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21 U.S.C. § 821 — Rules and regulations
Federal law — U.S. Code and appendices · legal_authorities
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.
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Source file: Laws/federal/codes/united-states-code/title-21/section-821-rules-and-regulations--8ad08d1de2.md
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Source location: Title 21, Chapter 13, § 821; chapter-013-drug-abuse-prevention-and-control.md
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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.
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Federal law — U.S. Code and appendices · legal_authorities
The Congress makes the following findings and declarations:
(1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.
(2) The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people.
(3) A major portion of the traffic in controlled substances flows through interstate and foreign commerce. Incidents of the traffic which are not an integral part of the interstate or foreign flow, such as manufacture, local distribution, and possession, nonetheless have a substantial and direct effect upon interstate commerce because—
(A) after manufacture, many controlled substances are transported in interstate commerce,
(B) controlled substances distributed locally usually have been transported in interstate commerce immediately before their distribution, and
(C) controlled substances possessed commonly flow through interstate commerce immediately prior to such possession.
(4) Local distribution and possession of controlled substances contribute to swelling the interstate traffic in such substances.
(5) Controlled substances manufactured and distributed intrastate cannot be differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate.
(6) Federal control of the intrastate incidents of the traffic in controlled substances is essential to the effective control of the interstate incidents
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 801
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Federal law — U.S. Code and appendices · legal_authorities
As used in this subchapter:
(1) The term “addict” means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction.
(2) The term “administer” refers to the direct application of a controlled substance to the body of a patient or research subject by—
(A) a practitioner (or, in his presence, by his authorized agent), or
(B) the patient or research subject at the direction and in the presence of the practitioner,
whether such application be by injection, inhalation, ingestion, or any other means.
(3) The term “agent” means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier’s or warehouseman’s business.
(4) The term “Drug Enforcement Administration” means the Drug Enforcement Administration in the Department of Justice.
(5) The term “control” means to add a drug or other substance, or immediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise.
(6) The term “controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.
(7) The term “counterfeit substance” means a controlled substance which, or the container or labelin
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 802
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The President is authorized to negotiate agreements which provide—
(1) that the United States shall carry out the provisions of part C of the Controlled Substances Act ([21 U.S.C. 821](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section821&num=0&edition=prelim) et seq.) as necessary to provide for the lawful distribution of controlled substances in the freely associated states; and
(2) that a freely associated state which institutes and maintains a voluntary system to report annual estimates of narcotics needs to the International Narcotics Control Board, and which imposes controls on imports of narcotic drugs consistent with the Single Convention on Narcotic Drugs, 1961, shall be eligible for exports of narcotic drugs from the United States in the same manner as a country meeting the requirements of subsection (a) of section 953 11 See References in Text note below. of title 21.
**(b) Effective date** Agreements concluded pursuant to this section shall become effective pursuant to [section 1901(f)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title48-section1901/f/5&num=0&edition=prelim) or [section 1931(d)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title48-section1931/d/5&num=0&edition=prelim), as may be applicable.
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Federal law — U.S. Code and appendices · legal_authorities
Page 805
TITLE 21—FOOD AND DRUGS
§ 822
(D) any actions taken by the manufacturer
to prevent diversion of the drug product; and
(E) such other factors as are relevant to
and consistent with the public health and
safety, including the factors described in
subsection (b) as applied to the drug prod-
uct.
(3) Status pending application for reinstate-
ment
A transaction involving a particular drug
product that is the subject of a bona fide pend-
ing application for reinstatement of exemp-
tion filed with the Attorney General not later
than 60 days after a regulation removing the
exemption is issued pursuant to subsection (a)
shall not be considered to be a regulated
transaction if the transaction occurs during
the pendency of the application and, if the At-
torney General denies the application, during
the period of 60 days following the date on
which the Attorney General denies the appli-
cation, unless—
(A) the Attorney General has evidence
that, applying the factors described in sub-
section (b) to the drug product, the drug
product is being diverted; and
(B) the Attorney General so notifies the
applicant.
(4) Amendment and modification
A regulation reinstating an exemption under
paragraph (1) may be modified or revoked with
respect to a particular drug product upon a
finding that—
(A) applying the factors described in sub-
section (b) to the drug product, the drug
product is being diverted; or
(B) there is a significant change in the
data that led to the issuance of the regula-
tion.
(Pub. L. 91–513, title II, § 204, as added Pub. L.
103–200, § 2(b)(1), Dec. 17, 1993, 107 Stat. 2334;
amended Pub. L. 104–237, title IV, § 401(c), Oct. 3,
1996, 110 Stat. 3108; Pub. L. 109–177, title VII,
§ 712(a)(2), Mar. 9, 2006, 120 Stat. 263.)
Editorial No
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 821
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