§ 384. — Importation of covered products.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC384]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VIII--IMPORTS AND EXPORTS
Sec. 384. Importation of covered products
(a) Regulations
The Secretary, after consultation with the United States Trade
Representative and the Commissioner of Customs, shall promulgate
regulations permitting pharmacists and wholesalers to import into the
United States covered products.
(b) Limitation
Regulations under subsection (a) of this section shall--
(1) require that safeguards be in place to ensure that each
covered product imported pursuant to such subsection complies with
section 355 of this title (including with respect to being safe and
effective for its intended use), with sections 351 and 352 of this
title, and with other applicable requirements of this chapter;
(2) require that an importer of a covered product pursuant to
subsection (a) of this section comply with the applicable provisions
of this section, including subsection (d) of this section; and
(3) contain any additional provisions determined by the
Secretary to be appropriate as a safeguard to protect the public
health or as a means to facilitate the importation of such products.
(c) Records
Regulations under subsection (a) of this section shall require that
records regarding the importation of covered products pursuant to such
subsection be provided to and maintained by the Secretary for a period
of time determined to be necessary by the Secretary.
(d) Importation
Regulations under subsection (a) of this section shall require an
importer of a covered product pursuant to such subsection to provide to
the Secretary the following information and records:
(1) The name and amount of the active ingredient of such product
and description of the dosage form.
(2) The date that the product is shipped and the quantity of the
product that is shipped, points of origin and destination for the
product, the price paid for the product by the importer, and (once
the product is distributed) the price for which such product is sold
by the importer.
(3) Documentation from the foreign seller specifying the
original source of the product and the amount of each lot of the
product originally received.
(4) The manufacturer's lot or control number of the product
imported.
(5) The name, address, and telephone number of the importer,
including the professional license number of the importer, if any.
(6) For a product that is coming directly from the first foreign
recipient of the product from the manufacturer:
(A) Documentation demonstrating that such product came from
such recipient and was received by the recipient from such
manufacturer.
(B) Documentation of the amount of each lot of the product
received by such recipient to demonstrate that the amount being
imported into the United States is not more than the amount that
was received by the recipient.
(C) In the case of the initial imported shipment,
documentation demonstrating that each batch of such shipment was
statistically sampled and tested for authenticity and
degradation.
(D) In the case of all subsequent shipments from such
recipient, documentation demonstrating that a statistically
valid sample of such shipments was tested for authenticity and
degradation.
(E) Certification from the importer or manufacturer of such
product that the product is approved for marketing in the United
States and meets all labeling requirements under this chapter.
(7) For a product that is not coming directly from the first
foreign recipient of the product from the manufacturer:
(A) Documentation demonstrating that each batch in all
shipments offered for importation into the United States was
statistically sampled and tested for authenticity and
degradation.
(B) Certification from the importer or manufacturer of such
product that the product is approved for marketing in the United
States and meets all labeling requirements under this chapter.
(8) Laboratory records, including complete data derived from all
tests necessary to assure that the product is in compliance with
established specifications and standards.
(9) Documentation demonstrating that the testing required by
paragraphs (6) through (8) was performed at a qualifying laboratory
(as defined in subsection (k) of this section).
(10) Any other information that the Secretary determines is
necessary to ensure the protection of the public health.
(e) Testing
Regulations under subsection (a) of this section--
(1) shall require that testing referred to in paragraphs (6)
through (8) of subsection (d) of this section be conducted by the
importer of the covered product pursuant to subsection (a) of this
section, or the manufacturer of the product;
(2) shall require that if such tests are conducted by the
importer, information needed to authenticate the product being
tested, and to confirm that the labeling of such product complies
with labeling requirements under this chapter, be supplied by the
manufacturer of such product to the pharmacist or wholesaler, and
shall require that such information be kept in strict confidence and
used only for purposes of testing under this chapter; and
(3) may include such additional provisions as the Secretary
determines to be appropriate to provide for the protection of trade
secrets and commercial or financial information that is privileged
or confidential.
(f) Country limitation
Regulations under subsection (a) of this section shall provide that
covered products may be imported pursuant to such subsection only from a
country, union, or economic area that is listed in subparagraph (A) of
section 382(b)(1) of this title or designated by the Secretary, subject
to such limitations as the Secretary determines to be appropriate to
protect the public health.
(g) Suspension of importations
The Secretary shall require that importations of specific covered
products or importations by specific importers pursuant to subsection
(a) of this section be immediately suspended upon discovery of a pattern
of importation of such products or by such importers that is counterfeit
or in violation of any requirement pursuant to this section, until an
investigation is completed and the Secretary determines that the public
is adequately protected from counterfeit and violative covered products
being imported pursuant to subsection (a) of this section.
(h) Prohibited agreements
No manufacturer of a covered product may enter into a contract or
agreement that includes a provision to prevent the sale or distribution
of covered products imported pursuant to subsection (a) of this section.
(i) Studies; reports
(1) Study by Secretary
(A) In general
The Secretary shall conduct, or contract with an entity to
conduct, a study on the imports permitted pursuant to subsection
(a) of this section, including consideration of the information
received under subsection (d) of this section. In conducting
such study, the Secretary or entity shall--
(i) evaluate the compliance of importers with
regulations under subsection (a) of this section, and the
number of shipments pursuant to such subsection, if any,
that have been determined to be counterfeit, misbranded, or
adulterated, and determine how such compliance contrasts
with the number of shipments of prescription drugs
transported within the United States that have been
determined to be counterfeit, misbranded, or adulterated;
and
(ii) consult with the United States Trade Representative
and the Commissioner of Patents and Trademarks to evaluate
the effect of importations pursuant to subsection (a) of
this section on trade and patent rights under Federal law.
(B) Report
Not later than 2 years after the effective date of final
regulations under subsection (a) of this section, the Secretary
shall prepare and submit to the Congress a report describing the
findings of the study under subparagraph (A).
(2) Study by General Accounting Office
The Comptroller General of the United States shall conduct a
study to determine the effect of this section on the price of
covered products sold to consumers at retail. Not later than 18
months after the effective date of final regulations under
subsection (a) of this section, the Comptroller General shall
prepare and submit to the Congress a report describing the findings
of such study.
(j) Construction
Nothing in this section shall be construed to limit the statutory,
regulatory, or enforcement authority of the Secretary relating to the
importation of covered products, other than with respect to section
381(d)(1) of this title as provided in this section.
(k) Definitions
(1) Covered product
(A) In general
For purposes of this section, the term ``covered product''
means a prescription drug, except that such term does not
include a controlled substance in schedule I, II, or III under
section 812(c) of this title or a biological product as defined
in section 262 of title 42.
(B) Charitable contributions; parenteral drugs
Notwithstanding any other provision of this section, section
381(d)(1) of this title--
(i) continues to apply to a covered product donated or
otherwise supplied for free by the manufacturer of the drug
to a charitable or humanitarian organization, including the
United Nations and affiliates, or to a government of a
foreign country; and
(ii) continues to apply to a covered product that is a
parenteral drug the importation of which pursuant to
subsection (a) of this section is determined by the
Secretary to pose a threat to the public health.
(2) Other terms
For purposes of this section:
(A) The term ``importer'' means a pharmacist or wholesaler.
(B) The term ``pharmacist'' means a person licensed by a
State to practice pharmacy, including the dispensing and selling
of prescription drugs.
(C) The term ``prescription drug'' means a drug subject to
section 353(b) of this title.
(D) The term ``qualifying laboratory'' means a laboratory in
the United States that has been approved by the Secretary for
purposes of this section.
(E) The term ``wholesaler'' means a person licensed as a
wholesaler or distributor of prescription drugs in the United
States pursuant to section 353(e)(2)(A) of this title. Such term
does not include a person authorized to import drugs under
section 381(d)(1) of this title.
(l) Conditions
This section shall become effective only if the Secretary
demonstrates to the Congress that the implementation of this section
will--
(1) pose no additional risk to the public's health and safety;
and
(2) result in a significant reduction in the cost of covered
products to the American consumer.
(m) Sunset
Effective upon the expiration of the 5-year period beginning on the
effective date of final regulations under subsection (a) of this
section, this section ceases to have any legal effect.
(June 25, 1938, ch. 675, Sec. 804, as added Pub. L. 106-387, Sec. 1(a)
[title VII, Sec. 745(c)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A-36.)
Transfer of Functions
For transfer of functions, personnel, assets, and liabilities of the
United States Customs Service of the Department of the Treasury,
including functions of the Secretary of the Treasury relating thereto,
to the Secretary of Homeland Security, and for treatment of related
references, see sections 203(1), 551(d), 552(d), and 557 of Title 6,
Domestic Security, and the Department of Homeland Security
Reorganization Plan of November 25, 2002, as modified, set out as a note
under section 542 of Title 6.
Findings
Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 745(b)], Oct. 28, 2000,
114 Stat. 1549, 1549A-35, provided that: ``The Congress makes the
following findings:
``(1) The cost of prescription drugs for Americans continues to
rise at an alarming rate.
``(2) Millions of Americans, including Medicare beneficiaries on
fixed incomes, face a daily choice between purchasing life-
sustaining prescription drugs, or paying for other necessities, such
as food and housing.
``(3) Many life-saving prescription drugs are available in
countries other than the United States at substantially lower
prices, even though such drugs were developed and are approved for
use by patients in the United States.
``(4) Many Americans travel to other countries to purchase
prescription drugs because the medicines that they need are
unaffordable in the United States.
``(5) Americans should be able to purchase medicines at prices
that are comparable to prices for such medicines in other countries,
but efforts to enable such purchases should not endanger the gold
standard for safety and effectiveness that has been established and
maintained in the United States.''
Section Referred to in Other Sections
This section is referred to in sections 331, 333, 381 of this title.
