HHS 21 CFR PART 1304-2011 RECORDS AND REPORTS OF REGISTRANTS《登记者的记录与报告》.pdf

1、64 21 CFR Ch. II (4111 Edition) 1303.35 within the period permitted for filing a request for a hearing of notice of ap-pearance, file with the Administrator a waiver of an opportunity for a hearing or to participate in a hearing, together with a written statement regarding his position on the matter

2、s of fact and law involved in such hearing. Such state-ment, if admissible, shall be made a part of the record and shall be consid-ered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein. (d) If any person entitled t

3、o a hearing or to participate in a hearing pursuant to paragraph (b) of this section, fails to file a request for a hearing or notice of appearance, or if he so files and fails to appear at the hearing, he shall be deemed to have waived his opportunity for the hearing or to participate in the hearin

4、g, unless he shows good cause for such failure. (e) If all persons entitled to a hearing or to participate in a hearing waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Administrator may cancel the hearing, if scheduled, and issue his final order p

5、ursuant to 1303.37 without a hearing. 36 FR 7786, 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 1303.35 Burden of proof. (a) At any hearing regarding the de-termination or adjustment of an aggre-gate production quota,

6、 each interested person participating in the hearing shall have the burden of proving any propositions of fact or law asserted by him in the hearing. (b) At any hearing regarding the issuance, adjustment, suspension, or denial of a procurement or individual manufacturing quota, the Administra-tion s

7、hall have the burden of proving that the requirements of this part for such issuance, adjustment, suspension, or denial are satisfied. 36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, Mar. 24, 1997 1303.36 Tim

8、e and place of hearing. (a) If any applicant or registrant re-quests a hearing on the issuance, ad-justment, suspension, or denial of his procurement and/or individual manu-facturing quota pursuant to 1303.34, the Administrator shall hold such hearing. Notice of the hearing shall be given to the app

9、licant or registrant of the time and place at least 30 days prior to the hearing, unless the appli-cant or registrant waives such notice and requests the hearing be held at an earlier time, in which case the Admin-istrator shall fix a date for such hear-ing as early as reasonably possible. (b) The h

10、earing will commence at the place and time designated in the notice given pursuant to paragraph (a) of this section or in the notice of hearing pub-lished in the FEDERAL REGISTER pursu-ant to 1303.11(c) or 1303.13 (c), but thereafter it may be moved to a dif-ferent place and may be continued from da

11、y to day or recessed to a later day without notice other than an-nouncement thereof by the presiding officer at the hearing. 36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973 1303.37 Final order. As soon as practicable after the pre-sidin

12、g officer has certified the record to the Administrator, the Adminis-trator shall issue his order on the de-termination or adjustment of the ag-gregate production quota or on the issuance, adjustment, suspension, or denial of the procurement quota or in-dividual manufacturing quota, as case may be.

13、The order shall include the findings of fact and conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. The Administrator shall serve one copy of his order upon each party in the hearing. 36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920,

14、 Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973 PART 1304RECORDS AND REPORTS OF REGISTRANTS GENERAL INFORMATION Sec. VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00074 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo r

15、eproduction or networking permitted without license from IHS-,-,-65 Drug Enforcement Administration, Justice 1304.03 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 inven-tories. 1304.05 Records of authori

16、zed central fill pharmacies and retail pharmacies. 1304.06 Records and reports for electronic prescriptions. INVENTORY REQUIREMENTS 1304.11 Inventory requirements. CONTINUING RECORDS 1304.21 General requirements for continuing records. 1304.22 Records for manufacturers, distribu-tors, dispensers, re

17、searchers, 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 recordk

18、eeping require-ments applicable to drug products con-taining gamma-hydroxybutyric acid. REPORTS 1304.31 Reports from manufacturers import-ing narcotic raw material. 1304.32 Reports of manufacturers importing coca leaves. 1304.33 Reports to ARCOS. ONLINE PHARMACIES 1304.40 Notification by online phar

19、macies. 1304.45 Internet Web site disclosure require-ments. 1304.50 Disclosure requirements for Web sites of nonpharmacy practitioners that dispense controlled substances by means of the Internet. 1304.55 Reports by online pharmacies. AUTHORITY: 21 U.S.C. 821, 827, 831, 871(b), 958(e), 965, unless o

20、therwise noted. GENERAL INFORMATION 1304.01 Scope of part 1304. Inventory and other records and re-ports required under section 307, sec-tion 311, or section 1008(e) of the Act (21 U.S.C. 827, 831, and 958(e) shall be in accordance with, and contain the infor-mation required by, those sections and b

21、y the sections of this part. 74 FR 15623, Apr. 6, 2009 1304.02 Definitions. 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 1304.03 Persons required to keep records and file reports

22、. (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 t

23、his chapter or pursuant to 1307.111307.15 of this chapter, shall maintain the records and inventories and shall file the reports required by this part for persons registered to conduct such ac-tivities. This latter requirement should not be construed as requiring stocks of controlled substances bein

24、g used in various activities under one registra-tion to be stored separately, nor that separate records are required for each activity. The intent of the Administra-tion is to permit the registrant to keep one set of records which are adapted by the registrant to account for controlled substances us

25、ed 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 per-mitting several activities under one registration. Thus, when a researcher manufactures a con

26、trolled 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 docu-ment the transfer; when he imports a substance, he keeps as part of his records the documentation required of an importer; and when subst

27、ances 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

28、items in one VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00075 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-66 21 CFR Ch. II (4111 Edition) 1304.03 place, and

29、 every two years take inven-tory of all items on hand, regardless of whether the substances were manufac-tured by him, imported by him, or pur-chased domestically by him, of whether the substances will be administered to subjects, distributed to other research-ers, or destroyed during chemical anal-

30、ysis. (b) A registered individual practi-tioner is required to keep records, as described in 1304.04, of controlled sub-stances in Schedules II, III, IV, and V which are dispensed, other than by pre-scribing or administering in the lawful course of professional practice. (c) Except as provided in 13

31、04.06, a registered individual practitioner is not required to keep records of con-trolled substances in Schedules II, III, IV, and V that are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxi-fication treatment of

32、an individual. (d) A registered individual practi-tioner 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 practi-tioner regularly engages in the dis-pensing or administering

33、of controlled substances and charges patients, either separately or together with charges for other professional services, for sub-stances so dispensed or administered. Records are required to be kept for controlled substances administered in the course of maintenance or detoxi-fication treatment of

34、 an individual. (e) Each registered mid-level practi-tioner shall maintain in a readily re-trievable manner those documents re-quired 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 documen

35、ts available for inspection and copying by author-ized employees of the Administration. Examples of such documentation in-clude protocols, practice guidelines or practice agreements. (f) Registered persons using any con-trolled substances while conducting preclinical research, in teaching at a regis

36、tered establishment which main-tains records with respect to such sub-stances or conducting research in con-formity with an exemption granted under section 505(i) or 512(j) of the Fed-eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(i) or 360b(j) at a registered establishment which maintains records

37、 in accordance with either of those sec-tions, are not required to keep records if he/she notifies the Administration of the name, address, and registration number of the establishment maintain-ing such records. This notification shall be given at the time the person applies for registration or rere

38、gistra-tion and shall be made in the form of an attachment to the application, which shall be filed with the applica-tion. (g) A distributing registrant who uti-lizes a freight forwarding facility shall maintain records to reflect transfer of controlled substances through the fa-cility. These record

39、s must contain the date, time of transfer, number of car-tons, crates, drums or other packages in which commercial containers of con-trolled substances are shipped and au-thorized signatures for each transfer. A distributing registrant may, as part of the initial request to operate a freight forward

40、ing 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 1

41、304.04 of this part. These records must be maintained for a period of two years. (h) A person is required to keep the records and file the reports specified in 1304.06 and part 1311 of this chapter if they are either of the following: (1) An electronic prescription appli-cation provider. (2) An elec

42、tronic pharmacy applica-tion provider. 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, 1

43、993; 62 FR 13958, Mar. 24, 1997; 65 FR 44679, July 19, 2000; 75 FR 16306, Mar. 31, 2010 VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00076 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted with

44、out license from IHS-,-,-67 Drug Enforcement Administration, Justice 1304.04 1304.04 Maintenance of records and inventories. (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 an

45、d 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 chapte

46、r) may be kept at a central location, rather than at the registered location, if the registrant has notified the Ad-ministration of his intention to keep central records. Written notification must be submitted by registered or cer-tified mail, return receipt requested, in triplicate, to the Special

47、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 per-mission to keep central records is de-nied, the registrant may maintain cen-tral records commencing 14 days after receipt of his notificatio

48、n by the Spe-cial 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 reg-istration number and type of DEA reg-istration of the registrant whose records

49、 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 lo-cation. (b) All registrants that are author-ized to maintain