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Drug Enforcement Administration, Justice § 1304.33

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Drug Enforcement Administration, Justice § 1304.33 Drug Enforcement Administration, Justice § 1304.33 § 1304.32 Reports of manufacturers im- made by the importing manufacturer porting coca leaves. in accordance with recognized chem- (a) Every manufacturer importing or ical procedures. These assays shall manufacturing from raw coca leaves form the basis of accounting for such shall submit information accounting coca leaves, which shall be accounted for the importation and for all manu- for in terms of their cocaine alkaloid facturing operations performed be- content or equivalency or their total tween the importation and the manu- anhydrous coca alkaloid content. facture of bulk or finished products Where final assay data is not deter- standardized in accordance with U.S. mined at the time of submission, the Pharmacopoeia, National Formulary, report shall be made on the basis of the or other recognized standards. The re- best data available, subject to adjust- ment, and the necessary adjusting en- ports shall be submitted quarterly on tries shall be made on the next report. company letterhead to the Drug En- (e) Where factory procedure is such forcement Administration, Drug and that partial withdrawals of medicinal Chemical Evaluation Section, Wash- coca leaves are made from individual ington, DC 20537, on or before the 15th containers, there shall be attached to day of the month immediately fol- the container a stock record card on lowing the period for which it is sub- which shall be kept a complete record mitted. of withdrawals therefrom. (b) The following information shall (f) All in-process inventories should be submitted for raw coca leaf, ecgo- be expressed in terms of end-products nine, ecgonine for conversion or fur- and not precursors. Once precursor ma- ther manufacture, benzoylecgonine, terial has been changed or placed into manufacturing coca extracts (list for process for the manufacture of a speci- tinctures and extracts; and others sep- fied end-product, it must no longer be arately), other crude alkaloids and accounted for as precursor stocks other derivatives (quantities should be available for conversion or use, but reported as grams of actual quantity rather as end-product in-process inven- involved and the cocaine alkaloid con- tories. tent or equivalency): (1) Beginning inventory; [62 FR 13962, Mar. 24, 1997] (2) Imports; (3) Gains on reweighing; § 1304.33 Reports to ARCOS. (4) Quantity purchased; (a) Reports generally. All reports re- (5) Quantity produced; quired by this section shall be filed (6) Other receipts; with the ARCOS Unit, PO 28293, Cen- (7) Quantity returned to processes for tral Station, Washington, DC 20005 on reworking; DEA Form 333, or on media which con- (8) Material used in purification for tains the data required by DEA Form sale; 333 and which is acceptable to the (9) Material used for manufacture or ARCOS Unit. production; (b) Frequency of reports. Acquisition/ (10) Losses on reweighing; Distribution transaction reports shall (11) Material used for conversion; be filed every quarter not later than (12) Other dispositions and the 15th day of the month succeeding (13) Ending inventory. the quarter for which it is submitted; (c) The following information shall except that a registrant may be given be submitted for importation of coca permission to file more frequently (but leaves: not more frequently than monthly), de- (1) Import permit number; pending on the number of transactions (2) Date the shipment arrived at the being reported each time by that reg- United States port of entry; istrant. Inventories shall provide data (3) Actual quantity shipped; on the stocks of each reported con- (4) Assay (percent) of cocaine alka- trolled substance on hand as of the loid and close of business on December 31 of (5) Total cocaine alkaloid content. each year, indicating whether the sub- (d) Upon importation of coca leaves, stance is in storage or in process of samples will be selected and assays manufacturing. These reports shall be 69 VerDate Aug<31>2005 03:36 Apr 21, 2006 Jkt 208073 PO 00000 Frm 00079 Fmt 8010 Sfmt 8010 Y:\SGML\208073.XXX 208073 § 1304.33 21 CFR Ch. II (4–1–06 Edition) filed not later than January 15 of the (D) Phendimetrazine. following year. Manufacturing trans- (ii) Schedule IV action reports shall be filed annually (A) Barbital; for each calendar year not later than (B) Diethylpropion (Amfepramone); January 15 of the following year, ex- (C) Ethchlorvynol; cept that a registrant may be given (D) Ethinamate; permission to file more frequently (but (E) Lefetamine (SPA); not more frequently than quarterly). (c) Persons reporting. For controlled (F) Mazindol; substances in Schedules I, II, narcotic (G) Meprobamate; controlled substances in Schedule III, (H) Methylphenobarbital; and gamma-hydroxybutyric acid drug (I) Phenobarbital; product controlled substances in (J) Phentermine; and Schedule III, each person who is reg- (K) Pipradrol. istered to manufacture in bulk or dos- (2) Data shall be presented in such a age form, or to package, repackage, manner as to identify the particular label or relabel, and each person who is form, strength, and trade name, if any, registered to distribute, including each of the product containing the con- person who is registered to reverse dis- trolled substance for which the report tribute, shall report acquisition/dis- is being made. For this purpose, per- tribution transactions. In addition to sons filing reports shall utilize the Na- reporting acquisition/distribution tional Drug Code Number assigned to transactions, each person who is reg- the product under the National Drug istered to manufacture controlled sub- Code System of the Food and Drug Ad- stances in bulk or dosage form shall re- port manufacturing transactions on ministration. controlled substances in Schedules I (e) Transactions reported. Acquisition/ and II, each narcotic controlled sub- distribution transaction reports shall stance listed in Schedules III, IV, and provide data on each acquisition to in- V, gamma-hydroxybutyric acid drug ventory (identifying whether it is, e.g., product controlled substances in by purchase or transfer, return from a Schedule III, and on each psychotropic customer, or supply by the Federal controlled substance listed in Sched- Government) and each reduction from ules III and IV as identified in para- inventory (identifying whether it is, graph (d) of this section. e.g., by sale or transfer, theft, destruc- (d) Substances covered. (1) Manufac- tion or seizure by Government agen- turing and acquisition/distribution cies). Manufacturing reports shall pro- transaction reports shall include data vide data on material manufactured, on each controlled substance listed in manufacture from other material, use Schedules I and II, on each narcotic in manufacturing other material and controlled substance listed in Schedule use in producing dosage forms. III (but not on any material, com- (f) Exceptions. A registered institu- pound, mixture or preparation con- tional practitioner who repackages or taining a quantity of a substance hav- relabels exclusively for distribution or ing a stimulant effect on the central who distributes exclusively to (for dis- nervous system, which material, com- pound, mixture or preparation is listed pensing by) agents, employees, or af- in Schedule III or on any narcotic con- filiated institutional practitioners of trolled substance listed in Schedule V), the registrant may be exempted from and on gamma-hydroxybutyric acid filing reports under this section by ap- drug products listed in Schedule III. plying to the ARCOS Unit of the Ad- Additionally, reports on manufacturing ministration. transactions shall include the fol- (Approved by the Office of Management and lowing psychotropic controlled sub- Budget under control number 1117–0003) stances listed in Schedules III and IV: (i) Schedule III [62 FR 13962, Mar. 24, 1997, as amended at 68 (A) Benzphetamine; FR 41229, July 11, 2003; 70 FR 294, Jan. 4, 2005] (B) Cyclobarbital; (C) Methyprylon; and 70 VerDate Aug<31>2005 03:36 Apr 21, 2006 Jkt 208073 PO 00000 Frm 00080 Fmt 8010 Sfmt 8010 Y:\SGML\208073.XXX 208073.
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