21 CFR 1304.31 - Reports from manufacturers importing narcotic raw material.

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§ 1304.31 Reports from manufacturers importing narcotic raw material.

(a) 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 quarterly on company letterhead to the Drug and Chemical Evaluation Section, Drug Enforcement Administration, on or before the 15th day of the month immediately following the period for which it is submitted. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.

(b) The following information shall be submitted for each type of narcotic raw material (quantities are expressed as grams of anhydrous morphine alkaloid):

(1) Beginning inventory;

(2) Gains on reweighing;

(3) Imports;

(4) Other receipts;

(5) Quantity put into process;

(6) Losses on reweighing;

(7) Other dispositions and

(8) Ending inventory.

(c) 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):

(1) Beginning inventory;

(2) Gains on reweighing;

(3) Quantity extracted from narcotic raw material;

(4) Quantity produced/manufactured/synthesized;

(5) Quantity sold;

(6) Quantity returned to conversion processes for reworking;

(7) Quantity used for conversion;

(8) Quantity placed in process;

(9) Other dispositions;

(10) Losses on reweighing and

(11) Ending inventory.

(d) The following information shall be submitted for importation of each narcotic raw material:

(1) Import permit number;

(2) Date shipment arrived at the United States port of entry;

(3) Actual quantity shipped;

(4) Assay (percent) of morphine, codeine and thebaine and

(5) Quantity shipped, expressed as anhydrous morphine alkaloid.

(e) 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.

(f) 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.

(g) 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 must no longer be accounted for as precursor stocks available for conversion or use, but rather as end-product in-process inventories.

[62 FR 13961, Mar. 24, 1997, as amended at 75 FR 10677, Mar. 9, 2010]

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