
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC830]

 
                        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
 
Sec. 830. Regulation of listed chemicals and certain machines


(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--
        (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--
        (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.

(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, 
Secs. 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.)

                       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.


                               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.

                  Section Referred to in Other Sections

    This section is referred to in sections 802, 827, 841, 842, 843, 958 
of this title.
