stance to be produced therefrom shall be stated.

(e) All narcotic controlled substances listed in schedules I, II, and III, either bulk finished goods or goods already packaged, which are used during the quarter for packaging or repackaging into commercial containers shall be reported as credit entries in BND Form 234d, and in each instance clearly identified with the entry of substance used in such packaging. A separate entry shall be made for each different size of commercial container produced, but all entries representing a single packaging lot shall be grouped together. The number of commercial containers of a given size produced, the size of the commercial container (indicating the number of pills, tablets, ounces, etc.), the narcotic controlled substance contained in each unit in the commercial container, the total narcotic controlled substance content of each commercial container, and the aggregate narcotic controlled substance content of all commercial containers, represented by the entry shall be indicated. The recoverable wastes salvaged from the packaging operation and the losses in packaging shall be shown as credit entries on the form. All recoverable wastes reported during the quarter shall be returned to raw stock and further accounted for as raw materials. Any goods actively in process of packaging at the close of the quarter shall be so reported. Where substances are placed in process for packaging during one quarter and a portion thereof are removed as commercial containers, produced during the same quarter, the portion thus removed shall be reported as commercial containers produced and the remainder reported as in process at the end of the quarter.

(f) Each manufacturer and importer shall submit as a part of his fourth quarterly report (BND Form 234) an inventory (BND Form 234e) of narcotic controlled substances listed in schedules I, II, and III which are in his possession on December 31 of each year. The substances shall be classified as follows:

(1) Raw materials.
(2) Goods in process.

(3) Finished bulk stock.

(4) Finished goods in marketable commercial containers.

(5) Miscellaneous stock.

[36 F.R. 7793, Apr. 24, 1971, as amended at 36 F.R. 18732, Sept. 21, 1971]

§ 304.32 Reports of distributors and exporters.

(a) Every registered distributor except any officer or agency of the Veterans Administration or who or which is exempted from registration pursuant to § 301.25 of this chapter) and registered exporter shall submit a monthly report on BND Form 235 and its supplements 235a and 235b accounting for all transactions involving narcotic controlled substances listed in schedules I and II, including all receipts (BND Form 235a) and dispositions (BND Form 235b). The report shall be submitted to the Distribution Audit Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Washington, D.C. 20537, on or before the 15th day of the month succeeding that for which the return is submitted.

(b) All narcotic controlled substances listed in schedules I and II received by a distributor or exporter shall be recorded on BND Form 235a in order and at the time of receipt. Where a record on BND Form 235a cannot, for any good and sufficient reason, be made immediately, the distributor or exporter shall have available for inspection such invoices, delivery or duplicate sales slips, or other papers or records as may be required to evidence any unrecorded purchase or other receipt.

(c) All dispositions of narcotic controlled substances listed in schedules I and II, including distributions, exports, and losses, shall be reported on BND Form 235b. A separate sheet, properly headed in the space provided, shall be used for each different type of transaction. On each sheet separate entries shall be made of dispositions of each substance and of each different type and size of container or unit involved. All losses reported shall be fully explained.

(d) Each distributor and exporter shall submit, as part of his December 31 monthly report on BND Form 235 and its supplements, an inventory on BND Form 235c of narcotic controlled substances listed in schedules I and II which are in his possession on December 31 of each year. A separate entry shall be made for each narcotic substance as follows:

(1) The name, quantity, and narcotic content of the drug or preparation;

(2) The size of each commercial container; and

(3) The number of commercial containers.

(e) The distributor and exporter shall report on BND Form 235 a complete summary of transactions for the month.

[36 F.R. 7793, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971; 36 F.R. 18732, Sept. 21, 1971]

§ 304.33

Reports from manufacturers importing opium.

(a) Every manufacturer importing crude opium shall submit, in addition to the report on BND Form 234 and its supplements, BND Form 247 and its supplements, 247a and 247b, accounting for the importation and for all manufacturing operations performed between importation and the production in bulk of finished marketable products, standardized in accordance with the U.S. Pharmacopeia, National Formulary, or other recognized medical standards. Subsequent manufacture from such products, including bottling or packaging operations, shall be accounted for in the quarterly returns on BND Form 234 and its supplements. BND Form 247 and its supplements shall be submitted quarterly to the Distribution Audit Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Washington, D.C. 20537, on or before the 15th day of the month immediately following the period for which it is submitted.

(b) The report of manufacture from crude opium shall consist of summaries (BND Forms 247 and 247a) with supporting detail sheets (on BND Form 247b) accounting for original manufacture from crude opium, production from morphine for further manufacture and production from manufacturing opium, and also accounting for stocks of crude opium, manufacturing opium, morphine for further manufacture and other crude alkaloids.

(c) The detail sheets (BND Form 247b) supporting the summary of original manufacture from crude opium shall show separately the crude opium used for the manufacture of opium tinctures and extracts, crude opium used for the extraction of alkaloids, crude opium used for the manufacture of controlled substances listed in schedule V, and crude opium used for the production of manufacturing opium; and shall show separately the medicinal opium, alkaloids and salts, opium tinctures and extracts, controlled substances listed in schedule V, and manufacturing opium produced.

(d) Importation of opium shall be reported in summarized entries in the

debit summary of the quarterly report (BND Form 234) and shall be immediately reported by similar summarized entries in the credit summary of the quarterly report (BND Form 234) as transferred to importing manufacturer's report. Such importations shall further be reported in summary (BND Form 247) and supporting detail sheets (BND Form 247b). Products manufactured therefrom shall be reported as produced in accordance with paragraphs (b) and (c) of this section and, with the exception of manufacturing opium, morphine for further manufacture, and other crude or unfinished alkaloids, shall be transferred to the quarterly report (BND Form 234) when reported produced.

(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. These assays shall be accounted for in terms of its anhydrous morphine alkaloid content. 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 entires shall be made on the next report.

(f) Upon withdrawal of crude opium from customs custody, the importing manufacturer shall assign to each container an identification mark or number by which the opium will be associated with the lot assay and identified in reports.

(g) 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.

(h) Opium products and derivatives which are produced for exclusive use in further manufacturing purposes shall be reported produced when they come into existence in that form in which they are to be so used. Medicinal opium, morphine and its salts, or other alkaloids or derivatives produced exclusively for distribution shall be reported as produced when manufacture has actually been completed and the finished marketable product ready for packaging and distribution. Such products shall be regarded as ready for packaging and distribution as soon as all processing other than mere packaging has been com

pleted. Medicinal opium, tinctures, extracts, or other products manufactured partly for distribution and partly for use in further manufacture will be reported produced as soon as manufacture is complete and they are ready either for use in further manufacture or for packaging for distribution.

(i) Subject to § 303.24 (c) of this chapter, no accumulations of morphine or other narcotic controlled substances in their pure or near-pure states shall be permitted to remain inactively in process for an unreasonable time in light of efficient industrial practices. All such products nearing completion of their respective processes and approaching a condition of purity shall be carefully protected, promptly completed, and immediately transferred to finished stocks, and reported as produced.

(j) In making conversions of opium alkaloids and their salts to anhydrous morphine the quantity of the particular alkaloid or salt in avoirdupois ounces shall be multipled by a conversion factor arrived at by ascertaining the ratio, carried to the fourth decimal place, between the respective molecular weight of such alkaloid or salt and the molecular weight of anhydrous morphine (285.16), such weights being computed to the third decimal place from the chemical formulae of the substances and the atomic weights of elements, as adopted by the International Committee on Chemical Elements and published in the latest edition of the U.S. Pharmacopoeia. [36 F.R. 7794, Apr. 24, 1971]

§ 304.34 Reports of manufacturers importing medicinal coca leaves.

(a) Every manufacturer importing raw coca leaves for the manufacture of medicinal products shall submit, in addition to the report on BND Form 234 and its supplements, BND Form 168 and its supplements, 168a and 168b, 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. Pharmacopeia, National Formulary, or other recognized standards. Subsequent manufacture from such products, including bottling or packaging operations, shall be accounted for in quarterly reports on BND Form 234 and its supplements. Reports on Form 168 and its supplements shall be submitted quarterly to the Distribution Audit Branch, Bureau of Nar

66-017 0-72

cotics and Dangerous Drugs, Department of Justice, Washington, D.C. 20537, on or before the 15th day of the month immediately following the period for which it is submitted.

(b) The report of manufacture from medicinal coca leaves shall consist of summaries (BND Forms 168 and 168a) with supporting detail sheets (BND Form 168b) accounting for original manufacture from such leaves, conversions or production from manufacturing coca extracts, and also accounting for stocks of raw coca leaves, manufacturing coca extracts, and other crude coca alkaloids.

(c) The detail sheets (BND Form 168b) supporting the summary of original manufacture from medicinal coca leaves, shall show separately the coca leaves used for the manufacture of manufacturing coca extracts, coca leaves used for the direct manufacture of marketable coca tinctures and extracts, and coca leaves used for the extraction of alkaloids, and shall show separately the coca alkaloids and salts, coca tinctures and extracts, and manufacturing coca extracts produced.

(d) Importations of medicinal coca leaves shall be reported in summarized entries in the debit summary of the quarterly report (BND Form 234) and shall be immediately reported by similar summarized entries in the credit summary of the quarterly report (BND Form 234) as transferred to importing manufacturer's report. Such importations shall further be reported in summary (BND Form 168) and supporting detail sheets (BND Form 168b). Products manufactured therefrom shall be reported as produced in accordance with paragraph (h) of this section and, with the exception of manufacturing coca extracts, residues or bases for further manufacture, and other crude or unfinished alkaloids, shall be transferred to the quarterly report (BND Form 234) when reported produced.

(e) Upon importation of medicinal 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 submitting the 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) Upon withdrawal of medicinal coca leaves from customs custody, the importing manufacturer shall assign to each bale or container an identification mark or number by which the coca leaves will be associated with the lot assay and identified in reports.

(g) 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.

(h) Manufacturing coca extracts shall be reported as produced when they come into existence in that form in which they are intended for exclusive use in further manufacture. Cocaine and its salts, ecgonine and its salts, or other alkaloids or derivatives produced exclusively for distribution shall be reported as produced when manufacture has actually been completed and the finished marketable product is ready for packaging and distribution. Such products shall be regarded as ready for packaging and distribution as soon as all processing other than mere packaging has been completed. Tinctures, extracts, or other products manufactured partly for distribution and partly for use in further manufacture shall be reported produced as soon as manufacture is complete and they are ready either for use in further manufacture or for packaging for distribution.

(i) No accumulations of cocaine or ecgonine or other narcotic controlled substances in their pure or near-pure states shall be permitted to remain inactively in process. All such products nearing completion of their respective processes and approaching a condition of purity shall be carefully protected, promptly completed, and immediately transferred to finished stocks and reported as produced.

(j) In making conversions of coca alkaloids and their salts to cocaine alkaloid and to anhydrous ecgonine alkaloid, the quantity of the particular alkaloid or salt in avoirdupois ounces shall be multipled by a conversion factor arrived at by ascertaining the ratio, carried to the fourth decimal place, between the molecular weight of such alkaloid or salt and the molecular weight of cocaine alkaloid (303.172) or anhydrous

ecgonine alkaloid (185.125), as the case may be, such weights being computed to the third decimal place from the chemical formulae of the substances and the atomic weights of elements, as adopted by the International Committee on Chemical Elements and published in the latest edition of the U.S. Pharmacopeia. [36 F.R. 7795, Apr. 24, 1971]

§ 304.35 Reports from manufacturers importing special coca leaves.

(a) Every manufacturer using special coca leaves imported into the United States shall submit a quarterly report (BND Form 249) accounting for all transactions involving such leaves or substances derived therefrom which contain cocaine or ecgonine, or any salts, derivatives, or preparations from which cocaine or ecgonine may be synthesized or made. This report shall be submitted to the Distribution Audit Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Washington, D.C. 20537, on or before the 15th day of the month following the period for which the report is made. Such report shall include a report of all importations of special coca leaves (BND Form 249a), a report of all materials entered into the processes of manufacture (BND Form 249b), a report of the various substances produced therefrom (BND Forms 249c, 249d, and 249e), a report of all such substances destroyed (BND Form 249f), and a summary of operations (BND Form 249g).

(b) The report of importations shall provide in appropriate columns the following data as to each importation:

(1) The date of the import permit; (2) The serial number of the import permit;

(3) The name of the foreign consignor;

(4) The address of the foreign consignor;

(5) The foreign port of export; (6) The number of bales imported; (7) The serial numbers of the bales imported; and

(8) The quantity imported in avoirdupois pounds.

(c) The report of materials entered into the process of manufacture shall provide in appropriate columns the following information as to each lot of leaves dumped:

(1) The lot number of specification, a specification to be assigned to each dump for identification purposes in or

der to avoid repeating the serial numbers of the bales when the lot is subsequently referred to;

(2) The date the leaves entered into the process of manufacture;

(3) The number of bales dumped; (4) The serial numbers of the bales; (5) The quantity of leaves entered into the process of manufacture, stated in avoirdupois pounds;

(6) The quantity of alcohol used for each extraction or wash of the leaves;

(7) The quantity of water used for each water extraction or dilution;

(8) The quantity of any other or additional substance introduced at any stage into the process of manufacture; and

(9) The dry weight of any filter cloth or other absorbent material to be later removed from the process after saturation.

(d) The reports of substances produced from special coca leaves shall provide in columns the following information as to each production lot or dump: (1) The lot number;

(2) The quantity of ground leaves entered into process, in terms of avoirdupois ounces and the quantity, in ounces and grains, of alkaloid contained therein as determined by analysis;

(3) The quantity of substance in process after each distinct step in the manufacturing process and the total alkaloid contained in each, stated in ounces and grains;

(4) The quantity of exhausted or spent leaves and the quantity of each residue removed from process, and the total alkaloid contained in each, stated in ounces and grains;

(5) The weight of the used filter cloth or other absorbent material removed, after saturation; and

(6) The quantity, in gallons, of finished extract produced.

(e) The report of substances destroyed, shall provide in appropriate columns the following data as to each lot destroyed:

(1) The lot number;

(1) The summary of raw coca leaves shall include:

(i) The quantity of special coca leaves on hand at the beginning of the quarter; (ii) The quantity of special coca leaves imported during the quarter;

(iii) The quantity of special coca leaves entered into the process of manufacture during the quarter;

(iv) The quantity of special coca leaves on hand at the end of the quarter; and

(v) Any other transaction during the quarter which increased or decreased the quantity of raw coca leaves on hand. (2) The summary of coca leaves in process shall include:

(i) The quantity of special coca leaves in process at the beginning of the quarter;

(ii) The quantity of such leaves placed in the process during the quarter;

(iii) The quantity of such leaves represented by lots completed during the quarter;

(iv) The quantity of such leaves represented by lots in process at the end of the quarter; and

(v) Any other transaction during the quarter which increased or decreased the quantity of leaves in process.

(3) The summary of residues removed from production processes shall provide in appropriate columns, separately as to spent leaves, each residue and saturated material, the following information:

(i) The quantity of each, on hand at the beginning of the quarter, awaiting destruction;

(ii) The quantity of each removed from process during the quarter;

(iii) The quantity of each destroyed during the quarter;

(iv) The quantity of each on hand at the end of the quarter; and

(v) Any other transaction during the quarter affecting the quantity of such residues on hand.

[36 F.R. 7795, Apr. 24, 1971]

(2) The quantity of spent leaves, residues, and saturated materials destroyed, stated separately for each; and

305.02

305.03

305.04

(3) The name of the Government officer witnessing the destruction.

(f) The summary shall include a complete accounting for all transactions in raw leaves, leaves in process, and residues removed from production processes.

Distributions requiring order forms. Persons entitled to obtain and execute order forms.