Persons required to register
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.
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.
The 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.
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.
(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.
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.
Delivery of controlled substances by ultimate users for disposal
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.
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
the employee is—(aa) the physician of the person receiving hospice care; and(bb) registered under section 823(f) 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.
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.
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.
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.)