HHS 21 CFR PART 1307-2011 MISCELLANEOUS《杂项》.pdf

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1、102 21 CFR Ch. II (4111 Edition) 1306.27 1306.27 Provision of prescription in-formation between retail phar-macies and central fill pharmacies for initial and refill prescriptions of Schedule III, IV, or V controlled substances. Prescription information may be pro-vided to an authorized central fill

2、 phar-macy by a retail pharmacy for dis-pensing purposes. The following re-quirements shall also apply: (a) Prescriptions for controlled sub-stances listed in Schedule III, IV or V may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile. The retail

3、 pharmacy transmitting the pre-scription information must: (1) Write the word CENTRAL FILL on the face of the original prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted and the name of the retail pharmac

4、y pharmacist trans-mitting the prescription, and the date of transmittal; (2) Ensure that all information re-quired to be on a prescription pursuant to 1306.05 of this part is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of inform

5、a-tion); (3) Indicate in the information trans-mitted the number of refills already dispensed and the number of refills re-maining; (4) Maintain the original prescription for a period of two years from the date the prescription was last refilled; (5) Keep a record of receipt of the filled prescripti

6、on, including the date of receipt, the method of delivery (pri-vate, common or contract carrier) and the name of the retail pharmacy em-ployee accepting delivery. (b) The central fill pharmacy receiv-ing the transmitted prescription must: (1) Keep a copy of the prescription (if sent via facsimile) o

7、r an electronic record of all the information trans-mitted by the retail pharmacy, includ-ing the name, address, and DEA reg-istration number of the retail phar-macy transmitting the prescription; (2) Keep a record of the date of re-ceipt of the transmitted prescription, the name of the licensed pha

8、rmacist filling the prescription, and dates of filling or refilling of the prescription; (3) Keep a record of the date the filled prescription was delivered to the retail pharmacy and the method of delivery (i.e. private, common or contract car-rier). 68 FR 37411, June 24, 2003 PART 1307MISCELLANEOU

9、S GENERAL INFORMATION Sec. 1307.01 Definitions. 1307.02 Application of State law and other Federal law. 1307.03 Exceptions to regulations. SPECIAL EXCEPTIONS FOR MANUFACTURE AND DISTRIBUTION OF CONTROLLED SUBSTANCES 1307.11 Distribution by dispenser to another practitioner or reverse distributor. 13

10、07.12 Distribution to supplier or manufac-turer. 1307.13 Incidental manufacture of controlled substances. DISPOSAL OF CONTROLLED SUBSTANCES 1307.21 Procedure for disposing of controlled substances. 1307.22 Disposal of controlled substances by the Administration. SPECIAL EXEMPT PERSONS 1307.31 Native

11、 American Church. AUTHORITY: 21 U.S.C. 821, 822(d), 871(b), un-less otherwise noted. SOURCE: 36 FR 7801, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973. GENERAL INFORMATION 1307.01 Definitions. Any term contained in this part shall have the definition set forth in

12、 section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. 62 FR 13966, Mar. 24, 1997 1307.02 Application of State law and other Federal law. Nothing in this chapter shall be con-strued as authorizing or permitting any person to do any act which such person is not authorized or permitted

13、to do under other Federal laws or obli-gations under international treaties, conventions or protocols, or under the VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00112 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction

14、or networking permitted without license from IHS-,-,-103 Drug Enforcement Administration, Justice 1307.12 law of the State in which he/she desires to do such act nor shall compliance with such parts be construed as compli-ance with other Federal or State laws unless expressly provided in such other

15、laws. 62 FR 13966, Mar. 24, 1997 1307.03 Exceptions to regulations. Any person may apply for an excep-tion to the application of any provision of this chapter by filing a written re-quest with the Office of Diversion Con-trol, Drug Enforcement Administra-tion, stating the reasons for such ex-ception

16、. See the Table of DEA Mailing Addresses in 1321.01 of this chapter for the current mailing address. The Ad-ministrator may grant an exception in his discretion, but in no case shall he/ she be required to grant an exception to any person which is otherwise re-quired by law or the regulations cited

17、in this section. 75 FR 10678, Mar. 9, 2010 SPECIAL EXCEPTIONS FOR MANUFACTURE AND DISTRIBUTION OF CONTROLLED SUBSTANCES 1307.11 Distribution by dispenser to another practitioner or reverse dis-tributor. (a) A practitioner who is registered to dispense a controlled substance may distribute (without b

18、eing registered to distribute) a quantity of such sub-stance to (1) Another practitioner for the pur-pose of general dispensing by the prac-titioner to patients, provided that (i) The practitioner to whom the con-trolled substance is to be distributed is registered under the Act to dispense that con

19、trolled substance; (ii) The distribution is recorded by the distributing practitioner in accord-ance with 1304.22(c) of this chapter and by the receiving practitioner in ac-cordance with 1304.22(c) of this chap-ter; (iii) If the substance is listed in Schedule I or II, an order form is used as requi

20、red in part 1305 of this chapter; and (iv) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section and 1301.25 of this chapter dur-ing each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of th

21、e total number of dosage units of all con-trolled substances distributed and dis-pensed by the practitioner during the same calendar year. (2) A reverse distributor who is reg-istered to receive such controlled sub-stances. (b) If, during any calendar year in which the practitioner is registered to

22、dispense, the practitioner has reason to believe that the total number of dosage units of all controlled substances which will be distributed by him pursu-ant to paragraph (a)(1) of this section and 1301.25 of this chapter will exceed 5 percent of this total number of dos-age units of all controlled

23、 substances distributed and dispensed by him dur-ing that calendar year, the practitioner shall obtain a registration to distribute controlled substances. (c) The distributions that a reg-istered retail pharmacy makes to auto-mated dispensing systems at long term care facilities for which the retail

24、 pharmacy also holds registrations do not count toward the 5 percent limit in paragraphs (a)(1)(iv) and (b) of this sec-tion. 68 FR 41229, July 11, 2003, as amended at 70 FR 25466, May 13, 2005 1307.12 Distribution to supplier or manufacturer. (a) Any person lawfully in possession of a controlled su

25、bstance listed in any schedule may distribute (without being registered to distribute) that substance to the person from whom he/she ob-tained it or to the manufacturer of the substance, or, if designated, to the manufacturers registered agent for ac-cepting returns, provided that a writ-ten record

26、is maintained which indi-cates the date of the transaction, the name, form and quantity of the sub-stance, the name, address, and reg-istration number, if any, of the person making the distribution, and the name, address, and registration number, if known, of the supplier or manufac-turer. In the ca

27、se of returning a con-trolled substance in Schedule I or II, an order form shall be used in the manner prescribed in part 1305 of this chapter and be maintained as the written VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00113 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3

28、C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-104 21 CFR Ch. II (4111 Edition) 1307.13 record of the transaction. Any person not required to register pursuant to sections 302(c) or 1007(b)(1) of the Act (21 U.S.C. 822(c) or 957(b)(1)

29、 shall be ex-empt from maintaining the records re-quired by this section. (b) Distributions referred to in para-graph (a) may be made through a freight forwarding facility operated by the person to whom the controlled sub-stance is being returned provided that prior arrangement has been made for the

30、 return and the person making the distribution delivers the controlled substance directly to an agent or em-ployee of the person to whom the con-trolled substance is being returned. 65 FR 44679, July 19, 2000; 65 FR 45829, July 25, 2000, as amended at 68 FR 41229, July 11, 2003 1307.13 Incidental ma

31、nufacture of controlled substances. Any registered manufacturer who, in-cidentally but necessarily, manufac-tures a controlled substance as a result of the manufacture of a controlled sub-stance or basic class of controlled sub-stance for which he is registered and has been issued an individual manu

32、fac-turing quota pursuant to part 1303 of this chapter (if such substance or class is listed in Schedule I or II) shall be ex-empt from the requirement of registra-tion pursuant to part 1301 of this chap-ter and, if such incidentally manufac-tured substance is listed in Schedule I or II, shall be ex

33、empt from the require-ment of an individual manufacturing quota pursuant to part 1303 of this chapter, if such substances are disposed of in accordance with 1307.21. 36 FR 7801, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesig-nated at 62 FR 13967, Mar. 24, 1997 DISPOS

34、AL OF CONTROLLED SUBSTANCES 1307.21 Procedure for disposing of controlled substances. (a) Any person in possession of any controlled substance and desiring or re-quired to dispose of such substance may request assistance from the Spe-cial Agent in Charge of the Adminis-tration in the area in which t

35、he person is located for authority and instruc-tions to dispose of such substance. The request should be made as follows: (1) If the person is a registrant, he/ she shall list the controlled substance or substances which he/she desires to dispose of on DEA Form 41, and submit three copies of that fo

36、rm to the Special Agent in Charge in his/her area; or (2) If the person is not a registrant, he/she shall submit to the Special Agent in Charge a letter stating: (i) The name and address of the per-son; (ii) The name and quantity of each controlled substance to be disposed of; (iii) How the applican

37、t obtained the substance, if known; and (iv) The name, address, and registra-tion number, if known, of the person who possessed the controlled sub-stances prior to the applicant, if known. (b) The Special Agent in Charge shall authorize and instruct the applicant to dispose of the controlled substan

38、ce in one of the following manners: (1) By transfer to person registered under the Act and authorized to pos-sess the substance; (2) By delivery to an agent of the Ad-ministration or to the nearest office of the Administration; (3) By destruction in the presence of an agent of the Administration or

39、other authorized person; or (4) By such other means as the Spe-cial Agent in Charge may determine to assure that the substance does not be-come available to unauthorized per-sons. (c) In the event that a registrant is required regularly to dispose of con-trolled substances, the Special Agent in Char

40、ge may authorize the registrant to dispose of such substances, in ac-cordance with paragraph (b) of this sec-tion, without prior approval of the Ad-ministration in each instance, on the condition that the registrant keep records of such disposals and file peri-odic reports with the Special Agent in

41、Charge summarizing the disposals made by the registrant. In granting such authority, the Special Agent in Charge may place such conditions as he deems proper on the disposal of con-trolled substances, including the meth-od of disposal and the frequency and detail of reports. (d) This section shall n

42、ot be con-strued as affecting or altering in any VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00114 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-105 Drug Enfor

43、cement Administration, Justice Pt. 1308 way the disposal of controlled sub-stances through procedures provided in laws and regulations adopted by any State. 36 FR 7801, Apr. 24, 1971, as amended at 37 FR 15922, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, Se

44、pt. 22, 1982; 62 FR 13967, Mar. 24, 1997 1307.22 Disposal of controlled sub-stances by the Administration. Any controlled substance delivered to the Administration under 1307.21 or forfeited pursuant to section 511 of the Act (21 U.S.C. 881) may be delivered to any department, bureau, or other agen-

45、cy of the United States or of any State upon proper application addressed to the Office of Diversion Control, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in 1321.01 of this chapter for the current mailing address. The application shall show the name, address, and official

46、 title of the person or agency to whom the controlled drugs are to be deliv-ered, including the name and quantity of the substances desired and the pur-pose for which intended. The delivery of such controlled drugs shall be or-dered by the Administrator, if, in his opinion, there exists a medical or

47、 sci-entific need therefor. 75 FR 10678, Mar. 9, 2010 SPECIAL EXEMPT PERSONS 1307.31 Native American Church. The listing of peyote as a controlled substance in Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the N

48、ative American Church so using pe-yote are exempt from registration. Any person who manufactures peyote for or distributes peyote to the Native Amer-ican Church, however, is required to obtain registration annually and to comply with all other requirements of law. PART 1308SCHEDULES OF CONTROLLED SU

49、BSTANCES GENERAL INFORMATION Sec. 1308.01 Scope of part 1308. 1308.02 Definitions. 1308.03 Administration Controlled Sub-stances Code Number. SCHEDULES 1308.11 Schedule I. 1308.12 Schedule II. 1308.13 Schedule III. 1308.14 Schedule IV. 1308.15 Schedule V. EXCLUDED NONNARCOTIC SUBSTANCES 1308.21 Application for exclusion of a non-narcotic substance. 1308.22 Excluded substances. EXEMPT CHEMICAL PREPARATIONS 1308.23 Exemption of certain ch