§823. Registration requirements — Inbound Citations
21 U.S.C. § 823
Implementing Regulations (Code of Federal Regulations)
Statutory authority for 25 regulations in the Code of Federal Regulations.
Code of Federal Regulations Citations
Cited by 32 regulations in the Code of Federal Regulations.
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(i) Except as provided in paragraph (1)(ii) of this definition, such term does not include an anabolic steroid that is expressly intended for administration through implants to cattle or other nonhuman species and that has been approved by the Secretary of Health and Human Services for such administration.(ii) If any person prescribes, dispenses, or distributes such steroid for human use, the person shall be considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of this definition.
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(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:
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(i) Who is registered under 21 U.S.C. 823;
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(c) As a condition on registration under this part and section 303 of the Act (21 U.S.C. 823) to dispense controlled substances in schedule II, III, IV, or V, qualified practitioners, as defined in § 1300.01 of this chapter, must meet the training requirements set forth in section 303(m) of the Act (21 U.S.C. 823(m)). No qualified practitioner is required to complete the training more than once. This requirement applies from the first registration or renewal of registration by a qualified practitioner that occurs on or after June 27, 2023.
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(k) The Administration shall establish an expedited review process for entities holding state medical marijuana licenses who seek registration as a marijuana manufacturer, distributor, or dispenser. Such applicants shall submit, along with the applicable DEA form or forms, proof of a state medical marijuana license in the form specified by the Administrator. The Administrator shall register an applicant under this subsection unless the Administrator determines that the issuance of such registration is inconsistent with the public interest, taking into account the factors set forth at 21 U.S.C. 823(e) through (g), as applicable, and the requirements of the Single Convention on Narcotic Drugs, including any quota requirement. In general, registration of an applicant that complies with a state-law regime that contains robust protections against diversion, requirements for record-keeping and reporting, and safety and inspection measures will not be inconsistent with the public interest so long as registration is consistent with the Single Convention.(i) A registered marijuana manufacturer may cultivate, produce, process, package, label, and transfer marijuana and products containing marijuana to registered distributors or other registered manufacturers, subject to the limitations of its state license.(ii) A registered distributor may receive marijuana and products containing marijuana from registered manufacturers and transfer marijuana and products containing marijuana to registered dispensers or other registered distributors, subject to the limitations of its state license.(iii) A registered dispenser may dispense marijuana and products containing marijuana to individuals authorized by state law to possess marijuana and products containing marijuana for medical purposes, subject to the limitations of its state license.(iv) Registrations under this subpart do not authorize the manufacture, distribution, dispensing, or use of marijuana or products containing marijuana for non-medical purposes.(v) A single entity may be granted multiple types of registrations.(2) For purposes of 21 U.S.C. 823(e) through (g), and for any other purpose, a state license shall constitute conclusive evidence that the applicant is authorized under state law to engage in the activity for which registration is sought.(3) A registration issued under this section shall not exceed the scope of the holder's state medical marijuana license. If the state medical marijuana license is suspended, revoked, or expires, the DEA registration is automatically suspended.(4) Notwithstanding any other provision of this part, the Administrator shall require registrants under this subsection to submit only such reports and records, and to use only such order forms, as the Administrator concludes are necessary to comply with federal statutory and treaty obligations. The Administrator shall accept state-required reports, records, and forms to the maximum extent permissible.(5) Notwithstanding part 1306 of this chapter or any other provision of these rules, a certification or other document (including an electronic document) that state law deems sufficient for a user to obtain marijuana or products containing marijuana for medical purposes shall be sufficient to permit dispensing of marijuana or products containing marijuana to a user so long as the certification or other document is dated as of, and signed on, the day when issued; bears the full name and address of the user; and contains the name, address, and state license number of the practitioner who signed the certification or other document and is authorized to do so under state law.(6) Part 1318 of this chapter shall not apply to entities holding valid licenses under this paragraph (k)(6).(i) All manufacturers registered under this subsection shall establish a nominal price for the purchase of their marijuana crops. The Administration shall then purchase the entity's crops at that price and sell the crops back to the entity, or a related or subsidiary entity, at the same price with the addition of the administrative fee as calculated under § 1318.06(a) of this chapter.(ii) All registered manufacturers shall store marijuana crops in a facility to which the Administration maintains access until the transaction set forth in paragraph (k)(6)(i) of this section is complete. The Administration shall have the right to inspect such facilities on demand.(iii) A registration for a manufacturer under this subsection shall specify the areas in which marijuana cultivation is permitted.(7) The Administrator shall make every effort to process all applications submitted within 60 days of the publication of this regulation in the Federal Register within six months. Notwithstanding paragraph (a) of this section, any applicant that submits an application within 60 days of the publication of this rule in the Federal Register may engage in the manufacture, distribution, and/or dispensing of marijuana or products containing marijuana for medical purposes in conformity with a state-issued license during the pendency of the application.(8) A registrant under this subsection is exempt from the labeling, packaging, and sealing requirements under part 1302 of this chapter, and other provisions of these rules so long as they label, package, and seal marijuana and products containing marijuana in conformity with state law and so long as the label includes the warning required by 21 U.S.C. 825(c), where applicable.(9) Notwithstanding part 1317 of this chapter. or any other provision of these rules, a registrant under this paragraph may dispose of marijuana and products containing marijuana in conformity with state law.(10) Notwithstanding any other provision of these rules, a registrant under this paragraph has sufficient physical-security requirements if the registrant meets the requirements of state law.
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(a) A pharmacy that has been issued a registration under § 1301.13 may request that the Administrator modify its registration to authorize the pharmacy to dispense controlled substances by means of the Internet as an online pharmacy. The Administrator may deny an application for a modification of registration if the Administrator determines that the issuance of a modification would be inconsistent with the public interest. In determining the public interest, the Administrator will consider the factors listed in section 303(f) of the Act (21 U.S.C. 823(f)).
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(a) An emergency medical services agency shall be issued a registration under § 1301.13 if the agency submits an application demonstrating it is authorized to conduct such activity under the laws of each State in which the agency practices, unless the Administration determines that the issuance of such a registration would be inconsistent with the requirements of 21 U.S.C. 823(k) or the public interest based on the factors listed in 21 U.S.C. 823(g).(1) An agency has the option of requesting a single registration in each State where the agency administers controlled substances in lieu of a separate registration for each location of the agency within a State.(2) If a hospital where an emergency medical services agency is based is registered under § 1301.13, the agency may use the registration of the hospital to administer controlled substances in accordance with § 1306.07(g) of this chapter, without being separately registered as an emergency medical services agency.
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The Administrator may inspect, or cause to be inspected, the establishment of an applicant or registrant, pursuant to subpart A of part 1316 of this chapter. The Administrator shall review the application for registration and other information gathered by the Administrator regarding an applicant in order to determine whether the applicable standards of section 303 (21 U.S.C. 823) or section 1008 (21 U.S.C. 958) of the Act have been met by the applicant.
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(iii) Such amounts of any controlled substance listed in Schedule I or II as the Administrator shall find to be necessary to provide for the medical, scientific, or other legitimate needs of the United States 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 Act (21 U.S.C. 823); or
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(a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if the issuance of registration or reregistration is required under the applicable provisions of sections 303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the issuance of registration or reregistration is not required, the Administrator shall deny the application. Before denying any application, the Administrator shall issue an order to show cause pursuant to § 1301.37 and, if requested by the applicant, shall hold a hearing on the application pursuant to § 1301.41.
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(a) For any registration issued under section 303 of the Act (21 U.S.C. 823), the Administrator may:(1) Suspend the registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time.(2) Revoke the registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)).
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(a) If, upon examination of the application for registration from any applicant and other information gathered by the Administration regarding the applicant, the Administrator is unable to make the determinations required by the applicable provisions of section 303 and/or section 1008 of the Act (21 U.S.C. 823 and 958) to register the applicant, the Administrator shall serve upon the applicant an order to show cause why the registration should not be denied.
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(d) At any other hearing for the denial of a registration, the Administration shall have the burden of proving that the requirements for such registration pursuant to section 303 or section 1008(c) and (d) of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied.
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(a) Only persons who are registered with DEA under section 303 of the Act (21 U.S.C. 823) to handle Schedule I or II controlled substances, and persons who are registered with DEA under section 1008 of the Act (21 U.S.C. 958) to export these substances may obtain and use DEA Form 222 (order forms) or issue electronic orders for these substances. Persons not registered to handle Schedule I or II controlled substances and persons registered only to import controlled substances are not entitled to obtain Form 222 or issue electronic orders for these substances.
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An order for Schedule I and II controlled substances, whether on a DEA Form 222 or an electronic order, may be filled only by a person registered with DEA as a manufacturer or distributor of controlled substances listed in Schedule I or II pursuant to section 303 of the Act (21 U.S.C. 823) or as an importer of such substances pursuant to section 1008 of the Act (21 U.S.C. 958), except for the following:
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(1) An employee or contractor of the Department of Veterans Affairs (VA) who is acting in the scope of such employment or contract, and registered under section 303(g) of the Act (21 U.S.C. 823(g)) (§ 1301.13 of this chapter) in any state or is utilizing the registration of a hospital or clinic operated by the VA registered under section 303(f);
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Procedures governing the registration of manufacturers, distributors, importers and exporters of List I chemicals pursuant to Sections 102, 302, 303, 1007 and 1008 of the Act (21 U.S.C. 802, 822, 823, 957 and 958) are set forth generally by those sections and specifically by the sections of this part.
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The Administrator may inspect, or cause to be inspected, the establishment of an applicant or registrant, pursuant to subpart A of part 1316 of this chapter. The Administrator shall review the application for registration and other information gathered by the Administrator regarding an applicant in order to determine whether the applicable standards of Section 303 of the Act (21 U.S.C. 823) have been met by the applicant.
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(a) The Administrator shall issue a Certificate of Registration (DEA Form 511) to an applicant if the issuance of registration or reregistration is required under the applicable provisions of section 303 of the Act (21 U.S.C. 823). In the event that the issuance of registration or reregistration is not required, the Administrator shall deny the application. Before denying any application, the Administrator shall issue an order to show cause pursuant to Section 1309.46 and, if requested by the applicant, shall hold a hearing on the application pursuant to § 1309.51.
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(a) If, upon examination of the application for registration from any applicant and other information gathered by the Administration regarding the applicant, the Administrator is unable to make the determinations required by the applicable provisions of section 303 of the Act (21 U.S.C. 823) to register the applicant, the Administrator shall serve upon the applicant an order to show cause why the application for registration should not be denied.
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(a) At any hearing for the denial of a registration, the Administration shall have the burden of proving that the requirements for such registration pursuant to section 303 of the Act (21 U.S.C. 823) are not satisfied.
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(a) The chemical mixtures meeting the criteria in paragraphs (c) or (d) of this section are exempted by the Administrator from application of sections 302, 303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C. 822, 823, 830, 957, 958, and 971) to the extent described in paragraphs (b) and (c) of this section.
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(i) The following chemical mixtures, in the form and quantity listed in the application submitted (indicated as the “date”) are designated as exempt chemical mixtures for the purposes set forth in this section and are exempted by the Administrator from application of Sections 302, 303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C. 822, 823, 830, 957, 958, and 971):
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(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
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(a) As provided in section 303(a) of the Act (21 U.S.C. 823(a)), the Administrator may grant an application for a registration to manufacture marihuana, including the cultivation of cannabis, only if he determines that such registration is consistent with the public interest and with United States obligations under the Single Convention.
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(a) In accordance with section 303(a) of the Act (21 U.S.C. 823(a)), the Administrator shall consider the public interest factors set forth in paragraphs (a)(1) through (6) of this section:(1) Maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes;(2) Compliance with applicable State and local law;(3) Promotion of technical advances in the art of manufacturing these substances and the development of new substances;(4) Prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances;(5) Past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and(6) Such other factors as may be relevant to and consistent with the public health and safety.
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(1) An employee or contractor of the Department of Veterans Affairs (VA) who is acting in the scope of such employment or contract, and registered under section 303(g) of the Controlled Substances Act (Act) (21 U.S.C. 823(g)) (21 CFR 1301.13) in any state or is utilizing the registration of a hospital or clinic operated by the VA registered under section 303(f);
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(a) This subpart and subparts B through D of this part establish the procedures by which the Secretary of Health and Human Services (the Secretary) will determine whether an applicant seeking to become an Opioid Treatment Program (OTP) is qualified under section 303(h) of the Controlled Substances Act (CSA) (21 U.S.C. 823(h)) to dispense Medications for Opioid Use Disorder (MOUD) in the treatment of Opioid Use Disorder (OUD), and establishes the Secretary's standards regarding the appropriate quantities of MOUD that may be provided for unsupervised use by individuals undergoing such treatment (21 U.S.C. 823(h)). Under this subpart and subparts B through D, an applicant seeking to become an OTP must first obtain from the Secretary or, by delegation, from the Assistant Secretary for Mental Health and Substance Use, a certification that the applicant is qualified under the Secretary's standards and will comply with such standards. Eligibility for certification will depend upon the applicant obtaining accreditation from an Accreditation Body that has been approved by the Secretary. This subpart and subparts B through D also establish the procedures whereby an entity can apply to become an approved Accreditation Body, and the requirements and general standards for Accreditation Bodies to ensure that OTPs are consistently evaluated for compliance with the Secretary's standards for treatment of OUD with MOUD.
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(1) An OTP must be the subject of a current, valid certification from the Secretary to be considered qualified by the Secretary under section 303(h) of the Controlled Substances Act (21 U.S.C. 823(h)(1)) to dispense MOUD in the treatment of OUD. An OTP must be determined to be qualified under section 303(h) of the Controlled Substances Act and must be determined to be qualified by the Attorney General under section 303(h), to be registered by the Attorney General to dispense MOUD to individuals for treatment of OUD.
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The following definitions apply to this part:
United States Code Citations
Cited by 47 provisions in release 119-102.
Citations to 21 U.S.C. § 823 as a whole
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(i) manufacturers or distributors registered under subsection (a), (b), (e), or (f) of section 823 of this title who do not dispense controlled substances to an unregistered individual or entity;
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(a) A registration pursuant to section 823 of this title to manufacture, distribute, or dispense a controlled substance or a list I chemical may be suspended or revoked by the Attorney General upon a finding that the registrant—(1) has materially falsified any application filed pursuant to or required by this subchapter or subchapter II;(2) has been convicted of a felony under this subchapter or subchapter II or any other law of the United States, or of any State, relating to any substance defined in this subchapter as a controlled substance or a list I chemical;(3) has had his State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals or has had the suspension, revocation, or denial of his registration recommended by competent State authority;(4) has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section; or(5) has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a–7(a) of title 42.A registration pursuant to section 823(h) of this title to dispense a narcotic drug for maintenance treatment or detoxification treatment may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in section 823(h) of this title.
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(4) has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section; or
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(1) Before taking action pursuant to this section, or pursuant to a denial of registration under section 823 of this title, the Attorney General shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked, or suspended.
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(f) In the event the Attorney General suspends or revokes a registration granted under section 823 of this title, all controlled substances or list I chemicals owned or possessed by the registrant pursuant to such registration at the time of suspension or the effective date of the revocation order, as the case may be, may, in the discretion of the Attorney General, be placed under seal. No disposition may be made of any controlled substances or list I chemicals under seal until the time for taking an appeal has elapsed or until all appeals have been concluded except that a court, upon application therefor, may at any time order the sale of perishable controlled substances or list I chemicals. Any such order shall require the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all such controlled substances or list I chemicals (or proceeds of sale deposited in court) shall be forfeited to the United States; and the Attorney General shall dispose of such controlled substances or list I chemicals in accordance with section 881(e) of this title. All right, title, and interest in such controlled substances or list I chemicals shall vest in the United States upon a revocation order becoming final.
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(1) Every manufacturer registered under section 823 of this title shall, at such time or times and in such form as the Attorney General may require, make periodic reports to the Attorney General of every sale, delivery or other disposal by him of any controlled substance, and each distributor shall make such reports with respect to narcotic controlled substances, identifying by the registration number assigned under this subchapter the person or establishment (unless exempt from registration under section 822(d) of this title) to whom such sale, delivery, or other disposal was made.
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(e) In addition to the reporting and recordkeeping requirements under any other provision of this subchapter, each manufacturer registered under section 823 of this title shall, with respect to narcotic and nonnarcotic controlled substances manufactured by it, make such reports to the Attorney General, and maintain such records, as the Attorney General may require to enable the United States to meet its obligations under articles 19 and 20 of the Single Convention on Narcotic Drugs and article 16 of the Convention on Psychotropic Substances. The Attorney General shall administer the requirements of this subsection in such a manner as to avoid the unnecessary imposition of duplicative requirements under this subchapter on manufacturers subject to the requirements of this subsection.
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(1) The Attorney General shall issue forms pursuant to subsections (a) and (c)(2) only to persons validly registered under section 823 of this title (or exempted from registration under section 822(d) of this title). Whenever any such form is issued to a person, the Attorney General shall, before delivery thereof, insert therein the name of such person, and it shall be unlawful for any other person (A) to use such form for the purpose of obtaining controlled substances or (B) to furnish such form to any person with intent thereby to procure the distribution of such substances.
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(a) It shall be unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by this subchapter or subchapter II. It shall be unlawful for any person knowingly or intentionally to possess any list I chemical obtained pursuant to or under authority of a registration issued to that person under section 823 of this title or section 958 of this title if that registration has been revoked or suspended, if that registration has expired, or if the registrant has ceased to do business in the manner contemplated by his registration. It shall be unlawful for any person to knowingly or intentionally purchase at retail during a 30 day period more than 9 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product, except that, of such 9 grams, not more than 7.5 grams may be imported by means of shipping through any private or commercial carrier or the Postal Service. Any person who violates this subsection may be sentenced to a term of imprisonment of not more than 1 year, and shall be fined a minimum of $1,000, or both, except that if he commits such offense after a prior conviction under this subchapter or subchapter II, or a prior conviction for any drug, narcotic, or chemical offense chargeable under the law of any State, has become final, he shall be sentenced to a term of imprisonment for not less than 15 days but not more than 2 years, and shall be fined a minimum of $2,500, except, further, that if he commits such offense after two or more prior convictions under this subchapter or subchapter II, or two or more prior convictions for any drug, narcotic, or chemical offense chargeable under the law of any State, or a combination of two or more such offenses have become final, he shall be sentenced to a term of imprisonment for not less than 90 days but not more than 3 years, and shall be fined a minimum of $5,000. Notwithstanding any penalty provided in this subsection, any person convicted under this subsection for the possession of flunitrazepam shall be imprisoned for not more than 3 years, shall be fined as otherwise provided in this section, or both. The imposition or execution of a minimum sentence required to be imposed under this subsection shall not be suspended or deferred. Further, upon conviction, a person who violates this subsection shall be fined the reasonable costs of the investigation and prosecution of the offense, including the costs of prosecution of an offense as defined in sections 1918 and 1920 of title 28, except that this sentence shall not apply and a fine under this section need not be imposed if the court determines under the provision of title 18 that the defendant lacks the ability to pay.
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(2) places, including factories, warehouses, and other establishments, and conveyances, where persons registered under section 823 of this title (or exempt from registration under section 822(d) of this title or by regulation of the Attorney General) or regulated persons may lawfully hold, manufacture, distribute, dispense, administer, or otherwise dispose of controlled substances or listed chemicals or where records relating to those activities are maintained.
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(B) in any case in which the Attorney General 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 823 of this title, or
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(e) No registration shall be issued under this subchapter for a period in excess of one year. Unless the regulations of the Attorney General otherwise provide, sections 822(f), 825, 827, and 830 of this title shall apply to persons registered under this section to the same extent such sections apply to persons registered under section 823 of this title.
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Part E of subchapter I shall apply with respect to functions of the Attorney General (and of officers and employees of the Bureau of Narcotics and Dangerous Drugs) under this subchapter, to administrative and judicial proceedings under this subchapter, and to violations of this subchapter, to the same extent that such part applies to functions of the Attorney General (and such officers and employees) under subchapter I, to such proceedings under subchapter I, and to violations of subchapter I. For purposes of the application of this section to section 880 or 881 of this title, any reference in such section 880 or 881 of this title to “this subchapter” shall be deemed to be a reference to this subchapter, any reference to section 823 of this title shall be deemed to be a reference to section 958 of this title, and any reference to section 822(d) of this title shall be deemed to be a reference to section 957(b)(2) of this title.
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(3) The term “Drug Enforcement Administration registration” means registration with the Drug Enforcement Administration under section 303 of the Controlled Substances Act (21 U.S.C. 823) 302 of the Controlled Substances Act (21 U.S.C. 822) by health care practitioners authorized to dispense, prescribe, administer, or conduct research with, controlled substances.
Citations to §823(a)
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(a) The Attorney General shall register an applicant to import or export a controlled substance in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the factors enumerated in paragraph (1) through (6) of section 823(a) of this title shall be considered.
Citations to §823(e)
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(1) The Attorney General shall register an applicant to import a controlled substance in schedule III, IV, or V or to export a controlled substance in schedule III or IV, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the factors enumerated in paragraphs (1) through (6) of section 823(e) of this title shall be considered.
Citations to §823(g)
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(ii) nonpharmacy practitioners who are registered under section 823(g) of this title and whose activities are authorized by that registration;
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(iii) any hospital or other medical facility that is operated by an agency of the United States (including the Armed Forces), provided such hospital or other facility is registered under section 823(g) of this title;
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(viii) a pharmacy registered under section 823(g) of this title whose dispensing of controlled substances via the Internet consists solely of—(I) refilling prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (55); or(II) filling new prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (56); or
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(i) while the patient is being treated by, and physically located in, a hospital or clinic registered under section 823(g) of this title; and
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(III) registered under section 823(g) of this title in the State in which the patient is located, unless the practitioner—(aa) is exempted from such registration in all States under section 822(d) of this title; or(bb) is—(AA) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and(BB) registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;
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(BB) registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;
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(iii) registered under section 823(g) of this title in the State in which the patient is located, unless the practitioner—(I) is exempted from such registration in all States under section 822(d) of this title; or(II) is—(aa) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and(bb) registered under section 823(g) of this title in any State or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;
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(bb) registered under section 823(g) of this title in any State or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;
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(I) that prevents the patient from being in the physical presence of a practitioner registered under section 823(g) of this title who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor;
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(II) that prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;
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(II) is registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title; and
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(A) Notwithstanding paragraph (1), a person registered to conduct research with a controlled substance under section 823(g) of this title may conduct the research under a single registration if—(i) the research occurs exclusively on sites all of which are—(I) within the same city or county; and(II) under the control of the same institution, organization, or agency; and(ii) before commencing the research, the researcher notifies the Attorney General of each site where—(I) the research will be conducted; or(II) the controlled substance will be stored or administered.
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(bb) registered under section 823(g) of this title; and
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(ii) a research protocol filed with an application for registration approval under section 823(g) of this title; or
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(ii) a research protocol filed with an application for registration approval under section 823(g) of this title; and
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(2) Each pharmacy with a modified registration under section 823(g) of this title that authorizes the dispensing of controlled substances by means of the Internet shall report to the Attorney General the controlled substances it dispenses, in the amount specified, and in such time and manner as the Attorney General by regulation shall require, except that the Attorney General, under this paragraph, may not require any pharmacy to report any information other than the total quantity of each controlled substance that the pharmacy has dispensed each month. For purposes of this paragraph, no reporting shall be required unless the pharmacy has met 1 of the following thresholds in the month for which the reporting is required:(A) 100 or more prescriptions dispensed.(B) 5,000 or more dosage units of all controlled substances combined.
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(B) is registered under section 823(g) of this title in the State in which the patient will be located when receiving the telemedicine treatment, unless the practitioner—(i) is exempted from such registration in all States under section 822(d) of this title; or(ii) is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract and is registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title.
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(ii) is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract and is registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title.
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(A) delivering, distributing, or dispensing a controlled substance by means of the Internet by an online pharmacy that is not validly registered with a modification authorizing such activity as required by section 823(g) of this title (unless exempt from such registration);
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(B) Examples of activities that violate subparagraph (A) include, but are not limited to, knowingly or intentionally causing the placement on the Internet of an advertisement that refers to or directs prospective buyers to Internet sellers of controlled substances who are not registered with a modification under section 823(g) of this title.
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(1) In any case in which the State has reason to believe that an interest of the residents of that State has been or is being threatened or adversely affected by the action of a person, entity, or Internet site that violates the provisions of section 823(g), 829(e), or 831 of this title, the State may bring a civil action on behalf of such residents in a district court of the United States with appropriate jurisdiction—(A) to enjoin the conduct which violates this section;(B) to enforce compliance with this section;(C) to obtain damages, restitution, or other compensation, including civil penalties under section 842(b) of this title; and(D) to obtain such other legal or equitable relief as the court may find appropriate.
Citations to §823(g)(1)(B)
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(I) subparagraphs (B) through (E) of paragraph (1); and
Citations to §823(g)(1)(C)
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(I) subparagraphs (B) through (E) of paragraph (1); and
Citations to §823(g)(1)(D)
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(I) subparagraphs (B) through (E) of paragraph (1); and
Citations to §823(g)(1)(E)
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(I) subparagraphs (B) through (E) of paragraph (1); and
Citations to §823(h)
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(3) Notwithstanding paragraph (1), a registrant that is dispensing pursuant to section 823(h) of this title narcotic drugs to individuals for maintenance treatment or detoxification treatment shall not be required to have a separate registration to incorporate one or more mobile medication units into the registrant’s practice to dispense such narcotics at locations other than the registrant’s principal place of business or professional practice described in paragraph (1), so long as the registrant meets such standards for operation of a mobile medication unit as the Attorney General may establish.
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(a) A registration pursuant to section 823 of this title to manufacture, distribute, or dispense a controlled substance or a list I chemical may be suspended or revoked by the Attorney General upon a finding that the registrant—(1) has materially falsified any application filed pursuant to or required by this subchapter or subchapter II;(2) has been convicted of a felony under this subchapter or subchapter II or any other law of the United States, or of any State, relating to any substance defined in this subchapter as a controlled substance or a list I chemical;(3) has had his State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals or has had the suspension, revocation, or denial of his registration recommended by competent State authority;(4) has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section; or(5) has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a–7(a) of title 42.A registration pursuant to section 823(h) of this title to dispense a narcotic drug for maintenance treatment or detoxification treatment may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in section 823(h) of this title.
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(1) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety. A failure to comply with a standard referred to in section 823(h) of this title may be treated under this subsection as grounds for immediate suspension of a registration granted under such section. A suspension under this subsection shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction.
Citations to §823(i)
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(B) In determining the public interest for the purposes of subparagraph (A), the Attorney General shall consider the factors specified in section 823(i) of this title.
Citations to §823(n)
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(i) a notification submitted to the Attorney General under section 823(n) of this title;
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(i) the information provided as part of a notification submitted to the Attorney General under section 823(n) of this title; or