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U.S.C. 802 and 951) and in §§ 301.02 and 311.02 of this chapter.

[36 F.R. 7789, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971]

§ 304.03 Persons required to keep records and file reports.

(a) Each registrant shall maintain the records and inventories and shall file the reports required by this part, except as exempted by this section. Any registrant who is authorized to conduct other activities without being registered to conduct those activities, either pursuant to § 301.22(b) of this chapter or pursuant to §§ 307.11-307.15 of this chapter, shall maintain the records and inventories and shall file the reports required by this part for persons registered to conduct such activities (e.g., when a registered manufacturer conducts chemical analysis, he shall maintain the records and inventories required of chemical analysis).

(b) A registered individual practitioner is not required to keep records with respect to narcotic controlled substances listed in schedules II through V which he prescribes or administers in the lawful course of his professional practice; he shall keep records, however, with respect to such substances that he dispenses other than by prescribing or administering.

(c) A registered individual practitioner is not required to keep records with respect to nonnarcotic controlled substances listed in schedules II through V which he dispenses in any manner unless he regularly charges his patients, either separately or together with charges for other professional services, for such substances so dispensed (e.g., when he substitutes his services for those of a pharmacist).

(d) A registered person using any controlled substance in research conducted in conformity with an exemption granted under section 505 (i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355 (i) or 360b(j)) at a registered establishment which maintains records in accordance with either of those sections is not required to keep records if he notifies the Bureau of the name, address, and registration number of the establishment maintaining such records.

(e) A registered person using any controlled substance in preclinical research or in teaching at a registered establishment which maintains records with respect to such substances is not required

to keep records if he notifies the Bureau of the name, address, and registration number of the establishment maintaining such records.

(f) Notice required by paragraphs (d) and (e) of this section shall be given at the time the person applies for registration or reregistration and shall be made in the form of an attachment to the application, which shall be filed with the application.

[36 F.R. 7790, Apr. 24, 1971, as amended at 36 F.R. 18731, Sept. 21, 1971]

§ 304.04 Maintenance of records and

inventories.

(a) Every inventory and other record required to be kept under the Part shall be kept by the registrant and be available, for at least 2 years from the date of such inventory or record, for inspecting and copying by authorized employees of the Bureau, except that financial and shipping records (such as invoices and packing slips but not executed order forms subject to § 305.13 of this chapter) may be kept at a central location, rather than at the registered location, if the registrant obtains from the Bureau approval of his central recordkeeping system and a permit to keep central records. The central recordkeeping system of any person whose system was approved by the Bureau prior to May 1, 1971, shall continue to be approved under this paragraph if such person satisfies the Bureau by July 1, 1971, of such approval and applies for a permit to keep central records. The permit to keep central records shall be issued by the Bureau to a registrant upon application if the Bureau approves his central recordkeeping system and shall be subject to the following conditions:

(1) The permit shall specify the nature of the records to be kept centrally and the exact location where the records will be kept;

(2) The registrant agrees to deliver all or any part of such records to the registered location within 48 hours of receipt of a written request from the Bureau for such records and, if the Bureau chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Bureau to inspect such records at the central location upon request by such employees without a warrant of any kind; and

(3) The failure of the registrant to perform his agreements under the permit

shall revoke without further action by the Bureau such permit and all other such permits held by the registrant under other registrations. In the event of a revocation of other permits under this subparagraph, the registrant shall, within 30 days after such revocation, comply with the requirements of this section that all records be kept at the registered location.

(b) Each registered manufacturer, distributor, importer, and exporter shall maintain inventories and records of controlled substances as follows:

(1) Inventories and records of controlled substances listed in schedules I and II shall be maintained separately from all of the records of the registrant; and

(2) Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.

(c) Each registered individual practitioner required to keep records and institutional practitioner shall maintain inventories and records of controlled substances in the manner prescribed in paragraph (b) of this section.

(d) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:

(1) Inventories and records of all controlled substances listed in schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for such substances shall be maintained in a separate prescription file; and

(2) Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy, and prescriptions for such substances shall be maintained either in separate prescription file for controlled substances listed in schedules III, IV, and V only or in such form that they are readily retrievable from the other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than 1-inch

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(a) Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, substances ordered by a customer but not yet invoiced, substances stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples.

(b) A separate inventory shall be made by a registrant for each registered location. In the event controlied substances in the possession or under the control of the registrant at a location for which he is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. Each inventory for a registered location shall be kept at the registered location.

(c) A separate inventory shall be made by a registrant for each independent activity for which he is registered, except as provided in § 304.18.

(d) A registrant may take an inventory on a date that is within 4 days of his biennial inventory date pursuant to § 304.13 if he notifies in advance the Regional Director of the Bureau in his region of the date on which he will take the inventory. A registrant may take an inventory either as of the opening of business or as of the close of business on the inventory date. The registrant shall indicate on the inventory records whether the inventory is taken as of the opening or as of the close of business and the date the inventory is taken.

(e) An inventory must be maintained in a written, typewritten or printed form. An inventory taken by use of an oral recording device must be promptly transcribed.

[36 F.R. 7790, Apr. 24, 1971]

§ 304.12

Initial inventory date.

(a) Every person required to keep records who is provisionally registered on May 1, 1971, shall take an inventory of all stocks of controlled substances on hand on that date in accordance with §§ 304.15-304.19, as applicable.

(b) Every person required to keep records who is registered after May 1, 1971, and who was not provisionally registered on that date, shall take an inventory of all stocks of controlled substances on hand on the date he first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with §§ 304.15-304.19, as applicable.

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

§ 304.13 Biennial inventory date.

Every 2 years following the date on which the initial inventory is taken by a registrant pursuant to § 304.12, the registrant shall take a new inventory of all stocks of controlled substances on hand. The biennial inventory may be taken (a) on the day of the year on which the initial inventory was taken or (b) on the registrant's regular general physical inventory date, if any, which is nearest to and does not vary by more than 6 months from the biennial date that would otherwise apply or (c) on any other fixed date which does not vary by more than 6 months from the biennial date that would otherwise apply. If the registrant elects to take the biennial inventory on his regular general physical inventory date or another fixed date, he shall notify the Bureau of this election and of the date on which the biennial inventory will be taken.

[36 F.R. 7791, Apr. 24, 1971]

§ 304.14 Inventory date for newly controlled substances.

On the effective date of a rule by the Director pursuant to §§ 308.48, 308.49, or 308.50 of this chapter adding a substance to any schedule of controlled substances, which substance was, immediately prior to that date, not listed on any such schedule, every registrant required to keep records who possesses that substance shall take an inventory of all stocks of the substance on hand. Thereafter such substance shall be included in each inventory made by the registrant pursuant to § 304.13.

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

§ 304.15 Inventories of manufacturers.

Each person registered or authorized (by § 301.22(b), § 307.12, or § 307.15 of this chapter) to manufacture controlled substances shall include the following information in his inventory:

(a) For each controlled substance in bulk form to be used in (or capable of use in) the manufacture of the same or other controlled or non-controlled substances in finished form:

(1) The name of the substance; and

(2) The total quantity of the substance to the nearest metric unit weight consistent with unit size (except that for inventories made in 1971, avoirdupois weights may be utilized where metric weights are not readily available).

(b) For each controlled substance in the process of manufacture on the inventory date:

(1) The name of the substance;

(2) The quantity of the substance in each batch and/or stage of manufacture, identified by the batch number or other appropriate identifying number;

(3) The physical form which the substance is to take upon completion of the manufacturing process (e.g., granulations, tablets, capsules, or solutions), identified by the batch number or other appropriate identifying number, and if possible the finished form of the substance (e.g., 10-milligram tablet or 10milligram concentration per fluid ounce or milliliter) and the number or volume thereof; and

(c) For each controlled substance in finished form:

(1) The name of the substance;

(2) Each finished form of the substance (e.g., 10-milligram tablet or 10milligram concentration per fluid ounce or milliliter);

(3) The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3milliliter vial); and

(4) The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials).

(d) For each controlled substance not included in paragraphs (a), (b) or (c) of this section (e.g., damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compoundings):

(1) The name of the substance;

(2) The total quantity of the substance to the nearest metric unit weight

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

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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 recorts snail e naintained by a registrant for ach ndepend ent activity for vich he is registered. except as provided in § 104.25 ma 104.28.

(d) In recording tates receipt, mportance, distribution, exportation, r other transfers, me tate m which the controlled substances are actually e ceived. imported. fistributed. exported. or otherwise ransferred nail be used is the date of receipt or distribution of any documents of transfer e... nvoices r packing slips

[36 FR. 7792. Apr. 14, 1972, as amendect it 36 FR. 13336, July 11, 1972,

§ 304.22 Records of manufacturers.

Each person registered or authorized (by § 301.22 bor § 307.25 of s manter) to manufacture conrailed substances shall maintain recoris with he following information:

(a) For each conciled substance bulk form to be used in. or cacacle if we in, or being used in the man in care the same or other ccrled ir controlled substances fmster f (1) The name of the substates (2) The quantity make C bulk form by the registers Term the date, quantity and cast identifying number of manufactured;

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(3) The quantity received form persons, including the date o tity of each receipt and the came acdress, and registration

er i e other person from whom the suberance was received;

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

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

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

(ii) The quantity used 11 manufacture;

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(iii) The finished form (e.g., 10-mlgram tablets or 10-milligram concer tration per fiuid ounce or milliliter,

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

(v) The quantity used in quality control;

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

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