21 Usc 822

§ 821

TITLE 21—FOOD AND DRUGS

(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 subsection (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 regulation.
(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.)
AMENDMENTS
2006—Subsec. (e). Pub. L. 109–177 struck out subsec.
(e). Text read as follows: ‘‘Pursuant to subsection (d)(1)
of this section, the Attorney General shall by regulation reinstate the exemption with respect to a particular ephedrine, pseudoephedrine, or phenylpropanolamine drug product if the Attorney General determines
that the drug product is manufactured and distributed
in a manner that prevents diversion. In making this determination the Attorney General shall consider the
factors listed in subsection (d)(2) of this section. Any
regulation issued pursuant to this subsection may be
amended or revoked based on the factors listed in subsection (d)(4) of this section.’’
1996—Subsec. (e). Pub. L. 104–237 added subsec. (e).
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–237 not applicable to sale
of any pseudoephedrine or phenylpropanolamine product prior to 12 months after Oct. 3, 1996, except that, on
application of manufacturer of particular drug product,
Attorney General may exercise sole and judicially unreviewable discretion to extend such effective date up
to additional 6 months, see section 401(g) of Pub. L.
104–237, set out as a note under section 802 of this title.
EFFECTIVE DATE
Section effective on date that is 120 days after Dec.
17, 1993, see section 11 of Pub. L. 103–200, set out as an
Effective Date of 1993 Amendment note under section
802 of this title.

PART C—REGISTRATION OF MANUFACTURERS,
DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
§ 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.)
AMENDMENTS
2004—Pub. L. 108–447 substituted ‘‘listed chemicals’’
for ‘‘the registration and control of regulated persons
and of regulated transactions’’.
1993—Pub. L. 103–200 inserted before period at end
‘‘and to the registration and control of regulated persons and of regulated transactions’’.
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103–200 effective on date that
is 120 days after Dec. 17, 1993, see section 11 of Pub. L.
103–200, set out as a note under section 802 of this title.

Page 692
EFFECTIVE DATE

Section effective on first day of seventh calendar
month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91–513, set out as a note under section 801 of
this title.

§ 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.
(b) Authorized activities
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) Exceptions
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 of this title.
(d) Waiver
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) 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
1 See

References in Text note below.

Page 693

§ 822

TITLE 21—FOOD AND DRUGS

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.
(f) Inspection
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.
(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 longterm 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.
(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.)
REFERENCES IN TEXT
This subchapter, referred to in subsecs. (b), (c), and
(g)(1), was in the original ‘‘this title’’, meaning title II
of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the ‘‘Controlled Substances Act’’. For
complete classification of title II to the Code, see second paragraph of Short Title note set out under section
801 of this title and Tables.
Section 802(25) of this title, referred to in subsec.
(c)(3), was redesignated section 802(26) of this title by

Pub. L. 98–473, title II, § 507(a), Oct. 12, 1984, 98 Stat.
2071, and was further redesignated section 802(27) of this
title by Pub. L. 99–570, title I, § 1003(b)(2), Oct. 27, 1986,
100 Stat. 3207–6.
AMENDMENTS
2014—Subsec. (e). Pub. L. 113–143 designated existing
provisions as par. (1) and added par. (2).
2010—Subsec. (g). Pub. L. 111–273 added subsec. (g).
1993—Subsec. (a)(1). Pub. L. 103–200, § 3(b)(1), inserted
‘‘or list I chemical’’ after ‘‘controlled substance’’ in
two places.
Subsec. (b). Pub. L. 103–200, § 3(b)(2), inserted ‘‘or list
I chemicals’’ after ‘‘controlled substances’’ and ‘‘or
chemicals’’ after ‘‘such substances’’.
Subsec. (c). Pub. L. 103–200, § 3(b)(3), inserted ‘‘or list
I chemical’’ after ‘‘controlled substance’’ wherever appearing.
Subsec. (e). Pub. L. 103–200, § 3(b)(4), inserted ‘‘or list
I chemicals’’ after ‘‘controlled substances’’.
1984—Subsec. (a). Pub. L. 98–473 designated existing
provisions as par. (1), struck out provisions relating to
dispensing controlled substances, and added par. (2).
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103–200 effective on date that
is 120 days after Dec. 17, 1993, see section 11 of Pub. L.
103–200, set out as a note under section 802 of this title.
EFFECTIVE DATE
Section effective on first day of seventh calendar
month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91–513, set out as a note under section 801 of
this title.
FINDINGS
Pub. L. 111–273, § 2, Oct. 12, 2010, 124 Stat. 2858, provided that: ‘‘Congress finds the following:
‘‘(1) The nonmedical use of prescription drugs is a
growing problem in the United States, particularly
among teenagers.
‘‘(2) According to the Department of Justice’s 2009
National Prescription Drug Threat Assessment—
‘‘(A) the number of deaths and treatment admissions for controlled prescription drugs (CPDs) has
increased significantly in recent years;
‘‘(B) unintentional overdose deaths involving prescription opioids, for example, increased 114 percent
from 2001 to 2005, and the number of treatment admissions for prescription opioids increased 74 percent from 2002 to 2006; and
‘‘(C) violent crime and property crime associated
with abuse and diversion of CPDs has increased in
all regions of the United States over the past 5
years.
‘‘(3) According to the Office of National Drug Control Policy’s 2008 Report ‘Prescription for Danger’,
prescription drug abuse is especially on the rise for
teens—
‘‘(A) one-third of all new abusers of prescription
drugs in 2006 were 12- to 17-year-olds;
‘‘(B) teens abuse prescription drugs more than
any illicit drug except marijuana—more than cocaine, heroin, and methamphetamine combined;
and
‘‘(C) responsible adults are in a unique position to
reduce teen access to prescription drugs because
the drugs often are found in the home.
‘‘(4)(A) Many State and local law enforcement agencies have established drug disposal programs (often
called ‘take-back’ programs) to facilitate the collection and destruction of unused, unwanted, or expired
medications. These programs help get outdated or unused medications off household shelves and out of the
reach of children and teenagers.
‘‘(B) However, take-back programs often cannot
dispose of the most dangerous pharmaceutical
drugs—controlled substance medications—because
Federal law does not permit take-back programs to

§ 822a

TITLE 21—FOOD AND DRUGS

accept controlled substances unless they get specific
permission from the Drug Enforcement Administration and arrange for full-time law enforcement officers to receive the controlled substances directly
from the member of the public who seeks to dispose
of them.
‘‘(C) Individuals seeking to reduce the amount of
unwanted controlled substances in their household
consequently have few disposal options beyond discarding or flushing the substances, which may not be
appropriate means of disposing of the substances.
Drug take-back programs are also a convenient and
effective means for individuals in various communities to reduce the introduction of some potentially
harmful substances into the environment, particularly into water.
‘‘(D) Long-term care facilities face a distinct set of
obstacles to the safe disposal of controlled substances
due to the increased volume of controlled substances
they handle.
‘‘(5) This Act [see Short Title of 2010 Amendment
note set out under section 801 of this title] gives the
Attorney General authority to promulgate new regulations, within the framework of the Controlled Substances Act [21 U.S.C. 801 et seq.], that will allow patients to deliver unused pharmaceutical controlled
substances to appropriate entities for disposal in a
safe and effective manner consistent with effective
controls against diversion.
‘‘(6) The goal of this Act is to encourage the Attorney General to set controlled substance diversion prevention parameters that will allow public and private
entities to develop a variety of methods of collection
and disposal of controlled substances, including some
pharmaceuticals, in a secure, convenient, and responsible manner. This will also serve to reduce instances
of diversion and introduction of some potentially
harmful substances into the environment.’’

Page 694

§ 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
The Attorney General, in coordination with
the Administrator of the Drug Enforcement Administration, the Secretary of Health and
Human Services, and the Director of the Office
of National Drug Control Policy, shall coordinate with covered entities in expanding or making available disposal sites for unwanted prescription medications.
(Pub. L. 114–198, title II, § 203, July 22, 2016, 130
Stat. 717.)
CODIFICATION
Section was enacted as part of the Comprehensive
Addiction and Recovery Act of 2016, and not as part of
the Controlled Substances Act which comprises this
subchapter.

PROVISIONAL REGISTRATION
Pub. L. 91–513, title II, § 703, Oct. 27, 1970, 84 Stat. 1283,
as amended by Pub. L. 99–514, § 2, Oct. 22, 1986, 100 Stat.
2095, provided that:
‘‘(a)(1) Any person who—
‘‘(A) is engaged in manufacturing, distributing, or
dispensing any controlled substance on the day before
the effective date of section 302 [this section], and
‘‘(B) is registered on such day under section 510 of
the Federal Food, Drug, and Cosmetic Act [section
360 of this title] or under section 4722 of the Internal
Revenue Code of 1986 [formerly I.R.C. 1954, section
4722 of Title 26],
shall, with respect to each establishment for which
such registration is in effect under any such section, be
deemed to have a provisional registration under section
303 [section 823 of this title] for the manufacture, distribution, or dispensing (as the case may be) of controlled substances.
‘‘(2) During the period his provisional registration is
in effect under this section, the registration number assigned such person under such section 510 [section 360
of this title] or under such section 4722 [section 4722 of
Title 26] (as the case may be) shall be his registration
number for purposes of section 303 of this title [section
823 of this title].
‘‘(b) The provisions of section 304 [section 824 of this
title], relating to suspension and revocation of registration, shall apply to a provisional registration
under this section.
‘‘(c) Unless sooner suspended or revoked under subsection (b), a provisional registration of a person under
subsection (a)(1) of this section shall be in effect until—
‘‘(1) the date on which such person has registered
with the Attorney General under section 303 [section
823 of this title] or has had his registration denied
under such section, or
‘‘(2) such date as may be prescribed by the Attorney
General for registration of manufacturers, distributors, or dispensers, as the case may be,
whichever occurs first.’’

§ 823. Registration requirements
(a) Manufacturers of controlled substances in
schedule I or II
The 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