or the total number of units of finished form; and

(3) The reason for the substance being maintained by the registrant and whether such substance is capable of use in the manufacture of any controlled substance in finished form.

[36 F.R. 7791, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971; 36 F.R. 18732, Sept. 21, 1971]

§ 304.16 Inventories of distributors.

Each person registered or authorized (by §§ 301.22 (b) or 307.11-307.14 of this chapter) to distribute controlled substances shall include in his inventory the same information required of manufacturers pursuant to § 304.15 (c) and (d). [36 F.R. 7791, Apr. 24, 1971, as amended at 36 F.R. 18732, Sept. 21, 1971]

§ 304.17 Inventories of dispensers and

researchers.

Each person registered or authorized (by § 301.22 (b) of this chapter) to dispense or conduct research with controlled substances and required to keep records pursuant to § 304.03 shall include in his inventory the same information required of manufacturers pursuant to § 304.15 (c) and (d). In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows:

(a) If the substance is listed in schedule I or II, he shall make an exact count or measure of the contents; and

(b) If the substance is listed in schedule III, IV, or V, he shall make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he must make an exact count of the contents.

[36 F.R. 7791, Apr. 24, 1971, as amended at 36 F.R. 18732, Sept. 21, 1971]

§ 304.18 Inventories of importers and

exporters.

Each person registered or authorized (by § 301.22(b) of this chapter) to import or export controlled substances shall include in his inventory the same information required of manufacturers pursuant to § 304.15 (a), (c), and (d). Each such person who is also registered as a manufacturer or as a distributor shall include in his inventory as an importer or exporter only those stocks of controlled

Each person registered or authorized (by § 301.22 (b) of this chapter) to conduct chemical analysis with controlled substances shall include in his inventory the same information required of manufacturers pursuant to § 305.15 (a), (c), and (d) as to substances which have been manufactured, imported, or received by such person. If less than 1 kilogram of any controlled substance (other than a hallucinogenic controlled substance listed in schedule I), or less than 20 grams of a hallucinogenic substance listed in schedule I (other than lysergic acid diethylamide), or less than 0.5 gram of lysergic acid diethylamide, is on hand at the time of inventory, that substance need not be included in the inventory. Laboratories of the Bureau may possess up to 150 grams of any hallucinogenic substance in schedule I without regard to a need for an inventory of those substances. No inventory is required of known or suspected controlled substances received as evidentiary materials for analysis.

[36 F.R. 7791, Apr. 24, 1971, as amended at 36 F.R. 18732, Sept. 21, 1971]

§ 304.21

CONTINUING RECORDS

General requirements for continuing records.

(a) On and after May 1, 1971, every registrant required to keep records pursuant to § 304.03 shall maintain on a current basis a complete and accurate record of each such substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him, except that no registrant shall be required to maintain a perpetual inventory.

(b) Separate records shall be maintained by a registrant for each registered location except as provided in § 304.04(a). In the event controlled substances are in the possession or under the control of a registrant at a location for which he is not registered, the substances shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.

(c) Separate records shall be maintained by a registrant for each independent activity for which he is registered, except as provided in §§ 304.25 and 304.26.

(d) In recording dates of receipt, importation, distribution, exportation, or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported, or otherwise transferred shall be used as the date of receipt or distribution of any documents of transfer (e.g., invoices or packing slips).

[36 F.R. 7792, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971]

§ 304.22 Records of manufacturers.

Each person registered or authorized (by § 301.22(b) or § 307.15 of this chapter) to manufacture conrtolled substances shall maintain records with the following information:

(a) For each controlled substance in bulk form to be used in, or capable of use in, or being used in, the manufacture of the same or other controlled or noncontrolled substances in finished form, (1) The name of the substance; (2) The quantity manufactured in bulk form by the registrant, including the date, quantity and batch or other identifying number each batch manufactured;

of

(3) The quantity received from other persons, including the date and quantity of each receipt and the name, address, and registration number of the other person from whom the substance was received;

(4) The quantity imported directly by the registrant (under a registration as an importer) for use in manufacture by him, including the date, quantity, and import permit or declaration number for each importation;

(5) The quantity used to manufacture the same substance in finished form, including:

(i) The date and batch or other identifying number of each manufacture;

(ii) The quantity used in the manufacture;

(iii) The finished form (e.g., 10-milligram tablets or 10-milligram concentration per fiuid ounce or milliliter);

(iv) The number of units of finished form manufactured;

(v) The quantity used in quality control;

(vi) The quantity lost during manufacturing and the causes therefor, if known;

(vii) The total quantity of the substance contained in the finished form; (viii) The theoretical and actual yields; and

(ix) Such other information as is necessary to account for all controlled substances used in the manufacturing process;

(6) The quantity used to manufacture other controlled and noncontrolled substances, including the name of each substance manufactured and the information required in subparagraph (5) of this paragraph;

(7) The quantity distributed in bulk form to other persons, including the date and quantity of each distribution and the name, address, and registration number of each person to whom a distribution was made;

(8) The quantity exported directly by the registrant (under a registration as an exporter), including the date, quantity, and export permit or declaration number of each exportation;

(9) The quantity distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity distributed or disposed.

(b) For each controlled substance in finished form,

(1) The name of the substance;

(2) Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

(3) The number of containers of each such commercial finished form manufactured from bulk form by the registrant, including the information required pursuant to subparagraph (5) of paragraph (a) of this section;

(4) The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers in each receipt and the name, address, and registration number of the person from whom the units were received;

(5) The number of units of finished forms and/or commercial containers imported directly by the person (under a registration or authorization to import),

including the date of, the number of units and/or commercial containers in, and the import permit or declaration number for, each importation;

(6) The number of units and/or commercial containers manufactured by the registrant from units in finished form received from others or imported, including:

(i) The date and batch or other identifying number of each manufacture; (ii) The operation performed (e.g., repackaging or relabeling);

(iii) The number of units of finished form used in the manufacture, the number manufactured and the number lost during manufacture, with the causes for such losses, if known; and

(iv) Such other information as is necessary to account for all controlled substances used in the manufacturing process;

(7) The number of commercial containers distributed to other persons, including the date of and number of containers in each distribution, and the name, address, and registration number of the person to whom the containers were distributed;

(8) The number of commercial containers exported directly by the registrant (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and (9) The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed.

[36 F.R. 7792, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971; 36 F.R. 18732, Sept. 21, 1971]

form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

(c) The number of commercial containers of each such finished form received from other persons, including the date of and number of containers in each receipt and the name, address, and registration number of the person from whom the containers were received;

(d) The number of commercial containers or each such finished form imported directly by the person (under a registration or authorization to import), including the date of, the number of commercial containers in, and the import permit or declaration number for, each importation;

(e) The number of commercial containers of each such finished form distributed to other persons, including the date of and number of containers in each distribution and the name, address, and registration number of the person to whom the containers were distributed;

(f) The number of commercial containers of each such finished form exported directly by the person (under a registration or authorization to export), including the date of, the number of commercial containers in, and the export permit or declaration number for, each exportation; and

(g) The number of units or volume of finished forms and/or commercial containers distributed or disposed of in any other manner by the person (e.g., by distribution as complimentary samples or by destruction) including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity of the substance in finished form distributed or disposed.

[36 F.R. 7792, Apr. 24, 1971, as amended at 36 F.R. 18732, Sept. 21, 1971]

§ 304.24 Records for dispensers and researchers.

Each person registered or authorized (by § 301.22(b) of this chapter) to dispense or conduct research with controlled substances and required to keep records pursuant to § 304.03 shall maintain records with the following information for each controlled substance:

(a) The name of the substance;

(b) Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

(c) The number of commercial containers of each such finished form received from other persons, including the date of and number of containers in each receipt and the name, address, and registration number of the person from whom the containers were received:

(d) The number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser; and

(e) The number of units or volume of such finished forms and/or commercial containers disposed of in any other manner by the registrant, including the date and manner of disposal and the quantity of the substance in finished form disposed.

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

§ 304.25 Records for importers.

Each person registered or authorized (by § 301.22 (b) of this chapter) to import controlled substances shall maintain records with the following information for each controlled substance:

(a) The name of the substance;

(b) The quantity (or number of units or volume in finished form) imported, including the date, quantity (or number of units or volume), and import permit or declaration number for each importation;

(c) The quantity (or number of units or volume in finished form) distributed to other persons, including the date and quantity (or number of units or volume) of each distribution and the name, address, and registration number of each person to whom a distribution was made; and

(d) The quantity disposed of in any other manner by the registrant (except quantities used in manufacturing by an importer under a registration as a manufacturer, which quantities are to be recorded pursuant to § 304.22 (a) (4) or (b) (5)), including the date and manner of disposal and the quantity disposed. [36 F.R. 7793, Apr. 24, 1971, as amended at 36 F.R. 18732, Sept. 21, 1971]

§ 304.26 Records for exporters.

Each person registered or authorized (by § 301.22(b) of this chapter) to export controlled substances shall maintain rec

ords with the following information for each controlled substance:

(a) The name of the substance;

(b) The quantity (or number of units or volume in finished form) received from other persons, including the date and quantity (or number of units or volume) of each receipt and the name, address, and registration number of each person from whom the substance was received;

(c) The quantity (or number of units or volume in finished form) exported, including the date, quantity (or number of units or volume), and the export permit or declaration number for each exportation, but excluding all quantities (and numbers of units and volumes) manufactured by an exporter under a registration as a manufacturer, which quantities (and numbers of units and volumes) are to be recorded pursuant to § 304.22 (a) (8) or (b) (8); and

(d) The quantity disposed of in any other manner by the registrant, including the date and manner of disposal and the quantity disposed.

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

§ 304.27 Records for chemical analysts.

(a) Each person registered or authorized (by § 301.22(b) of this chapter) to conduct chemical analysis with controlled substances shall maintain records with the following information (to the extent known and reasonably ascertainable by him) for each controlled substance:

(1) The name of the substance;

(2) The form or forms in which the substance is received, imported, or manufactured by the registrant (e.g., powder, granulation, tablet, capsule, or solution) and the concentration of the substance in such form (e.g., C.P., U.S.P., N.F., 10milligram tablet or 10-milligram concentration per milliliter);

(3) The total number of the forms received, imported or manufactured (e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder), including the date and quantity of each receipt, importation, or manufacture and the name, address, and registration number, if any, of the person from whom the substance was received;

(4) The quantity distributed, exported, or destroyed in any manner by the registrant (except quantities used in chemical analysis or other laboratory work), including the date and manner of distri

bution, exportation, or destruction, and the name, address, and registration number, if any, of each person to whom the substance was distributed or exported.

(b) Records of controlled substances used in chemical analysis or other laboratory work are not required.

(c) Records relating to known or suspected controlled substances received as evidentiary material for analysis are not required under paragraph (a) of this section.

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

§ 304.31

REPORTS

Reports from manufacturers and importers.

(a) Each registered manufacturer and registered importer shall submit a quarterly report (BND Form 234) accounting for all stocks of narcotic controlled substances listed in schedules I, II, and III on hand at the beginning and at the end of the quarter, and for all receipts (BND Form 234a), dispositions (BND Form 234b), manufacturing (BND Form 234c) and packaging (BND Form 234d), of such substances. The returns 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 the period for which it is submitted.

(b) All narcotic controlled substances listed in schedules I, II, and III received by a manufacturer or importer, shall be recorded on Form 234a in order and at the time of receipt. Where record on Form 234a cannot, for any good and sufficient reason, be made immediately, the manufacturer or importer 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 receipt.

(c) All dispositions of narcotic controlled substances listed in schedules I, II, and III by a manufacturer or importer, including exports, distributions, and losses, shall be reported on BND Form 234b. 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 used to report dispositions of each substance and of each different type and size of container or unit in

volved. All losses reported shall be fully explained. The details of all exports and all domestic distributions of narcotic controlled substances shall be reported in full on BND Form 234b, except that the details of distributions of narcotic controlled substances listed in schedule III sold to dispensers shall be included in summarized entries on BND Form 234b. For all such distributions not reported in detail the manufacturer shall have available for inspection original sales orders, delivery slips, or other papers or records sufficient to fully evidence and explain the dispositions.

(d) All narcotic controlled substances listed in schedules I, II, and II used in the production of other drugs or preparations, with the exception of transactions involving original manufacture from raw opium or coca leaves, shall be entered on BND Form 234c in the order and at the time they are placed into the process of manufacture. All narcotic controlled substances listed in schedules I, II, and III and preparations produced therefrom shall be entered on the same form, at the time of production, which entry shall be clearly identified with the entry of substances used in their production. Where record of "Used for Production" or "Production" cannot be made immediately the manufacturer shall have available such batch tags, production orders, or other papers as may be required to evidence any unrecorded quantity used or produced. Any loss in manufacture, and any recoverable wastes salvaged from the manufacture shall be reported. All such wastes shall be returned to raw stock and included in the report of raw materials on hand at the end of the month. Any narcotic controlled substances listed in schedules I, II, and III actively in process of manufacture at the end of the month shall be so reported. Where substances are placed in process during one quarter and a portion of the production is removed from process as finished goods during the same quarter, the portion thus removed from process shall be reported "Produced" and the remainder reported as "In process" at the close of the period. Narcotic controlled substances listed in schedules I, II, and III placed in process for the manufacture of narcotic controlled substances listed in schedule V shall be reported on a separate BND Form 234c, on which the kind and quantity of narcotic used and the name of the sub