1. U.S. Code
  2. title 21
  3. chapter 13
  4. subchapter I
  5. part C
  6. § 822

Collapse to view only § 822. Persons required to register

§ 821. Rules and regulations

The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals.

(Pub. L. 91–513, title II, § 301, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 103–200, § 3(a), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 108–447, div. B, title VI, § 633(b), Dec. 8, 2004, 118 Stat. 2922.)

CITE AS: 21 USC 821

§ 822. Persons required to register
(a) Period of registration
(1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him.
(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years.
(3)
(A) Except as provided in subparagraph (C), the registration of any registrant under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals terminates if and when such registrant—
(i) dies;
(ii) ceases legal existence;
(iii) discontinues business or professional practice; or
(iv) surrenders such registration.
(B) In the case of such a registrant who ceases legal existence or discontinues business or professional practice, such registrant shall promptly notify the Attorney General in writing of such fact.
(C) No registration under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals, and no authority conferred thereby, may be assigned or otherwise transferred except upon such conditions as the Attorney General may specify and then only pursuant to written consent. A registrant to whom a registration is assigned or transferred pursuant to the preceding sentence may not manufacture, distribute, or dispense controlled substances or list I chemicals pursuant to such registration until the Attorney General receives such written consent.
(D) In the case of a registrant under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals desiring to discontinue business or professional practice altogether or with respect to controlled substances and list I chemicals (without assigning or transferring such business or professional practice to another entity), such registrant shall return to the Attorney General for cancellation—
(i) the registrant’s certificate of registration;
(ii) any unexecuted order forms in the registrant’s possession; and
(iii) any other documentation that the Attorney General may require.
(b) Authorized activities
(c) ExceptionsThe following persons shall not be required to register and may lawfully possess any controlled substance or list I chemical under this subchapter:
(1) An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance or list I chemical if such agent or employee is acting in the usual course of his business or employment.
(2) A common or contract carrier or warehouseman, or an employee thereof, whose possession of the controlled substance or list I chemical is in the usual course of his business or employment.
(3) An ultimate user who possesses such substance for a purpose specified in section 802(25) 1
1 See References in Text note below.
of this title.
(d) Waiver
(e) Separate registration
(1) A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or list I chemicals.
(2) Notwithstanding paragraph (1), a registrant who is a veterinarian shall not be required to have a separate registration in order to transport and dispense controlled substances in the usual course of veterinary practice at a site other than the registrant’s registered principal place of business or professional practice, so long as the site of transporting and dispensing is located in a State where the veterinarian is licensed to practice veterinary medicine and is not a principal place of business or professional practice.
(3) Notwithstanding paragraph (1), a registrant that is dispensing pursuant to section 823(g) 1 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.
(f) Inspection
(g) Delivery of controlled substances by ultimate users for disposal
(1) An ultimate user who has lawfully obtained a controlled substance in accordance with this subchapter may, without being registered, deliver the controlled substance to another person for the purpose of disposal of the controlled substance if—
(A) the person receiving the controlled substance is authorized under this subchapter to engage in such activity; and
(B) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances.
(2) In developing regulations under this subsection, the Attorney General shall take into consideration the public health and safety, as well as the ease and cost of program implementation and participation by various communities. Such regulations may not require any entity to establish or operate a delivery or disposal program.
(3) The Attorney General may, by regulation, authorize long-term care facilities, as defined by the Attorney General by regulation, to dispose of controlled substances on behalf of ultimate users who reside, or have resided, at such long-term care facilities in a manner that the Attorney General determines will provide effective controls against diversion and be consistent with the public health and safety.
(4) If a person dies while lawfully in possession of a controlled substance for personal use, any person lawfully entitled to dispose of the decedent’s property may deliver the controlled substance to another person for the purpose of disposal under the same conditions as provided in paragraph (1) for an ultimate user.
(5)
(A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law and—
(i) the disposal occurs after the death of a person receiving hospice care;
(ii) the controlled substance is expired; or
(iii)(I) the employee is—(aa) the physician of the person receiving hospice care; and(bb) registered under section 823(g) of this title; and(II) the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified.
(B) For the purposes of this paragraph:
(i) The terms “hospice care” and “hospice program” have the meanings given to those terms in section 1395x(dd) of title 42.
(ii) The term “employee of a qualified hospice program” means a physician, physician assistant, nurse, or other person who—(I) is employed by, or pursuant to arrangements made by, a qualified hospice program;(II)(aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and(bb) is acting within the scope of such employment in accordance with applicable State law; and(III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion.
(iii) The term “qualified hospice program” means a hospice program that—(I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person’s death;(II) at the time when the controlled substances are first ordered—(aa) provides a copy of the written policies and procedures to the patient or patient representative and family;(bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and(cc) documents in the patient’s clinical record that the written policies and procedures were provided and discussed; and(III) at the time following the disposal of the controlled substances—(aa) documents in the patient’s clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and(bb) the time, date, and manner in which that disposal occurred.
(Pub. L. 91–513, title II, § 302, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 98–473, title II, § 510, Oct. 12, 1984, 98 Stat. 2072; Pub. L. 103–200, § 3(b), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 111–273, § 3(a), Oct. 12, 2010, 124 Stat. 2859; Pub. L. 113–143, § 2, Aug. 1, 2014, 128 Stat. 1750; Pub. L. 115–271, title III, § 3222(a), Oct. 24, 2018, 132 Stat. 3948; Pub. L. 117–53, § 2, Nov. 10, 2021, 135 Stat. 411; Pub. L. 117–215, title I, § 103(b)(1)(B), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, § 1252(a), Dec. 29, 2022, 136 Stat. 5681.)

CITE AS: 21 USC 822

§ 822a. Prescription drug take back expansion
(a) Definition of covered entity
In this section, the term “covered entity” means—
(1) a State, local, or tribal law enforcement agency;
(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 pharmacy;
(6) an eligible long-term care facility; or
(7) any other entity authorized by the Drug Enforcement Administration to dispose of prescription medications.
(b) Program authorized
(Pub. L. 114–198, title II, § 203, July 22, 2016, 130 Stat. 717.)

CITE AS: 21 USC 822a

§ 823. Registration requirements
(a) Manufacturers of controlled substances in schedule I or IIThe Attorney General shall register an applicant to manufacture controlled substances 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 following factors shall be considered:
(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.
(b) Distributors of controlled substances in schedule I or IIThe Attorney General shall register an applicant 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 public interest, the following factors shall be considered:
(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 manufacture, distribution, or dispensing of such substances;
(4) past experience in the distribution of controlled substances; and
(5) such other factors as may be relevant to and consistent with the public health and safety.
(c) Manufacturers of marijuana for research purposes
(1)
(A) As it relates to applications to manufacture marijuana for research purposes, when the Attorney General places a notice in the Federal Register to increase the number of entities registered under this chapter to manufacture marijuana to supply appropriately registered researchers 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 application shall be deemed complete when the applicant has submitted documentation showing each of the following:
(i) The requirements designated in the notice 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 controlled substances in schedule I; and(II) for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under 355(i) 1
1 So in original. Probably should be preceded by “section”.
of this title.
(iv) The applicant will transfer or sell any marijuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General.
(v) The applicant has completed the application and review process under subsection (a) for the bulk manufacture of controlled substances in schedule I.
(vi) The applicant has established and begun operation of a process for storage and handling of controlled substances in schedule I, including for inventory control and monitoring security in accordance with section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act.
(vii) The applicant is licensed by each State in which the applicant will conduct operations under this subsection, to manufacture marijuana, if that State requires such a license.
(C) Not later than 30 days after the date on which the Attorney General receives supplemental information requested under subparagraph (A)(ii) with respect to an application, the Attorney General shall approve or deny the application.
(2) If an application described in this subsection is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant.
(d) Limits of authorized activities
(e) Manufacturers of controlled substances in schedule III, IV, or VThe Attorney General shall register an applicant 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 public interest, the following factors shall be considered:
(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 industrial 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 manufacture, distribution, or dispensing of such substances;
(5) past experience in the manufacture, distribution, and dispensing of controlled substances, and the existence in the establishment of effective controls against diversion; and
(6) such other factors as may be relevant to and consistent with the public health and safety.
(f) Distributors of controlled substances in schedule III, IV, or VThe Attorney General shall register an applicant 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 public interest, the following factors shall be considered:
(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 manufacture, distribution, or dispensing of such substances;
(4) past experience in the distribution of controlled substances; and
(5) such other factors as may be relevant to and consistent with the public health and safety.
(g) Research by practitioners; pharmacies; research applications; construction of Article 7 of the Convention on Psychotropic Substances
(1) The Attorney General shall register practitioners (including pharmacies, as distinguished from pharmacists) to dispense, or conduct research with, controlled substances in schedule II, III, IV, or V and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet, if the applicant is authorized to dispense, or conduct research with respect to, controlled substances under the laws of the State in which he practices. The Attorney General may deny an application for such registration 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 disciplinary authority.
(B) The applicant’s experience in dispensing, or conducting research with respect to controlled substances.
(C) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(D) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(E) Such other conduct which may threaten the public health and safety.
Separate registration under this part for practitioners engaging in research with controlled substances in schedule II, III, IV, or V, who are already registered under this part in another capacity, shall not be required.
(2)
(A) Registration applications by practitioners wishing to conduct research with controlled substances in schedule I shall be referred to the Secretary, who shall determine the qualifications and competency of each practitioner requesting registration, as well as the merits of the research protocol. The Secretary, in determining the merits of each research protocol, shall consult with the Attorney General as to effective procedures to adequately safeguard against diversion of such controlled substances from legitimate medical or scientific use. Registration 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 scientific 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 procedures in place to adequately safeguard against diversion of the controlled substance for legitimate medical or scientific use pursuant to section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act, including demonstrating that the security measures are adequate for storing the quantity of marijuana the applicant would be authorized to possess.
(ii) The Attorney General may deny an application for registration under this subparagraph only if the Attorney General determines that the issuance of the registration would be inconsistent with the public interest. In determining the public interest, the Attorney General shall consider the factors listed in—(I) subparagraphs (B) through (E) of paragraph (1); and(II) subparagraph (A) of paragraph (1), if the applicable State requires practitioners conducting 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 subparagraph, the Attorney General shall—(aa) approve the application; or(bb) request supplemental information.(II) For purposes of subclause (I), an application shall be deemed complete when the applicant 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 supplemental information as described in clause (iii)(I)(bb) in connection with an application described in this subparagraph, the Attorney General shall approve or deny the application.
(v) If an application described in this subparagraph is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant.
(vi)(I) If the Attorney General grants an application for registration under clause (i), the registrant may amend or supplement the research protocol without notification to, or review by, the Drug Enforcement Administration if the registrant does not change—(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 marijuana or cannabidiol is stored, tracked, or administered.(II)(aa) If a registrant under clause (i) seeks to change the type of marijuana or cannabidiol (including any derivative, extract, preparation, and compound thereof), the source of such marijuana 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 Attorney General, not later than 30 days before implementing an amended or supplemental research protocol.(bb) A registrant may proceed with an amended or supplemental research protocol described in item (aa) if the Attorney General does not explicitly object during the 30-day period beginning 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 measures 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 permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol.(ee) A registrant may proceed with an amended or supplemental research protocol described in item (dd) if the Attorney General does not explicitly object during the 30-day period beginning 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 include—(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 quantity does not impact the source of the marijuana 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 providing the notification not later than 3 days after receipt of the notification by the Attorney General; and(BB) notice of receipt of a notification using an electronic means permitted under item (aa) is provided to the registrant providing the notification 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 notification in accordance with item (aa) may proceed with the research as if the change in quantity has been approved on such date, unless the Attorney General notifies the registrant of an objection described in item (ee).(BB) The date described in this subitem is the date on which a registrant submitting a notification under item (aa) receives the registered mail return receipt with respect to the notification 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 Attorney General, not later than 10 days after receiving the notification, explicitly objects based on a finding that the change in quantity—(AA) does impact the source of the marijuana or cannabidiol or the conditions under which the marijuana or cannabidiol is stored, tracked, or administered; or(BB) necessitates that the registrant implement additional security measures to safeguard against diversion or abuse.(IV) Nothing in this clause shall limit the authority of the Secretary of Health and Human Services over requirements related to research protocols, including changes in—(aa) the method of administration of marijuana or cannabidiol;(bb) the dosing of marijuana or cannabidiol; and(cc) the number of individuals or patients involved in research.
(3) Article 7 of the Convention on Psychotropic Substances shall not be construed to prohibit, or impose additional restrictions upon, research involving drugs or other substances scheduled under the convention which is conducted in conformity with this subsection and other applicable provisions of this subchapter.
(h) Practitioners dispensing narcotic drugs for narcotic treatment; annual registration; separate registration; qualificationsPractitioners 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 Attorney General shall register an applicant to dispense narcotic drugs to individuals for maintenance 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;
(2) if the Attorney General determines that the applicant will comply with standards established 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 applicant 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 unsupervised use by individuals in such treatment.
(i) Applicants for distribution of list I chemicalsThe Attorney General shall register an applicant 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 determining the public interest for the purposes of this subsection, the Attorney General shall consider—
(1) maintenance by the applicant of effective controls against diversion of listed chemicals into other than legitimate channels;
(2) compliance by the applicant with applicable Federal, State, and local law;
(3) any prior conviction record of the applicant under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law;
(4) any past experience of the applicant in the manufacture and distribution of chemicals; and
(5) such other factors as are relevant to and consistent with the public health and safety.
(j) Registration to manufacture certain controlled substances for use only in a clinical trial
(1) For purposes of registration to manufacture 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 accordance 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 manufacture a controlled substance under subsection (a) for use only in a clinical trial, the Attorney General shall, in accordance with the regulations issued by the Attorney General, issue a notice 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 hearing on the application under section 958(i) of this title.
(k) Emergency medical services that administer controlled substances
(1) RegistrationFor the purpose of enabling emergency medical services professionals to administer controlled substances in schedule II, III, IV, or V to ultimate users receiving emergency medical services in accordance with the requirements of this subsection, the Attorney General—
(A) shall register an emergency medical services agency 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; and
(B) may deny an application for such registration 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
(3) Hospital-based agency
(4) Administration outside physical presence of medical director or authorizing medical professionalEmergency medical services professionals of a registered emergency medical services agency 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 administration 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 response to a request by the emergency medical services professional with respect 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) DeliveryA 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—
(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) StorageA registered emergency medical services agency may store controlled substances—
(A) at a registered location of the agency;
(B) at any designated location of the agency or in an emergency services vehicle situated at a registered or designated location of the agency; or
(C) in an emergency medical services vehicle used by the agency that is—
(i) traveling from, or returning to, a registered or designated location of the agency in the course of responding to an emergency; or
(ii) otherwise actively in use by the agency under circumstances that provide for security of the controlled substances consistent with the requirements established by regulations of the Attorney General.
(7) No treatment as distribution
(8) Restocking of emergency medical services vehicles at a hospitalNotwithstanding paragraph (13)(J), a registered emergency medical services agency may receive controlled substances from a hospital for purposes of restocking an emergency medical services vehicle following an emergency 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 controlled substances.
(9) Maintenance of records
(A) In general
(B) RequirementsSuch records—
(i) shall include records of deliveries of controlled substances between all locations of the agency; and
(ii) shall be maintained, whether electronically 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 requirementsA registered emergency medical services agency, under the supervision of a medical director, shall be responsible for ensuring that—
(A) all emergency medical services professionals who administer controlled substances 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 registered location and each designated location of the agency;
(C) the applicable physical security requirements established by regulation of the Attorney General are complied with wherever 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 standing orders issued or adopted in accordance with paragraph (9).
(11) RegulationsThe Attorney General may issue regulations—
(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 locations, including in emergency medical service vehicles; and
(C) addressing the ability of hospitals, emergency medical services agencies, registered 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 constructionNothing in this subsection shall be construed—
(A) to limit the authority vested in the Attorney General by other provisions of this subchapter to take measures to prevent diversion of controlled substances; or
(B) to override the authority of any State to regulate the provision of emergency medical services consistent with this subsection.
(13) DefinitionsIn this section:
(A) The term “authorizing medical professional” means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant)—
(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 medical services agency under paragraph (5).
(C) The term “emergency medical services” means emergency medical response and emergency mobile medical services provided 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), nongovernmental (including hospital-based agencies), 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, including the administering of controlled substances, to members of the general public on an emergency basis.
(E) The term “emergency medical services professional” means a health care professional (including a nurse, paramedic, or emergency medical technician) licensed or certified by the State in which the professional practices and credentialed by a medical director of the respective emergency medical services agency to provide emergency medical services within the scope of the professional’s State license or certification.
(F) The term “emergency medical services vehicle” means an ambulance, fire apparatus, supervisor truck, or other vehicle used by an emergency medical services agency for the purpose of providing or facilitating emergency medical care and transport or transporting controlled substances to and from the registered and designated locations.
(G) The term “hospital-based” means, with respect to an agency, owned or operated 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 medical services agency” means—
(i) an emergency medical services agency that is registered pursuant to this subsection; or
(ii) a hospital-based emergency medical services agency that is covered by the registration 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 subsection (g), which shall be where the agency receives controlled substances from distributors.
(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 emergency medical services in the geographic jurisdiction of such agency or authority within 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 administering 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 telephone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional.
(l)2
2 So in original. Two subsecs. (l) have been enacted.
“Factors as may be relevant to and consistent with the public health and safety” defined
(l)2 Required training for prescribers
(1) Training requiredAs 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, beginning 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 certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties.
(ii) The physician holds a board certification from the American Board of Addiction Medicine.
(iii) The physician holds a board certification in addiction medicine from the American Osteopathic Association.
(iv) The physician has, with respect to the treatment and management of patients with opioid or other substance use disorders, or the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid or other substance use disorders, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by—(I) the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic 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 Commission for Continuing Education Provider 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 immediately preceding the date on which the physician first registers or renews under this section and has successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited 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 disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder; or(II) the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid and other substance 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 dispensing 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 patients 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 Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Associates, or any other organization approved or accredited by the Assistant Secretary for Mental Health and Substance Use or the Accreditation Council for Continuing Medical Education.
(ii) The practitioner has graduated in good standing from an accredited physician assistant school or accredited school of advanced practice nursing in the United States during the 5-year period immediately preceding the date on which the practitioner first registers or renews under this section and has successfully completed a comprehensive physician assistant or advanced practice nursing curriculum that included not fewer than 8 hours of training on treating and managing patients with opioid and other substance use disorders, including the appropriate 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
(B) Notification
(3) Rule of constructionNothing in this subsection shall be construed—
(A) to preclude the use, by a qualified practitioner, of training received pursuant to this subsection to satisfy registration requirements of a State or for some other lawful purpose; or
(B) to preempt any additional requirements by a State related to the dispensing of controlled substances under schedule II, III, IV, or V.
(4) DefinitionsIn this section:
(A) First applicable registration
(B) Qualified practitionerIn this subsection, the term “qualified practitioner” means a practitioner who—
(i) is licensed under State law to prescribe 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.)

CITE AS: 21 USC 823

§ 824. Denial, revocation, or suspension of registration
(a) GroundsA 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)(1) 1
1 See References in Text note below.
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)(1) 1 of this title.
(b)
(c) Service of show cause order; proceedings
(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.
(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 registrant;
(B) direct the applicant or registrant to appear 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 pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan.
(4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States.
(5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d).
(d) Suspension of registration in cases of imminent danger
(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)(1) 1 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.
(2) In this subsection, the phrase “imminent danger to the public health or safety” means that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this subchapter or subchapter II, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.
(e) Suspension and revocation of quotas
(f) Disposition of controlled substances or list I chemicals
(g) Seizure or placement under seal of controlled substances or list I chemicals
(h) Order to prohibit registration based on prior historyThe Attorney General may issue an order to prohibit, conditionally or unconditionally, and permanently or for such period as the Attorney General may determine, any person from being registered under this subchapter to manufacture, distribute, or dispense a controlled substance or a list I chemical, if the Attorney General finds that—
(1) such person meets or has met any of the conditions for suspension or revocation of registration under subsection (a); and
(2) such person has a history of prior suspensions or revocations of registration.
(Pub. L. 91–513, title II, § 304, Oct. 27, 1970, 84 Stat. 1255; Pub. L. 93–281, § 4, May 14, 1974, 88 Stat. 125; Pub. L. 98–473, title II, §§ 304, 512, 513, Oct. 12, 1984, 98 Stat. 2050, 2073; Pub. L. 100–93, § 8(j), Aug. 18, 1987, 101 Stat. 695; Pub. L. 103–200, § 3(d), Dec. 17, 1993, 107 Stat. 2337; Pub. L. 103–322, title XXXIII, § 330024(e), Sept. 13, 1994, 108 Stat. 2151; Pub. L. 106–310, div. B, title XXXV, § 3502(b), Oct. 17, 2000, 114 Stat. 1227; Pub. L. 114–145, § 2(a)(2), (b), Apr. 19, 2016, 130 Stat. 354; Pub. L. 117–36, § 2, Aug. 6, 2021, 135 Stat. 328; Pub. L. 117–215, title I, § 103(b)(1)(C), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, § 1262(b)(1), Dec. 29, 2022, 136 Stat. 5682.)

CITE AS: 21 USC 824

§ 825. Labeling and packaging
(a) Symbol
(b) Unlawful distribution without identifying symbol
(c) Warning on label
(d) Containers to be securely sealed
(e) False labeling of anabolic steroids
(1) It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, an anabolic steroid or product containing an anabolic steroid, unless the steroid or product bears a label clearly identifying an anabolic steroid or product containing an anabolic steroid by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC).
(2)
(A) A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
(B) A product is described in this subparagraph if the product—
(i) is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b), (j)]; or
(ii) is exempt from the provisions of section 505 of such Act relating to new drugs because—(I) it is intended solely for investigational use as described in section 505(i) of such Act; and(II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.
(Pub. L. 91–513, title II, § 305, Oct. 27, 1970, 84 Stat. 1256; Pub. L. 113–260, § 3(a), Dec. 18, 2014, 128 Stat. 2931.)

CITE AS: 21 USC 825

§ 826. Production quotas for controlled substances
(a) Establishment of total annual needs
(1) The Attorney General shall determine the total quantity and establish production quotas for each basic class of controlled substance in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. Except as provided in paragraph (2), production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.
(2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance.
(b) Individual manufacturing quotas; revised quotas
(c) Manufacturing quotas for registered manufacturers
(d) Quotas for registrants who have not manufactured controlled substance during one or more preceding years
(e) Quota increases
(f) Incidental production exception
(g) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine
(h) Quotas applicable to drugs in shortage
(1) Not later than 30 days after the receipt of a request described in paragraph (2), the Attorney General shall—
(A) complete review of such request; and
(B)
(i) as necessary to address a shortage of a controlled substance, increase the aggregate and individual production quotas under this section applicable to such controlled substance and any ingredient therein to the level requested; or
(ii) if the Attorney General determines that the level requested is not necessary to address a shortage of a controlled substance, the Attorney General shall provide a written response detailing the basis for the Attorney General’s determination.
The Secretary shall make the written response provided under subparagraph (B)(ii) available to the public on the Internet Web site of the Food and Drug Administration.
(2) A request is described in this paragraph if—
(A) the request pertains to a controlled substance on the list of drugs in shortage maintained under section 356e of this title;
(B) the request is submitted by the manufacturer of the controlled substance; and
(C) the controlled substance is in schedule II.
(i) Strengthening considerations for DEA opioid quotas
(1)
(A) In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a “covered controlled substance”), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States.
(B) In estimating diversion under this paragraph, the Attorney General—
(i) shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and
(ii) may take into consideration whatever other sources of information the Attorney General determines reliable.
(C) After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered.
(2)
(A) For any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General, in consultation with the Secretary of Health and Human Services, shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential diversion, in the United States.
(B) Not later than 1 year after October 24, 2018, and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance:
(i) An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance.
(ii) An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year.
(3) Not later than 1 year after October 24, 2018, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will—
(A) take into consideration changes in the accepted medical use of the covered controlled substances; and
(B) work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events.
(Pub. L. 91–513, title II, § 306, Oct. 27, 1970, 84 Stat. 1257; Pub. L. 94–273, § 3(16), Apr. 21, 1976, 90 Stat. 377; Pub. L. 109–177, title VII, § 713, Mar. 9, 2006, 120 Stat. 264; Pub. L. 112–144, title X, § 1005, July 9, 2012, 126 Stat. 1105; Pub. L. 115–271, title III, § 3282(a), Oct. 24, 2018, 132 Stat. 3954.)

CITE AS: 21 USC 826

§ 826a. Attorney General report on drug shortages
Not later than 6 months after July 9, 2012, and annually thereafter, the Attorney General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on the Judiciary of the Senate a report on drug shortages that—
(1) identifies the number of requests received under section 826(h) of this title (as added by section 1005 of this Act), the average review time for such requests, the number of requests granted and denied under such section, and, for each of the requests denied under such section, the basis for such denial;
(2) describes the coordination between the Drug Enforcement Administration and Food and Drug Administration on efforts to prevent or alleviate drug shortages; and
(3) identifies drugs containing a controlled substance subject to section 826 of this title when such a drug is determined by the Secretary to be in shortage.
(Pub. L. 112–144, title X, § 1006, July 9, 2012, 126 Stat. 1105.)

CITE AS: 21 USC 826a

§ 827. Records and reports of registrants
(a) InventoryExcept as provided in subsection (c)—
(1) every registrant under this subchapter shall, on May 1, 1971, or as soon thereafter as such registrant first engages in the manufacture, distribution, or dispensing of controlled substances, and every second year thereafter, make a complete and accurate record of all stocks thereof on hand, except that the regulations prescribed under this section shall permit each such biennial inventory (following the initial inventory required by this paragraph) to be prepared on such registrant’s regular general physical inventory date (if any) which is nearest to and does not vary by more than six months from the biennial date that would otherwise apply;
(2) on the effective date of each regulation of the Attorney General controlling a substance that immediately prior to such date was not a controlled substance, each registrant under this subchapter manufacturing, distributing, or dispensing such substance shall make a complete and accurate record of all stocks thereof on hand; and
(3) on and after May 1, 1971, every registrant under this subchapter manufacturing, distributing, or dispensing a controlled substance or substances shall maintain, on a current basis, a complete and accurate record of each such substance manufactured, received, sold, delivered, or otherwise disposed of by him, except that this paragraph shall not require the maintenance of a perpetual inventory.
(b) Availability of records
(c) NonapplicabilityThe foregoing provisions of this section shall not apply—
(1)
(A) to the prescribing of controlled substances in schedule II, III, IV, or V by practitioners acting in the lawful course of their professional practice unless such substance is prescribed in the course of maintenance or detoxification treatment of an individual; or
(B) to the administering of a controlled substance in schedule II, III, IV, or V unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges his patients, either separately or together with charges for other professional services, for substances so dispensed or administered or unless such substance is administered in the course of maintenance treatment or detoxification treatment of an individual;
(2)
(A) to the use of controlled substances, at establishments registered under this subchapter which keep records with respect to such substances, in research conducted in conformity with an exemption granted under section 355(i) or 360b(j) of this title;
(B) to the use of controlled substances, at establishments registered under this subchapter which keep records with respect to such substances, in preclinical research or in teaching; or
(3) to the extent of any exemption granted to any person, with respect to all or part of such provisions, by the Attorney General by or pursuant to regulation on the basis of a finding that the application of such provisions (or part thereof) to such person is not necessary for carrying out the purposes of this subchapter.
Nothing in the Convention on Psychotropic Substances shall be construed as superseding or otherwise affecting the provisions of paragraph (1)(B), (2), or (3) of this subsection.
(d) Periodic reports to Attorney General
(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.
(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.
(e) Reporting and recordkeeping requirements of drug conventions
(f) Records and reports of registrants
(1) The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances:
(A) The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant.
(B) The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A).
(2) The information required to be made available under paragraph (1) shall be made available not later than the 30th day of the first month following the quarter to which the information relates.
(3)
(A) All registered manufacturers and distributors shall be responsible for reviewing the information made available by the Attorney General under this subsection.
(B) In determining whether to initiate proceedings under this subchapter against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this subchapter or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant.
(g) Investigational uses of drugs; procedures
(h) Change of address
(i) Reporting requirements for GHBIn the case of a drug product containing gamma hydroxybutyric acid for which an application has been approved under section 355 of this title, the Attorney General may, in addition to any other requirements that apply under this section with respect to such a drug product, establish any of the following as reporting requirements:
(1) That every person who is registered as a manufacturer of bulk or dosage form, as a packager, repackager, labeler, relabeler, or distributor shall report acquisition and distribution transactions quarterly, not later than the 15th day of the month succeeding the quarter for which the report is submitted, and annually report end-of-year inventories.
(2) That all annual inventory reports shall be filed no later than January 15 of the year following that for which the report is submitted and include data on the stocks of the drug product, drug substance, bulk drug, and dosage forms on hand as of the close of business December 31, indicating whether materials reported are in storage or in process of manufacturing.
(3) That every person who is registered as a manufacturer of bulk or dosage form shall report all manufacturing transactions both inventory increases, including purchases, transfers, and returns, and reductions from inventory, including sales, transfers, theft, destruction, and seizure, and shall provide data on material manufactured, manufactured from other material, use in manufacturing other material, and use in manufacturing dosage forms.
(4) That all reports under this section must include the registered person’s registration number as well as the registration numbers, names, and other identifying information of vendors, suppliers, and customers, sufficient to allow the Attorney General to track the receipt and distribution of the drug.
(5) That each dispensing practitioner shall maintain for each prescription the name of the prescribing practitioner, the prescribing practitioner’s Federal and State registration numbers, with the expiration dates of these registrations, verification that the prescribing practitioner possesses the appropriate registration to prescribe this controlled substance, the patient’s name and address, the name of the patient’s insurance provider and documentation by a medical practitioner licensed and registered to prescribe the drug of the patient’s medical need for the drug. Such information shall be available for inspection and copying by the Attorney General.
(6) That section 830(b)(3) of this title (relating to mail order reporting) applies with respect to gamma hydroxybutyric acid to the same extent and in the same manner as such section applies with respect to the chemicals and drug products specified in subparagraph (A)(i) of such section.
(j) Electronic reporting format
(Pub. L. 91–513, title II, § 307, Oct. 27, 1970, 84 Stat. 1258; Pub. L. 93–281, § 5, May 14, 1974, 88 Stat. 125; Pub. L. 95–633, title I, §§ 104, 110, Nov. 10, 1978, 92 Stat. 3772, 3773; Pub. L. 98–473, title II, §§ 514, 515, Oct. 12, 1984, 98 Stat. 2074; Pub. L. 106–172, § 4, Feb. 18, 2000, 114 Stat. 9; Pub. L. 110–425, § 3(c), Oct. 15, 2008, 122 Stat. 4824; Pub. L. 115–271, title III, § 3273(a), Oct. 24, 2018, 132 Stat. 3952; Pub. L. 117–215, title I, § 103(b)(1)(D), Dec. 2, 2022, 136 Stat. 2263.)

CITE AS: 21 USC 827

§ 828. Order forms
(a) Unlawful distribution of controlled substances
(b) Nonapplicability of provisions
Nothing in subsection (a) shall apply to—
(1) the exportation of such substances from the United States in conformity with subchapter II;
(2) the delivery of such a substance to or by a common or contract carrier for carriage in the lawful and usual course of its business, or to or by a warehouseman for storage in the lawful and usual course of its business; but where such carriage or storage is in connection with the distribution by the owner of the substance to a third person, this paragraph shall not relieve the distributor from compliance with subsection (a); or
(3) the delivery of such a substance for the purpose of disposal by an ultimate user, long-term care facility, or other person acting in accordance with section 822(g) of this title.
(c) Preservation and availability
(1) Every person who in pursuance of an order required under subsection (a) distributes a controlled substance shall preserve such order for a period of two years, and shall make such order available for inspection and copying by officers and employees of the United States duly authorized for that purpose by the Attorney General, and by officers or employees of States or their political subdivisions who are charged with the enforcement of State or local laws regulating the production, or regulating the distribution or dispensing, of controlled substances and who are authorized under such laws to inspect such orders.
(2) Every person who gives an order required under subsection (a) shall, at or before the time of giving such order, make or cause to be made a duplicate thereof on a form to be issued by the Attorney General in blank in accordance with subsection (d) and regulations prescribed by him pursuant to this section, and shall, if such order is accepted, preserve such duplicate for a period of two years and make it available for inspection and copying by the officers and employees mentioned in paragraph (1) of this subsection.
(d) Issuance
(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.
(2) The Attorney General may charge reasonable fees for the issuance of such forms in such amounts as he may prescribe for the purpose of covering the cost to the United States of issuing such forms, and other necessary activities in connection therewith.
(e) Unlawful acts
(Pub. L. 91–513, title II, § 308, Oct. 27, 1970, 84 Stat. 1259; Pub. L. 111–273, § 3(b), Oct. 12, 2010, 124 Stat. 2860.)

CITE AS: 21 USC 828

§ 829. Prescriptions
(a) Schedule II substances
(b) Schedule III and IV substances
(c) Schedule V substances
(d) Non-prescription drugs with abuse potential
(e) Controlled substances dispensed by means of the Internet
(1) No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.
(2) As used in this subsection:
(A) The term “valid prescription” means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—
(i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or
(ii) a covering practitioner.
(B)
(i) The term “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.
(ii) Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.
(C) The term “covering practitioner” means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who—
(i) has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and
(ii) is temporarily unavailable to conduct the evaluation of the patient.
(3) Nothing in this subsection shall apply to—
(A) the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine; or
(B) the dispensing or selling of a controlled substance pursuant to practices as determined by the Attorney General by regulation, which shall be consistent with effective controls against diversion.
(f) Partial fills of schedule II controlled substances
(1) Partial fillsA prescription for a controlled substance in schedule II may be partially filled if—
(A) it is not prohibited by State law;
(B) the prescription is written and filled in accordance with this subchapter, regulations prescribed by the Attorney General, and State law;
(C) the partial fill is requested by the patient or the practitioner that wrote the prescription; and
(D) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
(2) Remaining portions
(A) In generalExcept as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II—
(i) may be filled; and
(ii) shall be filled not later than 30 days after the date on which the prescription is written.
(B) Emergency situationsIn emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II—
(i) may be filled; and
(ii) shall be filled not later than 72 hours after the prescription is issued.
(3) Currently lawful partial fills
(Pub. L. 91–513, title II, § 309, Oct. 27, 1970, 84 Stat. 1260; Pub. L. 110–425, § 2, Oct. 15, 2008, 122 Stat. 4820; Pub. L. 114–198, title VII, § 702(a), July 22, 2016, 130 Stat. 740.)

CITE AS: 21 USC 829

§ 829a. Delivery of a controlled substance by a pharmacy to an administering practitioner
(a) In general
Notwithstanding section 802(10) of this title, a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this subchapter and the regulations issued by the Attorney General under this subchapter, for the purpose of administering the controlled substance by the practitioner if—
(1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this subchapter;
(2) the controlled substance is a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment and is to be administered by injection or implantation;
(3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place;
(4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients;
(5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 45 days after the date of receipt of the controlled substance by the practitioner; and
(6) notwithstanding any exceptions under section 827 of this title, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General.
(b) Modification of number of days before which controlled substance shall be administered
(1) Initial 2-year period
During the 2-year period beginning on October 24, 2018, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will—
(A) reduce the risk of diversion; or
(B) protect the public health.
(2) Modifications after submission of report
(3) Minimum number of days
(Pub. L. 91–513, title II, § 309A, as added Pub. L. 115–271, title III, § 3204(a), Oct. 24, 2018, 132 Stat. 3945; amended Pub. L. 117–215, title I, § 103(b)(1)(E), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, §§ 1262(b)(2), 1264, Dec. 29, 2022, 136 Stat. 5682, 5685.)

CITE AS: 21 USC 829a

§ 830. Regulation of listed chemicals and certain machines
(a) Record of regulated transactions
(1) Each regulated person who engages in a regulated transaction involving a listed chemical, a tableting machine, or an encapsulating machine shall keep a record of the transaction for two years after the date of the transaction.
(2) A record under this subsection shall be retrievable and shall include the date of the regulated transaction, the identity of each party to the regulated transaction, a statement of the quantity and form of the listed chemical, a description of the tableting machine or encapsulating machine, and a description of the method of transfer. Such record shall be available for inspection and copying by the Attorney General.
(3) It is the duty of each regulated person who engages in a regulated transaction to identify each other party to the transaction. It is the duty of such other party to present proof of identity to the regulated person. The Attorney General shall specify by regulation the types of documents and other evidence that constitute proof of identity for purposes of this paragraph.
(b) Reports to Attorney General
(1) Each regulated person shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regulation—
(A) any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this subchapter;
(B) any proposed regulated transaction with a person whose description or other identifying characteristic the Attorney General furnishes in advance to the regulated person;
(C) any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person; and
(D) any regulated transaction in a tableting machine or an encapsulating machine.
Each report under subparagraph (A) shall be made at the earliest practicable opportunity after the regulated person becomes aware of the circumstance involved. A regulated person may not complete a transaction with a person whose description or identifying characteristic is furnished to the regulated person under subparagraph (B) unless the transaction is approved by the Attorney General. The Attorney General shall make available to regulated persons guidance documents describing transactions and circumstances for which reports are required under subparagraph (A) and subparagraph (C).
(2) A regulated person that manufactures a listed chemical shall report annually to the Attorney General, in such form and manner and containing such specific data as the Attorney General shall prescribe by regulation, information concerning listed chemicals manufactured by the person. The requirement of the preceding sentence shall not apply to the manufacture of a drug product that is exempted under section 802(39)(A)(iv) of this title.
(3)Mail order reporting.—
(A) As used in this paragraph:
(i) The term “drug product” means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act 1
1 See References in Text note below.
[21 U.S.C. 301 et seq.] for distribution in the United States.
(ii) The term “valid prescription” means a prescription which is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner’s professional practice.
(B) Each regulated person who engages in a transaction with a nonregulated person or who engages in an export transaction which—
(i) involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals); and
(ii) uses or attempts to use the Postal Service or any private or commercial carrier;
shall, on a monthly basis, submit a report of each such transaction conducted during the previous month to the Attorney General in such form, containing such data, and at such times as the Attorney General shall establish by regulation.
(C) The data required for such reports shall include—
(i) the name of the purchaser;
(ii) the quantity and form of the ephedrine, pseudoephedrine, or phenylpropanolamine purchased; and
(iii) the address to which such ephedrine, pseudoephedrine, or phenylpropanolamine was sent.
(D) Except as provided in subparagraph (E), the following distributions to a nonregulated person, and the following export transactions, shall not be subject to the reporting requirement in subparagraph (B):
(i) Distributions of sample packages of drug products when such packages contain not more than two solid dosage units or the equivalent of two dosage units in liquid form, not to exceed 10 milliliters of liquid per package, and not more than one package is distributed to an individual or residential address in any 30-day period.
(ii) Distributions of drug products by retail distributors that may not include face-to-face transactions to the extent that such distributions are consistent with the activities authorized for a retail distributor as specified in section 802(49) of this title, except that this clause does not apply to sales of scheduled listed chemical products at retail.
(iii) Distributions of drug products to a resident of a long term care facility (as that term is defined in regulations prescribed by the Attorney General) or distributions of drug products to a long term care facility for dispensing to or for use by a resident of that facility.
(iv) Distributions of drug products pursuant to a valid prescription.
(v) Exports which have been reported to the Attorney General pursuant to section 954 or 971 of this title or which are subject to a waiver granted under section 971(f)(2) of this title.
(vi) Any quantity, method, or type of distribution or any quantity, method, or type of distribution of a specific listed chemical (including specific formulations or drug products) or of a group of listed chemicals (including specific formulations or drug products) which the Attorney General has excluded by regulation from such reporting requirement on the basis that such reporting is not necessary for the enforcement of this subchapter or subchapter II.
(E) The Attorney General may revoke any or all of the exemptions listed in subparagraph (D) for an individual regulated person if he finds that drug products distributed by the regulated person are being used in violation of this subchapter or subchapter II. The regulated person shall be notified of the revocation, which will be effective upon receipt by the person of such notice, as provided in section 971(c)(1) of this title, and shall have the right to an expedited hearing as provided in section 971(c)(2) of this title.
(c) Confidentiality of information obtained by Attorney General; non-disclosure; exceptions
(1) Except as provided in paragraph (2), any information obtained by the Attorney General under this section which is exempt from disclosure under section 552(a) of title 5, by reason of section 552(b)(4) of such title, is confidential and may not be disclosed to any person.
(2) Information referred to in paragraph (1) may be disclosed only—
(A) to an officer or employee of the United States engaged in carrying out this subchapter, subchapter II, or the customs laws;
(B) when relevant in any investigation or proceeding for the enforcement of this subchapter, subchapter II, or the customs laws;
(C) when necessary to comply with an obligation of the United States under a treaty or other international agreement; or
(D) to a State or local official or employee in conjunction with the enforcement of controlled substances laws or chemical control laws.
(3) The Attorney General shall—
(A) take such action as may be necessary to prevent unauthorized disclosure of information by any person to whom such information is disclosed under paragraph (2); and
(B) issue guidelines that limit, to the maximum extent feasible, the disclosure of proprietary business information, including the names or identities of United States exporters of listed chemicals, to any person to whom such information is disclosed under paragraph (2).
(4) Any person who is aggrieved by a disclosure of information in violation of this section may bring a civil action against the violator for appropriate relief.
(5) Notwithstanding paragraph (4), a civil action may not be brought under such paragraph against investigative or law enforcement personnel of the Drug Enforcement Administration.
(d) Scheduled listed chemicals; restrictions on sales quantity; requirements regarding nonliquid formsWith respect to ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product—
(1) the quantity of such base sold at retail in such a product by a regulated seller, or a distributor required to submit reports by subsection (b)(3) may not, for any purchaser, exceed a daily amount of 3.6 grams, without regard to the number of transactions; and
(2) such a seller or distributor may not sell such a product in nonliquid form (including gel caps) at retail unless the product is packaged in blister packs, each blister containing not more than 2 dosage units, or where the use of blister packs is technically infeasible, the product is packaged in unit dose packets or pouches.
(e) Scheduled listed chemicals; behind-the-counter access; logbook requirement; training of sales personnel; privacy protections
(1) Requirements regarding retail transactions
(A) In generalEach regulated seller shall ensure that, subject to subparagraph (F), sales by such seller of a scheduled listed chemical product at retail are made in accordance with the following:
(i) In offering the product for sale, the seller places the product such that customers do not have direct access to the product before the sale is made (in this paragraph referred to as “behind-the-counter” placement). For purposes of this paragraph, a behind-the-counter placement of a product includes circumstances in which the product is stored in a locked cabinet that is located in an area of the facility involved to which customers do have direct access.
(ii) The seller delivers the product directly into the custody of the purchaser.
(iii) The seller maintains, in accordance with criteria issued by the Attorney General, a written or electronic list of such sales that identifies the products by name, the quantity sold, the names and addresses of purchasers, and the dates and times of the sales (which list is referred to in this subsection as the “logbook”), except that such requirement does not apply to any purchase by an individual of a single sales package if that package contains not more than 60 milligrams of pseudoephedrine.
(iv) In the case of a sale to which the requirement of clause (iii) applies, the seller does not sell such a product unless the sale is made in accordance with the following:(I) The prospective purchaser—(aa) presents an identification card that provides a photograph and is issued by a State or the Federal Government, or a document that, with respect to identification, is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of title 8, Code of Federal Regulations (as in effect on or after March 9, 2006); and(bb) signs the written logbook and enters in the logbook his or her name, address, and the date and time of the sale, or for transactions involving an electronic logbook, the purchaser provides a signature using one of the following means:(AA) Signing a device presented by the seller that captures signatures in an electronic format. Such device shall display the notice described in clause (v). Any device used shall preserve each signature in a manner that clearly links that signature to the other electronically-captured logbook information relating to the prospective purchaser providing that signature.(BB) Signing a bound paper book. Such bound paper book shall include, for such purchaser, either (aaa) a printed sticker affixed to the bound paper book at the time of sale which either displays the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale, or a unique identifier which can be linked to that electronic information, or (bbb) a unique identifier which can be linked to that information and which is written into the book by the seller at the time of sale. The purchaser shall sign adjacent to the printed sticker or written unique identifier related to that sale. Such bound paper book shall display the notice described in clause (v).(CC) Signing a printed document that includes, for such purchaser, the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale. Such document shall be printed by the seller at the time of the sale. Such document shall contain a clearly identified signature line for a purchaser to sign. Such printed document shall display the notice described in clause (v). Each signed document shall be inserted into a binder or other secure means of document storage immediately after the purchaser signs the document.(II) The seller enters in the logbook the name of the product and the quantity sold. Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.(III) The logbook maintained by the seller includes the prospective purchaser’s name, address, and the date and time of the sale, as follows:(aa) If the purchaser enters the information, the seller must determine that the name entered in the logbook corresponds to the name provided on such identification and that the date and time entered are correct.(bb) If the seller enters the information, the prospective purchaser must verify that the information is correct.(cc) Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.
(v) The written or electronic logbook includes, in accordance with criteria of the Attorney General, a notice to purchasers that entering false statements or misrepresentations in the logbook, or supplying false information or identification that results in the entry of false statements or misrepresentations, may subject the purchasers to criminal penalties under section 1001 of title 18, which notice specifies the maximum fine and term of imprisonment under such section.
(vi) Regardless of whether the logbook entry is written or electronic, the seller maintains each entry in the logbook for not fewer than 2 years after the date on which the entry is made.
(vii) In the case of individuals who are responsible for delivering such products into the custody of purchasers or who deal directly with purchasers by obtaining payments for the products, the seller has submitted to the Attorney General a self-certification that all such individuals have, in accordance with criteria under subparagraph (B)(ii), undergone training provided by the seller to ensure that the individuals understand the requirements that apply under this subsection and subsection (d).
(viii) The seller maintains a copy of such certification and records demonstrating that individuals referred to in clause (vii) have undergone the training.
(ix) If the seller is a mobile retail vendor:(I) The seller complies with clause (i) by placing the product in a locked cabinet.(II) The seller does not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.
(B) Additional provisions regarding certifications and training
(i) In general
(ii) Issuance of criteria; self-certificationThe Attorney General shall by regulation establish criteria for certifications under this paragraph. The criteria shall—(I) provide that the certifications are self-certifications provided through the program under clause (iii);(II) provide that a separate certification is required for each place of business at which a regulated seller sells scheduled listed chemical products at retail; and(III) include criteria for training under subparagraph (A)(vii).
(iii) Program for regulated sellers(I) The program shall be carried out through an Internet site of the Department of Justice and such other means as the Attorney General determines to be appropriate.(II) The program shall inform regulated sellers that section 1001 of title 18 applies to such certifications.(III) The program shall make available to such sellers an explanation of the criteria under clause (ii).(IV) The program shall be designed to permit the submission of the certifications through such Internet site.(V) The program shall be designed to automatically provide the explanation referred to in subclause (III), and an acknowledgement that the Department has received a certification, without requiring direct interactions of regulated sellers with staff of the Department (other than the provision of technical assistance, as appropriate).
(iv) Availability of certification to State and local officials
(v) Publication of list of self-certified persons
(C) Privacy protectionsIn order to protect the privacy of individuals who purchase scheduled listed chemical products, the Attorney General shall by regulation establish restrictions on disclosure of information in logbooks under subparagraph (A)(iii). Such regulations shall—
(i) provide for the disclosure of the information as appropriate to the Attorney General and to State and local law enforcement agencies; and
(ii) prohibit accessing, using, or sharing information in the logbooks for any purpose other than to ensure compliance with this subchapter or to facilitate a product recall to protect public health and safety.
(D) False statements or misrepresentations by purchasers
(E) Good faith protection
(F) Inapplicability of requirements to certain sales
(G) Certain measures regarding theft and diversion
(2) Mail-order reporting; verification of identity of purchaser; 30-day restriction on quantities for individual purchasersEach regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General is subject to the following:
(A) The person shall, prior to shipping the product, confirm the identity of the purchaser in accordance with procedures established by the Attorney General. The Attorney General shall by regulation establish such procedures.
(B) The person may not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.
(C) Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General may not sell any scheduled listed chemical product at retail unless such regulated person has submitted to the Attorney General a self-certification including a statement that the seller understands each of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements. The Attorney General shall by regulation establish criteria for certifications of mail-order distributors that are consistent with the criteria established for the certifications of regulated sellers under paragraph (1)(B).
(3) Exemptions for certain products
(Pub. L. 91–513, title II, § 310, as added Pub. L. 95–633, title II, § 202(a), Nov. 10, 1978, 92 Stat. 3774; amended Pub. L. 100–690, title VI, § 6052(a), Nov. 18, 1988, 102 Stat. 4312; Pub. L. 103–200, §§ 2(c), 10, Dec. 17, 1993, 107 Stat. 2336, 2341; Pub. L. 104–237, title II, § 208, title IV, § 402, Oct. 3, 1996, 110 Stat. 3104, 3111; Pub. L. 106–310, div. B, title XXXVI, § 3652, Oct. 17, 2000, 114 Stat. 1239; Pub. L. 109–177, title VII, §§ 711(a)(2)(B), (b)(1), (c)(1), (2), (d), 716(b)(2), Mar. 9, 2006, 120 Stat. 257, 261, 267; Pub. L. 110–415, § 2, Oct. 14, 2008, 122 Stat. 4349; Pub. L. 111–268, §§ 2, 3, Oct. 12, 2010, 124 Stat. 2847.)

CITE AS: 21 USC 830

§ 831. Additional requirements relating to online pharmacies and telemedicine
(a) In general
(b) Licensure
(c) Internet pharmacy site disclosure informationEach online pharmacy shall post in a visible and clear manner on the homepage of each Internet site it operates, or on a page directly linked thereto in which the hyperlink is also visible and clear on the homepage, the following information for each pharmacy that delivers, distributes, or dispenses controlled substances pursuant to orders made on, through, or on behalf of, that website:
(1) The name and address of the pharmacy as it appears on the pharmacy’s Drug Enforcement Administration certificate of registration.
(2) The pharmacy’s telephone number and email address.
(3) The name, professional degree, and States of licensure of the pharmacist-in-charge, and a telephone number at which the pharmacist-in-charge can be contacted.
(4) A list of the States in which the pharmacy is licensed to dispense controlled substances.
(5) A certification that the pharmacy is registered under this part to deliver, distribute, or dispense by means of the Internet controlled substances.
(6) The name, address, telephone number, professional degree, and States of licensure of any practitioner who has a contractual relationship to provide medical evaluations or issue prescriptions for controlled substances, through referrals from the website or at the request of the owner or operator of the website, or any employee or agent thereof.
(7) The following statement, unless revised by the Attorney General by regulation: “This online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation or medical evaluation via telemedicine in accordance with applicable requirements of section 309.”.
(d) Notification
(1) In general
(2)The notification required under paragraph (1) shall include—
(A) the information required to be posted on the online pharmacy’s Internet site under subsection (c) and shall notify the Attorney General and the applicable State boards of pharmacy, under penalty of perjury, that the information disclosed on its Internet site under subsection (c) is true and accurate;
(B) the online pharmacy’s Internet site address and a certification that the online pharmacy shall notify the Attorney General of any change in the address at least 30 days in advance; and
(C) the Drug Enforcement Administration registration numbers of any pharmacies and practitioners referred to in subsection (c), as applicable.
(3) Existing online pharmacies
(e) Declaration of compliance
(f) Reports
(g) Notice and designations concerning Indian tribes
(1) In general
(2) Designations
(A) In general
(B) Practitioners
(h) Special registration for telemedicine
(1) In generalThe Attorney General may issue to a practitioner a special registration to engage in the practice of telemedicine for purposes of section 802(54)(E) of this title if the practitioner, upon application for such special registration—
(A) demonstrates a legitimate need for the special registration; and
(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.
(2) RegulationsNot later than 1 year after October 24, 2018, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying—
(A) the limited circumstances in which a special registration under this subsection may be issued; and
(B) the procedure for obtaining a special registration under this subsection.
(3) Denials
(i) Reporting of telemedicine by VHA during medical emergency situations
(1) In general
(2) To Attorney General
(j) Clarification concerning prescription transfers
(Pub. L. 91–513, title II, § 311, as added Pub. L. 110–425, § 3(d)(1), Oct. 15, 2008, 122 Stat. 4825; amended Pub. L. 115–271, title III, § 3232, Oct. 24, 2018, 132 Stat. 3950; Pub. L. 117–215, title I, § 103(b)(1)(F), Dec. 2, 2022, 136 Stat. 2263.)

CITE AS: 21 USC 831

§ 832. Suspicious orders
(a) Reporting
Each registrant shall—
(1) design and operate a system to identify suspicious orders for the registrant;
(2) ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and
(3) upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business.
(b) Suspicious order database
(1) In general
(2) Satisfaction of reporting requirements
(c) Sharing information with the States
(1) In general
(2) Timing
(3) Coordination
(Pub. L. 91–513, title II, § 312, as added Pub. L. 115–271, title III, § 3292(b), Oct. 24, 2018, 132 Stat. 3956.)

CITE AS: 21 USC 832