocks of each reported con- (d) Upon importation of coca leaves, trolled substance on hand as of the samples will be selected and assays close of business on December 31 of made by the importing manufacturer each year, indicating whether the sub- in accordance with recognized chem- stance is in storage or in process of ical procedures. These assays shall manufacturing. These reports shall be form the basis of accounting for such filed not later than January 15 of the coca leaves, which shall be accounted following year. Manufacturing trans- for in terms of their cocaine alkaloid action reports shall be filed annually content or equivalency or their total for each calendar year not later than anhydrous coca alkaloid content. January 15 of the following year, ex- Where final assay data is not deter- cept that a registrant may be given mined at the time of submission, the permission to file more frequently (but report shall be made on the basis of the not more frequently than quarterly). best data available, subject to adjust- (c) Persons reporting. For controlled ment, and the necessary adjusting en- substances in Schedules I, II, narcotic tries shall be made on the next report. controlled substances in Schedule III, (e) Where factory procedure is such and gamma-hydroxybutyric acid drug that partial withdrawals of medicinal product controlled substances in coca leaves are made from individual Schedule III, each person who is reg- containers, there shall be attached to istered to manufacture in bulk or dos- the container a stock record card on age form, or to package, repackage, which shall be kept a complete record label or relabel, and each person who is of withdrawals therefrom. registered to distribute, including each (f) All in-process inventories should person who is registered to reverse dis- be expressed in terms of end-products tribute, shall report acquisition/dis- and not precursors. Once precursor ma- tribution transactions. In addition to terial has been changed or placed into reporting acquisition/distribution 78 VerDate Mar<15>2010 13:51 May 02, 2013 Jkt 229076 PO 00000 Frm 00088 Fmt 8010 Sfmt 8010 Y:\SGML\229076.XXX 229076 pmangrum on DSK3VPTVN1PROD with CFR.
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