21 U.S.C. § 823 — Registration requirements

Page 809 TITLE 21—FOOD AND DRUGS § 823 (2) a manufacturer, distributor, or reverse distributor of prescription medications; (3) a retail pharmacy; (4) a registered narcotic treatment program; (5) a hospital or clinic with an onsite phar- macy; (6) an eligible long-term care facility; or (7) any other entity authorized by the Drug Enforcement Administration to dispose of pre- scription medications. (b) Program authorized The Attorney General, in coordination with the Administrator of the Drug Enforcement Ad- ministration, the Secretary of Health and Human Services, and the Director of the Office of National Drug Control Policy, shall coordi- nate with covered entities in expanding or mak- ing available disposal sites for unwanted pre- scription medications. (Pub. L. 114–198, title II, § 203, July 22, 2016, 130 Stat. 717.) Editorial Notes CODIFICATION Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the Controlled Substances Act which comprises this subchapter. Statutory Notes and Related Subsidiaries ACCESS TO INCREASED DRUG DISPOSAL Pub. L. 115–271, title III, subtitle B, ch. 6, Oct. 24, 2018, 132 Stat. 3950, provided that: ‘‘SEC. 3251. SHORT TITLE. ‘‘This chapter may be cited as the ‘Access to In- creased Drug Disposal Act of 2018’. ‘‘SEC. 3252. DEFINITIONS. ‘‘In this chapter— ‘‘(1) the term ‘Attorney General’ means the Attor- ney General, acting through the Assistant Attorney General for the Office of Justice Programs; ‘‘(2) the term ‘authorized collector’ means a nar- cotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse dis- tributor, that is authorized as a collector under sec- tion 1317.40 of title 21, Code of Federal Regulations (or any successor regulation); ‘‘(3) the term ‘covered grant’ means a grant award- ed under section 3003 [probably means section 3253; no section 3003 of Pub. L. 115–271 has been enacted]; and ‘‘(4) the term ‘eligible collector’ means a person who is eligible to be an authorized collector. ‘‘SEC. 3253. AUTHORITY TO MAKE GRANTS. ‘‘The Attorney General shall award grants to States to enable the States to increase the participation of el- igible collectors as authorized collectors. ‘‘SEC. 3254. APPLICATION. ‘‘A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum— ‘‘(1) identifies the single State agency that oversees pharmaceutical care and will be responsible for com- plying with the requirements of the grant; ‘‘(2) details a plan to increase participation rates of eligible collectors as authorized collectors; and ‘‘(3) describes how the State will select eligible col- lectors to be served under the grant. ‘‘SEC. 3255. USE OF GRANT FUNDS. ‘‘A State that receives a covered grant, and any sub- recipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances asso- ciated with the participation of eligible collectors as authorized collectors. ‘‘SEC. 3256. ELIGIBILITY FOR GRANT. ‘‘The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General. ‘‘SEC. 3257. DURATION OF GRANTS. ‘‘The Attorney General shall determine the period of years for which a covered grant is made to a State. ‘‘SEC. 3258. ACCOUNTABILITY AND OVERSIGHT. ‘‘A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that— ‘‘(1) lists the ultimate recipients of the grant amounts; ‘‘(2) describes the activities undertaken by the State using the grant amounts; and ‘‘(3) contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors. ‘‘SEC. 3259. DURATION OF PROGRAM. ‘‘The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act [Oct. 24, 2018]. ‘‘SEC. 3260. AUTHORIZATION OF APPROPRIATIONS. ‘‘There is authorized to be appropriated to the Attor- ney General such sums as may be necessary to carry out this chapter.’’ § 823. Registration requirements (a) Manufacturers of controlled substances in schedule I or II The Attorney General shall register an appli- cant to manufacture controlled substances in schedule I or II if he determines that such reg- istration is consistent with the public interest and with United States obligations under inter- national treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be consid- ered: (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 le- gitimate medical, scientific, research, or in- dustrial channels, by limiting the importation and bulk manufacture of such controlled sub- stances 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 manu- facture, 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 di- version; and Page 810 TITLE 21—FOOD AND DRUGS § 823 1 So in original. Probably should be preceded by ‘‘section’’. (6) such other factors as may be relevant to and consistent with the public health and safe- ty. (b) Distributors of controlled substances in schedule I or II The Attorney General shall register an appli- cant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the pub- lic interest, the following factors shall be con- sidered: (1) maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels; (2) compliance with applicable State and local law; (3) prior conviction record of applicant under Federal or State laws relating to the manufac- ture, distribution, or dispensing of such sub- stances; (4) past experience in the distribution of con- trolled substances; and (5) such other factors as may be relevant to and consistent with the public health and safe- ty. (c) Manufacturers of marijuana for research pur- poses (1)(A) As it relates to applications to manufac- ture marijuana for research purposes, when the Attorney General places a notice in the Federal Register to increase the number of entities reg- istered under this chapter to manufacture mari- juana to supply appropriately registered re- searchers in the United States, the Attorney General shall, not later than 60 days after the date on which the Attorney General receives a completed application— (i) approve the application; or (ii) request supplemental information. (B) For purposes of subparagraph (A), an appli- cation shall be deemed complete when the appli- cant has submitted documentation showing each of the following: (i) The requirements designated in the no- tice in the Federal Register are satisfied. (ii) The requirements under this chapter are satisfied. (iii) The applicant will limit the transfer and sale of any marijuana manufactured under this subsection— (I) to researchers who are registered under this chapter to conduct research with con- trolled substances in schedule I; and (II) for purposes of use in preclinical re- search or in a clinical investigation pursu- ant to an investigational new drug exemp- tion under 355(i) 1 of this title. (iv) The applicant will transfer or sell any marijuana manufactured under this subsection only with prior, written consent for the trans- fer or sale by the Attorney General. (v) The applicant has completed the applica- tion and review process under subsection (a) for the bulk manufacture of controlled sub- stances in schedule I. (vi) The applicant has established and begun operation of a process for storage and handling of controlled substances in schedule I, includ- ing for inventory control and monitoring secu- rity in accordance with section 105 of the Med- ical Marijuana and Cannabidiol Research Ex- pansion Act. (vii) The applicant is licensed by each State in which the applicant will conduct operations under this subsection, to manufacture mari- juana, if that State requires such a license. (C) Not later than 30 days after the date on which the Attorney General receives supple- mental information requested under subpara- graph (A)(ii) with respect to an application, the Attorney General shall approve or deny the ap- plication. (2) If an application described in this sub- section is denied, the Attorney General shall provide a written explanation of the basis of de- nial to the applicant. (d) Limits of authorized activities Registration granted under subsections (a) and (b) of this section shall not entitle a registrant to (1) manufacture or distribute controlled sub- stances in schedule I or II other than those spec- ified in the registration, or (2) manufacture any quantity of those controlled substances in ex- cess of the quota assigned pursuant to section 826 of this title. (e) Manufacturers of controlled substances in schedule III, IV, or V The Attorney General shall register an appli- cant to manufacture controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the pub- lic interest, the following factors shall be con- sidered: (1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule III, IV, or V compounded therefrom into other than legitimate medical, scientific, or indus- trial channels; (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 or State laws relating to the manufac- ture, distribution, or dispensing of such sub- stances; (5) past experience in the manufacture, dis- tribution, and dispensing of controlled sub- stances, and the existence in the establish- ment of effective controls against diversion; and (6) such other factors as may be relevant to and consistent with the public health and safe- ty. (f) Distributors of controlled substances in schedule III, IV, or V The Attorney General shall register an appli- cant to distribute controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the pub- Page 811 TITLE 21—FOOD AND DRUGS § 823 lic interest, the following factors shall be con- sidered: (1) maintenance of effective controls against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels; (2) compliance with applicable State and local law; (3) prior conviction record of applicant under Federal or State laws relating to the manufac- ture, distribution, or dispensing of such sub- stances; (4) past experience in the distribution of con- trolled substances; and (5) such other factors as may be relevant to and consistent with the public health and safe- ty. (g) Research by practitioners; pharmacies; re- search applications; construction of Article 7 of the Convention on Psychotropic Sub- stances (1) The Attorney General shall register practi- tioners (including pharmacies, as distinguished from pharmacists) to dispense, or conduct re- search with, controlled substances in schedule II, III, IV, or V and shall modify the registra- tions of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet, if the applicant is author- ized to dispense, or conduct research with re- spect to, controlled substances under the laws of the State in which he practices. The Attorney General may deny an application for such reg- istration or such modification of registration if the Attorney General determines that the issuance of such registration or modification would be inconsistent with the public interest. In determining the public interest, the following factors shall be considered: (A) The recommendation of the appropriate State licensing board or professional discipli- nary authority. (B) The applicant’s experience in dispensing, or conducting research with respect to con- trolled substances. (C) The applicant’s conviction record under Federal or State laws relating to the manufac- ture, distribution, or dispensing of controlled substances. (D) Compliance with applicable State, Fed- eral, or local laws relating to controlled sub- stances. (E) Such other conduct which may threaten the public health and safety. Separate registration under this part for practi- tioners engaging in research with controlled substances in schedule II, III, IV, or V, who are already registered under this part in another ca- pacity, shall not be required. (2)(A) Registration applications by practi- tioners wishing to conduct research with con- trolled substances in schedule I shall be referred to the Secretary, who shall determine the quali- fications and competency of each practitioner requesting registration, as well as the merits of the research protocol. The Secretary, in deter- mining the merits of each research protocol, shall consult with the Attorney General as to ef- fective procedures to adequately safeguard against diversion of such controlled substances from legitimate medical or scientific use. Reg- istration for the purpose of bona fide research with controlled substances in schedule I by a practitioner deemed qualified by the Secretary may be denied by the Attorney General only on a ground specified in section 824(a) of this title. (B)(i) The Attorney General shall register a practitioner to conduct research with marijuana (including any derivative, extract, preparation, and compound thereof) if— (I) the applicant’s research protocol has been reviewed and allowed— (aa) by the Secretary of Health and Human Services under section 355(i) of this title; (bb) by the National Institutes of Health or another Federal agency that funds sci- entific research; or (cc) pursuant to sections 1301.18 and 1301.32 of title 21, Code of Federal Regulations, or any successors thereto; and (II) the applicant has demonstrated to the Attorney General that there are effective pro- cedures in place to adequately safeguard against diversion of the controlled substance for legitimate medical or scientific use pursu- ant to section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act, in- cluding demonstrating that the security meas- ures are adequate for storing the quantity of marijuana the applicant would be authorized to possess. (ii) The Attorney General may deny an appli- cation for registration under this subparagraph only if the Attorney General determines that the issuance of the registration would be incon- sistent with the public interest. In determining the public interest, the Attorney General shall consider the factors listed in— (I) subparagraphs (B) through (E) of para- graph (1); and (II) subparagraph (A) of paragraph (1), if the applicable State requires practitioners con- ducting research to register with a board or authority described in such subparagraph (A). (iii)(I) Not later than 60 days after the date on which the Attorney General receives a complete application for registration under this subpara- graph, the Attorney General shall— (aa) approve the application; or (bb) request supplemental information. (II) For purposes of subclause (I), an applica- tion shall be deemed complete when the appli- cant has submitted documentation showing that the requirements under clause (i) are satisfied. (iv) Not later than 30 days after the date on which the Attorney General receives supple- mental information as described in clause (iii)(I)(bb) in connection with an application de- scribed in this subparagraph, the Attorney Gen- eral shall approve or deny the application. (v) If an application described in this subpara- graph is denied, the Attorney General shall pro- vide a written explanation of the basis of denial to the applicant. (vi)(I) If the Attorney General grants an appli- cation for registration under clause (i), the reg- istrant may amend or supplement the research protocol without notification to, or review by, the Drug Enforcement Administration if the registrant does not change— Page 812 TITLE 21—FOOD AND DRUGS § 823 (aa) the quantity or type of marijuana or cannabidiol (including any derivative, extract, preparation, and compound thereof); (bb) the source of such marijuana or cannabidiol; or (cc) the conditions under which such mari- juana or cannabidiol is stored, tracked, or ad- ministered. (II)(aa) If a registrant under clause (i) seeks to change the type of marijuana or cannabidiol (in- cluding any derivative, extract, preparation, and compound thereof), the source of such mari- juana or cannabidiol, or the conditions under which such marijuana or cannabidiol is stored, tracked, or administered, the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attor- ney General, not later than 30 days before imple- menting an amended or supplemental research protocol. (bb) A registrant may proceed with an amend- ed or supplemental research protocol described in item (aa) if the Attorney General does not ex- plicitly object during the 30-day period begin- ning on the date on which the Attorney General receives the notice under item (aa). (cc) The Attorney General may only object to an amended or supplemental research protocol under this subclause if additional security meas- ures are needed to safeguard against diversion or abuse. (dd) If a registrant under clause (i) seeks to address additional security measures identified by the Attorney General under item (cc), the registrant shall notify the Attorney General via registered mail, or an electronic means per- mitted by the Attorney General, not later than 30 days before implementing an amended or sup- plemental research protocol. (ee) A registrant may proceed with an amend- ed or supplemental research protocol described in item (dd) if the Attorney General does not ex- plicitly object during the 30-day period begin- ning on the date on which the Attorney General receives the notice under item (dd). (III)(aa) If a registrant under clause (i) seeks to change the quantity of marijuana needed for research and the change in quantity does not impact the factors described in item (bb) or (cc) of subclause (I) of this clause, the registrant shall notify the Attorney General via registered mail or using an electronic means permitted by the Attorney General. (bb) A notification under item (aa) shall in- clude— (AA) the Drug Enforcement Administration registration number of the registrant; (BB) the quantity of marijuana or cannabidiol already obtained; (CC) the quantity of additional marijuana or cannabidiol needed to complete the research; and (DD) an attestation that the change in quan- tity does not impact the source of the mari- juana or cannabidiol or the conditions under which the marijuana or cannabidiol is stored, tracked, or administered. (cc) The Attorney General shall ensure that— (AA) any registered mail return receipt with respect to a notification under item (aa) is submitted for delivery to the registrant pro- viding the notification not later than 3 days after receipt of the notification by the Attor- ney General; and (BB) notice of receipt of a notification using an electronic means permitted under item (aa) is provided to the registrant providing the no- tification not later than 3 days after receipt of the notification by the Attorney General. (dd)(AA) On and after the date described in subitem (BB), a registrant that submits a notifi- cation in accordance with item (aa) may proceed with the research as if the change in quantity has been approved on such date, unless the At- torney General notifies the registrant of an ob- jection described in item (ee). (BB) The date described in this subitem is the date on which a registrant submitting a notifi- cation under item (aa) receives the registered mail return receipt with respect to the notifica- tion or the date on which the registrant receives notice that the notification using an electronic means permitted under item (aa) was received by the Attorney General, as the case may be. (ee) A notification submitted under item (aa) shall be deemed to be approved unless the Attor- ney General, not later than 10 days after receiv- ing the notification, explicitly objects based on a finding that the change in quantity— (AA) does impact the source of the mari- juana or cannabidiol or the conditions under which the marijuana or cannabidiol is stored, tracked, or administered; or (BB) necessitates that the registrant imple- ment additional security measures to safe- guard against diversion or abuse. (IV) Nothing in this clause shall limit the au- thority of the Secretary of Health and Human Services over requirements related to research protocols, including changes in— (aa) the method of administration of mari- juana or cannabidiol; (bb) the dosing of marijuana or cannabidiol; and (cc) the number of individuals or patients in- volved in research. (3) Article 7 of the Convention on Psycho- tropic Substances shall not be construed to pro- hibit, or impose additional restrictions upon, re- search involving drugs or other substances scheduled under the convention which is con- ducted in conformity with this subsection and other applicable provisions of this subchapter. (h) Practitioners dispensing narcotic drugs for narcotic treatment; annual registration; sep- arate registration; qualifications Practitioners who dispense narcotic drugs (other than narcotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment shall obtain annually a separate registration for that purpose. The At- torney General shall register an applicant to dispense narcotic drugs to individuals for main- tenance treatment or detoxification treatment (or both)— (1) if the applicant is a practitioner who is determined by the Secretary to be qualified (under standards established by the Secretary) to engage in the treatment with respect to which registration is sought; Page 813 TITLE 21—FOOD AND DRUGS § 823 (2) if the Attorney General determines that the applicant will comply with standards es- tablished by the Attorney General respecting (A) security of stocks of narcotic drugs for such treatment, and (B) the maintenance of records (in accordance with section 827 of this title) on such drugs; and (3) if the Secretary determines that the ap- plicant will comply with standards established by the Secretary (after consultation with the Attorney General) respecting the quantities of narcotic drugs which may be provided for un- supervised use by individuals in such treat- ment. (i) Applicants for distribution of list I chemicals The Attorney General shall register an appli- cant to distribute a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest. Registration under this subsection shall not be required for the distribution of a drug product that is exempted under clause (iv) or (v) of section 802(39)(A) of this title. In deter- mining the public interest for the purposes of this subsection, the Attorney General shall con- sider— (1) maintenance by the applicant of effective controls against diversion of listed chemicals into other than legitimate channels; (2) compliance by the applicant with applica- ble Federal, State, and local law; (3) any prior conviction record of the appli- cant under Federal or State laws relating to controlled substances or to chemicals con- trolled under Federal or State law; (4) any past experience of the applicant in the manufacture and distribution of chemi- cals; and (5) such other factors as are relevant to and consistent with the public health and safety. (j) Registration to manufacture certain con- trolled substances for use only in a clinical trial (1) For purposes of registration to manufac- ture a controlled substance under subsection (e) for use only in a clinical trial, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in ac- cordance with section 824(c) of this title, not later than 180 days after the date on which the application is accepted for filing. (2) For purposes of registration to manufac- ture a controlled substance under subsection (a) for use only in a clinical trial, the Attorney General shall, in accordance with the regula- tions issued by the Attorney General, issue a no- tice of application not later than 90 days after the application is accepted for filing. Not later than 90 days after the date on which the period for comment pursuant to such notice ends, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 824(c) of this title, unless the Attorney General has granted a hear- ing on the application under section 958(i) of this title. (k) Emergency medical services that administer controlled substances (1) Registration For the purpose of enabling emergency med- ical services professionals to administer con- trolled substances in schedule II, III, IV, or V to ultimate users receiving emergency med- ical services in accordance with the require- ments of this subsection, the Attorney Gen- eral— (A) shall register an emergency medical services agency if the agency submits an ap- plication demonstrating it is authorized to conduct such activity under the laws of each State in which the agency practices; and (B) may deny an application for such reg- istration if the Attorney General determines that the issuance of such registration would be inconsistent with the requirements of this subsection or the public interest based on the factors listed in subsection (g). (2) Option for single registration In registering an emergency medical serv- ices agency pursuant to paragraph (1), the At- torney General shall allow such agency the op- tion of a single registration in each State where the agency administers controlled sub- stances in lieu of requiring a separate reg- istration for each location of the emergency medical services agency. (3) Hospital-based agency If a hospital-based emergency medical serv- ices agency is registered under subsection (g), the agency may use the registration of the hospital to administer controlled substances in accordance with this subsection without being registered under this subsection. (4) Administration outside physical presence of medical director or authorizing medical professional Emergency medical services professionals of a registered emergency medical services agen- cy may administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services if the administra- tion is— (A) authorized by the law of the State in which it occurs; and (B) pursuant to— (i) a standing order that is issued and adopted by one or more medical directors of the agency, including any such order that may be developed by a specific State authority; or (ii) a verbal order that is— (I) issued in accordance with a policy of the agency; and (II) provided by a medical director or authorizing medical professional in re- sponse to a request by the emergency medical services professional with re- spect to a specific patient— (aa) in the case of a mass casualty incident; or (bb) to ensure the proper care and treatment of a specific patient. (5) Delivery A registered emergency medical services agency may deliver controlled substances from a registered location of the agency to an unregistered location of the agency only if the agency— Page 814 TITLE 21—FOOD AND DRUGS § 823 (A) designates the unregistered location for such delivery; and (B) notifies the Attorney General at least 30 days prior to first delivering controlled substances to the unregistered location. (6) Storage A registered emergency medical services agency may store controlled substances— (A) at a registered location of the agency; (B) at any designated location of the agen- cy or in an emergency services vehicle situ- ated at a registered or designated location of the agency; or (C) in an emergency medical services vehi- cle used by the agency that is— (i) traveling from, or returning to, a reg- istered or designated location of the agen- cy in the course of responding to an emer- gency; or (ii) otherwise actively in use by the agency under circumstances that provide for security of the controlled substances consistent with the requirements estab- lished by regulations of the Attorney Gen- eral. (7) No treatment as distribution The delivery of controlled substances by a registered emergency medical services agency pursuant to this subsection shall not be treat- ed as distribution for purposes of section 828 of this title. (8) Restocking of emergency medical services vehicles at a hospital Notwithstanding paragraph (13)(J), a reg- istered emergency medical services agency may receive controlled substances from a hos- pital for purposes of restocking an emergency medical services vehicle following an emer- gency response, and without being subject to the requirements of section 828 of this title, provided all of the following conditions are satisfied: (A) The registered or designated location of the agency where the vehicle is primarily situated maintains a record of such receipt in accordance with paragraph (9). (B) The hospital maintains a record of such delivery to the agency in accordance with section 827 of this title. (C) If the vehicle is primarily situated at a designated location, such location notifies the registered location of the agency within 72 hours of the vehicle receiving the con- trolled substances. (9) Maintenance of records (A) In general A registered emergency medical services agency shall maintain records in accordance with subsections (a) and (b) of section 827 of this title of all controlled substances that are received, administered, or otherwise dis- posed of pursuant to the agency’s registra- tion, without regard to subsection 827(c)(1)(B) of this title. (B) Requirements Such records— (i) shall include records of deliveries of controlled substances between all loca- tions of the agency; and (ii) shall be maintained, whether elec- tronically or otherwise, at each registered and designated location of the agency where the controlled substances involved are received, administered, or otherwise disposed of. (10) Other requirements A registered emergency medical services agency, under the supervision of a medical di- rector, shall be responsible for ensuring that— (A) all emergency medical services profes- sionals who administer controlled sub- stances using the agency’s registration act in accordance with the requirements of this subsection; (B) the recordkeeping requirements of paragraph (9) are met with respect to a reg- istered location and each designated loca- tion of the agency; (C) the applicable physical security re- quirements established by regulation of the Attorney General are complied with wher- ever controlled substances are stored by the agency in accordance with paragraph (6); and (D) the agency maintains, at a registered location of the agency, a record of the stand- ing orders issued or adopted in accordance with paragraph (9). (11) Regulations The Attorney General may issue regula- tions— (A) specifying, with regard to delivery of controlled substances under paragraph (5)— (i) the types of locations that may be designated under such paragraph; and (ii) the manner in which a notification under paragraph (5)(B) must be made; (B) specifying, with regard to the storage of controlled substances under paragraph (6), the manner in which such substances must be stored at registered and designated loca- tions, including in emergency medical serv- ice vehicles; and (C) addressing the ability of hospitals, emergency medical services agencies, reg- istered locations, and designated locations to deliver controlled substances to each other in the event of— (i) shortages of such substances; (ii) a public health emergency; or (iii) a mass casualty event. (12) Rule of construction Nothing in this subsection shall be con- strued— (A) to limit the authority vested in the At- torney General by other provisions of this subchapter to take measures to prevent di- version of controlled substances; or (B) to override the authority of any State to regulate the provision of emergency med- ical services consistent with this subsection. (13) Definitions In this section: (A) The term ‘‘authorizing medical profes- sional’’ means an emergency or other physi- cian, or another medical professional (in- cluding an advanced practice registered nurse or physician assistant)— Page 815 TITLE 21—FOOD AND DRUGS § 823 2 So in original. Two subsecs. (l) have been enacted. (i) who is registered under this chapter; (ii) who is acting within the scope of the registration; and (iii) whose scope of practice under a State license or certification includes the ability to provide verbal orders. (B) The term ‘‘designated location’’ means a location designated by an emergency med- ical services agency under paragraph (5). (C) The term ‘‘emergency medical serv- ices’’ means emergency medical response and emergency mobile medical services pro- vided outside of a fixed medical facility. (D) The term ‘‘emergency medical services agency’’ means an organization providing emergency medical services, including such an organization that— (i) is governmental (including fire-based and hospital-based agencies), nongovern- mental (including hospital-based agen- cies), private, or volunteer-based; (ii) provides emergency medical services by ground, air, or otherwise; and (iii) is authorized by the State in which the organization is providing such services to provide emergency medical care, includ- ing the administering of controlled sub- stances, to members of the general public on an emergency basis. (E) The term ‘‘emergency medical services professional’’ means a health care profes- sional (including a nurse, paramedic, or emergency medical technician) licensed or certified by the State in which the profes- sional practices and credentialed by a med- ical director of the respective emergency medical services agency to provide emer- gency medical services within the scope of the professional’s State license or certifi- cation. (F) The term ‘‘emergency medical services vehicle’’ means an ambulance, fire appa- ratus, supervisor truck, or other vehicle used by an emergency medical services agen- cy for the purpose of providing or facili- tating emergency medical care and trans- port or transporting controlled substances to and from the registered and designated lo- cations. (G) The term ‘‘hospital-based’’ means, with respect to an agency, owned or oper- ated by a hospital. (H) The term ‘‘medical director’’ means a physician who is registered under subsection (g) and provides medical oversight for an emergency medical services agency. (I) The term ‘‘medical oversight’’ means supervision of the provision of medical care by an emergency medical services agency. (J) The term ‘‘registered emergency med- ical services agency’’ means— (i) an emergency medical services agency that is registered pursuant to this sub- section; or (ii) a hospital-based emergency medical services agency that is covered by the reg- istration of the hospital under subsection (g). (K) The term ‘‘registered location’’ means a location that appears on the certificate of registration issued to an emergency medical services agency under this subsection or sub- section (g), which shall be where the agency receives controlled substances from distribu- tors. (L) The term ‘‘specific State authority’’ means a governmental agency or other such authority, including a regional oversight and coordinating body, that, pursuant to State law or regulation, develops clinical protocols regarding the delivery of emer- gency medical services in the geographic ju- risdiction of such agency or authority with- in the State that may be adopted by medical directors. (M) The term ‘‘standing order’’ means a written medical protocol in which a medical director determines in advance the medical criteria that must be met before admin- istering controlled substances to individuals in need of emergency medical services. (N) The term ‘‘verbal order’’ means an oral directive that is given through any method of communication including by radio or tele- phone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individ- uals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional. (l) 2 ‘‘Factors as may be relevant to and con- sistent with the public health and safety’’ de- fined In this section, the phrase ‘‘factors as may be relevant to and consistent with the public health and safety’’ means factors that are rel- evant to and consistent with the findings con- tained in section 801 of this title. (l) 2 Required training for prescribers (1) Training required As a condition on registration under this section to dispense controlled substances in schedule II, III, IV, or V, the Attorney General shall require any qualified practitioner, begin- ning with the first applicable registration for the practitioner, to meet the following: (A) If the practitioner is a physician (as defined under section 1395x(r) of title 42) and the practitioner meets one or more of the following conditions: (i) The physician holds a board certifi- cation in addiction psychiatry or addiction medicine from the American Board of Med- ical Specialties. (ii) The physician holds a board certifi- cation from the American Board of Addic- tion Medicine. (iii) The physician holds a board certifi- cation in addiction medicine from the American Osteopathic Association. (iv) The physician has, with respect to the treatment and management of pa- tients with opioid or other substance use disorders, or the safe pharmacological management of dental pain and screening, brief intervention, and referral for appro- priate treatment of patients with or at Page 816 TITLE 21—FOOD AND DRUGS § 823 risk of developing opioid or other sub- stance use disorders, completed not less than 8 hours of training (through class- room situations, seminars at professional society meetings, electronic communica- tions, or otherwise) that is provided by— (I) the American Society of Addiction Medicine, the American Academy of Ad- diction Psychiatry, the American Med- ical Association, the American Osteo- pathic Association, the American Dental Association, the American Association of Oral and Maxillofacial Surgeons, the American Psychiatric Association, or any other organization accredited by the Accreditation Council for Continuing Medical Education (ACCME) or the Com- mission for Continuing Education Pro- vider Recognition (CCEPR); (II) any organization accredited by a State medical society accreditor that is recognized by the ACCME or the CCEPR; (III) any organization accredited by the American Osteopathic Association to provide continuing medical education; or (IV) any organization approved by the Assistant Secretary for Mental Health and Substance Use, the ACCME, or the CCEPR. (v) The physician graduated in good standing from an accredited school of allopathic medicine, osteopathic medicine, dental surgery, or dental medicine in the United States during the 5-year period im- mediately preceding the date on which the physician first registers or renews under this section and has successfully com- pleted a comprehensive allopathic or os- teopathic medicine curriculum or accred- ited medical residency or dental surgery or dental medicine curriculum that included not less than 8 hours of training on— (I) treating and managing patients with opioid or other substance use dis- orders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treat- ment of a substance use disorder; or (II) the safe pharmacological manage- ment of dental pain and screening, brief intervention, and referral for appro- priate treatment of patients with or at risk of developing opioid and other sub- stance use disorders. (B) If the practitioner is not a physician (as defined under section 1395x(r) of title 42), the practitioner is legally authorized by the State to dispense controlled substances under schedule II, III, IV, or V and is dis- pensing such substances within such State in accordance with all applicable State laws, and the practitioner meets one or more of the following conditions: (i) The practitioner has completed not fewer than 8 hours of training with respect to the treatment and management of pa- tients with opioid or other substance use disorders (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Ad- diction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteo- pathic Association, the American Nurses Credentialing Center, the American Psy- chiatric Association, the American Asso- ciation of Nurse Practitioners, the Amer- ican Academy of Physician Associates, or any other organization approved or accred- ited by the Assistant Secretary for Mental Health and Substance Use or the Accredi- tation Council for Continuing Medical Education. (ii) The practitioner has graduated in good standing from an accredited physi- cian assistant school or accredited school of advanced practice nursing in the United States during the 5-year period imme- diately preceding the date on which the practitioner first registers or renews under this section and has successfully com- pleted a comprehensive physician assist- ant or advanced practice nursing cur- riculum that included not fewer than 8 hours of training on treating and man- aging patients with opioid and other sub- stance use disorders, including the appro- priate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder. (2) One-time training (A) In general The Attorney General shall not require any qualified practitioner to complete the training described in clause (iv) or (v) of paragraph (1)(A) or clause (i) or (ii) of para- graph (1)(B) more than once. (B) Notification Not later than 90 days after December 29, 2022, the Attorney General shall provide to qualified practitioners a single written, elec- tronic notification of the training described in clauses (iv) and (v) of paragraph (1)(A) or clauses (i) and (ii) of paragraph (1)(B). (3) Rule of construction Nothing in this subsection shall be con- strued— (A) to preclude the use, by a qualified practitioner, of training received pursuant to this subsection to satisfy registration re- quirements of a State or for some other law- ful purpose; or (B) to preempt any additional require- ments by a State related to the dispensing of controlled substances under schedule II, III, IV, or V. (4) Definitions In this section: (A) First applicable registration The term ‘‘first applicable registration’’ means the first registration or renewal of registration by a qualified practitioner under this section that occurs on or after the date that is 180 days after December 29, 2022. (B) Qualified practitioner In this subsection, the term ‘‘qualified practitioner’’ means a practitioner who— Page 817 TITLE 21—FOOD AND DRUGS § 823 (i) is licensed under State law to pre- scribe controlled substances; and (ii) is not solely a veterinarian. (Pub. L. 91–513, title II, § 303, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 93–281, § 3, May 14, 1974, 88 Stat. 124; Pub. L. 95–633, title I, § 109, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 98–473, title II, § 511, Oct. 12, 1984, 98 Stat. 2073; Pub. L. 103–200, § 3(c), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 106–310, div. B, title XXXV, § 3502(a), Oct. 17, 2000, 114 Stat. 1222; Pub. L. 107–273, div. B, title II, § 2501, Nov. 2, 2002, 116 Stat. 1803; Pub. L. 109–56, § 1(a), (b), Aug. 2, 2005, 119 Stat. 591; Pub. L. 109–177, title VII, § 712(a)(3), Mar. 9, 2006, 120 Stat. 263; Pub. L. 109–469, title XI, § 1102, Dec. 29, 2006, 120 Stat. 3540; Pub. L. 110–425, § 3(b), Oct. 15, 2008, 122 Stat. 4824; Pub. L. 114–89, § 3, Nov. 25, 2015, 129 Stat. 701; Pub. L. 114–145, § 2(a)(1), Apr. 19, 2016, 130 Stat. 354; Pub. L. 114–198, title III, § 303(a)(1), (b), July 22, 2016, 130 Stat. 720, 723; Pub. L. 115–83, § 2, Nov. 17, 2017, 131 Stat. 1267; Pub. L. 115–271, title III, §§ 3201(a)–(d), 3202(a), Oct. 24, 2018, 132 Stat. 3943, 3944; Pub. L. 117–215, title I, §§ 101, 102(a), 103(a), Dec. 2, 2022, 136 Stat. 2258, 2260, 2261; Pub. L. 117–328, div. FF, title I, §§ 1262(a), 1263(a), Dec. 29, 2022, 136 Stat. 5681, 5683.) Editorial Notes REFERENCES IN TEXT Schedules I, II, III, IV, and V, referred to in subsecs. (a) to (g)(2), (k)(1), (4), and (l)(1), (3)(B), are set out in section 812(c) of this title. This chapter, referred to in subsecs. (c)(1)(A), (B) and (k)(13)(A)(i), was in the original ‘‘this Act’’, meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables. Section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act, referred to in subsecs. (c)(1)(B)(vi) and (g)(2)(B)(i)(II), is section 105 of Pub. L. 117–215, which is set out as a note below. This subchapter, referred to in subsecs. (g)(3) and (k)(12)(A), was in the original ‘‘this title’’, meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the ‘‘Controlled Substances Act’’. For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables. AMENDMENTS 2022—Subsecs. (c) to (e). Pub. L. 117–215, § 103(a)(1), (2), added subsec. (c) and redesignated former subsecs. (c) and (d) as (d) and (e), respectively. Former subsec. (e) redesignated (f). Subsec. (f). Pub. L. 117–215, § 103(a)(1), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g). Pub. L. 117–215, § 101, designated introductory provi- sions through first sentence of concluding provisions as par. (1), redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1), designated second to fourth sentences of concluding provisions as subpar. (A) of par. (2), added subpar. (B) of par. (2), and designated last sentence of concluding provisions as par. (3). Subsec. (f)(2)(B)(vi). Pub. L. 117–215, § 102(a), added cl. (vi). Subsec. (g). Pub. L. 117–215, § 103(a)(1), redesignated subsec. (f) as (g). Former subsec. (g) redesignated (h). Subsec. (h). Pub. L. 117–328, § 1262(a), which directed amendment of subsec. (g) by substituting ‘‘Practi- tioners who dispense narcotic drugs (other than nar- cotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment’’ for ‘‘(1) Except as provided in paragraph (2), practi- tioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment’’, redesignating subpars. (A) to (C) of former par. (1) as pars. (1) to (3), respectively, redesignating cls. (i) and (ii) of par. (2) as subpars. (A) and (B), respectively, and striking former par. (2) which related to waiver of reg- istration requirements, was executed to subsec. (h) to reflect the probable intent of Congress and the redesig- nation of subsec. (g) as (h) by Pub. L. 117–215, § 103(a)(1). See Amendment note below. Pub. L. 117–215, § 103(a)(1), redesignated subsec. (g) as (h). Former subsec. (h) redesignated (i). Subsec. (h)(2). Pub. L. 117–215, § 103(a)(3), substituted ‘‘subsection (g)’’ for ‘‘subsection (f)’’ wherever appear- ing. Subsec. (i). Pub. L. 117–215, § 103(a)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j). Subsec. (j). Pub. L. 117–215, § 103(a)(1), redesignated subsec. (i) as (j). Former subsec. (j) redesignated (k). Subsec. (j)(1). Pub. L. 117–215, § 103(a)(4), substituted ‘‘subsection (e)’’ for ‘‘subsection (d)’’. Subsec. (k). Pub. L. 117–215, § 103(a)(1), (5), redesig- nated subsec. (j) as (k) and substituted ‘‘subsection (g)’’ for ‘‘subsection (f)’’ wherever appearing. Former sub- sec. (k) redesignated (l). Subsec. (l). Pub. L. 117–328, § 1263(a), added subsec. (l) relating to required training for prescribers. Pub. L. 117–215, § 103(a)(1), redesignated subsec. (k) as (l). 2018—Subsec. (g)(2)(B)(iii)(II). Pub. L. 115–271, § 3201(a), amended subcl. (II) generally. Prior to amend- ment, subcl. (II) read as follows: ‘‘The applicable num- ber is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notifica- tion, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients.’’ Subsec. (g)(2)(G)(ii)(VIII). Pub. L. 115–271, § 3202(a), added subcl. (VIII). Subsec. (g)(2)(G)(iii)(II). Pub. L. 115–271, § 3201(b), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: ‘‘during the period beginning on July 22, 2016, and ending on October 1, 2021, a quali- fying other practitioner, as defined in clause (iv).’’ Subsec. (g)(2)(G)(iii)(III). Pub. L. 115–271, § 3201(b)(1), (c), added subcl. (III). Subsec. (g)(2)(G)(iv). Pub. L. 115–271, § 3201(d), sub- stituted ‘‘nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant’’ for ‘‘nurse practi- tioner or physician assistant’’ wherever appearing. 2017—Subsecs. (j), (k). Pub. L. 115–83 added subsec. (j) and redesignated former subsec. (j) as (k). 2016—Subsec. (g)(2)(B). Pub. L. 114–198, § 303(a)(1)(A), added cls. (i) to (iii) and struck out former cls. (i) to (iii) which read as follows: ‘‘(i) The practitioner is a qualifying physician (as de- fined in subparagraph (G)). ‘‘(ii) With respect to patients to whom the practi- tioner will provide such drugs or combinations of drugs, the practitioner has the capacity to refer the pa- tients for appropriate counseling and other appropriate ancillary services. ‘‘(iii) The total number of such patients of the practi- tioner at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notifi- cation to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notifi- cation under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The Secretary may by regulation change such total number.’’ Subsec. (g)(2)(D)(ii). Pub. L. 114–198, § 303(a)(1)(B)(i), substituted ‘‘Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subpara- graph (B)’’ for ‘‘Upon receiving a notification under subparagraph (B)’’. Page 818 TITLE 21—FOOD AND DRUGS § 823 Subsec. (g)(2)(D)(iii). Pub. L. 114–198, § 303(a)(1)(B)(ii), inserted ‘‘and shall forward such determination to the Attorney General’’ after ‘‘a waiver under subparagraph (B)’’ and substituted ‘‘assign the practitioner’’ for ‘‘as- sign the physician’’. Subsec. (g)(2)(G)(ii)(I). Pub. L. 114–198, § 303(a)(1)(C)(i), amended subcl. (I) generally. Prior to amendment, subcl. (I) read as follows: ‘‘The physician holds a sub- specialty board certification in addiction psychiatry from the American Board of Medical Specialties.’’ Subsec. (g)(2)(G)(ii)(II). Pub. L. 114–198, § 303(a)(1)(C)(ii), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: ‘‘The physician holds an addiction certification from the American So- ciety of Addiction Medicine.’’ Subsec. (g)(2)(G)(ii)(III). Pub. L. 114–198, § 303(a)(1)(C)(iii), struck out ‘‘subspecialty’’ before ‘‘board certification’’. Subsec. (g)(2)(G)(ii)(IV). Pub. L. 114–198, § 303(a)(1)(C)(iv), amended subcl. (IV) generally. Prior to amendment, subcl. (IV) read as follows: ‘‘The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Med- ical Association, the American Osteopathic Associa- tion, the American Psychiatric Association, or any other organization that the Secretary determines is ap- propriate for purposes of this subclause.’’ Subsec. (g)(2)(G)(iii), (iv). Pub. L. 114–198, § 303(a)(1)(C)(v), added cls. (iii) and (iv). Subsec. (g)(2)(H)(i)(III). Pub. L. 114–198, § 303(a)(1)(D)(i), added subcl. (III). Subsec. (g)(2)(H)(ii). Pub. L. 114–198, § 303(a)(1)(D)(ii), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: ‘‘Not later than 120 days after October 17, 2000, the Secretary shall issue a treatment improve- ment protocol containing best practice guidelines for the treatment and maintenance of opiate-dependent pa- tients. The Secretary shall develop the protocol in con- sultation with the Director of the National Institute on Drug Abuse, the Administrator of the Drug Enforce- ment Administration, the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration and other sub- stance abuse disorder professionals. The protocol shall be guided by science.’’ Subsec. (g)(2)(I), (J). Pub. L. 114–198, § 303(b), added subpar. (I) and struck out former subpars. (I) and (J) which limited a State’s ability to preclude a practi- tioner from dispensing or prescribing certain approved drugs and provided the effective date of the paragraph and authorized the Secretary and the Attorney General to make certain determinations. Subsec. (j). Pub. L. 114–145 added subsec. (j). 2015—Subsec. (i). Pub. L. 114–89 added subsec. (i). 2008—Subsec. (f). Pub. L. 110–425, in introductory pro- visions, inserted ‘‘and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet’’ after ‘‘schedule II, III, IV, or V’’ and substituted ‘‘or such modification of registration if the Attorney General de- termines that the issuance of such registration or modification’’ for ‘‘if he determines that the issuance of such registration’’. 2006—Subsec. (g)(2)(B)(iii). Pub. L. 109–469, § 1102(1), substituted ‘‘unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notifi- cation to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notifi- cation under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The’’ for ‘‘except that the’’. Subsec. (g)(2)(J)(i). Pub. L. 109–469, § 1102(2)(A), sub- stituted ‘‘thereafter.’’ for ‘‘thereafter except as pro- vided in clause (iii) (relating to a decision by the Sec- retary or the Attorney General that this paragraph should not remain in effect).’’ Subsec. (g)(2)(J)(ii). Pub. L. 109–469, § 1102(2)(B), sub- stituted ‘‘December 29, 2006’’ for ‘‘October 17, 2000’’ in introductory provisions. Subsec. (g)(2)(J)(iii). Pub. L. 109–469, § 1102(2)(C), sub- stituted ‘‘subparagraph (B)(iii) should be applied by limiting the total number of patients a practitioner may treat to 30, then the provisions in such subpara- graph (B)(iii) permitting more than 30 patients shall not apply, effective’’ for ‘‘this paragraph should not re- main in effect, this paragraph ceases to be in effect’’. Subsec. (h). Pub. L. 109–177 substituted ‘‘clause (iv) or (v) of section 802(39)(A) of this title’’ for ‘‘section 802(39)(A)(iv) of this title’’ in introductory provisions. 2005—Subsec. (g)(2)(B)(iii). Pub. L. 109–56, § 1(b), sub- stituted ‘‘The total’’ for ‘‘In any case in which the practitioner is not in a group practice, the total’’. Subsec. (g)(2)(B)(iv). Pub. L. 109–56, § 1(a), struck out cl. (iv) which read as follows: ‘‘In any case in which the practitioner is in a group practice, the total number of such patients of the group practice at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, except that the Secretary may by regulation change such total num- ber, and the Secretary for such purposes may by regu- lation establish different categories on the basis of the number of practitioners in a group practice and estab- lish for the various categories different numerical limi- tations on the number of such patients that the group practice may have.’’ 2002—Subsec. (g)(2)(I). Pub. L. 107–273, § 2501(1), which directed the substitution of ‘‘on the date of approval by the Food and Drug Administration of a drug in sched- ule III, IV, or V, a State may not preclude a practi- tioner from dispensing or prescribing such drug, or combination of such drugs,’’ for ‘‘on October 17, 2000, a State may not preclude a practitioner from dispensing or prescribing drugs in schedule III, IV, or V, or com- binations of such drugs,’’, was executed by making the substitution for the phrase which in the original began with ‘‘on the date of the enactment of the Drug Addic- tion Treatment Act of 2000,’’ rather than the editorial translation ‘‘on October 17, 2000,’’ to reflect the prob- able intent of Congress. Subsec. (g)(2)(J)(i). Pub. L. 107–273, § 2501(2), which di- rected the substitution of ‘‘the date referred to in sub- paragraph (I),’’ for ‘‘October 17, 2000,’’ was executed by making the substitution for text which in the original read ‘‘the date of the enactment of the Drug Addiction Treatment Act of 2000,’’ rather than the editorial trans- lation ‘‘October 17, 2000,’’ to reflect the probable intent of Congress. 2000—Subsec. (g). Pub. L. 106–310 designated existing provisions as par. (1), substituted ‘‘Except as provided in paragraph (2), practitioners who dispense’’ for ‘‘Prac- titioners who dispense’’, redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1) and redesignated former subpars. (A) and (B) of former par. (2) as cls. (i) and (ii), respectively, of subpar. (B) of par. (1), and added par. (2). 1993—Subsec. (h). Pub. L. 103–200 added subsec. (h). 1984—Subsec. (f). Pub. L. 98–473 amended subsec. (f) generally, substituting provisions relating to registra- tion authority of Attorney General respecting dis- pensation or conduct of research with controlled re- search, and separate authority of Secretary respecting registration, for provisions relating to general registra- tion requirements respecting dispensation or conduct of research with controlled or nonnarcotic controlled substances. 1978—Subsec. (f). Pub. L. 95–633 inserted provision re- lating to the construction of the Convention on Psy- chotropic Substances. 1974—Subsec. (g). Pub. L. 93–281 added subsec. (g). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2008 AMENDMENT Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section Page 819 TITLE 21—FOOD AND DRUGS § 823 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title. EFFECTIVE DATE OF 2005 AMENDMENT Pub. L. 109–56, § 1(c), Aug. 2, 2005, 119 Stat. 591, pro- vided that: ‘‘This section [amending this section] shall take effect on the date of enactment of this Act [Aug. 2, 2005].’’ EFFECTIVE DATE OF 1993 AMENDMENT Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title. EFFECTIVE DATE OF 1978 AMENDMENT Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title. EFFECTIVE DATE Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title. REGULATIONS Pub. L. 117–215, title I, § 102(b), Dec. 2, 2022, 136 Stat. 2261, provided that: ‘‘Not later than 1 year after the date of enactment of this Act [Dec. 2, 2022], the Attor- ney General shall promulgate regulations to carry out the amendment made by this section [amending this section].’’ UPDATE REGULATIONS Pub. L. 117–328, div. FF, title I, § 1252(b), Dec. 29, 2022, 136 Stat. 5681, provided that: ‘‘Not later than 18 months after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services shall re- vise section 8.12(e)(1) of title 42, Code of Federal Regu- lations (or successor regulations), to eliminate the re- quirement that an opioid treatment program only admit an individual for treatment under the program if the individual has been addicted to opioids for at least 1 year before being so admitted for treatment.’’ Pub. L. 114–198, title III, § 303(c), July 22, 2016, 130 Stat. 723, provided that: ‘‘Not later than 18 months after the date of enactment of this Act [July 22, 2016], the Attorney General and the Secretary of Health and Human Services, as appropriate, shall update regula- tions regarding practitioners described in subsection (a)(3)(B)(vii) (as amended by this section) [probably means subsec. (a)(3)(B)(vii) ‘‘of this section’’, set out as a note below] to include nurse practitioners and physi- cian assistants to ensure the quality of patient care and prevent diversion.’’ ADEQUATE AND UNINTERRUPTED SUPPLY Pub. L. 117–215, title I, § 104, Dec. 2, 2022, 136 Stat. 2263, provided that: ‘‘(a) IN GENERAL.—On an annual basis, the Attorney General, in consultation with the Secretary of Health and Human Services, shall assess whether there is an adequate and uninterrupted supply of marijuana, in- cluding of specific strains, for research purposes. ‘‘(b) REPORT TO CONGRESS.—If the Attorney General, in consultation with the Secretary of Health and Human Services, determines there is an inadequate or interrupted supply of marijuana, including of specific strains for research purposes, the Attorney General shall report to Congress within 60 days of the deter- mination on at least— ‘‘(1) the factors contributing to the inadequate or interrupted supply of marijuana; ‘‘(2) expected impacts of the inadequate or inter- rupted supply on ongoing research protocols; and ‘‘(3) specific steps the Attorney General will take to restore an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes.’’ [For definition of ‘‘marijuana’’ as used in section 104 of Pub. L. 117–215, set out above, see section 2(a) of Pub. L. 117–215, set out as a note under section 801 of this title.] SECURITY REQUIREMENTS Pub. L. 117–215, title I, § 105, Dec. 2, 2022, 136 Stat. 2264, provided that: ‘‘(a) IN GENERAL.—An individual or entity engaged in researching marijuana or its components shall store it in a securely locked, substantially constructed cabinet. ‘‘(b) REQUIREMENTS FOR OTHER MEASURES.—Any other security measures required by the Attorney General to safeguard against diversion shall be consistent with those required for practitioners conducting research on other controlled substances in schedules I and II in sec- tion 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) that have a similar risk of diversion and abuse.’’ [For definitions of ‘‘marijuana’’, ‘‘controlled sub- stances’’, and ‘‘practitioners’’ as used in section 105 of Pub. L. 117–215, set out above, see section 2(a) of Pub. L. 117–215, set out as a note under section 801 of this title.] DEVELOPMENT OF FOOD AND DRUG ADMINISTRATION- APPROVED DRUGS USING CANNABIDIOL AND MARIJUANA Pub. L. 117–215, title II, Dec. 2, 2022, 136 Stat. 2264, provided that: ‘‘SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL. ‘‘Notwithstanding any provision of the Controlled Substances Act (21 U.S.C. 801 et seq.), the Safe and Drug-Free Schools and Communities Act (20 U.S.C. 7101 et seq.), chapter 81 of title 41, United States Code, or any other Federal law, an appropriately registered cov- ered institution of higher education, practitioner, or manufacturer may manufacture, distribute, dispense, or possess marijuana or cannabidiol if the marijuana or cannabidiol is manufactured, distributed, dispensed, or possessed, respectively, for purposes of medical re- search for drug development or subsequent commercial production in accordance with section 202. ‘‘SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUCTION AND DISTRIBUTION OF FOOD AND DRUG ADMINISTRATION-APPROVED DRUGS. ‘‘The Attorney General shall register an applicant to manufacture or distribute cannabidiol or marijuana for the purpose of commercial production of a drug con- taining or derived from marijuana that is approved by the Secretary of Health and Human Services under sec- tion 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in accordance with the applicable re- quirements under subsection (a) or (b) of section 303 of the Controlled Substances Act (21 U.S.C. 823).’’ [For definitions of terms used in title II of Pub. L. 117–215, set out above, see section 2(a) of Pub. L. 117–215, set out as a note under section 801 of this title.] TREATMENT FOR CHILDREN Pub. L. 115–271, title III, § 3202(b), Oct. 24, 2018, 132 Stat. 3945, provided that: ‘‘The Secretary of Health and Human Services shall consider ways to ensure that an adequate number of qualified practitioners, as defined in [former] subparagraph (G)(ii) of section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) [former 21 U.S.C. 823(h)(2)], who have a specialty in pe- diatrics or the treatment of children or adolescents, are granted a waiver under such section 303(g)(2) to treat children and adolescents with substance use disorders.’’ GRANTS TO ENHANCE ACCESS TO SUBSTANCE USE DISORDER TREATMENT Pub. L. 115–271, title III, § 3203, Oct. 24, 2018, 132 Stat. 3945, provided that: ‘‘(a) IN GENERAL.—The Secretary of Health and Human Services shall establish a grant program under which the Secretary may make grants to accredited Page 820 TITLE 21—FOOD AND DRUGS § 824 1 See References in Text note below. schools of allopathic medicine or osteopathic medicine and teaching hospitals located in the United States to support the development of curricula that meet the re- quirements under [former] subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act [former 21 U.S.C. 823(h)(2)(G)(ii)], as added by section 3202(a) of this Act. ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There is au- thorized to be appropriated, for grants under subsection (a), $4,000,000 for each of fiscal years 2019 through 2023.’’ REPORTS TO CONGRESS Pub. L. 114–198, title III, § 303(a)(3), July 22, 2016, 130 Stat. 722, provided that: ‘‘(A) IN GENERAL.—Not later than 3 years after the date of enactment of this Act [July 22, 2016] and not later than 3 years thereafter, the Secretary of Health and Human Services, in consultation with the Drug En- forcement Administration and experts in opioid use disorder research and treatment, shall— ‘‘(i) perform a thorough review of the provision of opioid use disorder treatment services in the United States, including services provided in opioid treat- ment programs and other specialty and nonspecialty settings; and ‘‘(ii) submit a report to the Congress on the find- ings and conclusions of such review. ‘‘(B) CONTENTS.—Each report under subparagraph (A) shall include an assessment of— ‘‘(i) compliance with the requirements of [former] section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) [former 21 U.S.C. 823(h)(2)], as amend- ed by this section; ‘‘(ii) the measures taken by the Secretary of Health and Human Services to ensure such compliance; ‘‘(iii) whether there is further need to increase or decrease the number of patients a practitioner, pur- suant to a waiver under [former] section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) [former 21 U.S.C. 823(h)(2)], is permitted to treat; ‘‘(iv) the extent to which, and proportions with which, the full range of Food and Drug Administra- tion-approved treatments for opioid use disorder are used in routine health care settings and specialty substance use disorder treatment settings; ‘‘(v) access to, and use of, counseling and recovery support services, including the percentage of patients receiving such services; ‘‘(vi) changes in State or local policies and legisla- tion relating to opioid use disorder treatment; ‘‘(vii) the use of prescription drug monitoring pro- grams by practitioners who are permitted to dispense narcotic drugs to individuals pursuant to a waiver de- scribed in clause (iii); ‘‘(viii) the findings resulting from inspections by the Drug Enforcement Administration of practi- tioners described in clause (vii); and ‘‘(ix) the effectiveness of cross-agency collaboration between [the] Department of Health and Human Serv- ices and the Drug Enforcement Administration for expanding effective opioid use disorder treatment.’’ PROVISIONAL REGISTRATION For provisional registration of persons engaged in manufacturing, distributing, or dispensing of con- trolled substances on the day before the effective date of section 822 of this title who are registered on such date under section 360 of this title or section 4722 of Title 26, Internal Revenue Code, see section 703 of Pub. L. 91–513, set out as a note under section 822 of this title. § 824. Denial, revocation, or suspension of reg- istration (a) Grounds 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 sub- chapter 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, dis- tribution, or dispensing of controlled sub- stances or list I chemicals or has had the sus- pension, revocation, or denial of his registra- tion recommended by competent State author- ity; (4) has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as deter- mined under such section; or (5) has been excluded (or directed to be ex- cluded) from participation in a program pursu- ant to section 1320a–7(a) of title 42. A registration pursuant to section 823(h)(1) 1 of this title to dispense a narcotic drug for mainte- nance 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)(1) 1 of this title. (b) Limits of revocation or suspension The Attorney General may limit revocation or suspension of a registration to the particular controlled substance or list I chemical with re- spect to which grounds for revocation or suspen- sion exist. (c) Service of show cause order; proceedings (1) Before taking action pursuant to this sec- tion, or pursuant to a denial of registration under section 823 of this title, the Attorney Gen- eral shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked, or suspended. (2) An order to show cause under paragraph (1) shall— (A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or reg- istrant; (B) direct the applicant or registrant to ap- pear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and (C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance. (3) Upon review of any corrective action plan submitted by an applicant or registrant pursu- ant to paragraph (2), the Attorney General shall determine whether denial, revocation, or sus- pension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan.