-CITE-
21 USC Sec. 830 01/22/02
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 830. Regulation of listed
chemicals and certain machines
-STATUTE-
(a) Record
of regulated transactions
(1) Each regulated person
who engages in a regulated transaction involving
a listed chemical, a tableting machine, or an encapsulating
machine shall keep a record of the transaction for two
years after the date of the transaction.
(2) A record
under this subsection shall be retrievable and shall include the date
of the regulated transaction, the identity of each party to the regulated
transaction, a statement of the quantity and form of the listed chemical,
a description of the tableting machine or encapsulating machine, and
a description of the method of transfer. Such record shall be available
for inspection and copying by the Attorney General.
(3) It
is the duty of each regulated person who engages in a regulated transaction
to identify each other party to the transaction. It is the duty of
such other party to present proof of identity to the regulated person.
The Attorney General shall specify by regulation the types of documents
and other evidence that constitute proof of identity for purposes
of this paragraph.
(b) Reports
to Attorney General
(1) Each regulated person
shall report to the Attorney General, in
such form and manner as the Attorney General shall prescribe by regulation
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(A) any regulated transaction
involving an extraordinary quantity
of a listed chemical, an uncommon method of payment or delivery,
or any other circumstance that the regulated person believes
may indicate that the listed chemical will be used in violation
of this subchapter;
(B) any proposed regulated
transaction with a person whose description
or other identifying characteristic the Attorney General
furnishes in advance to the regulated person;
(C) any unusual or excessive
loss or disappearance of a listed chemical
under the control of the regulated person; and
(D) any regulated transaction
in a tableting machine or an encapsulating
machine. Each report
under subparagraph (A) shall be made at the earliest practicable
opportunity after the regulated person becomes aware of the
circumstance involved.
A regulated person may
not complete a transaction
with a person whose description or identifying characteristic
is furnished to the regulated person under subparagraph
(B) unless the transaction is approved by the Attorney General.
The Attorney General shall make available to regulated persons
guidance documents describing transactions and circumstances
for which reports are required under subparagraph (A) and
subparagraph (C).
(2) A regulated person that
manufactures a listed chemical shall report annually to the Attorney
General, in such form and manner and containing such specific data
as the Attorney General shall prescribe by regulation, information
concerning listed chemicals manufactured by the person. The requirement
of the preceding sentence shall not apply to the manufacture of a
drug product that is exempted under section 802(39)(A)(iv) of this
title.
(3) Mail
order reporting. -
(A) As used in this paragraph:
(i) The term ''drug
product'' means an active ingredient in dosage
form that has been approved or otherwise may be lawfully
marketed under the Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
for distribution in the United States.
(ii) The term ''valid
prescription'' means a prescription which is
issued for a legitimate medical purpose by an individual
practitioner licensed
by law to administer and prescribe the drugs
concerned and acting in the usual course of the practitioner's
professional practice.
(B) Each regulated person
who engages in a transaction with a nonregulated
person or who engages in an export transaction which -
(i) involves ephedrine,
pseudoephedrine, or phenylpropanolamine (including
drug products containing these chemicals); and
(ii) uses or attempts
to use the Postal Service or any private or
commercial carrier; shall,
on a monthly basis, submit a report of each such transaction conducted
during the previous month to the Attorney General in such
form, containing such
data, and at such times as the Attorney General
shall establish by regulation.
(C) The data required
for such reports shall include -
(i) the name of the
purchaser;
(ii) the quantity and
form of the ephedrine, pseudoephedrine, or
phenylpropanolamine purchased; and
(iii) the address to
which such ephedrine, pseudoephedrine, or phenylpropanolamine
was sent.
(D) Except as provided
in subparagraph (E), the following distributions
to a nonregulated person, and the following export transactions,
shall not be subject to the reporting requirement in subparagraph
(B):
(i) Distributions of
sample packages of drug products when such packages
contain not more than two solid dosage units or the equivalent
of two dosage units in liquid form, not to exceed 10 milliliters
of liquid per package, and not more than one package is
distributed to an individual or residential address in any
30-day period.
(ii) Distributions of
drug products by retail distributors that may
not include face-to-face transactions to the extent that such
distributions are consistent with the activities authorized for
a retail distributor
as specified in section 802(46) of this title.
(iii) Distributions
of drug products to a resident of a long term
care facility (as that term is defined in regulations prescribed
by the Attorney General) or distributions of drug products
to a long term care facility for dispensing to or for use
by a resident of that facility.
(iv) Distributions of
drug products pursuant to a valid prescription.
(v) Exports which have
been reported to the Attorney General pursuant
to section 954 or 971
of this title or which are subject to
a waiver granted under section 971(e)(2) of this title.
(vi) Any quantity, method,
or type of distribution or any quantity,
method, or type of distribution of a specific listed chemical
(including specific formulations or drug products) or of
a group of listed chemicals
(including specific formulations or drug products) which the Attorney
General has excluded by regulation
from such reporting requirement on the basis that such
reporting is not necessary
for the enforcement of this subchapter or
subchapter II of this chapter.
(E) The Attorney General
may revoke any or all of the exemptions listed
in subparagraph (D) for an individual regulated person if he
finds that drug products
distributed by the regulated person are being
used in violation of this subchapter or subchapter II of this
chapter. The regulated
person shall be notified of the revocation, which
will be effective upon receipt by the person of such notice,
as provided in section
971(c)(1) of this title, and shall have the right to an expedited
hearing as provided in section 971(c)(2) of this
title.
(c) Confidentiality
of information obtained by Attorney General; non-disclosure;
exceptions
(1) Except as provided in
paragraph (2), any information obtained by
the Attorney General under this section which is exempt from
disclosure under section
552(a) of title 5, by reason of section 552(b)(4)
of such title, is confidential and may not be disclosed to
any person.
(2) Information referred
to in paragraph (1) may be disclosed only
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(A) to an officer or employee
of the United States engaged in carrying
out this subchapter, subchapter II of this chapter, or the
customs laws;
(B) when relevant in any
investigation or proceeding for the enforcement
of this subchapter, subchapter II of this chapter, or the
customs laws;
(C) when necessary to
comply with an obligation of the United States
under a treaty or other international agreement; or
(D) to a State or local
official or employee in conjunction with
the enforcement of controlled substances laws or chemical
control laws.
(3) The Attorney General
shall -
(A) take such action as
may be necessary to prevent unauthorized
disclosure of information by any person to whom such information
is disclosed under paragraph (2); and
(B) issue guidelines that
limit, to the maximum extent feasible,
the disclosure of proprietary business information, including
the names or identities of United States exporters of listed
chemicals, to any person to whom such information is disclosed
under paragraph (2).
(4) Any person who is aggrieved
by a disclosure of information in violation
of this section may bring a civil action against the violator
for appropriate relief.
(5) Notwithstanding paragraph
(4), a civil action may not be brought
under such paragraph against investigative or law enforcement
personnel of the Drug Enforcement Administration.
-SOURCE-
(Pub. L. 91-513, title II,
Sec. 310, as added Pub. L. 95-633, title II,
Sec. 202(a), Nov. 10, 1978, 92 Stat. 3774; amended Pub. L. 100-690,
title VI, Sec. 6052(a), Nov. 18, 1988, 102 Stat. 4312; Pub.
L. 103-200, Sec. 2(c), 10, Dec. 17, 1993, 107 Stat. 2336, 2341;
Pub. L. 104-237, title II, Sec. 208, title IV, Sec. 402, Oct.
3, 1996, 110 Stat. 3104, 3111;
Pub. L. 106-310, div. B, title XXXVI,
Sec. 3652, Oct. 17, 2000, 114 Stat. 1239.)
-REFTEXT-
REFERENCES
IN TEXT
The Food, Drug, and Cosmetic
Act, referred to in subsec. (b)(3)(A)(i),
probably means the Federal Food, Drug, and Cosmetic Act,
act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which
is classified generally to
chapter 9 (Sec. 301 et seq.) of this title.
For complete classification of this Act to the Code, see section
301 of this title and Tables.
This subchapter, referred
to in subsec. (b)(3)(D)(vi), (E), was in
the original ''this title'', meaning title II of Pub. L. 91-513,
Oct. 27, 1970, 84 Stat. 1242,
as amended, 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.
Subchapter II of this chapter,
referred to in subsecs. (b)(3)(D)(iv),
(E) and (c)(2)(A), (B), was in the original ''title III'',
meaning title III of Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
1285, as amended. Part A of
title III comprises subchapter II of this
chapter. For classification of Part B, consisting of sections
1101 to 1105 of title III,
see Tables.
The customs laws, referred
to in subsec. (c)(2)(A), (B), are classified
generally to Title 19, Customs Duties.
-MISC2-
AMENDMENTS
2000 - Subsec. (b)(3). Pub.
L. 106-310 added subpars. (A), (D), and
(E), redesignated former subpars. (A) and (B) as (B) and (C),
respectively, and inserted
''or who engages in an export transaction''
after ''nonregulated person'' in introductory provisions
of subpar. (B).
1996 - Subsec. (a)(1). Pub.
L. 104-237, Sec. 208, substituted ''for
two years after the date of the transaction.'' for the dash after
''record of the transaction'' and struck out subpars. (A) and
(B) which read as follows:
''(A) for 4 years after
the date of the transaction, if the listed
chemical is a list I chemical or if the transaction involves
a tableting machine or an
encapsulating machine; and
''(B) for 2 years after
the date of the transaction, if the listed
chemical is a list II chemical.''
Subsec. (b)(3). Pub. L. 104-237,
Sec. 402, added par. (3).
1993 - Subsec. (a)(1). Pub.
L. 103-200, Sec. 2(c)(1), substituted ''list
I chemical'' for ''precursor chemical'' in subpar. (A) and ''a
list II chemical'' for ''an essential chemical'' in subpar.(B).
Subsec. (b). Pub. L. 103-200,
Sec. 10, designated existing provisions
as par. (1), redesignated former pars. (1) to (4) as subpars.
(A) to (D), respectively, in concluding provisions, substituted
''subparagraph (A)'' for ''paragraph (1)'' in two places,
''subparagraph (B)'' for ''paragraph (2)'', and ''subparagraph
(C)'' for ''paragraph (3)'', and added par. (2).
Subsec. (c)(2)(D). Pub. L.
103-200, Sec. 2(c)(2), substituted ''chemical
control laws'' for ''precursor chemical laws''.
1988 - Pub. L. 100-690 amended
section generally, substituting provisions
relating to regulation of listed chemicals and certain machines
for provisions relating to reporting by any person who distributes,
sells, or imports any piperidine.
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 OF 1988 AMENDMENT
Amendment by Pub. L. 100-690
effective 120 days after Nov. 18, 1988,
see section 6061 of Pub. L. 100-690, set out as a note under
section 802
of this title.
EFFECTIVE
DATE; TIME TO SUBMIT PIPERIDINE REPORT; REQUIRED INFORMATION
Section 203(a) of title II
of Pub. L. 95-633 provided that:
''(1) Except as provided
under paragraph (2), the amendments made by
this title (enacting this section and amending sections 841
to 843
of this title) shall take effect on the date of the enactment
of this Act (Nov. 10, 1978).
''(2) Any person required
to submit a report under section 310(a)(1)
of the Controlled Substances Act (subsec. (a)(1) of this section)
respecting a distribution, sale, or importation of piperidine
during the 90 days after the date of the enactment of this
Act (Nov. 10, 1978) may submit such report any time up to 97
days after such date of enactment.
''(3) Until otherwise provided
by the Attorney General by regulation,
the information required to be reported by a person under
section 310(a)(1) of the Controlled Substances Act (as added
by section 202(a)(2) of this
title) (subsec. (a)(1) of this section)
with respect to the person's distribution, sale, or importation
of piperidine shall -
''(A) be the information
described in subparagraphs (A) and (B) of
such section, and ''(B)
except as provided in paragraph (2) of this subsection, be
reported not later than seven days after the date of such
distribution, sale, or
importation.''
REPEALS
Pub. L. 96-359, Sec. 8(b),
Sept. 26, 1980, 94 Stat. 1194, repealed
section 203(d) of Pub. L. 95-633, which had provided for the
repeal of this section effective Jan. 1, 1981.
REGULATIONS
FOR PIPERIDINE REPORTING
Section 203(b) of Pub. L.
95-633 required the Attorney General to publish
proposed interim regulations for piperidine reporting under section
830(a) of this title not later than 30 days after
enactment, and final interim
regulations not later than 75 days after
enactment, such final interim regulations to be effective on
and after the ninety-first
day after enactment.
REPORT TO
PRESIDENT AND CONGRESS ON EFFECTIVENESS OF TITLE II OF PUB.
L. 95-633
Section 203(c) of Pub. L.
95-633 required the Attorney General to analyze
and evaluate the impact and effectiveness of the amendments made
by title II of Pub. L. 95-633, and report to the President and
Congress not later than Mar.
1, 1980.
-SECREF-
SECTION REFERRED
TO IN OTHER SECTIONS
This section is referred
to in sections 802, 827,
841, 842, 843,
958 of
this title.
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