21 U.S.C. § 822
Persons required to register
United States · Title 21 — FOOD AND DRUGS · Status: effective
Cite this
- Citation
- 21 U.S.C. § 822, Persons required to register, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454618
- Permanent ID
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Full text
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—
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—
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:
An agent or employee of a research institution that is conducting research with a controlled substance if—
the researcher who is so registered—
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.
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—
the research occurs exclusively on sites all of which are—
before commencing the research, the researcher notifies the Attorney General of each site where—
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—
The Attorney General may, in consultation with the Secretary, issue regulations addressing, with respect to research sites described in subparagraph (A)—
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—
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—
the employee is—
For the purposes of this paragraph:
The term “employee of a qualified hospice program” means a physician, physician assistant, nurse, or other person who—
The term “qualified hospice program” means a hospice program that—
at the time when the controlled substances are first ordered—
at the time following the disposal of the controlled substances—
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—
the person may, notwithstanding subsections (a) and (b), continue to conduct the research on the substance until—
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—
the activities and the quantities of the substance involved in the activities are stated in—
a notification to the Attorney General that includes—
Activities permitted under paragraph (1) include—
processing the substance to create extracts, tinctures, oils, solutions, derivatives, or other forms of the substance consistent with—
The authority under paragraph (1) to manufacture substances does not include the authority to grow marihuana.
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone. The law that originally enacted this section predates the public laws loaded here, so only later amendments are listed.
- A joint resolution making continuing appropriations for the fiscal year 1985, and for other purposes.House: no recorded tallySenate: no recorded tally
- Domestic Chemical Diversion Control Act of 1993House: no recorded tallySenate: no recorded tally
- Secure and Responsible Drug Disposal Act of 2010House: no recorded tallySenate: no recorded tally
- Veterinary Medicine Mobility Act of 2014House: no recorded tallySenate: no recorded tally
- SUPPORT for Patients and Communities Act
- Ensuring Compliance Against Drug Diversion Act of 2021House: 412–5Senate: no recorded tally
- Medical Marijuana and Cannabidiol Research Expansion ActHouse: 325–95Senate: no recorded tally
- Consolidated Appropriations Act, 2023House: 225–201Senate: no recorded tally
- HALT Fentanyl Act