HHS 21 CFR PART 1305-2011 ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES《表I和II中管制物质的订购》.pdf

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1、82 21 CFR Ch. II (4111 Edition) 1304.55 on its homepage and in a manner that identifies itself as being responsible for the operation of the Web site. 74 FR 15623, Apr. 6, 2009 1304.55 Reports by online phar-macies. (a) Each online pharmacy shall re-port to the Administrator the total quantity of ea

2、ch controlled substance that the pharmacy has dispensed each calendar month. The report must in-clude the total quantity of such dis-pensing by any means, regardless of whether the controlled substances are dispensed by means of the Internet. Thus, such reporting shall include all controlled substan

3、ces dispensed via Internet transactions, mail-order transactions, face-to-face transactions, or any other means. However, the phar-macy is not required to describe in its report to the Administrator such means of dispensing. Such reporting is required for every calendar month in which the total quan

4、tity of controlled substances dispensed by the pharmacy meets or exceeds one of the following thresholds: (1) 100 or more prescriptions for con-trolled substances filled; or (2) 5,000 or more dosage units dis-pensed of all controlled substances combined. (b) Each online pharmacy shall re-port a nega

5、tive response if, during a given calendar month, its total dis-pensing of controlled substances falls below both of the thresholds in para-graph (a) of this section. (c) The reporting requirements of this section apply to every pharmacy that, at any time during a calendar month, holds a modified reg

6、istration authorizing it to operate as an online pharmacy, regardless of whether the online pharmacy dispenses any con-trolled substances by means of the Internet during the month. (d) Reports will be submitted to DEA electronically via online reporting, electronic file upload, or other means as app

7、roved by DEA. (e) Reports shall be filed every month not later than the fifteenth day of the month succeeding the month for which they are submitted. (f) An online pharmacy filing a report under paragraph (a) of this section shall utilize the National Drug Code number assigned to the product under t

8、he National Drug Code System of the Food and Drug Administration, and in-dicate the total number of dosage units dispensed for each such National Drug Code number. (g) Records required to be kept under this section must be kept by the reg-istrant for at least two years from the date of such records.

9、 The information shall be readily retrievable from the ordinary business records of the reg-istrant and available for inspection and copying by authorized employees of the Administration. 74 FR 15623, Apr. 6, 2009 PART 1305ORDERS FOR SCHED-ULE I AND II CONTROLLED SUB-STANCES Subpart AGeneral Require

10、ments Sec. 1305.01 Scope of part 1305. 1305.02 Definitions. 1305.03 Distributions requiring a Form 222 or digitally signed electronic order. 1305.04 Persons entitled to order Schedule I and II controlled substances. 1305.05 Power of attorney. 1305.06 Persons entitled to fill orders for Schedule I an

11、d II controlled substances. 1305.07 Special procedure for filling certain orders. Subpart BDEA Form 222 1305.11 Procedure for obtaining DEA Forms 222. 1305.12 Procedure for executing DEA Forms 222. 1305.13 Procedure for filling DEA Forms 222. 1305.14 Procedure for endorsing DEA Forms 222. 1305.15 Un

12、accepted and defective DEA Forms 222. 1305.16 Lost and stolen DEA Forms 222. 1305.17 Preservation of DEA Forms 222. 1305.18 Return of unused DEA Forms 222. 1305.19 Cancellation and voiding of DEA Forms 222. Subpart CElectronic Orders 1305.21 Requirements for electronic orders. 1305.22 Procedure for

13、filling electronic or-ders. 1305.23 Endorsing electronic orders. 1305.24 Central processing of orders. 1305.25 Unaccepted and defective electronic orders. 1305.26 Lost electronic orders. VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00092 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe

14、on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-83 Drug Enforcement Administration, Justice 1305.05 1305.27 Preservation of electronic orders. 1305.28 Canceling and voiding electronic or-ders. 1305.29 Reporting to DEA. AUTHO

15、RITY: 21 U.S.C. 821, 828, 871(b), unless otherwise noted. SOURCE: 70 FR 16911, Apr. 1, 2005, unless otherwise noted. Subpart AGeneral Requirements 1305.01 Scope of part 1305. Procedures governing the issuance, use, and preservation of orders for Schedule I and II controlled substances are set forth

16、generally by section 308 of the Act (21 U.S.C. 828) and specifically by the sections of this part. 1305.02 Definitions. Any term contained in this part shall have the definition set forth in the Act or part 1300 of this chapter. 1305.03 Distributions requiring a Form 222 or a digitally signed elec-t

17、ronic order. Either a DEA Form 222 or its elec-tronic equivalent as set forth in sub-part C of this part and Part 1311 of this chapter is required for each distribu-tion of a Schedule I or II controlled substance except for the following: (a) Distributions to persons exempted from registration under

18、 Part 1301 of this chapter. (b) Exports from the United States that conform with the requirements of the Act. (c) Deliveries to a registered analyt-ical laboratory or its agent approved by DEA. (d) Delivery from a central fill phar-macy, as defined in 1300.01(b)(44) of this chapter, to a retail phar

19、macy. 1305.04 Persons entitled to order Schedule I and II controlled sub-stances. (a) Only persons who are registered with DEA under section 303 of the Act (21 U.S.C. 823) to handle Schedule I or II controlled substances, and persons who are registered with DEA under sec-tion 1008 of the Act (21 U.S

20、.C. 958) to export these substances may obtain and use DEA Form 222 (order forms) or issue electronic orders for these sub-stances. Persons not registered to han-dle Schedule I or II controlled sub-stances and persons registered only to import controlled substances are not entitled to obtain Form 22

21、2 or issue electronic orders for these substances. (b) An order for Schedule I or II con-trolled substances may be executed only on behalf of the registrant named on the order and only if his or her reg-istration for the substances being pur-chased has not expired or been revoked or suspended. 1305.

22、05 Power of attorney. (a) A registrant may authorize one or more individuals, whether or not lo-cated at his or her registered location, to issue orders for Schedule I and II controlled substances on the reg-istrants behalf by executing a power of attorney for each such individual, if the power of a

23、ttorney is retained in the files, with executed Forms 222 where applicable, for the same period as any order bearing the signature of the at-torney. The power of attorney must be available for inspection together with other order records. (b) A registrant may revoke any power of attorney at any time

24、 by exe-cuting a notice of revocation. (c) The power of attorney and notice of revocation must be similar to the following format: Power of Attorney for DEA Forms 222 and Electronic Orders llllllllllllllllllllllll(Name of registrant) llllllllllllllllllllllll(Address of registrant) llllllllllllllllll

25、llllll(DEA registration number) I, llll (name of person granting power), the undersigned, who am au-thorized to sign the current application for registration of the above-named registrant under the Controlled Sub-stances Act or Controlled Substances Import and Export Act, have made, constituted, and

26、 appointed, and by these presents, do make, constitute, and appoint llll (name of attorney- in-fact), my true and lawful attorney for me in my name, place, and stead, to execute applications for Forms 222 and to sign orders for Schedule I and II con-trolled substances, whether these or-ders be on Fo

27、rm 222 or electronic, in VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00093 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-84 21 CFR Ch. II (4111 Edition) 1305.0

28、6 accordance with 21 U.S.C. 828 and Part 1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and con-firm all that said attorney must law-fully do or cause to be done by virtue hereof. llllllllllllllllllllllll(Signature of person granting power) I, llll (name of attorney-in-fact), h

29、ereby affirm that I am the person named herein as attorney-in-fact and that the signature affixed hereto is my signature. (signature of attorney-in-fact) Witnesses: 1. llllll 2. llllll Signed and dated on the llll day of llll, (year), at llll . Notice of Revocation The foregoing power of attorney is

30、 hereby revoked by the undersigned, who is authorized to sign the current application for registration of the above-named registrant under the Con-trolled Substances Act or the Con-trolled Substances Import and Export Act. Written notice of this revocation has been given to the attorney-in-fact llll

31、 this same day. llllllllllllllllllllllll(Signature of person revoking power) Witnesses: 1. llllll 2. llllll Signed and dated on the llll day of llll , (year), at llll . (d) A power of attorney must be exe-cuted by the person who signed the most recent application for DEA reg-istration or reregistrat

32、ion; the person to whom the power of attorney is being granted; and two witnesses. (e) A power of attorney must be re-voked by the person who signed the most recent application for DEA reg-istration or reregistration, and two witnesses. 1305.06 Persons entitled to fill orders for Schedule I and II c

33、ontrolled substances. An order for Schedule I and II con-trolled substances, whether on a DEA Form 222 or an electronic order, may be filled only by a person registered with DEA as a manufacturer or dis-tributor of controlled substances listed in Schedule I or II pursuant to section 303 of the Act (

34、21 U.S.C. 823) or as an importer of such substances pursuant to section 1008 of the Act (21 U.S.C. 958), except for the following: (a) A person registered with DEA to dispense the substances, or to export the substances, if he/she is dis-continuing business or if his/her reg-istration is expiring wi

35、thout rereg-istration, may dispose of any Schedule I or II controlled substances in his/her possession with a DEA Form 222 or an electronic order in accordance with 1301.52 of this chapter. (b) A purchaser who has obtained any Schedule I or II controlled substance by either a DEA Form 222 or an elec

36、-tronic order may return the substance to the supplier of the substance with either a DEA Form 222 or an electronic order from the supplier. (c) A person registered to dispense Schedule II substances may distribute the substances to another dispenser with either a DEA Form 222 or an elec-tronic orde

37、r only in the circumstances described in 1307.11 of this chapter. (d) A person registered or authorized to conduct chemical analysis or re-search with controlled substances may distribute a Schedule I or II controlled substance to another person registered or authorized to conduct chemical analysis,

38、 instructional activities, or re-search with the substances with either a DEA Form 222 or an electronic order, if the distribution is for the purpose of furthering the chemical analysis, in-structional activities, or research. (e) A person registered as a compounder of narcotic substances for use at

39、 off-site locations in conjunction with a narcotic treatment program at the compounding location, who is au-thorized to handle Schedule II nar-cotics, is authorized to fill either a DEA Form 222 or an electronic order for distribution of narcotic drugs to off-site narcotic treatment programs only. 1

40、305.07 Special procedure for filling certain orders. A supplier of carfentanil, etorphine hydrochloride, or diprenorphine, if he or she determines that the purchaser is VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00094 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD

41、with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-85 Drug Enforcement Administration, Justice 1305.12 a veterinarian engaged in zoo and ex-otic animal practice, wildlife manage-ment programs, or research, and is au-thorized by the Administrator

42、 to han-dle these substances, may fill the order in accordance with the procedures set forth in 1305.17 except that: (a) A DEA Form 222 or an electronic order for carfentanil, etorphine hydro-chloride, and diprenorphine must con-tain only these substances in reason-able quantities. (b) The substance

43、s must be shipped, under secure conditions using substan-tial packaging material with no mark-ings on the outside that would indicate the content, only to the purchasers registered location. Subpart BDEA Form 222 1305.11 Procedure for obtaining DEA Forms 222. (a) DEA Forms 222 are issued in mail-ing

44、 envelopes containing either seven or fourteen forms, each form con-taining an original, duplicate, and trip-licate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit, which is based on the business activity of the reg-istrant, will be imposed on the number of DEA Forms 222, which will be fur-

45、nished on any requisition unless addi-tional forms are specifically requested and a reasonable need for such addi-tional forms is shown. (b) Any person applying for a reg-istration that would entitle him or her to obtain a DEA Form 222 may requisi-tion the forms by so indicating on the application f

46、orm; a DEA Form 222 will be supplied upon the registration of the applicant. Any person holding a reg-istration entitling him or her to obtain a DEA Form 222 may requisition the forms for the first time by contacting any Division Office or the Registration Section of the Administration. Any person a

47、lready holding a DEA Form 222 may requisition additional forms on DEA Form 222a, which is mailed to a registrant approximately 30 days after each shipment of DEA Forms 222 to that registrant, or by contacting any Division Office or the Registration Sec-tion of the Administration. All requisi-tion fo

48、rms (DEA Form 222a) must be submitted to the DEA Registration Section. (c) Each requisition must show the name, address, and registration num-ber of the registrant and the number of books of DEA Forms 222 desired. Each requisition must be signed and dated by the same person who signed the most recen

49、t application for registra-tion or for reregistration, or by any person authorized to obtain and exe-cute DEA Forms 222 by a power of at-torney under 1305.05. (d) DEA Forms 222 will be serially numbered and issued with the name, address, and registration number of the registrant, the authorized activity, and schedules of the registrant. This infor-mation cannot be altered or changed by the registrant; any errors must be corrected by the Registration Sectio