21 U.S.C. § 822

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(a)
1. (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. (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. (3)
  1. (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—
    1. (i)dies;
    2. (ii)ceases legal existence;
    3. (iii)discontinues business or professional practice; or
    4. (iv)surrenders such registration.
  2. (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.
  3. (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.
  4. (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—
    1. (i)the registrant’s certificate of registration;
    2. (ii)any unexecuted order forms in the registrant’s possession; and
    3. (iii)any other documentation that the Attorney General may require.
(b)Persons registered by the Attorney General under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals are authorized to possess, manufacture, distribute, or dispense such substances or chemicals (including any such activity in the conduct of research) to the extent authorized by their registration and in conformity with the other provisions of this subchapter.
(c)The following persons shall not be required to register and may lawfully possess any controlled substance or list I chemical under this subchapter:
1. (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. (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. (3)An ultimate user who possesses such substance for a purpose specified in section 802(27) of this title.
4. (4)An agent or employee of a research institution that is conducting research with a controlled substance if—
  1. (A)the agent or employee is acting within the scope of the professional practice of the agent or employee;
  2. (B)another agent or employee of the institution is registered to conduct research with a controlled substance in the same schedule;
  3. (C)the researcher who is so registered—
    1. (i)informs the Attorney General of the name, position title, and employing institution of the agent or employee who is not separately registered;
    2. (ii)authorizes that agent or employee to perform research under the registration of the registered researcher; and
    3. (iii)affirms that any act taken by that agent or employee involving a controlled substance shall be attributable to the registered researcher, as if the researcher had directly committed the act, for purposes of any proceeding under section 824(a) of this title to suspend or revoke the registration of the registered researcher; and
  4. (D)the Attorney General does not, within 30 days of receiving the information, authorization, and affirmation described in subparagraph (C), refuse, for a reason listed in section 824(a) of this title, to allow the agent or employee to possess the substance without a separate registration.
(d)The Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.
(e)
1. (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. (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. (3)Notwithstanding paragraph (1), a registrant that is dispensing pursuant to section 823(h) of this title narcotic drugs to individuals for maintenance treatment or detoxification treatment shall not be required to have a separate registration to incorporate one or more mobile medication units into the registrant’s practice to dispense such narcotics at locations other than the registrant’s principal place of business or professional practice described in paragraph (1), so long as the registrant meets such standards for operation of a mobile medication unit as the Attorney General may establish.
4. (4)
  1. (A)Notwithstanding paragraph (1), a person registered to conduct research with a controlled substance under section 823(g) of this title may conduct the research under a single registration if—
    1. (i)the research occurs exclusively on sites all of which are—
      1. (I)within the same city or county; and
      2. (II)under the control of the same institution, organization, or agency; and
    2. (ii)before commencing the research, the researcher notifies the Attorney General of each site where—
      1. (I)the research will be conducted; or
      2. (II)the controlled substance will be stored or administered.
  2. (B)A site described in subparagraph (A) shall be included in a registration described in that subparagraph only if the researcher has notified the Attorney General of the site—
    1. (i)in the application for the registration; or
    2. (ii)before the research is conducted, or before the controlled substance is stored or administered, at the site.
  3. (C)The Attorney General may, in consultation with the Secretary, issue regulations addressing, with respect to research sites described in subparagraph (A)—
    1. (i)the manner in which controlled substances may be delivered to the research sites;
    2. (ii)the storage and security of controlled substances at the research sites;
    3. (iii)the maintenance of records for the research sites; and
    4. (iv)any other matters necessary to ensure effective controls against diversion at the research sites.
(f)
1. (1)The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him.
2. (2)
  1. (A)If a person is registered to conduct research with a controlled substance and applies for a registration, or for a modification of a registration, to conduct research with a second controlled substance that is in the same schedule as the first controlled substance, or is in a schedule with a higher numerical designation than the schedule of the first controlled substance, a new inspection by the Attorney General of the registered location is not required.
  2. (B)Nothing in subparagraph (A) shall prohibit the Attorney General from conducting an inspection that the Attorney General determines necessary to ensure that a registrant maintains effective controls against diversion.
(g)
1. (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—
  1. (A)the person receiving the controlled substance is authorized under this subchapter to engage in such activity; and
  2. (B)the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances.
2. (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. (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. (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. (5)
  1. (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—
    1. (i)the disposal occurs after the death of a person receiving hospice care;
    2. (ii)the controlled substance is expired; or
    3. (iii)
      1. (I)the employee is—
        (aa)the physician of the person receiving hospice care; and
        (bb)registered under section 823(g) of this title; and
      2. (II)the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified.
  2. (B)For the purposes of this paragraph:
    1. (i)The terms “hospice care” and “hospice program” have the meanings given to those terms in section 1395x(dd) of title 42.
    2. (ii)The term “employee of a qualified hospice program” means a physician, physician assistant, nurse, or other person who—
      1. (I)is employed by, or pursuant to arrangements made by, a qualified hospice program;
      2. (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
      3. (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.
    3. (iii)The term “qualified hospice program” means a hospice program that—
      1. (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;
      2. (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
      3. (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.
(h)If a person is conducting research on a substance when the substance is added to schedule I, and the person is already registered to conduct research with a controlled substance in schedule I—
1. (1)not later than 90 days after the scheduling of the newly scheduled substance, the person shall submit a completed application for registration or modification of existing registration, to conduct research on the substance, in accordance with regulations issued by the Attorney General for purposes of this paragraph;
2. (2)the person may, notwithstanding subsections (a) and (b), continue to conduct the research on the substance until—
  1. (A)the person withdraws the application described in paragraph (1) of this subsection; or
  2. (B)the Attorney General serves on the person an order to show cause proposing the denial of the application under section 824(c) of this title;
3. (3)if the Attorney General serves an order to show cause as described in paragraph (2)(B) and the person requests a hearing, the hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time if so requested by the person; and
4. (4)if the person sends a copy of the application described in paragraph (1) to a manufacturer or distributor of the substance, receipt of the copy by the manufacturer or distributor shall constitute sufficient evidence that the person is authorized to receive the substance.
(i)
1. (1)Except as provided in paragraph (3), a person who is registered to perform research on a controlled substance may perform manufacturing activities with small quantities of that substance, including activities described in paragraph (2), without being required to obtain a manufacturing registration, if—
  1. (A)the activities are performed for the purpose of the research; and
  2. (B)the activities and the quantities of the substance involved in the activities are stated in—
    1. (i)a notification submitted to the Attorney General under section 823(n) of this title;
    2. (ii)a research protocol filed with an application for registration approval under section 823(g) of this title; or
    3. (iii)a notification to the Attorney General that includes—
      1. (I)the name of the registrant; and
      2. (II)an attestation that the research to be conducted with the small quantities of manufactured substance is consistent with the scope of the research that is the basis for the registration.
2. (2)Activities permitted under paragraph (1) include—
  1. (A)processing the substance to create extracts, tinctures, oils, solutions, derivatives, or other forms of the substance consistent with—
    1. (i)the information provided as part of a notification submitted to the Attorney General under section 823(n) of this title; or
    2. (ii)a research protocol filed with an application for registration approval under section 823(g) of this title; and
  2. (B)dosage form development studies performed for the purpose of requesting an investigational new drug exemption under section 355(i) of this title.
3. (3)The authority under paragraph (1) to manufacture substances does not include the authority to grow marihuana.