21 U.S.C. § 830 : US Code - Section 830: Regulation of listed chemicals and certain machines

Search 21 U.S.C. § 830 : US Code - Section 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.