HHS 21 CFR PART 1301-2011 REGISTRATION OF MANUFACTURERS DISTRIBUTORS AND DISPENSERS OF CONTROLLED SUBSTANCES《管制物质的制造商 批发商和销售商的登记》.pdf

1、21 Drug Enforcement Administration, Justice Pt. 1301 controlled substance that individual was previously prescribed. (l)(1) The term valid prescription means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by: (i) A practitioner who has con

2、ducted at least one in-person medical evalua-tion of the patient; or (ii) A covering practitioner. (2) Nothing in this paragraph (l) shall be construed to imply that one in-per-son medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual c

3、ourse of professional prac-tice. 74 FR 15619, Apr. 6, 2009 PART 1301REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CON-TROLLED SUBSTANCES GENERAL INFORMATION Sec. 1301.01 Scope of this part 1301. 1301.02 Definitions. 1301.03 Information; special instructions. REGISTRATION 1301.11 Per

4、sons required to register; require-ment of modification of registration au-thorizing activity as an online phar-macy. 1301.12 Separate registrations for separate locations. 1301.13 Application for registration; time for application; expiration date; registra-tion for independent activities; applica-

5、tion forms, fees, contents and signature; coincident activities. 1301.14 Filing of application; acceptance for filing; defective applications. 1301.15 Additional information. 1301.16 Amendments to and withdrawal of applications. 1301.17 Special procedures for certain appli-cations. 1301.18 Research

6、protocols. 1301.19 Special requirements for online pharmacies. EXCEPTIONS TO REGISTRATION AND FEES 1301.21 Exception from fees. 1301.22 Exemption of agents and employees; affiliated practitioners. 1301.23 Exemption of certain military and other personnel. 1301.24 Exemption of law enforcement offi-ci

7、als. 1301.25 Registration regarding ocean ves-sels, aircraft, and other entities. 1301.26 Exemptions from import or export requirements for personal medical use. 1301.27 Separate registration by retail phar-macies for installation and operation of automated dispensing systems at long term care facil

8、ities. 1301.28 Exemption from separate registra-tion for practitioners dispensing or pre-scribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment. ACTION ON APPLICATION FOR REGISTRATION: REV

9、OCATION OR SUSPENSION OF REGISTRATION 1301.31 Administrative review generally. 1301.32 Action on applications for research in Schedule I substances. 1301.33 Application for bulk manufacture of Schedule I and II substances. 1301.34 Application for importation of Schedule I and II substances. 1301.35

10、Certificate of registration; denial of registration. 1301.36 Suspension or revocation of registra-tion; suspension of registration pending final order; extension of registration pending final order. 1301.37 Order to show cause. HEARINGS 1301.41 Hearings generally. 1301.42 Purpose of hearing. 1301.43

11、 Request for hearing or appearance; waiver. 1301.44 Burden of proof. 1301.45 Time and place of hearing. 1301.46 Final order. MODIFICATION, TRANSFER, AND TERMINATION OF REGISTRATION 1301.51 Modification in registration. 1301.52 Termination of registration; transfer of registration; distribution upon

12、dis-continuance of business. SECURITY REQUIREMENTS 1301.71 Security requirements generally. 1301.72 Physical security controls for non-practitioners; narcotic treatment pro-grams and compounders for narcotic treatment programs; storage areas. 1301.73 Physical security controls for non-practitioners;

13、 compounders for narcotic treatment programs; manufacturing and compounding areas. 1301.74 Other security controls for non-practitioners; narcotic treatment pro-grams and compounders for narcotic treatment programs. 1301.75 Physical security controls for prac-titioners. VerDate Mar2010 07:57 May 04,

14、 2011 Jkt 223073 PO 00000 Frm 00031 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-22 21 CFR Ch. II (4111 Edition) 1301.01 1301.76 Other security controls for practi-tioners.

15、1301.77 Security controls for freight for-warding facilities. EMPLOYEE SCREENINGNON-PRACTITIONERS 1301.90 Employee screening procedures. 1301.91 Employee responsibility to report drug diversion. 1301.92 Illicit activities by employees. 1301.93 Sources of information for employee checks. AUTHORITY: 2

16、1 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 953, 956, 957, 958. SOURCE: 36 FR 7778, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973. GENERAL INFORMATION 1301.01 Scope of this part 1301. Procedures governing the registra-tion of manufacturers

17、, distributors, dispensers, importers, and exporters of controlled substances pursuant to sec-tions 301304 and 10071008 of the Act (21 U.S.C. 821824 and 957958) are set forth generally by those sections and specifi-cally by the sections of this part. 62 FR 13945, Mar. 24, 1997 1301.02 Definitions. A

18、ny term used 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 13945, Mar. 24, 1997 1301.03 Information; special instruc-tions. Information regarding procedures under these rules and instructions supplementing these rules w

19、ill be fur-nished upon request by writing to the Registration Section, Drug Enforce-ment Administration. See the Table of DEA Mailing Addresses in 1321.01 of this chapter for the current mailing ad-dress. 75 FR 10676, Mar. 9, 2010 REGISTRATION 1301.11 Persons required to register; requirement of mod

20、ification of reg-istration authorizing activity as an online pharmacy. (a) Every person who manufactures, distributes, dispenses, imports, or ex-ports any controlled substance or who proposes to engage in the manufacture, distribution, dispensing, importation or exportation of any controlled sub-sta

21、nce shall obtain a registration un-less exempted by law or pursuant to 1301.22 through 1301.26. Except as pro-vided in paragraph (b) of this section, only persons actually engaged in such activities are required to obtain a reg-istration; related or affiliated persons who are not engaged in such act

22、ivities are not required to be registered. (For example, a stockholder or parent cor-poration of a corporation manufac-turing controlled substances is not re-quired to obtain a registration.) (b) As provided in sections 303(f) and 401(h) of the Act (21 U.S.C. 823(f) and 841(h), it is unlawful for an

23、y person who falls within the definition of on-line pharmacy (as set forth in section 102(52) of the Act (21 U.S.C. 802(52) and 1300.04(h) of this chapter) to deliver, distribute, or dispense a controlled sub-stance by means of the Internet if such person is not validly registered with a modificatio

24、n of such registration au-thorizing such activity (unless such person is exempt from such modified registration requirement under the Act or this chapter). The Act further pro-vides that the Administrator may only issue such modification of registration to a person who is registered as a phar-macy u

25、nder section 303(f) of the Act (21 U.S.C. 823(f). Accordingly, any phar-macy registered pursuant to 1301.13 of this part that falls within the defini-tion of an online pharmacy and pro-poses to dispense controlled substances by means of the Internet must obtain a modification of its registration aut

26、hor-izing such activity following the sub-mission of an application in accordance with 1301.19 of this part. This require-ment does not apply to a registered pharmacy that does not fall within the definition of an online pharmacy set forth in 1300.04(h). Under the Act, per-sons other than registered

27、 pharmacies are not eligible to obtain such a modi-fication of registration but remain lia-ble under section 401(h) of the Act (21 U.S.C. 841(h) if they deliver, dis-tribute, or dispense a controlled sub-stance while acting as an online phar-macy without being validly registered VerDate Mar2010 07:5

28、7 May 04, 2011 Jkt 223073 PO 00000 Frm 00032 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-23 Drug Enforcement Administration, Justice 1301.13 with a modification authorizing

29、 such activity. 74 FR 15621, Apr. 6, 2009 1301.12 Separate registrations for separate locations. (a) A separate registration is re-quired for each principal place of busi-ness or professional practice at one general physical location where con-trolled substances are manufactured, distributed, import

30、ed, exported, or dis-pensed by a person. (b) The following locations shall be deemed not to be places where con-trolled substances are manufactured, distributed, or dispensed: (1) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such sub-stances are d

31、istributed directly from such warehouse to registered locations other than the registered location from which the substances were delivered or to persons not required to register by virtue of subsection 302(c)(2) or sub-section 1007(b)(1)(B) of the Act (21 U.S.C. 822(c)(2) or 957(b)(1)(B); (2) An of

32、fice used by agents of a reg-istrant where sales of controlled sub-stances are solicited, made, or super-vised but which neither contains such substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a dis-tribution point for filling sales orders;

33、and (3) An office used by a practitioner (who is registered at another location in the same State or jurisdiction of the United States) where controlled sub-stances are prescribed but neither ad-ministered nor otherwise dispensed as a regular part of the professional prac-tice of the practitioner at

34、 such office, and where no supplies of controlled substances are maintained. (4) A freight forwarding facility, as defined in 1300.01 of this part, provided that the distributing registrant oper-ating the facility has submitted writ-ten notice of intent to operate the fa-cility by registered mail, r

35、eturn re-ceipt requested (or other suitable means of documented delivery) and such notice has been approved. The no-tice shall be submitted to the Special Agent in Charge of the Administra-tions offices in both the area in which the facility is located and each area in which the distributing registr

36、ant main-tains a registered location that will transfer controlled substances through the facility. The notice shall detail the registered locations that will utilize the facility, the location of the facil-ity, the hours of operation, the indi-vidual(s) responsible for the controlled substances, th

37、e security and record-keeping procedures that will be em-ployed, and whether controlled sub-stances returns will be processed through the facility. The notice must also detail what state licensing re-quirements apply to the facility and the registrants actions to comply with any such requirements. T

38、he Special Agent in Charge of the DEA Office in the area where the freight forwarding facility will be operated will provide written notice of approval or dis-approval to the person within thirty days after confirmed receipt of the no-tice. Registrants that are currently op-erating freight forwardin

39、g facilities under a memorandum of understanding with the Administration must provide notice as required by this section no later than September 18, 2000 and re-ceive written approval from the Spe-cial Agent in Charge of the DEA Office in the area in which the freight for-warding facility is operate

40、d in order to continue operation of the facility. 62 FR 13945, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 65 FR 45829, July 25, 2000; 71 FR 69480, Dec. 1, 2006 1301.13 Application for registration; time for application; expiration date; registration for independent activities; applicat

41、ion forms, fees, contents and signature; coincident activities. (a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the appli-cat

42、ion for registration is granted and a Certificate of Registration is issued by the Administrator to such person. (b) Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his/her registration, except that a bulk VerDate Mar2010 07:57 May 04, 20

43、11 Jkt 223073 PO 00000 Frm 00033 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-24 21 CFR Ch. II (4111 Edition) 1301.13 manufacturer of Schedule I or II con-trolled substances

44、 or an importer of Schedule I or II controlled substances may apply to be reregistered no more than 120 days before the expiration date of their registration. (c) At the time a manufacturer, dis-tributor, reverse distributor, re-searcher, analytical lab, importer, ex-porter or narcotic treatment pro

45、gram is first registered, that business activ-ity shall be assigned to one of twelve groups, which shall correspond to the months of the year. The expiration date of the registrations of all reg-istrants within any group will be the last date of the month designated for that group. In assigning any

46、of these business activities to a group, the Ad-ministration may select a group the expiration date of which is less than one year from the date such business activity was registered. If the business activity is assigned to a group which has an expiration date less than three months from the date of

47、 which the business activity is registered, the reg-istration shall not expire until one year from that expiration date; in all other cases, the registration shall ex-pire on the expiration date following the date on which the business activity is registered. (d) At the time a retail pharmacy, hospi

48、tal/clinic, practitioner or teach-ing institution is first registered, that business activity shall be assigned to one of twelve groups, which shall cor-respond to the months of the year. The expiration date of the registrations of all registrants within any group will be the last day of the month d

49、esignated for that group. In assigning any of the above business activities to a group, the Administration may select a group the expiration date of which is not less than 28 months nor more than 39 months from the date such business ac-tivity was registered. After the initial registration period, the registration shall expire 36 months from the initial expiration date. (e) Any person who is required to be registered and who is not so registere