cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
31 rows where part_number = 1312 and title_number = 21 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:9.0.1.1.13.0.45.1 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.01 Scope of part 1312. | DEA | Procedures governing the importation, exportation, transshipment and intransit shipment of controlled substances 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. | |||||||
| 21:21:9.0.1.1.13.0.45.10 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.17 Special report from importers. | DEA | [36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13969, Mar. 24, 1997] | Whenever requested by the Administrator, importers shall render to him not later than 30 days after receipt of the request therefor a statement under oath of the stocks of controlled substances on hand as of the date specified by the Administrator in his request, and, if desired by the Administrator, an estimate of the probable requirements for legitimate uses of the importer for any subsequent period that may be designated by the Administrator. In lieu of any special statement that may be considered necessary, the Administrator may accept the figures given upon the reports subsequent by said importer under part 1304 of this chapter. | ||||||
| 21:21:9.0.1.1.13.0.45.11 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.18 Import declaration. | DEA | [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, 1997; 75 FR 10682, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012; 81 FR 97028, Dec. 30, 2016] | (a) Any non-narcotic controlled substance listed in Schedule III, IV, or V, not subject to the requirement of an import permit pursuant to § 1312.13 (b) or (c) of this chapter, may be imported if that substance is needed for medical, scientific or other legitimate uses in the United States, and will be imported pursuant to a controlled substances import declaration. (b) Any person registered or authorized to import and seeking to import any non-narcotic controlled substance listed in Schedules III, IV, or V which is not subject to the requirement of an import permit as described in paragraph (a) of this section, must file a controlled substances import declaration (DEA Form 236) with the Administration through the DEA Diversion Control Division secure network application not later than 15 calendar days prior to the anticipated date of release by a customs officer and distribute an official record of the declaration as hereinafter directed in § 1312.19. The declaration must be signed and dated by the importer and must specify the address of the final destination for the shipment, which must be the importer's registered location. Upon receipt and review, the Administration will assign a transaction identification number to each completed declaration. The import declaration is not deemed filed, and therefore is not valid, until the Administration has issued a transaction identification number. The importer may only proceed with the import transaction once the transaction identification number has been issued. (c) DEA Form 236 must include the following information: (1) The name, address, and registration number of the importer; and the name and address and registration number of the import broker, if any; and (2) A complete description of the controlled substances to be imported, including drug name, dosage form, National Drug Code (NDC) number, the Administration Controlled Substances Code Number as set forth in part 1308 of this chapter, the number and size of packages or containers, the name and quantity of t… | ||||||
| 21:21:9.0.1.1.13.0.45.12 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.19 Distribution of import declaration. | DEA | [81 FR 97029, Dec. 30, 2016] | The importer must furnish an official record of the declaration (available through the DEA Diversion Control Division secure network application after the Administration issues a transaction identification number) to the foreign shipper. The foreign shipper must submit an official record of the declaration to the competent national authority of the exporting country, if required as a prerequisite to export authorization. The importer, or their agent, must submit an official record of the declaration and/or required data concerning the import transaction to a customs officer at the port of entry in compliance with all import control requirements of agencies with import control authorities under the Act or statutory authority other than the Controlled Substances Import and Export Act. The importer must ensure that an official record of the declaration accompanies the shipment to its final destination, which must only be the registered location of the importer ( i.e., drop shipments are prohibited). The importer must maintain an official record of the declaration in accordance with part 1304 of this chapter. | ||||||
| 21:21:9.0.1.1.13.0.45.2 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.02 Definitions. | DEA | [62 FR 13969, Mar. 24, 1997] | 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. | ||||||
| 21:21:9.0.1.1.13.0.45.3 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.03 Forms applicable to this part. | DEA | [81 FR 97025, Dec. 30, 2016] | |||||||
| 21:21:9.0.1.1.13.0.45.4 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.11 Requirement of authorization to import. | DEA | [81 FR 97026, Dec. 30, 2016] | (a) No person shall import, or cause to be imported, into the customs territory of the United States from any place outside thereof (but within the United States), or into the United States from any place outside thereof, any controlled substances listed in Schedule I or II, or any narcotic controlled substance listed in Schedule III, IV, or V, or any non-narcotic controlled substance listed in Schedule III which the Administrator has specifically designated by regulation in § 1312.30 or any non-narcotic controlled substance listed in Schedule IV or V which is also listed in Schedule I or II of the Convention on Psychotropic Substances, 1971, unless and until such person is properly registered under the Act (or, in accordance with part 1301 of this chapter, exempt from registration) and the Administration has issued him or her a permit to do so in accordance with § 1312.13. (b) No person shall import, or cause to be imported, into the customs territory of the United States from any place outside thereof (but within the United States), or into the United States from any place outside thereof, any non-narcotic controlled substance listed in Schedule III, IV, or V, excluding those described in paragraph (a) of this section, unless and until such person is properly registered under the Act (or, in accordance with part 1301 of this chapter, exempt from registration) and has filed an import declaration to do so in accordance with § 1312.18. (c) A separate permit or declaration is required for each shipment of a controlled substance to be imported. | ||||||
| 21:21:9.0.1.1.13.0.45.5 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.12 Application for import permit; return information. | DEA | [81 FR 97026, Dec. 30, 2016] | (a) Registered importers, other registrants authorized to import as a coincident activity of their registrations, and persons who in accordance with part 1301 of this chapter are exempt from registration, seeking to import a controlled substance in schedule I or II; any narcotic drug in schedule III, IV, or V; any non-narcotic drug in schedule III that has been specifically designated by regulation in § 1312.30; or any non-narcotic substance listed in schedule IV or V that is also listed in schedule I or II of the Convention on Psychotropic Substances, 1971, must submit an application for a permit to import controlled substances on DEA Form 357. All applications and supporting materials must be submitted to the Administration through the DEA Diversion Control Division secure network application. The application must be signed and dated by the importer and must contain the importer's registered address to which the controlled substances will be imported. (b) The applicant must include on the DEA Form 357 the registration number of the importer and a detailed description of each controlled substance to be imported including the drug name, dosage form, National Drug Code (NDC) number, the Administration Controlled Substance Code Number as set forth in part 1308 of this chapter, the number and size of the packages or containers, the name and quantity of the controlled substance contained in any finished dosage units, and the quantity of any controlled substance (expressed in anhydrous acid, base or alkaloid) given in kilograms or parts thereof. The application must also include the following: (1) The name/business name, address/business address, contact information ( e.g., telephone number(s), email address(es), etc.), and business of the consignor, if known at the time the application is submitted, but if unknown at that time, the fact should be indicated and the name and address afterwards furnished to the Administration as soon as ascertained by the importer; (2) The foreign port and country of initial exporta… | ||||||
| 21:21:9.0.1.1.13.0.45.6 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.13 Issuance of import permit. | DEA | [36 FR 23624, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 41776, Aug. 18, 1981; 52 FR 17289, May 7, 1987; 73 FR 6851, Feb. 6, 2008; 81 FR 97027, Dec. 30, 2016] | (a) The Administrator may authorize importation of any controlled substance 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 of poppy straw, or coca leaves, in such quantity as the Administrator finds necessary to provide for medical, scientific, 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 where domestic 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 substance is inadequate and will not be rendered adequate by the registration of additional manufacturers under section 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 importation of that substance for scientific purposes is only for delivery to officials of the United Nations, of the United 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 controlled substance is for ballistics or other analytical or scientific purposes, and that the importation of that substance is only for delivery to officials of the United Nations, of the United 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). (b) The Administrator may require that such non-narcotic controlled substances in Schedule III as he shall designate by regulation in § 1312.30 of this part be imported only pursuant to the issuance of an import permit. The Administrator may authorize the importation of such substances if he finds that the substance is being imported for medical, scientific or other legitimate uses.… | ||||||
| 21:21:9.0.1.1.13.0.45.7 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.14 Distribution of import permits. | DEA | [81 FR 97027, Dec. 30, 2016] | The Administration shall transmit the import permit to the competent national authority of the exporting country and shall make an official record of the import permit available to the importer through secure electronic means. The importer, or their agent, must submit an official record of the import permit and/or required data concerning the import transaction to a customs officer at the port of entry in compliance with all import control requirements of agencies with import control authorities under the Act or statutory authority other than the Controlled Substances Import and Export Act. The importer must maintain an official record of the import permit (available from the DEA Diversion Control Division secure network application after issuance) in accordance with part 1304 of this chapter as the record of authority for the importation and shall transmit an official record of the permit to the foreign exporter. If required by the foreign competent national authority, the importer shall ensure that an official record of the import permit is provided ( e.g., by transmitting an official record of the permit to the foreign exporter who shall transmit such record to the competent national authority of the exporting county). The importer must ensure that an official record of the permit accompanies the shipment of controlled substances to its final destination, the registered location of the importer ( i.e., drop shipments are prohibited). | ||||||
| 21:21:9.0.1.1.13.0.45.8 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.15 Shipments in greater or less amount than authorized. | DEA | [36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, May 29, 1981; 81 FR 97027, Dec. 30, 2016] | (a) If the shipment made under an import permit is greater than the maximum amount authorized to be imported under the permit, as determined at the weighing by the District Director of the U.S. Customs and Border Protection or customs service of an Insular Area, such difference shall be seized subject to forfeiture, pending an explanation; except that shipments of substances exceeding the maximum authorized amount by less than 1 percent may be released to the importer upon the filing by him of an amended import permit in accordance with § 1312.16(a). If the substance is included in Schedule I, it will be summarily forfeited to the Government. (b) If the shipment made under the permit is less than the maximum amount authorized to be imported under the permit as determined at the weighing by the District Director of the U.S. Customs and Border Protection or customs service of an Insular Area, such difference, when ascertained by the Administration, shall be recredited to the tentative allotment against which the quantity covered by the permit was charged, and the balance of any such tentative allotment with any such recredits will remain available to the importer to whom made (unless previously revoked in whole or in part), for importations pursuant to any permit or permits as are requested and issued during the remainder of the calendar year to which the allotment is applicable. No permit shall be issued for importation of a quantity of controlled substances as a charge against the tentative allotment for a given calendar year, after the close of such calendar year, unless the Administrator decides to make an exception for good cause shown. | ||||||
| 21:21:9.0.1.1.13.0.45.9 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.16 Amendment, cancellation, expiration of import permit. | DEA | [81 FR 97027, Dec. 30, 2016] | (a) Importers may only request that an import permit or application for an import permit be amended in accordance with paragraphs (a)(1) through (7) of this section. Requests for an amendment must be submitted through the DEA Diversion Control Division secure network application. Except as provided in paragraph (a)(5) of this section and § 1312.15(a), importers must submit all requests for an amendment at least one full business day in advance of the date of release by a customs officer. Importers must specifically request that an amendment be made; supplementary information submitted by an importer through the DEA Diversion Control Division secure network application will not automatically trigger the amendment process. While the request for an amendment is being reviewed by the Administration, the original permit will be temporarily stayed and may not be used to authorize entry of a shipment of controlled substances. If the importer's request for an amendment to an issued permit is granted by the Administration, the Administration will immediately cancel the original permit and re-issue the permit, as amended, with a revised permit number. The DEA and importer will distribute the amended permit in accordance with § 1312.14. If a request for an amendment is denied by the Administration, the temporary stay will be lifted; once lifted, the originally issued permit may immediately be used to authorize entry of a shipment in accordance with the terms of the permit, subject to the shipment being compliant with all other applicable laws. (1) An importer may request that an import permit or application for a permit be amended to change the National Drug Control number, description of the packaging, or trade name of the product, so long as the description is for the same basic class of controlled substance as in the original permit. (2) An importer may request that an import permit or application for a permit be amended to change the proposed port of entry, the date of release by a customs officer, or the method of tr… | ||||||
| 21:21:9.0.1.1.13.0.46.13 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.21 Requirement of authorization to export. | DEA | [81 FR 97029, Dec. 30, 2016] | (a) No person shall in any manner export, or cause to be exported, from the United States any controlled substance listed in Schedule I or II, or any narcotic controlled substance listed in Schedule III or IV, or any non-narcotic controlled substance in Schedule III which the Administrator has specifically designated by regulation in § 1312.30 or any non-narcotic controlled substance in Schedule IV or V which is also listed in Schedule I or II of the Convention on Psychotropic Substances, 1971, unless and until such person is properly registered under the Act (or, in accordance with part 1301 of this chapter, exempt from registration) and the Administrator has issued him or her a permit to do so in accordance with § 1312.23. (b) No person shall in any manner export, or cause to be exported, from the United States any non-narcotic controlled substance listed in Schedule III, IV, or V, excluding those described in paragraph (a) of this section, or any narcotic controlled substance listed in Schedule V, unless and until such person is properly registered under the Act (or, in accordance with part 1301 of this chapter, exempt from registration) and has furnished an export declaration as provided by section 1003 of the Act (21 U.S.C. 953(e)) to the Administration in accordance with § 1312.28. (c) A separate permit or declaration is required for each shipment of controlled substance to be exported. | ||||||
| 21:21:9.0.1.1.13.0.46.14 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.22 Application for export or reexport permit; return information. | DEA | [81 FR 97029, Dec. 30, 2016] | (a) Registered exporters, and persons who in accordance with part 1301 of this chapter are exempt from registration, seeking to export controlled substances must submit an application for a permit to export controlled substances on DEA Form 161. Registered exporters, and persons who in accordance with part 1301 of this chapter are exempt from registration, seeking to reexport controlled substances must submit an application for a permit to reexport controlled substances on DEA Form 161R or DEA Form 161R-EEA, whichever applies. All applications and supporting materials must be submitted to the Administration through the DEA Diversion Control Division secure network application. The application must be signed and dated by the exporter and contain the exporter's registered address from which the controlled substances will be exported. Controlled substances may not be exported until a permit number has been issued. (b) Exports of controlled substances by mail are prohibited. (c) Applications. (1) Except as provided in paragraph (c)(2) of this section, each application for a permit to export or reexport must include the following information: (i) The exporter's name/business name, address/business address, and contact information ( e.g., telephone number(s), email address (es), etc.); (ii) The exporter's registration number, address, and contact information ( e.g., telephone number(s), etc.) from which the controlled substances will be exported; (iii) A detailed description of each controlled substance to be exported including the drug name, dosage form, National Drug Code (NDC) number, Administration Controlled Substance Code Number as set forth in part 1308 of this chapter, the number and size of the packages or containers, the name and quantity of the controlled substance contained in any finished dosage units, and the quantity of any controlled substance (expressed in anhydrous acid, base, or alkaloid) given in kilograms or parts thereof; (iv) The name/business name, address/business address, contact inf… | ||||||
| 21:21:9.0.1.1.13.0.46.15 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.23 Issuance of export permit. | DEA | [36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17290, May 7, 1987; 72 FR 72929, Dec. 26, 2007; 81 FR 97032, Dec. 30, 2016] | (a) The Administrator may authorize exportation of any controlled substance listed in Schedule I or II or any narcotic controlled substance listed in Schedule III or IV if he finds that such exportation is permitted by subsections 1003(a), (b), (c), (d), or (f) of the Act (21 U.S.C. 953(a), (b), (c), (d), or (f). (b) The Administrator may require that such non-narcotic controlled substances in Schedule III as shall be designated by regulation in § 1312.30 of this part be exported only pursuant to the issuance of an export permit. The Administrator may authorize the exportation of such substances if he finds that such exportation is permitted by section 1003(e) of the Act (21 U.S.C. 953(e)). (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, it shall be exported only pursuant to the issuance of an export permit. The Administrator may authorize the exportation of such substances if he finds that such exportation is permitted by section 1003(e) of the Act (21 U.S.C. 953(e)). (d) The Administrator may require an applicant to submit such documents or written statements of fact relevant to the application as he deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable 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 consideration by the Administrator in granting or denying the application. (e) If an exportation is approved, the Administrator shall issue an export permit bearing his or her signature or that of his or her delegate. Each permit will be assigned a permit number that is a unique, randomly generated identifier. A permit shall not be altered or changed by any person after being signed. Any change or alteration upon the face of any permit after it has been signed renders it void and of no effect. Permits are not transferable. T… | ||||||
| 21:21:9.0.1.1.13.0.46.16 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.24 Distribution of export permit. | DEA | [81 FR 97032, Dec. 30, 2016] | The Administration shall transmit the export permit to the competent national authority of the importing country and shall make available to the exporter an official record of the export permit through secure electronic means. The exporter, or their agent, must submit an official record of the export permit and/or required data concerning the export transaction to a customs officer at the port of export in compliance with all export control requirements of agencies with export control authorities under the Act or statutory authority other than the Controlled Substances Import and Export Act. The exporter must maintain an official record of the export permit (available from the secure network application on the DEA Diversion Control Division Web site after the Administration issues a transaction identification number) in accordance with part 1304 of this chapter as the record of authority for the exportation and shall transmit an official record of the export permit to the foreign importer. The exporter must ensure that an official record of the permit accompanies the shipment to its final destination. No shipment of controlled substances denied release for any reason shall be allowed to be released from the United States without subsequent authorization from the Administration. | ||||||
| 21:21:9.0.1.1.13.0.46.17 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.25 Amendment, cancellation, expiration of export permit. | DEA | [81 FR 97032, Dec. 30, 2016] | (a) Exporters may only request that an export permit or application for an export permit be amended in accordance with paragraphs (a)(1) through (7) of this section. Requests for an amendment must be submitted through the DEA Diversion Control Division secure network application. Except as provided in paragraph (a)(5) of this section exporters must submit all requests for an amendment at least one full business day in advance of the date of release from the port of export. Exporters must specifically request that an amendment be made; supplementary information submitted by an exporter through the DEA Diversion Control Division secure network application will not automatically trigger the amendment process. While the request for an amendment is being reviewed by the Administration, the original permit will be temporarily stayed and may not be used to authorize release of a shipment of controlled substances. If the exporter's request for an amendment to an issued permit is granted by the Administration, the Administration will immediately cancel the original permit and re-issue the permit, as amended, with a revised permit number. The DEA and exporter will distribute the amended permit in accordance with § 1312.24. If a request for an amendment is denied by the Administration, the temporary stay will be lifted; once lifted, the originally issued permit may immediately be used to authorize release of a shipment in accordance with the terms of the permit. (1) An exporter may request that an export permit or application for a permit be amended to change the National Drug Control number, description of the packaging, or trade name of the product, so long as the description is for the same basic class of controlled substance as in the original permit. (2) An exporter may request that an export permit or application for a permit be amended to change the proposed port of export, the anticipated date of release by a customs officer, or the method of transport. (3) An exporter may request that an export permit or applica… | ||||||
| 21:21:9.0.1.1.13.0.46.18 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.26 Records required of exporter. | DEA | [81 FR 97033, Dec. 30, 2016] | In addition to any other records required by this chapter, the exporter must keep a record of any serial numbers that might appear on packages of narcotic drugs in quantities of one ounce or more in such a manner as will identify the foreign consignee, along with an official record of the export permit, in accordance with part 1304 of this chapter. | ||||||
| 21:21:9.0.1.1.13.0.46.19 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.27 Export/reexport declaration. | DEA | [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010; 81 FR 97033, Dec. 30, 2016] | (a) Any person registered or authorized to export and seeking to export any non-narcotic controlled substance listed in Schedule III, IV, or V, which is not subject to the requirement of an export permit pursuant to § 1312.23(b) or (c), or any person registered or authorized to export and seeking to export any controlled substance in Schedule V, must file a controlled substances export declaration (DEA Form 236) with the Administration through the DEA Diversion Control Division secure network application not less than 15 calendar days prior to the anticipated date of release by a customs officer at the port of export, and distribute an official record of the declaration as hereinafter directed in § 1312.28. The declaration must be signed and dated by the exporter and must contain the address of the registered location from which the substances will be shipped for exportation. Upon receipt and review, the Administration will issue a completed declaration a transaction identification number. The export declaration is not deemed filed, and therefore not valid, until the Administration has issued a transaction identification number. The exporter may only proceed with the export transaction once the transaction identification number has been issued. (b)(1) DEA Form 236 must include the following information: (i) The name/business name, address/business address, contact information ( e.g., telephone number(s), email address(es), etc.), and registration number, if any, of the exporter; and the name/business name, address/business address, contact information ( e.g., telephone number(s), email address(es), etc.), and registration number of the export broker, if any. (ii) A detailed description of each controlled substance to be exported including the drug name, dosage form, National Drug Code (NDC) number, Administration Controlled Substance Code Number as set forth in part 1308 of this chapter, the number and size of the packages or containers, the name and quantity of the controlled substance contained in any fini… | ||||||
| 21:21:9.0.1.1.13.0.46.20 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.28 Distribution of export declaration. | DEA | [81 FR 97035, Dec. 30, 2016] | (a) The exporter must ensure that an official record of the export declaration (available from the DEA Diversion Control Division secure network application after the Administration issues a transaction identification number) accompanies the shipment of controlled substances to its destination. (b) The exporter, or their agent, must submit an official record of the export declaration and/or required data concerning the export transaction to a customs officer at the port of export in compliance with all export control requirements of agencies with export control authorities under the Act or statutory authority other than the Controlled Substances Import and Export Act. (c) The exporter must maintain an official record of the export declaration and return information (both available from the Diversion Control Division secure network application after the Administration issues a transaction identification number) required pursuant to § 1312.27(d) as his or her record of authority for the exportation, in accordance with part 1304 of this chapter. | ||||||
| 21:21:9.0.1.1.13.0.46.21 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.29 Domestic release prohibited. | DEA | An exporter or a forwarding agent acting for an exporter must either deliver the controlled substances to the port or border, or deliver the controlled substances to a bonded carrier approved by the consignor for delivery to the port or border, and may not, under any other circumstances, release a shipment of controlled substances to anyone, including the foreign consignee or his agent, within the United States. | |||||||
| 21:21:9.0.1.1.13.0.46.22 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.30 Schedule III, IV, and V non-narcotic controlled substances requiring an import and export permit. | DEA | [52 FR 17291, May 7, 1987, as amended at 64 FR 35930, July 2, 1999; 83 FR 48953, Sept. 28, 2018; 85 FR 51645, Aug. 21, 2020; 91 FR 22723, Apr. 28, 2026] | The following Schedule III, IV, and V non-narcotic controlled substances have been specifically designated by the Administrator of the Drug Enforcement Administration as requiring import and export permits pursuant to sections 201(d)(1), 1002(b)(2), and 1003(e)(3) of the Act (21 U.S.C. 811(d)(1), 952(b)(2), and 953(e)(3)): (a) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product. (b) Marijuana, as defined in 21 U.S.C. 802(16), in a U.S. Food and Drug Administration approved product or subject to a state medical marijuana license. (c) Marijuana extract, as defined in 21 CFR 1308.11(d)(58), in a U.S. Food and Drug Administration approved product or subject to a state medical marijuana license. (d) Naturally derived delta-9-tetrahydrocannabinols in a U.S. Food and Drug Administration approved product or subject to a state medical marijuana license. (1) Naturally derived delta-9-tetrahydrocannabinols means those delta-9-tetrahydrocannabinols, except as in paragraphs (g)(2) and (3) of this section, that are naturally contained in a plant of the genus Cannabis (cannabis plant). (2) Naturally derived delta-9-tetrahydrocannabinols do not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639 o. (3) Naturally derived delta-9-tetrahydrocannabinols do not include any delta-9-tetrahydrocannabinols contained in substances excluded from the definition of marijuana as set forth in 21 U.S.C. 802(16)(B)(ii). (e) [Reserved] | ||||||
| 21:21:9.0.1.1.13.0.47.23 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.31 Schedule I: Application for prior written approval. | DEA | [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010; 81 FR 97035, Dec. 30, 2016] | (a) A controlled substance listed in schedule I may be imported into the United States for transshipment, or may be transferred or transshipped within the United States for immediate exportation, provided that: (1) The controlled substance is necessary for scientific, medical, or other legitimate purposes in the country of destination, and (2) A transshipment permit has been issued by the Administrator. (b) An application for a transshipment permit must be submitted to the Regulatory Section, Diversion Control Division, Drug Enforcement Administration, at least 30 calendar days, or in the case of an emergency as soon as is practicable, prior to the expected date of arrival at the first port in the United States. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. A separate permit is required for each shipment of controlled substance to be imported, transferred, or transshipped. Each application must contain the following: (1) The date of execution; (2) The identification and description of the controlled substance; (3) The net quantity thereof; (4) The number and size of the controlled substance containers; (5) The name, address, and business of the foreign exporter; (6) The foreign port of exportation; (7) The approximate date of exportation; (8) The identification of the exporting carrier; (9) The name, address and business of the importer, transferor, or transshipper; (10) The registration number, if any, of the importer, transferor or transshipper; (11) The U.S. port of entry; (12) The approximate date of entry; (13) The name, address and business of the consignee at the foreign port of entry; (14) The shipping route from the U.S. port of exportation to the foreign port of entry; (15) The approximate date of receipt by the consignee at the foreign port of entry; and (16) The signature of the importer, transferor or transshipper, or his agent accompanied by the agent's title. (c) An application shall be accompanied by an export license, perm… | ||||||
| 21:21:9.0.1.1.13.0.47.24 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.32 Schedules II, III, IV: Advance notice. | DEA | [81 FR 97036, Dec. 30, 2016] | (a) A controlled substance listed in Schedules II, III, or IV may be imported into the United States for transshipment, or may be transferred or transshipped within the United States for immediate exportation, provided that written notice is submitted to the Regulatory Section, Diversion Control Division, Drug Enforcement Administration, at least 15 calendar days prior to the expected date of date of arrival at the first port in the United States. See the Table of DEA mailing Addresses in § 1321.01 of this chapter for the current mailing addresses. (b) A separate advance notice is required for each shipment of controlled substance to be imported, transferred, or transshipped. Each advance notice must contain those items required by § 1312.31(b) and (c). If the export license, permit, or other authorization, issued by a competent national authority of the country of origin, is not written in English or bilingual with another language and English, the notice must be accompanied by a certified translation of the export license, permit, or other authorization. For purposes of this requirement, certified translation means that the translator has signed the translation legally attesting the accuracy of the translation. | ||||||
| 21:21:9.0.1.1.13.0.48.25 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.41 Hearings generally. | DEA | [36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] | (a) In any case where the Administrator shall hold a hearing regarding the denial of an application for an import, export or transshipment permit, the procedures for such hearing shall be governed generally by the adjudication procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by sections 1002 and 1003 of the Act (21 U.S.C. 952 and 953), by §§ 1312.42-1312.47, and by the procedures for administrative hearings under the Act set forth in §§ 1316.41-1316.67 of this chapter. (b) [Reserved] | ||||||
| 21:21:9.0.1.1.13.0.48.26 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.42 Purpose of hearing. | DEA | [36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] | (a) If requested by a person applying for an import, export, or transshipment permit, the Administrator shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the issuance or denial of such permit to such person. (b) Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law. | ||||||
| 21:21:9.0.1.1.13.0.48.27 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.43 Waiver or modification of rules. | DEA | [36 FR 23625, Dec. 11, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] | The Administrator of the presiding officer (with respect to matters pending before him) may modify or waive any rule in this part by notice in advance of the hearing, if he determines that no party in the hearing will be unduly prejudiced and the ends of justice will thereby be served. Such notice of modification or waiver shall be made a part of the record of the hearing. | ||||||
| 21:21:9.0.1.1.13.0.48.28 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.44 Request for hearing or appearance; waiver. | DEA | [37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] | (a) Any applicant entitled to a hearing pursuant to § 1312.42 and who desires a hearing on the denial of his application for an import, export, or transshipment permit shall, within 30 days after the date of receipt of the denial of his application, file with the Administrator a written request for a hearing in the form prescribed in § 1316.47 of this chapter. (b) Any applicant entitled to a hearing pursuant to § 1312.42 may, within the period permitted for filing a request for a hearing, file with the Administrator a waiver of an opportunity for a hearing, together with a written statement regarding his position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein. (c) If any applicant entitled to a hearing pursuant to § 1312.42 fails to appear at the hearing, he shall be deemed to have waived his opportunity for the hearing unless he shows good cause for such failure. (d) If the applicant waives or is deemed to have waived this opportunity for the hearing, the Administrator may cancel the hearing, if scheduled, and issue his final order pursuant to § 1312.47 without a hearing. | ||||||
| 21:21:9.0.1.1.13.0.48.29 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.45 Burden of proof. | DEA | [37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] | At any hearing on the denial of an application for an import, export, or transshipment permit, the Administrator shall have the burden of proving that the requirements for such permit pursuant to sections 1002, 1003, and 1004 of the Act (21 U.S.C. 952, 953, and 954) are not satisfied. | ||||||
| 21:21:9.0.1.1.13.0.48.30 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.46 Time and place of hearing. | DEA | [37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] | (a) If any applicant for an import, export, or transshipment permit requests a hearing on the issuance or denial of his application, the Administrator shall hold such hearing. Notice of the hearing shall be given to the applicant of the time and place at least 30 days prior to the hearing, unless the applicant waives such notice and requests the hearing be held at an earlier time, in which case the Administrator shall fix a date for such hearing as early as reasonably possible. (b) The hearing will commence at the place and time designated in the notice given pursuant to paragraph (a) of this section but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing. | ||||||
| 21:21:9.0.1.1.13.0.48.31 | 21 | Food and Drugs | II | 1312 | PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES | § 1312.47 Final order. | DEA | [37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] | As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall issue his order on the issuance or denial of the application for and import, export, or transshipment permit. The order shall include the findings of fact and conclusions of law upon which the order is based. The Administrator shall serve one copy of his order upon the applicant. |
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title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
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agency TEXT,
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source_citation TEXT,
amendment_citations TEXT,
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CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);