§1310.02. Substances covered. — Inbound Citations

(d) Each application for registration must include the Administration Chemical Code Number, as set forth in § 1310.02 of this chapter, for each List I chemical to be manufactured, distributed, imported, or exported.

(a) Any List I or List II chemical listed in § 1310.02 of this chapter may be imported if that chemical is necessary for medical, commercial, scientific, or other legitimate uses within the United States. Chemical importations into the United States for immediate transfer/transshipment outside the United States must comply with the procedures set forth in § 1313.31 and all other applicable laws.

(a) Any List I or List II chemical listed in § 1310.02 of this chapter which meets or exceeds the quantitative threshold criteria established in § 1310.04(f) of this chapter or is a listed chemical for which no threshold has been established as identified in § 1310.04(g) of this chapter, may be exported if that chemical is needed for medical, commercial, scientific, or other legitimate uses.

(a) A quantity of a chemical listed in § 1310.02 of this chapter that meets or exceeds the threshold reporting requirements found in § 1310.04(f) of this chapter may be imported into the United States for transshipment, or may be transferred or transshipped within the United States for immediate exportation, provided that advance notice is given to the Administration.

(a) An international transaction involving a chemical listed in § 1310.02 of this chapter which meets the threshold criteria established in § 1310.04 of this chapter may be arranged by a broker or trader if the chemical is needed for medical, commercial, scientific, or other legitimate uses.

(a) The Administrator may suspend any importation or exportation of a chemical listed in § 1310.02 of this chapter based on evidence that the chemical proposed to be imported or exported may be diverted to the clandestine manufacture of a controlled substance. If the Administrator so suspends, he shall provide written notice of such suspension to the regulated person. Such notice shall contain a statement of the legal and factual basis for the order.

(3) Fulfilling a formal obligation to complete the transaction by bringing together a buyer and seller, a buyer and transporter, or a seller and transporter, or by receiving any form of compensation for so doing.

Chemical export means transferring ownership or control, or the sending or taking of threshold quantities of listed chemicals out of the United States (whether or not such sending or taking out constitutes an exportation within the meaning of the customs and related laws of the United States).

Chemical exporter is a regulated person who, as the principal party in interest in the export transaction, has the power and responsibility for determining and controlling the sending of the listed chemical out of the United States.

Chemical importer is a regulated person who, as the principal party in interest in the import transaction, has the power and responsibility for determining and controlling the bringing in or introduction of the listed chemical into the United States.

Chemical mixture means a combination of two or more chemical substances, at least one of which is not a listed chemical, except that such term does not include any combination of a listed chemical with another chemical that is present solely as an impurity or which has been created to evade the requirements of the Act.

Combination ephedrine product means a drug product containing ephedrine or its salts, optical isomers, or salts of optical isomers, and therapeutically significant quantities of another active medicinal ingredient.

Competent national authority, for purposes of importation and exportation of controlled substances and listed chemicals, means an entity lawfully entitled to authorize the import and export of controlled substances, and to regulate or enforce national controls over listed chemicals, and included as such in the directory of “Competent National Authorities Under the International Drug Control Treaties” published by the United Nations Office on Drugs and Crime.

Customs officer means either an Officer of the Customs as defined in 19 U.S.C. 1401(i) (that is, of the U.S. Customs and Border Protection), or any individual duly authorized to accept entries of merchandise, to collect duties, and to enforce the customs laws of any commonwealth, territory, or possession of the United States.

Customs territory of the United States means the several States, the District of Columbia, and Puerto Rico.

Drug product means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Federal Food, Drug, and Cosmetic Act for distribution in the United States.

Encapsulating machine means any manual, semi-automatic, or fully automatic equipment which may be used to fill shells or capsules with any powdered, granular, semi-solid, or liquid material.

Established business relationship means the regulated person has imported or exported a listed chemical at least once within the past six months, or twice within the past twelve months from or to a foreign manufacturer, distributor, or end user of the chemical that has an established business with a fixed street address. A person or business that functions as a broker or intermediary is not a customer for purposes of this definition.

Established record as an importer means that the regulated person has imported a listed chemical at least once within the past six months, or twice within the past twelve months from a foreign supplier.

Export means, with respect to any article, any taking out or removal of such article from the United States (whether or not such taking out or removal constitutes an exportation within the meaning of the customs laws, export control laws enforced by other agencies, or related laws of the United States).

Hearing means any hearing held for the granting, denial, revocation, or suspension of a registration pursuant to sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).

Import means, with respect to any article, any bringing in or introduction of such article 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 (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States).

International transaction means a transaction involving the shipment of a listed chemical across an international border (other than a United States border) in which a broker or trader located in the United States participates.

Listed chemical means any List I chemical or List II chemical.

List I chemical means a chemical specifically designated by the Administrator in § 1310.02(a) of this chapter that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act and is important to the manufacture of a controlled substance.

List II chemical means a chemical, other than a List I chemical, specifically designated by the Administrator in § 1310.02(b) of this chapter that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act.

Mobile retail vendor means a person or entity that makes sales at retail from a stand that is intended to be temporary or is capable of being moved from one location to another, whether the stand is located within or on the premises of a fixed facility (such as a kiosk at a shopping center or an airport) or whether the stand is located on unimproved real estate (such as a lot or field leased for retail purposes).

Name means the official name, common or usual name, chemical name, or brand name of a substance.

Person includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.

Port of entry, unless distinguished as being a foreign port of entry, means any place at which a customs officer is duly authorized to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs laws of the United States (whether or not such place is a port of entry as defined in title 19 of the United States Code or its associated implementing regulations). Examples of ports of entry include, but are not limited to, places designated as ports of entry or customs stations in title 19 of the Code of Federal Regulations or by the governing customs authority of that area. When shipments are transported under U.S. Customs and Border Protection immediate transportation procedures, the port of entry shall be the port of final destination.

Port of export means, unless distinguished as being a foreign port of export, any place under the control of a customs officer where goods are loaded on an aircraft, vessel or other conveyance for export outside of the United States. For goods loaded aboard an aircraft or vessel in the United States that stops at several ports before departing the United States, the port of export is the first port where the goods were loaded. For goods off-loaded from the original conveyance to another conveyance (even if the aircraft or vessel belongs to the same carrier) at any port subsequent to the port where the first on-loading occurred in the United States, the port where the goods were loaded onto the last conveyance before departing the United States is the port of export. For reporting purposes, in the case of an otherwise lawful export occurring by mail, the port of export is the place of mailing.

Readily retrievable means that certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.

Register and registration refer only to registration required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 or 957).

Registrant means any person who is registered pursuant to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).

Regular customer means a person with whom the regulated person has an established business relationship for a specified listed chemical or chemicals that has been reported to the Administration subject to the criteria established in part 1313 of this chapter.

Regular importer means, with respect to a listed chemical, a person that has an established record as an importer of that listed chemical that is reported to the Administrator.

Regulated person means any individual, corporation, partnership, association, or other legal entity who manufactures, distributes, imports, or exports a listed chemical, a tableting machine, or an encapsulating machine, or who acts as a broker or trader for an international transaction involving a listed chemical, tableting machine, or encapsulating machine.

Regulated seller means a retail distributor (including a pharmacy or a mobile retail vendor), except that the term does not include an employee or agent of the distributor.

Regulated transaction means:

(3) Fulfilling a formal obligation to complete the transaction by bringing together a buyer and seller, a buyer and transporter, or a seller and transporter, or by receiving any form of compensation for so doing.

Chemical export means transferring ownership or control, or the sending or taking of threshold quantities of listed chemicals out of the United States (whether or not such sending or taking out constitutes an exportation within the meaning of the customs and related laws of the United States).

Chemical exporter is a regulated person who, as the principal party in interest in the export transaction, has the power and responsibility for determining and controlling the sending of the listed chemical out of the United States.

Chemical importer is a regulated person who, as the principal party in interest in the import transaction, has the power and responsibility for determining and controlling the bringing in or introduction of the listed chemical into the United States.

Chemical mixture means a combination of two or more chemical substances, at least one of which is not a listed chemical, except that such term does not include any combination of a listed chemical with another chemical that is present solely as an impurity or which has been created to evade the requirements of the Act.

Combination ephedrine product means a drug product containing ephedrine or its salts, optical isomers, or salts of optical isomers, and therapeutically significant quantities of another active medicinal ingredient.

Competent national authority, for purposes of importation and exportation of controlled substances and listed chemicals, means an entity lawfully entitled to authorize the import and export of controlled substances, and to regulate or enforce national controls over listed chemicals, and included as such in the directory of “Competent National Authorities Under the International Drug Control Treaties” published by the United Nations Office on Drugs and Crime.

Customs officer means either an Officer of the Customs as defined in 19 U.S.C. 1401(i) (that is, of the U.S. Customs and Border Protection), or any individual duly authorized to accept entries of merchandise, to collect duties, and to enforce the customs laws of any commonwealth, territory, or possession of the United States.

Customs territory of the United States means the several States, the District of Columbia, and Puerto Rico.

Drug product means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Federal Food, Drug, and Cosmetic Act for distribution in the United States.

Encapsulating machine means any manual, semi-automatic, or fully automatic equipment which may be used to fill shells or capsules with any powdered, granular, semi-solid, or liquid material.

Established business relationship means the regulated person has imported or exported a listed chemical at least once within the past six months, or twice within the past twelve months from or to a foreign manufacturer, distributor, or end user of the chemical that has an established business with a fixed street address. A person or business that functions as a broker or intermediary is not a customer for purposes of this definition.

Established record as an importer means that the regulated person has imported a listed chemical at least once within the past six months, or twice within the past twelve months from a foreign supplier.

Export means, with respect to any article, any taking out or removal of such article from the United States (whether or not such taking out or removal constitutes an exportation within the meaning of the customs laws, export control laws enforced by other agencies, or related laws of the United States).

Hearing means any hearing held for the granting, denial, revocation, or suspension of a registration pursuant to sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).

Import means, with respect to any article, any bringing in or introduction of such article 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 (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States).

International transaction means a transaction involving the shipment of a listed chemical across an international border (other than a United States border) in which a broker or trader located in the United States participates.

Listed chemical means any List I chemical or List II chemical.

List I chemical means a chemical specifically designated by the Administrator in § 1310.02(a) of this chapter that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act and is important to the manufacture of a controlled substance.

List II chemical means a chemical, other than a List I chemical, specifically designated by the Administrator in § 1310.02(b) of this chapter that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act.

Mobile retail vendor means a person or entity that makes sales at retail from a stand that is intended to be temporary or is capable of being moved from one location to another, whether the stand is located within or on the premises of a fixed facility (such as a kiosk at a shopping center or an airport) or whether the stand is located on unimproved real estate (such as a lot or field leased for retail purposes).

Name means the official name, common or usual name, chemical name, or brand name of a substance.

Person includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.

Port of entry, unless distinguished as being a foreign port of entry, means any place at which a customs officer is duly authorized to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs laws of the United States (whether or not such place is a port of entry as defined in title 19 of the United States Code or its associated implementing regulations). Examples of ports of entry include, but are not limited to, places designated as ports of entry or customs stations in title 19 of the Code of Federal Regulations or by the governing customs authority of that area. When shipments are transported under U.S. Customs and Border Protection immediate transportation procedures, the port of entry shall be the port of final destination.

Port of export means, unless distinguished as being a foreign port of export, any place under the control of a customs officer where goods are loaded on an aircraft, vessel or other conveyance for export outside of the United States. For goods loaded aboard an aircraft or vessel in the United States that stops at several ports before departing the United States, the port of export is the first port where the goods were loaded. For goods off-loaded from the original conveyance to another conveyance (even if the aircraft or vessel belongs to the same carrier) at any port subsequent to the port where the first on-loading occurred in the United States, the port where the goods were loaded onto the last conveyance before departing the United States is the port of export. For reporting purposes, in the case of an otherwise lawful export occurring by mail, the port of export is the place of mailing.

Readily retrievable means that certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.

Register and registration refer only to registration required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 or 957).

Registrant means any person who is registered pursuant to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).

Regular customer means a person with whom the regulated person has an established business relationship for a specified listed chemical or chemicals that has been reported to the Administration subject to the criteria established in part 1313 of this chapter.

Regular importer means, with respect to a listed chemical, a person that has an established record as an importer of that listed chemical that is reported to the Administrator.

Regulated person means any individual, corporation, partnership, association, or other legal entity who manufactures, distributes, imports, or exports a listed chemical, a tableting machine, or an encapsulating machine, or who acts as a broker or trader for an international transaction involving a listed chemical, tableting machine, or encapsulating machine.

Regulated seller means a retail distributor (including a pharmacy or a mobile retail vendor), except that the term does not include an employee or agent of the distributor.

Regulated transaction means:

(2) This section does not apply to any petition submitted regarding the classification of substances pursuant to the Controlled Substances Act, 21 U.S.C. 811. Such petitions are governed by 21 CFR 1308.43 and 1310.02(d) through (h).

(2) This section does not apply to any petition submitted regarding the classification of substances pursuant to the Controlled Substances Act, 21 U.S.C. 811. Such petitions are governed by 21 CFR 1308.43 and 1310.02(d) through (h).

(2) This section does not apply to any petition submitted regarding the classification of substances pursuant to the Controlled Substances Act, 21 U.S.C. 811. Such petitions are governed by 21 CFR 1308.43 and 1310.02(d) through (h).

(2) This section does not apply to any petition submitted regarding the classification of substances pursuant to the Controlled Substances Act, 21 U.S.C. 811. Such petitions are governed by 21 CFR 1308.43 and 1310.02(d) through (h).

(2) This section does not apply to any petition submitted regarding the classification of substances pursuant to the Controlled Substances Act, 21 U.S.C. 811. Such petitions are governed by 21 CFR 1308.43 and 1310.02(d) through (h).