HHS 21 CFR PART 1312-2011 IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES《管制物质的进出口》.pdf

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1、179 Drug Enforcement Administration, Justice Pt. 1312 of this chapter, cannot be consistently and accurately imported, stored, and displayed, the third-party auditor or certification organization must indi-cate that the application does not meet the requirements of this part. (2) If the pharmacy app

2、lication ac-cepts prescriptions with the practi-tioners digital signature, the third- party auditor or certification organiza-tion must indicate that the application does not meet the requirements of this part if the application does not consist-ently and accurately import, store, and verify the dig

3、ital signature. (3) If other information required under this chapter cannot be consist-ently and accurately imported, stored, and displayed, the third-party auditor or certification organization must indi-cate that the application has failed to meet the requirements for the specific information and

4、should not be used to process electronic prescriptions that require the additional information. 1311.302 Additional application pro-vider requirements. (a) If an application provider identi-fies or is made aware of any issue with its application that make the applica-tion non-compliant with the requ

5、ire-ments of this part, the application pro-vider must notify practitioners or pharmacies that use the application as soon as feasible, but no later than five business days after discovery, that the application should not be used to issue or process electronic controlled sub-stance prescriptions. (b

6、) When providing practitioners or pharmacies with updates to any issue that makes the application non-com-pliant with the requirements of this part, the application provider must in-dicate that the updates must be in-stalled before the practitioner or phar-macy may use the application to issue or pr

7、ocess electronic controlled sub-stance prescriptions. 1311.305 Recordkeeping. (a) If a prescription is created, signed, transmitted, and received elec-tronically, all records related to that prescription must be retained elec-tronically. (b) Records required by this subpart must be maintained electr

8、onically for two years from the date of their cre-ation or receipt. This record retention requirement shall not pre-empt any longer period of retention which may be required now or in the future, by any other Federal or State law or regu-lation, applicable to practitioners, pharmacists, or pharmacie

9、s. (c) Records regarding controlled sub-stances prescriptions must be readily retrievable from all other records. Electronic records must be easily read-able or easily rendered into a format that a person can read. (d) Records required by this part must be made available to the Admin-istration upon

10、request. (e) If an application service provider ceases to provide an electronic pre-scription application or an electronic pharmacy application or if a registrant ceases to use an application service provider, the application service pro-vider must transfer any records subject to this part to the re

11、gistrant in a for-mat that the registrants applications are capable of retrieving, displaying, and printing in a readable format. (f) If a registrant changes application providers, the registrant must ensure that any records subject to this part are migrated to the new application or are stored in a

12、 format that can be re-trieved, displayed, and printed in a readable format. (g) If a registrant transfers its elec-tronic prescription files to another reg-istrant, both registrants must ensure that the records are migrated to the new application or are stored in a for-mat that can be retrieved, di

13、splayed, and printed in a readable format. (h) Digitally signed prescription records must be transferred or mi-grated with the digital signature. PART 1312IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES Sec. 1312.01 Scope of part 1312. 1312.02 Definitions. IMPORTATION OF CONTROLLED SUBSTANCES 1

14、312.11 Requirement of authorization to im-port. 1312.12 Application for import permit. 1312.13 Issuance of import permit. VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00189 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reprodu

15、ction or networking permitted without license from IHS-,-,-180 21 CFR Ch. II (4111 Edition) 1312.01 1312.14 Distribution of copies of import per-mit. 1312.15 Shipments in greater or less amount than authorized. 1312.16 Cancellation of permit; expiration date. 1312.17 Special report from importers. 1

16、312.18 Contents of import declaration. 1312.19 Distribution of import declaration. EXPORTATION OF CONTROLLED SUBSTANCES 1312.21 Requirement of authorization to ex-port. 1312.22 Application for export permit. 1312.23 Issuance of export permit. 1312.24 Distribution of copies of export per-mit. 1312.25

17、 Expiration date. 1312.26 Records required of exporter. 1312.27 Contents of special controlled sub-stances invoice. 1312.28 Distribution of special controlled substances invoice. 1312.29 Domestic release prohibited. 1312.30 Schedule III, IV, and V non-narcotic controlled substances requiring an im-p

18、ort and export permit. TRANSSHIPMENT AND IN-TRANSIT SHIPMENT OF CONTROLLED SUBSTANCES 1312.31 Schedule I: Application for prior written approval. 1312.32 Schedules II, III, IV: Advance notice. HEARINGS 1312.41 Hearings generally. 1312.42 Purpose of hearing. 1312.43 Waiver or modification of rules. 1

19、312.44 Request for hearing or appearance; waiver. 1312.45 Burden of proof. 1312.46 Time and place of hearing. 1312.47 Final order. AUTHORITY: 21 U.S.C. 952, 953, 954, 957, 958. SOURCE: 36 FR 7815, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973. 1312.01 Scope of pa

20、rt 1312. Procedures governing the importa-tion, exportation, transshipment and intransit shipment of controlled sub-stances pursuant to section 1002, 1003, and 1004 of the Act (21 U.S.C. 952, 953, and 954) are governed generally by those sections and specifically by the sections of this part. 1312.0

21、2 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 13969, Mar. 24, 1997 IMPORTATION OF CONTROLLED SUBSTANCES 1312.11 Requirement of authoriza-tion to import. (a) No person shall import or ca

22、use to be imported any controlled substance listed in Schedule I or II or any nar-cotic controlled substance listed in Schedule III, IV or V or any non-nar-cotic controlled substance in Schedule III which the Administrator has spe-cifically designated by regulation in 1312.30 of this part or any non

23、-nar-cotic controlled substance in Schedule IV or V which is also listed in Schedule I or II of the Convention on Psycho-tropic Substances unless and until such person is properly registered under the Act (or exempt from registration) and the Administrator has issued him a permit to do so pursuant t

24、o 1312.13 of this part. (b) No person shall import or cause to be imported any non-narcotic con-trolled substance listed in Schedule III, IV or V, excluding those described in paragraph (a) of this section, unless and until such person is properly reg-istered under the Act (or exempt from registrati

25、on) and has filed an import declaration to do so with the Adminis-trator, pursuant to 1312.18 of this part. (c) When an import permit or dec-laration is required, a separate permit or declaration must be obtained for each consignment of controlled sub-stances to be imported. 36 FR 7815, Apr. 24, 197

26、1, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17289, May 7, 1987 1312.12 Application for import per-mit. (a) An application for a permit to im-port controlled substances shall be made on DEA Form 357. DEA Form 357 may be obtained from,

27、and shall be filed with, the Import/Export Unit, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in 1321.01 of this chapter for the current mailing address. Each application shall VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00190 Fmt 8010 Sfmt 8010 Y:SGML223073

28、.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-181 Drug Enforcement Administration, Justice 1312.13 show the date of execution; the reg-istration number of the importer; a de-tailed description of each cont

29、rolled substance to be imported including the drug name, dosage form, National Drug Code (NDC) number, the Administra-tion Controlled Substance Code Num-ber as set forth in part 1308 of this chapter, the number and size of pack-ages or containers, the name and quan-tity of the controlled substance c

30、on-tained in any finished dosage units, and the net quantity of any controlled substance (expressed in anhydrous acid, base or alkaloid) given in kilo-grams or parts thereof. The application shall also include the following: (1) The name, address, and business of the consignor, if known at the time

31、application is submitted, but if un-known at that time, the fact should be indicated and the name and address afterwards furnished to the Adminis-trator as soon as ascertained by the importer; (2) The foreign port of exportation (i.e., the place where the article will begin its journey of exportatio

32、n to the United States); (3) The port of entry into the United States; (4) The latest date said shipment will leave said foreign port; (5) The stock on hand of the con-trolled substance desired to be im-ported; (6) The name of the importing carrier or vessel (if known, or if unknown it should be sta

33、ted whether shipment will be made by express, freight, or other-wise, imports of controlled substances in Schedules I or II and narcotic drugs in Schedules III, IV, or V by mail being prohibited); (7) The total tentative allotment to the importer of such controlled sub-stance for the current calenda

34、r year; (8) The total number of kilograms of said allotment for which permits have previously been issued and the total quantity of controlled substance actu-ally imported during the current year to date. (b) If desired, alternative foreign ports of exportation within the same country may be indicat

35、ed upon the ap-plication (e.g., (1) Calcutta, (2) Bom-bay). If a formal permit is issued pursu-ant to such application, it will bear the names of the two ports in the order given in the application and will au-thorize shipment from either port. Al-ternate ports in different countries will not be aut

36、horized in the same permit. 36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 43218, Dec. 11, 1974; 45 FR 74715, Nov. 12, 1980; 51 FR 5319 and 5320, Feb. 13, 1986; 52 FR 17289, May 7, 1987; 62 FR 13969, Mar. 24, 199

37、7; 75 FR 10681, Mar. 9, 2010 1312.13 Issuance of import permit. (a) The Administrator may authorize importation of any controlled sub-stance listed in Schedule I or II or any narcotic drug listed in Schedule III, IV, or V if he finds: (1) That the substance is crude opium, poppy straw, concentrate o

38、f poppy straw, or coca leaves, in such quantity as the Administrator finds necessary to provide for medical, sci-entific, or other legitimate purposes; (2) That the substance is necessary to provide for medical and scientific needs or other legitimate needs of the United States during an emergency w

39、here do-mestic supplies of such substance or drug are found to be inadequate, or in any case in which the Administrator finds that competition among domestic manufacturers of the controlled sub-stance is inadequate and will not be rendered adequate by the registration of additional manufacturers und

40、er sec-tion 303 of the Controlled Substances Act (21 U.S.C. 823); or (3) That the domestic supply of any controlled substance is inadequate for scientific studies, and that the impor-tation of that substance for scientific purposes is only for delivery to offi-cials of the United Nations, of the Uni

41、ted States, or of any State, or to any person registered or exempted from registration under sections 1007 and 1008 of the Act (21 U.S.C. 957 and 958). (4) That the importation of the con-trolled substance is for ballistics or other analytical or scientific purposes, and that the importation of that

42、 sub-stance is only for delivery to officials of the United Nations, of the United VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00191 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without l

43、icense from IHS-,-,-182 21 CFR Ch. II (4111 Edition) 1312.14 States, or of any State, or to any per-son registered or exempted from reg-istration under sections 1007 and 1008 of the Act (21 U.S.C. 957 and 958). (b) The Administrator may require that such non-narcotic controlled sub-stances in Schedu

44、le III as he shall des-ignate by regulation in 1312.30 of this part be imported only pursuant to the issuance of an import permit. The Ad-ministrator may authorize the impor-tation of such substances if he finds that the substance is being imported for medical, scientific or other legiti-mate uses.

45、(c) If a non-narcotic substance listed in Schedule IV or V is also listed in Schedule I or II of the Convention on Psychotropic Substances, 1971, it shall be imported only pursuant to the issuance of an import permit. The Ad-ministrator may authorize the impor-tation of such substances if it is foun

46、d that the substance is being imported for medical, scientific or other legiti-mate uses. (d) The Administrator may require an applicant to submit such documents or written statements of fact relevant to the application as he deems nec-essary to determine whether the appli-cation should be granted.

47、The failure of the applicant to provide such docu-ments or statements within a reason-able time after being requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consider-ation by the Administrator in granting or denying the appli

48、cation. (e) Each import permit shall be issued in sextuplet and serially num-bered, with all six copies bearing the same serial number and being des-ignated original (Copy 1), dupli-cate (Copy 2), etc., respectively. All copies of import permits shall bear the signature of the Director or his dele-g

49、ate, and facsimiles of signatures shall not be used. No permit shall be altered or changed by any person after being signed by the Administrator or his del-egate and any change or alteration upon the face of any permit after it shall have been signed by the Adminis-trator or his delegate shall render it void and of no effect. Permits are not transferable. Each copy of the permit shall have printed or stamped thereon the disposition to be made thereof. Each