21 C.F.R. PART 1304—RECORDS AND REPORTS OF REGISTRANTS
Title 21 - Food and Drugs
Authority: 21 U.S.C. 821, 827, 871(b), 958(e), 965, unless otherwise noted.
Inventory and other records and reports required under section 307 or section 1008(d) of the Act (21 U.S.C. 827 and 958(d)) shall be in accordance with, and contain the information required by, those sections and by the sections of this part. [36 FR 7789, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. [62 FR 13958, Mar. 24, 1997] (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 §1301.22(b) of this chapter or pursuant to §§1307.11–1307.15 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. This latter requirement should not be construed as requiring stocks of controlled substances being used in various activities under one registration to be stored separately, nor that separate records are required for each activity. The intent of the Administration is to permit the registrant to keep one set of records which are adapted by the registrant to account for controlled substances used in any activity. Also, the Administration does not wish to acquire separate stocks of the same substance to be purchased and stored for separate activities. Otherwise, there is no advantage gained by permitting several activities under one registration. Thus, when a researcher manufactures a controlled item, he must keep a record of the quantity manufactured; when he distributes a quantity of the item, he must use and keep invoices or order forms to document the transfer; when he imports a substance, he keeps as part of his records the documentation required of an importer; and when substances are used in chemical analysis, he need not keep a record of this because such a record would not be required of him under a registration to do chemical analysis. All of these records may be maintained in one consolidated record system. Similarly, the researcher may store all of his controlled items in one place, and every two years take inventory of all items on hand, regardless of whether the substances were manufactured by him, imported by him, or purchased domestically by him, of whether the substances will be administered to subjects, distributed to other researchers, or destroyed during chemical analysis. (b) A registered individual practitioner is required to keep records, as described in §1304.04, of controlled substances in Schedules II, III, IV, and V which are dispensed, other than by prescribing or administering in the lawful course of professional practice. (c) A registered individual practitioner is not required to keep records of controlled substances in Schedules II, III, IV, and V which are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment of an individual. (d) A registered individual practitioner is not required to keep records of controlled substances listed in Schedules II, III, IV and V which are administered in the lawful course of professional practice unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered. Records are required to be kept for controlled substances administered in the course of maintenance or detoxification treatment of an individual. (e) Each registered mid-level practitioner shall maintain in a readily retrievable manner those documents required by the state in which he/she practices which describe the conditions and extent of his/her authorization to dispense controlled substances and shall make such documents available for inspection and copying by authorized employees of the Administration. Examples of such documentation include protocols, practice guidelines or practice agreements. (f) Registered persons using any controlled substances while conducting preclinical research, in teaching at a registered establishment which maintains records with respect to such substances or conducting research 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, are not required to keep records if he/she notifies the Administration of the name, address, and registration number of the establishment maintaining such records. This notification 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. (g) A distributing registrant who utilizes a freight forwarding facility shall maintain records to reflect transfer of controlled substances through the facility. These records must contain the date, time of transfer, number of cartons, crates, drums or other packages in which commercial containers of controlled substances are shipped and authorized signatures for each transfer. A distributing registrant may, as part of the initial request to operate a freight forwarding facility, request permission to store records at a central location. Approval of the request to maintain central records would be implicit in the approval of the request to operate the facility. Otherwise, a request to maintain records at a central location must be submitted in accordance with §1304.04 of this part. These records must be maintained for a period of two years. [36 FR 7790, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 50 FR 40523, Oct. 4, 1985; 51 FR 5320, Feb. 13, 1986; 51 FR 26154, July 21, 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, Mar. 24, 1997; 65 FR 44679, July 19, 2000] (a) Except as provided in paragraphs (a)(1) and (a)(2) of this section, every inventory and other records required to be kept under this part must be kept by the registrant and be available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized employees of the Administration. (1) Financial and shipping records (such as invoices and packing slips but not executed order forms subject to §§1305.17 and 1305.27 of this chapter) may be kept at a central location, rather than at the registered location, if the registrant has notified the Administration of his intention to keep central records. Written notification must be submitted by registered or certified mail, return receipt requested, in triplicate, to the Special Agent in Charge of the Administration in the area in which the registrant is located. Unless the registrant is informed by the Special Agent in Charge that permission to keep central records is denied, the registrant may maintain central records commencing 14 days after receipt of his notification by the Special Agent in Charge. All notifications must include the following: (i) The nature of the records to be kept centrally. (ii) The exact location where the records will be kept. (iii) The name, address, DEA registration number and type of DEA registration of the registrant whose records are being maintained centrally. (iv) Whether central records will be maintained in a manual, or computer readable, form. (2) A registered retail pharmacy that possesses additional registrations for automated dispensing systems at long term care facilities may keep all records required by this part for those additional registered sites at the retail pharmacy or other approved central location. (b) All registrants that are authorized to maintain a central recordkeeping system shall be subject to the following conditions: (1) The records to be maintained at the central record location shall not include executed order forms, prescriptions and/or inventories which shall be maintained at each registered location. (2) If the records are kept on microfilm, computer media or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than pricing information), a key to the code shall be provided to make the records understandable. (3) The registrant agrees to deliver all or any part of such records to the registered location within two business days upon receipt of a written request from the Administration for such records, and if the Administration chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Administration to inspect such records at the central location upon request by such employees without a warrant of any kind. (4) In the event that a registrant fails to comply with these conditions, the Special Agent in Charge may cancel such central recordkeeping authorization, and all other central recordkeeping authorizations held by the registrant without a hearing or other procedures. In the event of a cancellation of central recordkeeping authorizations under this paragraph the registrant shall, within the time specified by the Special Agent in Charge, comply with the requirements of this section that all records be kept at the registered location. (c) Registrants need not notify the Special Agent in Charge or obtain central recordkeeping approval in order to maintain records on an in-house computer system. (d) ARCOS participants who desire authorization to report from other than their registered locations must obtain a separate central reporting identifier. Request for central reporting identifiers will be submitted to: ARCOS Unit, P.O. Box 28293, Central Station, Washington, DC 20005. (e) All central recordkeeping permits previously issued by the Administration expired September 30, 1980. (f) Each registered manufacturer, distributor, importer, exporter, narcotic treatment program and compounder for narcotic treatment program 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. (g) 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 (f) of this section. (h) 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 a 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 high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for non-controlled substances. However, if a pharmacy employs an ADP system or other electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red “C” is waived. (Authority: 21 U.S.C. 821 and 871(b); 28 CFR 0.100) [36 FR 7790, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 37985, Oct. 25, 1974; 45 FR 44266, July 1, 1980; 47 FR 41735, Sept. 22, 1982; 51 FR 5320, Feb. 13, 1986; 62 FR 13959, Mar. 24, 1997; 70 FR 25466, May 13, 2005] (a) Every retail pharmacy that utilizes the services of a central fill pharmacy must keep a record of all central fill pharmacies, including name, address and DEA number, that are authorized to fill prescriptions on its behalf. The retail pharmacy must also verify the registration for each central fill pharmacy authorized to fill prescriptions on its behalf. These records must be made available upon request for inspection by DEA. (b) Every central fill pharmacy must keep a record of all retail pharmacies, including name, address and DEA number, for which it is authorized to fill prescriptions. The central fill pharmacy must also verify the registration for all retail pharmacies for which it is authorized to fill prescriptions. These records must be made available upon request for inspection by DEA. [68 FR 37410, June 24, 2003] (a) General requirements. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. An inventory taken by use of an oral recording device must be promptly transcribed. 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, ordered by a customer but not yet invoiced, 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. A separate inventory shall be made for each registered location and each independent activity registered, except as provided in paragraph (e)(4) of this section. In the event controlled substances in the possession or under the control of the registrant are stored at a location for which he/she 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. The inventory may be taken either as of opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory. (b) Initial inventory date. Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with paragraph (e) of this section as applicable. In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory. (c) Biennial inventory date. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date. (d) Inventory date for newly controlled substances. On the effective date of a rule by the Administrator pursuant to §§1308.45, 1308.46, or 1308.47 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 paragraph (c) of this section. (e) Inventories of manufacturers, distributors, dispensers, researchers, importers, exporters and chemical analysts. Each person registered or authorized (by §1301.13 or §§1307.11–1307.13 of this chapter) to manufacture, distribute, dispense, import, export, conduct research or chemical analysis with controlled substances and required to keep records pursuant to §1304.03 shall include in the inventory the information listed below. (1) Inventories of manufacturers. Each person registered or authorized to manufacture controlled substances shall include the following information in the inventory: (i) 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, the inventory shall include: (A) The name of the substance and (B) The total quantity of the substance to the nearest metric unit weight consistent with unit size. (ii) For each controlled substance in the process of manufacture on the inventory date, the inventory shall include: (A) The name of the substance; (B) The quantity of the substance in each batch and/or stage of manufacture, identified by the batch number or other appropriate identifying number; and (C) 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 10-milligram concentration per fluid ounce or milliliter) and the number or volume thereof. (iii) For each controlled substance in finished form the inventory shall include: (A) The name of the substance; (B) Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter); (C) The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and (D) The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials). (iv) For each controlled substance not included in paragraphs (e)(1) (i), (ii) or (iii) of this section (e.g., damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compoundings) the inventories shall include: (A) The name of the substance; (B) The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and (C) 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. (2) Inventories of distributors. Except for reverse distributors covered by paragraph (e)(3) of this section, each person registered or authorized to distribute controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this section. (3) Inventories of dispensers, researchers, and reverse distributors. Each person registered or authorized to dispense, conduct research, or act as a reverse distributor with controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this section. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser, researcher, or reverse distributor shall do as follows: (i) If the substance is listed in Schedule I or II, make an exact count or measure of the contents, or (ii) If the substance is listed in Schedule III, IV or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents. (4) Inventories of importers and exporters. Each person registered or authorized to import or export controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this section. Each such person who is also registered as a manufacturer or as a distributor shall include in his/her inventory as an importer or exporter only those stocks of controlled substances that are actually separated from his stocks as a manufacturer or as a distributor (e.g., in transit or in storage for shipment). (5) Inventories of chemical analysts. Each person registered or authorized to conduct chemical analysis with controlled substances shall include in his inventory the same information required of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this section 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 Administration 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. [62 FR 13959, Mar. 24, 1997, as amended at 68 FR 41228, July 11, 2003] (a) Every registrant required to keep records pursuant to §1304.03 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/her, 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 §1304.04 (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/she is registered, except as provided in §1304.22(d). (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 FR 7792, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13960, Mar. 24, 1997] Each person registered or authorized (by §1301.13(e) or §§1307.11–1307.13 of this chapter) to manufacture, distribute, dispense, import, export or conduct research with controlled substances shall maintain records with the information listed below. (a) Records for manufacturers. Each person registered or authorized to manufacture controlled substances shall maintain records with the following information: (1) 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, (i) The name of the substance; (ii) The quantity manufactured in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch manufactured; (iii) 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; (iv) The quantity imported directly by the registrant (under a registration as an importer) for use in manufacture by him/her, including the date, quantity, and import permit or declaration number for each importation; (v) The quantity used to manufacture the same substance in finished form, including: (A) The date and batch or other identifying number of each manufacture; (B) The quantity used in the manufacture; (C) The finished form (e.g., 10-milligram tablets or 10-milligram concentration per fluid ounce or milliliter); (D) The number of units of finished form manufactured; (E) The quantity used in quality control; (F) The quantity lost during manufacturing and the causes therefore, if known; (G) The total quantity of the substance contained in the finished form; (H) The theoretical and actual yields; and (I) Such other information as is necessary to account for all controlled substances used in the manufacturing process; (vi) The quantity used to manufacture other controlled and noncontrolled substances, including the name of each substance manufactured and the information required in paragraph (a)(1)(v) of this section; (vii) 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; (viii) 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; (ix) 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; and (x) The originals of all written certifications of available procurement quotas submitted by other persons (as required by §1303.12(f) of this chapter) relating to each order requiring the distribution of a basic class of controlled substance listed in Schedule I or II. (2) For each controlled substance in finished form, (i) The name of the substance; (ii) 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); (iii) The number of containers of each such commercial finished form manufactured from bulk form by the registrant, including the information required pursuant to paragraph (a)(1)(v) of this section; (iv) The number of units of finished forms and/or commercial containers acquired from other persons, including the date of and number of units and/or commercial containers in each acquisition to inventory and the name, address, and registration number of the person from whom the units were acquired; (v) 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; (vi) The number of units and/or commercial containers manufactured by the registrant from units in finished form received from others or imported, including: (A) The date and batch or other identifying number of each manufacture; (B) The operation performed (e.g., repackaging or relabeling); (C) 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 (D) Such other information as is necessary to account for all controlled substances used in the manufacturing process; (vii) The number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed; (viii) 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 (ix) 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. (b) Records for distributors. Except as provided in paragraph (e) of this section, each person registered or authorized to distribute controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraphs (a)(2)(i), (ii), (iv), (v), (vii), (viii) and (ix) of this section. (c) Records for dispensers and researchers. Each person registered or authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraph (a)(2)(i), (ii), (iv), (vii), and (ix) of this section. In addition, records shall be maintained of 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. In addition to the requirements of this paragraph, practitioners dispensing gamma-hydroxybutyric acid under a prescription must also comply with §1304.26. (d) Records for importers and exporters. Each person registered or authorized to import or export controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraphs (a)(2) (i), (iv), (v) and (vii) of this section. In addition, 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 paragraphs (a)(1) (iv) and (v) of this section; and 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 number 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 paragraphs (a)(1)(xiii) or (a)(2)(xiii) of this section. (e) Records for reverse distributors. Each person registered to distribute controlled substances as a reverse distributor shall maintain records with the following information for each controlled substance: (1) For each controlled substance in bulk form the following: (i) The name of the controlled substance. (ii) The total quantity of the controlled substance to the nearest metric unit weight consistent with unit size. (iii) 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 controlled substance was received. (iv) The quantity returned to the original manufacturer of the controlled substance or the manufacturer's agent, including the date of and quantity of each distribution and the name, address and registration number of the manufacturer or manufacturer's agent to whom the controlled substance was distributed. (v) The quantity disposed of including the date and manner of disposal and the signatures of two responsible employees of the registrant who witnessed the disposal. (2) For each controlled substance in finished form the following: (i) The name of the substance. (ii) 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). (iii) 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. (iv) The number of commercial containers of each such finished form distributed back to the original manufacturer of the substance or the manufacturer's agent, including the date of and number of containers in each distribution and the name, address, and registration number of the manufacturer or manufacturer's agent to whom the containers were distributed. (v) The number of units or volume of finished forms and/or commercial containers disposed of including the date and manner of disposal, the quantity of the substance in finished form disposed, and the signatures of two responsible employees of the registrant who witnessed the disposal. [62 FR 13960, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 70 FR 293, Jan. 4, 2005] (a) Each person registered or authorized (by §1301.22(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., 10-milligram 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 distribution, 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 FR 7793, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13961, Mar. 24, 1997] (a) Each person registered or authorized (by §1301.22 of this chapter) to maintain and/or detoxify controlled substance users in a narcotic treatment program shall maintain records with the following information for each narcotic controlled substance: (1) Name of substance; (2) Strength of substance; (3) Dosage form; (4) Date dispensed; (5) Adequate identification of patient (consumer); (6) Amount consumed; (7) Amount and dosage form taken home by patient; and (8) Dispenser's initials. (b) The records required by paragraph (a) of this section will be maintained in a dispensing log at the narcotic treatment program site and will be maintained in compliance with §1304.22 without reference to §1304.03. (c) All sites which compound a bulk narcotic solution from bulk narcotic powder to liquid for on-site use must keep a separate batch record of the compounding. (d) Records of identity, diagnosis, prognosis, or treatment of any patients which are maintained in connection with the performance of a narcotic treatment program shall be confidential, except that such records may be disclosed for purposes and under the circumstances authorized by part 310 and 42 CFR part 2. [39 FR 37985, Oct. 25, 1974. Redesignated and amended at 62 FR 13961, Mar. 24, 1997] Each person registered or authorized by §1301.22 of this chapter to compound narcotic drugs for off-site use in a narcotic treatment program shall maintain records which include the following information for each narcotic drug: (a) For each narcotic controlled substance in bulk form to be used in, or capable of use in, or being used in, the compounding of the same or other noncontrolled substances in finished form: (1) The name of the substance; (2) The quantity compounded in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch compounded; (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 compounding by him, including the date, quantity and import permit or declaration number of each importation; (5) The quantity used to compound the same substance in finished form, including: (i) The date and batch or other identifying number of each compounding; (ii) The quantity used in the compound; (iii) The finished form (e.g., 10-milligram tablets or 10-milligram concentration per fluid ounce or milliliter; (iv) The number of units of finished form compounded; (v) The quantity used in quality control; (vi) The quantity lost during compounding and the causes therefore, 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 compounding process; (6) The quantity used to manufacture other controlled and non-controlled substances; including the name of each substance manufactured and the information required in paragraph (a)(5) of this section; (7) The quantity distributed in bulk form to other programs, including the date and quantity of each distribution and the name, address and registration number of each program 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 exploration; and (9) The quantity disposed of by destruction, including the reason, date and manner of destruction. All other destruction of narcotic controlled substances will comply with §1307.22. (b) For each narcotic 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 or 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 compounded from bulk form by the registrant, including the information required pursuant to paragraph (a)(5) 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 compounded 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 compounding; (ii) The operation performed (e.g., repackaging or relabeling); (iii) The number of units of finished form used in the compound, the number compounded and the number lost during compounding, 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 compounding process; (7) The number of containers distributed to other programs, including the date, the number of containers in each distribution, and the name, address and registration number of the program 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 destroyed in any manner by the registrant, including the reason, the date and manner of destruction. All other destruction of narcotic controlled substances will comply with §1307.22. [39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997] In addition to the recordkeeping requirements for dispensers and researchers provided in §1304.22, practitioners dispensing gamma-hydroxybutyric acid that is manufactured or distributed in accordance with an application under section 505 of the Federal Food, Drug, and Cosmetic Act must maintain and make available for inspection and copying by the Attorney General, all of the following information for each prescription: (a) Name of the prescribing practitioner. (b) Prescribing practitioner's Federal and State registration numbers, with the expiration dates of these registrations. (c) Verification that the prescribing practitioner possesses the appropriate registration to prescribe this controlled substance. (d) Patient's name and address. (e) Patient's insurance provider, if available. [70 FR 293, Jan. 4, 2005] (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 Enforcement Administration, Drug and Chemical Evaluation Section, Washington, D.C. 20537, on or before the 15th day of the month immediately following the period for which it is submitted. (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] (a) Every manufacturer importing or manufacturing from raw coca leaves shall submit information 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. Pharmacopoeia, National Formulary, or other recognized standards. The reports shall be submitted quarterly on company letterhead to the Drug Enforcement Administration, Drug and Chemical Evaluation Section, Washington, DC 20537, on or before the 15th day of the month immediately following the period for which it is submitted. (b) The following information shall be submitted for raw coca leaf, ecgonine, ecgonine for conversion or further manufacture, benzoylecgonine, manufacturing coca extracts (list for tinctures and extracts; and others separately), other crude alkaloids and other derivatives (quantities should be reported as grams of actual quantity involved and the cocaine alkaloid content or equivalency): (1) Beginning inventory; (2) Imports; (3) Gains on reweighing; (4) Quantity purchased; (5) Quantity produced; (6) Other receipts; (7) Quantity returned to processes for reworking; (8) Material used in purification for sale; (9) Material used for manufacture or production; (10) Losses on reweighing; (11) Material used for conversion; (12) Other dispositions and (13) Ending inventory. (c) The following information shall be submitted for importation of coca leaves: (1) Import permit number; (2) Date the shipment arrived at the United States port of entry; (3) Actual quantity shipped; (4) Assay (percent) of cocaine alkaloid and (5) Total cocaine alkaloid content. (d) Upon importation of 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 submission, 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. (e) 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. (f) 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 13962, Mar. 24, 1997] (a) Reports generally. All reports required by this section shall be filed with the ARCOS Unit, PO 28293, Central Station, Washington, DC 20005 on DEA Form 333, or on media which contains the data required by DEA Form 333 and which is acceptable to the ARCOS Unit. (b) Frequency of reports. Acquisition/Distribution transaction reports shall be filed every quarter not later than the 15th day of the month succeeding the quarter for which it is submitted; except that a registrant may be given permission to file more frequently (but not more frequently than monthly), depending on the number of transactions being reported each time by that registrant. Inventories shall provide data on the stocks of each reported controlled substance on hand as of the close of business on December 31 of each year, indicating whether the substance is in storage or in process of manufacturing. These reports shall be filed not later than January 15 of the following year. Manufacturing transaction reports shall be filed annually for each calendar year not later than January 15 of the following year, except that a registrant may be given permission to file more frequently (but not more frequently than quarterly). (c) Persons reporting. For controlled substances in Schedules I, II, narcotic controlled substances in Schedule III, and gamma-hydroxybutyric acid drug product controlled substances in Schedule III, each person who is registered to manufacture in bulk or dosage form, or to package, repackage, label or relabel, and each person who is registered to distribute, including each person who is registered to reverse distribute, shall report acquisition/distribution transactions. In addition to reporting acquisition/distribution transactions, each person who is registered to manufacture controlled substances in bulk or dosage form shall report manufacturing transactions on controlled substances in Schedules I and II, each narcotic controlled substance listed in Schedules III, IV, and V, gamma-hydroxybutyric acid drug product controlled substances in Schedule III, and on each psychotropic controlled substance listed in Schedules III and IV as identified in paragraph (d) of this section. (d) Substances covered. (1) Manufacturing and acquisition/distribution transaction reports shall include data on each controlled substance listed in Schedules I and II, on each narcotic controlled substance listed in Schedule III (but not on any material, compound, mixture or preparation containing a quantity of a substance having a stimulant effect on the central nervous system, which material, compound, mixture or preparation is listed in Schedule III or on any narcotic controlled substance listed in Schedule V), and on gamma-hydroxybutyric acid drug products listed in Schedule III. Additionally, reports on manufacturing transactions shall include the following psychotropic controlled substances listed in Schedules III and IV: (i) Schedule III (A) Benzphetamine; (B) Cyclobarbital; (C) Methyprylon; and (D) Phendimetrazine. (ii) Schedule IV (A) Barbital; (B) Diethylpropion (Amfepramone); (C) Ethchlorvynol; (D) Ethinamate; (E) Lefetamine (SPA); (F) Mazindol; (G) Meprobamate; (H) Methylphenobarbital; (I) Phenobarbital; (J) Phentermine; and (K) Pipradrol. (2) Data shall be presented in such a manner as to identify the particular form, strength, and trade name, if any, of the product containing the controlled substance for which the report is being made. For this purpose, persons filing reports shall utilize the National Drug Code Number assigned to the product under the National Drug Code System of the Food and Drug Administration. (e) Transactions reported. Acquisition/distribution transaction reports shall provide data on each acquisition to inventory (identifying whether it is, e.g., by purchase or transfer, return from a customer, or supply by the Federal Government) and each reduction from inventory (identifying whether it is, e.g., by sale or transfer, theft, destruction or seizure by Government agencies). Manufacturing reports shall provide data on material manufactured, manufacture from other material, use in manufacturing other material and use in producing dosage forms. (f) Exceptions. A registered institutional practitioner who repackages or relabels exclusively for distribution or who distributes exclusively to (for dispensing by) agents, employees, or affiliated institutional practitioners of the registrant may be exempted from filing reports under this section by applying to the ARCOS Unit of the Administration. [62 FR 13962, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 70 FR 294, Jan. 4, 2005]
Title 21: Food and Drugs
PART 1304—RECORDS AND REPORTS OF REGISTRANTS
Section Contents
General Information
§ 1304.01 Scope of part 1304.
§ 1304.02 Definitions.
§ 1304.03 Persons required to keep records and file reports.
§ 1304.04 Maintenance of records and inventories.
§ 1304.05 Records of authorized central fill pharmacies and retail pharmacies.
Inventory Requirements
§ 1304.11 Inventory requirements.
Continuing Records
§ 1304.21 General requirements for continuing records.
§ 1304.22 Records for manufacturers, distributors, dispensers, researchers, importers and exporters.
§ 1304.23 Records for chemical analysts.
§ 1304.24 Records for maintenance treatment programs and detoxification treatment programs.
§ 1304.25 Records for treatment programs which compound narcotics for treatment programs and other locations.
§ 1304.26 Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid.
Reports
§ 1304.31 Reports from manufacturers importing narcotic raw material.
§ 1304.32 Reports of manufacturers importing coca leaves.
§ 1304.33 Reports to ARCOS.
General Information
top
§ 1304.01 Scope of part 1304.
top
§ 1304.02 Definitions.
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§ 1304.03 Persons required to keep records and file reports.
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§ 1304.04 Maintenance of records and inventories.
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§ 1304.05 Records of authorized central fill pharmacies and retail pharmacies.
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Inventory Requirements
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§ 1304.11 Inventory requirements.
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Continuing Records
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§ 1304.21 General requirements for continuing records.
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§ 1304.22 Records for manufacturers, distributors, dispensers, researchers, importers and exporters.
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§ 1304.23 Records for chemical analysts.
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§ 1304.24 Records for maintenance treatment programs and detoxification treatment programs.
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§ 1304.25 Records for treatment programs which compound narcotics for treatment programs and other locations.
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§ 1304.26 Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid.
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Reports
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§ 1304.31 Reports from manufacturers importing narcotic raw material.
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§ 1304.32 Reports of manufacturers importing coca leaves.
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§ 1304.33 Reports to ARCOS.
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