Pharmaceutical Market Access and Drug Safety Act of 2004 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions governing the importation of prescription drugs. Requires the Secretary of Health and Human Services to promulgate regulations allowing the importation of prescription drugs by registered exporters or registered importers from Canada within 90 days of passage of this Act and from Australia, European Union countries, Japan, New Zealand, or Switzerland within one year.
Provides for inspection, tracking of drugs, and registration and inspection fees for registered importers and exporters.
Requires manufacturers to: (1) submit a statement to the Secretary explaining each difference between a drug approved and distributed in the United States and a related drug distributed in a foreign country; and (2) submit an application to the Food and Drug Administration (FDA) for approval of a related drug that is distributed in a foreign country if there is no comparable drug already approved in at least half of the permitted countries that can be imported to the United States.
Allows for the immediate importation of prescription drugs for personal use from licensed Canadian pharmacies.
Amends the Clayton Act to prohibit drug manufacturers from preventing importation by engaging in behavior such as charging higher prices or limiting supplies to registered exporters and importers or changing the form of the drug for such purpose.
States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement.
Requires the Secretary of Homeland Security to refuse admission of drugs that violate importation provisions. Allows the destruction of certain violative shipments.
Amends the Controlled Substances Act to repeal the exemption that permitted individuals to import controlled substances for personal medical use.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2328 Introduced in Senate (IS)]
108th CONGRESS
2d Session
S. 2328
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
importation of prescription drugs, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 21, 2004
Mr. Dorgan (for himself, Ms. Snowe, Mr. Kennedy, Mr. McCain, Mr.
Daschle, Mr. Lott, Ms. Stabenow, Mr. Chafee, Mr. Johnson, Mr. Pryor,
and Mr. Feingold) introduced the following bill; which was read twice
and referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
importation of prescription drugs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Pharmaceutical Market Access and
Drug Safety Act of 2004''.
SEC. 2. FINDINGS.
Congress finds that--
(1) Americans unjustly pay up to 5 times more to fill their
prescriptions than consumers in other countries;
(2) the United States is the largest market for
pharmaceuticals in the world, yet American consumers pay the
highest prices for brand pharmaceuticals in the world;
(3) a prescription drug is neither safe nor effective to an
individual who cannot afford it;
(4) allowing and structuring the importation of
prescription drugs to ensure access to safe and affordable
drugs approved by the Food and Drug Administration will provide
a level of safety to American consumers that they do not
currently enjoy;
(5) American seniors alone will spend $1,800,000,000,000 on
pharmaceuticals over the next 10 years; and
(6) allowing open pharmaceutical markets could save
American consumers at least $38,000,000,000 each year.
SEC. 3. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF PRESCRIPTION
DRUGS.
Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381 et seq.) is amended by striking section 804.
SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF CERTAIN IMPORT
RESTRICTIONS.
(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section 3 of this
Act, is further amended by inserting after section 803 the following:
``SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF PRESCRIPTION DRUGS.
``(a) Importation of Prescription Drugs.--
``(1) In general.--The Secretary shall in accordance with
this section provide by regulation that, in the case of
qualifying drugs imported or offered for import into the United
States from registered exporters or by registered importers--
``(A) the limitation on importation that is
established in section 801(d)(1) is waived; and
``(B) the standards referred to in section 801(a)
regarding admission of the drugs are subject to
subsection (g) of this section (including with respect
to qualifying drugs to which section 801(d)(1) does not
apply).
``(2) Importers.--A qualifying drug may not be imported
under paragraph (1) unless--
``(A) the drug is imported by a pharmacy or a
wholesaler that is a registered importer; or
``(B) the drug is imported by an individual for
personal use or for the use of a family member of the
individual (not for resale) from a registered exporter.
``(3) Rule of construction.--This section shall apply only
with respect to a drug that is imported or offered for import
into the United States--
``(A) by a registered importer; or
``(B) from a registered exporter to an individual.
``(4) Definitions.--
``(A) Registered exporter; registered importer.--
For purposes of this section:
``(i) The term `registered exporter' means
an exporter for which a registration under
subsection (b) has been approved and is in
effect.
``(ii) The term `registered importer' means
a pharmacy, group of pharmacies, or a
wholesaler for which a registration under
subsection (b) has been approved and is in
effect.
``(iii) The term `registration condition'
means a condition that must exist for a
registration under subsection (b) to be
approved.
``(B) Qualifying drug.--For purposes of this
section, the term `qualifying drug' means a
prescription drug, other than any of the following:
``(i) A controlled substance, as defined in
section 102 of the Controlled Substances Act
(21 U.S.C. 802).
``(ii) A biological product, as defined in
section 351 of the Public Health Service Act
(42 U.S.C. 262).
``(iii) An infused drug, including a
peritoneal dialysis solution.
``(iv) An intravenously injected drug.
``(v) A drug that is inhaled during
surgery.
``(C) Other definitions.--For purposes of this
section:
``(i) The term `exporter' means a person
that is in the business of exporting a drug
from Canada to individuals in the United States
or that, pursuant to submitting a registration
under subsection (b), seeks to be in such
business.
``(ii) The term `importer' means a
pharmacy, a group of pharmacies, or a
wholesaler that is in the business of importing
a drug into the United States or that, pursuant
to submitting a registration under subsection
(b), seeks to be in such business.
``(iii) The term `pharmacist' means a
person licensed by a State to practice
pharmacy, including the dispensing and selling
of prescription drugs.
``(iv) The term `pharmacy' means a person
that--
``(I) is licensed by a State to
engage in the business of selling
prescription drugs at retail; and
``(II) employs 1 or more
pharmacists.
``(v) The term `prescription drug' means a
drug that is described in section 503(b)(1).
``(vi) The term `wholesaler'--
``(I) means a person licensed as a
wholesaler or distributor of
prescription drugs in the United States
under section 503(e)(2)(A); and
``(II) does not include a person
authorized to import drugs under
section 801(d)(1).
``(D) Permitted country.--The term `permitted
country' means--
``(i) Australia;
``(ii) Canada;
``(iii) a member country of the European
Union as of January 1, 2003;
``(iv) Japan;
``(v) New Zealand; and
``(vi) Switzerland.
``(b) Registration of Importers and Exporters.--
``(1) Registration of importers and exporters.--A
registration condition is that the importer or exporter
involved (referred to in this subsection as a `registrant')
submits to the Secretary a registration containing the
following:
``(A) The name of the registrant and an
identification of all places of business of the
registrant that relate to qualifying drugs, including
each warehouse or other facility owned or controlled
by, or operated for, the registrant.
``(B) Such information as the Secretary determines
to be necessary to demonstrate that the registrant is
in compliance with registration conditions under--
``(i) in the case of an importer,
subsections (c), (d), (e), (g), and (j)
(relating to the sources of exported drugs; the
inspection of facilities of the importer; the
payment of fees; compliance with the standards
referred to in section 801(a); and maintenance
of records and samples); or
``(ii) in the case of an exporter,
subsections (c), (d), (f), (g), (h), (i), and
(j) (relating to the sources of exported drugs;
the inspection of facilities of the exporter
and the marking of compliant shipments; the
payment of fees; and compliance with the
standards referred to in section 801(a); being
licensed as a pharmacist; conditions for
individual importation from Canada; and
maintenance of records and samples).
``(C) An agreement by the registrant that the
registrant will not under subsection (a) import or
export any drug that is not a qualifying drug.
``(D) An agreement by the registrant to--
``(i) notify the Secretary of a recall or
withdrawal of a drug distributed in a permitted
country that the registrant has exported or
imported, or intends to export or import, to
the United States under subsection (a);
``(ii) provide for the return to the
registrant of such drug; and
``(iii) cease, or not begin, the
exportation or importation of such drug unless
the Secretary has notified the registrant that
exportation or importation of such drug may
proceed.
``(E) An agreement by the registrant to ensure and
monitor compliance with each registration condition, to
promptly correct any noncompliance with such a
condition, and to promptly report to the Secretary any
such noncompliance.
``(F) A plan describing the manner in which the
registrant will comply with the agreement under
subparagraph (E).
``(G) An agreement by the registrant to enforce a
contract under subsection (c)(3)(B) against a party in
the chain of custody of a qualifying drug with respect
to the authority of the Secretary under clauses (ii)
and (iii) of that subsection.
``(H) An agreement by the registrant to notify the
Secretary of--
``(i) any change that the registrant
intends to make regarding information provided
under subparagraph (A) or (B); and
``(ii) any change that the registrant
intends to make in the compliance plan under
subparagraph (F).
``(I) In the case of an exporter--
``(i) An agreement by the exporter that a
qualifying drug will not under subsection (a)
be exported to any individual not authorized
pursuant to subsection (a)(2)(B) to be an
importer of such drug.
``(ii) An agreement to post a bond, payable
to the Treasury of the United States if, after
opportunity for an informal hearing, the
Secretary determines that the exporter has
exported a drug to the United States that is
not a qualifying drug or that is not in
compliance with subsections (g) or (i), that is
equal in value to the lesser of--
``(I) the value of drugs exported
by the exporter to the United States in
a typical 4-week period over the course
of a year under this section; or
``(II) $1,000,000.
``(J) Such other provisions as the Secretary may
require to protect the public health while permitting--
``(i) the importation by pharmacies, groups
of pharmacies, wholesalers as registered
importers of qualifying drugs under subsection
(a); and
``(ii) importation by individuals of
qualifying drugs under subsection (a).
``(2) Approval or disapproval of registration.--
``(A) In general.--Not later than 90 days after the
date on which a registrant submits to the Secretary a
registration under paragraph (1), the Secretary shall
notify the registrant whether the registration is
approved or is disapproved. The Secretary shall
disapprove a registration if there is reason to believe
that the registrant is not in compliance with one or
more registration conditions, and shall notify the
registrant of such reason. In the case of a disapproved
registration, the Secretary shall subsequently notify
the registrant that the registration is approved if the
Secretary determines that the registrant is in
compliance with such conditions.
``(B) Changes in registration information.--Not
later than 30 days after receiving a notice under
paragraph (1)(G) from a registrant, the Secretary shall
determine whether the change involved affects the
approval of the registration of the registrant under
paragraph (1), and shall inform the registrant of the
determination.
``(3) Publication of contact information for registered
exporters.--Through the Internet website of the Food and Drug
Administration, the Secretary shall make readily available to
the public a list of registered exporters, including contact
information for the exporters. Promptly after the approval of a
registration submitted under paragraph (1), the Secretary shall
update the Internet website accordingly.
``(4) Suspension and termination.--
``(A) Suspension.--With respect to the
effectiveness of a registration submitted under
paragraph (1):
``(i) Subject to clause (ii), if the
Secretary determines, after notice and
opportunity for a hearing, that the registrant
has failed to maintain substantial compliance
with all registration conditions, the Secretary
may suspend the registration.
``(ii) If the Secretary determines that,
under color of the registration, the exporter
has exported a drug or the importer has
imported a drug that is not a qualifying drug,
or a drug that does not meet the criteria under
subsection (g)(2)(A), or has exported a
qualifying drug to an individual in violation
of subsection (i)(1)(F), the Secretary shall
immediately suspend the registration. A
suspension under the preceding sentence is not
subject to the provision by the Secretary of
prior notice, and the Secretary shall provide
to the registrant an opportunity for a hearing
not later than 10 days after the date on which
the registration is suspended.
``(iii) The Secretary may reinstate the
registration, whether suspended under clause
(i) or (ii), if the Secretary determines that
the registrant has demonstrated that further
violations of registration conditions will not
occur.
``(B) Termination.--The Secretary, after notice and
opportunity for a hearing, may terminate the
registration under paragraph (1) of a registrant if the
Secretary determines that the registrant has engaged in
a pattern or practice of violating 1 or more
registration conditions, or if on 1 or more occasions
the Secretary has under subparagraph (A)(ii) suspended
the registration of the registrant. The Secretary may
make the termination permanent, or for a fixed period
of not less than 1 year. During the period in which the
registration is terminated, any registration submitted
under paragraph (1) by the registrant, or a person that
is a partner in the export or import enterprise, or a principal officer
in such enterprise, and any registration prepared with the assistance
of the registrant or such a person, has no legal effect under this
section.
``(c) Sources of Qualifying Drugs.--A registration condition is
that the exporter or importer involved agrees that a qualifying drug
will under subsection (a) be exported or imported to the United States
only if there is compliance with the following:
``(1) The drug was manufactured in an establishment--
``(A) required to register under subsection (h) or
(i) of section 510; or
``(B) inspected by the Secretary as provided by
this section.
``(2) The establishment is located in the United States or
in any foreign country, and the establishment manufactured the
drug for distribution in the United States or for distribution
in 1 or more of the permitted countries (without regard to
whether in addition the drug was manufactured for distribution
in a foreign country that is not a permitted country).
``(3) The exporter or importer obtained the drug--
``(A) directly from the establishment; or
``(B) directly from an entity that, by contract
with the exporter or importer--
``(i) provides to the exporter or importer
a statement (in such form and containing such
information as the Secretary may require) that,
for the chain of custody from the
establishment, identifies each prior sale,
purchase, or trade of the drug (including the
date of the transaction and the names and
addresses of all parties to the transaction);
``(ii) agrees to permit the Secretary to
inspect such statements and related records to
determine their accuracy;
``(iii) agrees, with respect to the
qualifying drugs involved, to permit the
Secretary to inspect warehouses and other
facilities of the entity for purposes of
determining whether the facilities are in
compliance with any standards under this Act
that are applicable to facilities of that type
in the United States; and
``(iv) has ensured, through such
contractual relationships as may be necessary,
that the Secretary has the same authority
regarding other parties in the chain of custody
from the establishment that the Secretary has
under clauses (ii) and (iii) regarding such
entity.
``(4) The foreign country from which the importer will
import the drug is a permitted country.
``(5) The foreign country from which the exporter will
export the drug is Canada.
``(6) During any period in which the drug was not in the
control of the manufacturer of the drug, the drug did not enter
any country that is not a permitted country.
``(7) The exporter or importer retains a sample of each lot
of the drug sufficient for testing by the Secretary.
``(d) Inspection of Facilities; Marking of Shipments.--
``(1) Inspection of facilities.--A registration condition
is that, for the purpose of assisting the Secretary in
determining whether the exporter involved is in compliance with
all other registration conditions--
``(A) the exporter agrees to permit the Secretary--
``(i) to conduct onsite inspections,
including monitoring on a day-to-day basis, of
places of business of the exporter that relate
to qualifying drugs, including each warehouse
or other facility owned or controlled by, or
operated for, the exporter;
``(ii) to have access, including on a day-
to-day basis, to--
``(I) records of the exporter that
relate to the export of such drugs,
including financial records; and
``(II) samples of such drugs;
``(iii) to carry out the duties described
in paragraph (3); and
``(iv) to carry out any other functions
determined by the Secretary to be necessary
regarding the compliance of the exporter; and
``(B) the Secretary has assigned 1 or more
employees of the Secretary to carry out the functions
described in this subsection for the Secretary not less
than every 3 weeks on the premises of places of
businesses referred to in subparagraph (A)(i), and such
an assignment remains in effect on a continuous basis.
``(2) Marking of compliant shipments.--A registration
condition is that the exporter involved agrees to affix to each
shipping container of qualifying drugs exported under
subsection (a) such markings as the Secretary determines to be
necessary to identify the shipment as being in compliance with
all registration conditions. Markings under the preceding
sentence--
``(A) shall be designed to prevent affixation of
the markings to any shipping container that is not
authorized to bear the markings; and
``(B) may include anti-counterfeiting or track-and-
trace technologies.
``(3) Certain duties relating to exporters.--Duties of the
Secretary with respect to an exporter include the following:
``(A) Verifying the chain of custody of a
statistically significant sample of qualifying drugs
from the establishment in which the drug was
manufactured to the exporter, which may be accomplished
by the use of anticounterfeiting or track-and-trace
technologies, if available.
``(B) Randomly reviewing records of exports to
individuals for the purpose of determining whether the
drugs are being imported by the individuals in
accordance with the conditions under subsection (i).
Such reviews shall be conducted in a manner that will
result in a statistically significant determination of
compliance with all such conditions.
``(C) Monitoring the affixing of markings under
paragraph (2).
``(D) Inspect as the Secretary determines is
necessary the warehouses and other facilities of other
parties in the chain of custody of qualifying drugs.
``(E) Determine whether the exporter is in
compliance with all other registration conditions.
``(4) Certain duties relating to importers.--Duties of the
Secretary with respect to an importer include the following:
``(A) As authorized under section 704, inspect not
less than every 3 weeks, the places of business of the
importer that relate to the receipt and distribution of
a qualifying drug, including each warehouse or other
facility owned or controlled by, or operated for, the
importer at which qualifying drugs are received or from
which they are distributed to pharmacies.
``(B) During the inspections under subparagraph
(A), verify the chain of custody of a statistically
significant sample of qualifying drugs from the
establishment in which the drug was manufactured to the
importer, which may be accomplished by the use of
anticounterfeiting or track-and-trace technologies, if
available.
``(C) Inspect as the Secretary determines is
necessary the warehouses and other facilities of other
parties in the chain of custody of qualifying drugs.
``(D) Determine whether the importer is in
compliance with all other registration conditions.
``(e) Importer Fees.--
``(1) Registration fee.--A registration condition is that
the importer involved pays to the Secretary a fee of $10,000
due on the date on which the importer first submits the
registration to the Secretary under subsection (b).
``(2) Inspection fee.--A registration condition is that the
importer involved pays to the Secretary in accordance with this
subsection a fee on a semiannual basis, with the first fee due
on the date that is 6 months after the date on which the
registration of the importer under subsection (b) is first
approved by the Secretary.
``(3) Amount of inspection fee.--
``(A) Aggregate total of fees.--The Secretary shall
ensure that the aggregate total of fees collected under
paragraph (2) for a fiscal year from all importers is
sufficient, and no more than necessary, to pay the
costs of administering this section with respect to
registered importers for a fiscal year, including--
``(i) inspection of the facilities of
importers under subsection (d)(4);
``(ii) reviewing qualifying drugs offered
for import to importers; and
``(iii) determining the compliance of
importers with registration conditions.
``(B) Limitation.--The aggregate total of fees
collected under paragraph (2) shall not exceed 1
percent of the total price of drugs imported annually
to the United States by registered importers under this
section.
``(C) Individual importer fee.--Subject to the
limitation described in subparagraph (B), a fee under
paragraph (2) for an importer shall be an amount that
is a reasonable estimate by the Secretary of the
semiannual share of the importer of the volume of drugs
imported by importers under this section.
``(D) Adjustment of fee.--The Secretary shall
annually adjust the fees under paragraph (2) to ensure
that the fees accurately reflect the actual costs
referred to in subparagraph (A) and do not exceed, in
the aggregate, 1 percent of the total price of drugs
imported annually to the United States under this
section.
``(4) Use of fees.--Subject to appropriations Acts, fees
collected by the Secretary under paragraphs (1) and (2) are
available only to the Secretary and are for the sole purpose of
paying the costs referred to in paragraph (3)(A).
``(f) Exporter Fees.--
``(1) Registration fee.--A registration condition is that
the exporter involved pays to the Secretary a fee of $10,000
due on the date on which the exporter first submits that
registration to the Secretary under subsection (b).
``(2) Inspection fee.--A registration condition is that the
exporter involved pays to the Secretary in accordance with this
subsection a fee on a semiannual basis, with the first fee due
on the date that is 6 months after the date on which the
registration of the exporter under subsection (b) is first
approved by the Secretary.
``(3) Amount of inspection fee.--
``(A) Aggregate total of fees.--The Secretary shall
ensure that the aggregate total of fees collected under
paragraph (2) for a fiscal year from all exporters is
sufficient, and not more than necessary, to pay the
costs of administering this section with respect to
registered exporters for a fiscal year, including--
``(i) monitoring foreign facilities under
subsection (d);
``(ii) developing, implementing, and
maintaining under such subsection a system to
mark shipments to indicate compliance with all
registration conditions; and
``(iii) conducting under such subsection
inspections within the United States to
determine compliance with conditions under subsections (h) and (i).
``(B) Limitation.--The aggregate total of fees
collected under paragraph (2) shall not exceed 1
percent of the total price of drugs imported annually
to the United States by registered exporters under this
section.
``(C) Individual exporter fee.--Subject to the
limitation described in subparagraph (B), a fee under
paragraph (2) for an exporter shall be an amount that
is a reasonable estimate by the Secretary of the
semiannual share of the exporter of the volume of drugs
exported by exporters under this section.
``(D) Adjustment of fee.--The Secretary shall
annually adjust the fees under paragraph (2) to ensure
that the fees accurately reflect the actual costs
referred to in subparagraph (A) and do not exceed, in
the aggregate, 1 percent of the total price of drugs
imported annually to the United States under this
section.
``(4) Use of fees.--Subject to appropriations Acts, fees
collected by the Secretary under paragraphs (1) and (2) are
only available to the Secretary and are for the sole purpose of
paying the costs referred to in paragraph (3)(A).
``(g) Compliance With Section 801(a).--
``(1) In general.--A registration condition is that each
qualifying drug exported under subsection (a) by the registered
exporter involved or imported under subsection (a) by the
registered importer involved is in compliance with the
standards referred to in section 801(a) regarding admission of
the drug into the United States, subject to paragraphs (2),
(3), and (4).
``(2) Section 505; approval status.--
``(A) In general.--For purposes of administrative
and judicial procedure, there is a presumption that a
drug proposed for export or import under subsection (a)
is an approved drug under section 505(b) if the
following criteria are met:
``(i) The drug proposed for export or
import is in compliance with subsection (c).
``(ii) The drug proposed for export or
import has the same active ingredient or
ingredients, route of administration, dosage
form, and strength, according to information
provided by the labeling of the drug proposed
for export or import, as a drug (referred to in
this subsection as a `U.S. label drug') that--
``(I) is manufactured by or for the
person that manufactures the drug
proposed for export or import; and
``(II) is approved under section
505(b).
``(B) Importation.--Subject to subparagraphs (D)
and (E), a drug meeting the criteria described in
subparagraph (A) may, in accordance with the other
subsections of this section, be imported into the
United States.
``(C) Notice by manufacturer; general provisions.--
``(i) In general.--The person that
manufactures a drug that may be imported under
subsection (a) shall in accordance with this
paragraph submit to the Secretary a notice
that--
``(I) includes each difference in
the drug from a condition established
in the approved application for the
U.S. label drug beyond the variations
provided for in the application, any
difference in labeling, the date on
which the drug with such difference
was, or will be, introduced for
commercial distribution in a permitted
country, and such additional
information as the Secretary may
require; or
``(II) states that there is no
difference in the drug from a condition
established in the approved application
for the U.S. label drug beyond the
variations provided for in the
application and differences in
labeling.
``(ii) Information regarding foreign
government.--A notice under clause (i)(I) shall
with respect to the permitted country that
approved the drug for commercial distribution,
or with respect to which such approval is
sought, include the following:
``(I) Information demonstrating
that the person submitting the notice
has also notified the government of the
permitted country in writing that the
person is submitting to the Secretary a
notice under clause (i)(I), which
notice describes the difference in the
drug from a condition established in
the approved application for the U.S.
label drug.
``(II) The information that the
person submitted or will submit to the
government of the permitted country for
purposes of obtaining approval for
commercial distribution of the drug in
the country which, if in a language
other than English, shall be
accompanied by an English translation
verified to be complete and accurate,
with the name, address, and a brief
statement of the qualifications of the
person that made the translation.
``(iii) Certifications.--The chief
executive officer and the chief medical officer
of the manufacturer involved shall each certify
in the notice under clause (i) that--
``(I) the information provided in
the notice is complete and true; and
``(II) a copy of the notice has
been provided to the Federal Trade
Commission and to the Assistant
Attorney General in charge of the
Antitrust Division of the Department of
Justice (referred to in this subsection
as the `Assistant Attorney General').
``(iv) Fee.--If a notice submitted under
clause (i) includes a difference that would,
under section 506A, require the submission of a
supplemental application if made as a change to
the U.S. label drug, the person that submits
the notice shall pay to the Secretary a fee in
the same amount as would apply if the person
were paying a fee pursuant to section
736(a)(1)(A)(ii). Subject to appropriations
Acts, fees collected by the Secretary under the
preceding sentence are available only to the
Secretary and are for the sole purpose of
paying the costs of reviewing notices submitted
under clause (i).
``(v) Timing of submission of notices.--
``(I) Prior approval notices.--A
notice under clause (i) to which
subparagraph (D) applies shall be
submitted to the Secretary not later
than 120 days before the drug with the
difference is introduced for commercial
distribution in a permitted country,
unless the country requires that
distribution of the drug with the
difference begin less than 120 days
after the country requires the
difference.
``(II) Other approval notices.--A
notice under clause (i) to which
subparagraph (E) applies shall be
submitted to the Secretary not later
than the day on which the drug with the
difference is introduced for commercial
distribution in a permitted country.
``(III) Other notices.--A notice
under clause (i) to which subparagraph
(F) applies shall be submitted to the
Secretary on the date that the drug is
first introduced for commercial
distribution in a permitted country and
annually thereafter.
``(vi) Review by secretary.--
``(I) In general.--In this
paragraph, the difference in a drug
that may be imported under subsection
(a) from the U.S. label drug shall be
treated by the Secretary as if it was a
manufacturing change to the U.S. label
drug under section 506A.
``(II) Review by the secretary.--
The Secretary shall review and approve
or disapprove the difference in a
notice submitted under clause (i), if
required under section 506A, not later
than 120 days after the date on which
the notice is submitted.
``(III) Establishment inspection.--
If review of such difference would
require an inspection by the Secretary
of the establishment in which the drug
is manufactured, such inspection shall
be authorized by section 704.
``(vii) Publication of information on
notices.--
``(I) In general.--Through the
Internet website of the Food and Drug
Administration, the Secretary shall
readily make available to the public a
list of notices submitted under clause
(i).
``(II) Contents.--The list under
subclause (I) shall include the date on
which a notice is submitted and
whether--
``(aa) a notice is under
review;
``(bb) the Secretary has
ordered that importation of the
drug from a permitted country
cease; or
``(cc) the importation of
the drug is permitted under
subsection (a).
``(III) Update.--The Secretary
shall promptly update the Internet
website with any changes to the list.
``(D) Notice; drug difference requiring prior
approval.--In the case of a notice under subparagraph
(C)(i) that includes a difference that would, under
section 506A(c) or (d)(3)(B)(i), require the approval
of a supplemental application before the difference
could be made to the U.S. label drug the following
shall occur:
``(i) Promptly after the notice is
submitted, the Secretary shall notify
registered exporters, registered importers, the
Federal Trade Commission, and the Assistant
Attorney General that the notice has been
submitted with respect to the drug involved.
``(ii) If the Secretary has not made a
determination whether a supplemental
application regarding the U.S. label drug would
be approved or disapproved by the date on which
the drug involved is to be introduced for
commercial distribution in a permitted country,
the Secretary shall--
``(I) order that the importation of
the drug involved from the permitted
country cease for the period in
which the Secretary completes review of the notice; and
``(II) promptly notify registered
exporters, registered importers, the
Federal Trade Commission, and the
Attorney General of the order.
``(iii) If the Secretary determines that
such a supplemental application regarding the
U.S. label drug would not be approved, the
Secretary shall--
``(I) order that the importation of
the drug involved from the permitted
country cease, or provide that an order
under clause (ii), if any, remains in
effect;
``(II) notify the permitted country
that approved the drug for commercial
distribution of the determination; and
``(III) promptly notify registered
exporters, registered importers, the
Federal Trade Commission, and the
Assistant Attorney General of the
determination.
``(iv) If the Secretary determines that
such a supplemental application regarding the
U.S. label drug would be approved, the
Secretary shall vacate the order under clause
(ii), if any, permit importation of the drug
under subsection (a), and promptly notify
registered exporters, registered importers, the
Federal Trade Commission, and the Assistant
Attorney General of the determination.
``(E) Notice; drug difference not requiring prior
approval.--In the case of a notice under subparagraph
(C)(i) that includes a difference that would, under
section 506A(d)(3)(B)(ii), not require the approval of
a supplemental application before the difference could
be made to the U.S. label drug the following shall
occur:
``(i) During the period in which the notice
is being reviewed by the Secretary, the
authority under this subsection to import the
drug involved continues in effect.
``(ii) If the Secretary determines that
such a supplemental application regarding the
U.S. label drug would not be approved, the
Secretary shall order that the importation of
the drug involved from the permitted country
cease, shall notify the permitted country that
approved the drug for commercial distribution
of the determination, and shall promptly notify
registered exporters, registered importers, the
Federal Trade Commission, and the Assistant
Attorney General of the determination.
``(F) Notice; drug difference not requiring
approval; no difference.--In the case of a notice under
subparagraph (C)(i) that includes a difference for
which, under section 506A(d)(1)(A), a supplemental
application would not be required for the difference to
be made to the U.S. label drug, or that states that
there is no difference, the Secretary--
``(i) may not order that the importation of
the drug involved cease; and
``(ii) shall promptly notify registered
exporters and registered importers.
``(G) Differences in active ingredient, route of
administration, dosage form, or strength.--
``(i) In general.--A person who
manufactures a U.S. label drug shall submit an
application under section 505(b) for a drug
that is manufactured for distribution in a
permitted country by or for the person that
manufactures the U.S. label drug if--
``(I) there is no drug for export
from at least half of the permitted
countries with the same active
ingredient or ingredients, route of
administration, dosage form, and
strength as the U.S. label drug; and
``(II) each active ingredient of
the drug is related to an active
ingredient of the U.S. label drug, as
defined in clause (v).
``(ii) Application under section 505(b).--
The application under section 505(b) required
under clause (i) shall--
``(I) request approval of the drug
for the indication or indications for
which the U.S. label drug is approved
under section 505;
``(II) include the information that
the person submitted to the government
of the permitted country for purposes
of obtaining approval for commercial
distribution of the drug in that
country, which if in a language other
than English, shall be accompanied by
an English translation verified to be
complete and accurate, with the name,
address, and a brief statement of the
qualifications of the person that made
the translation;
``(III) include a right of
reference to the application under
section 505(b) for the U.S. label drug;
and
``(IV) include such additional
information as the Secretary may
require.
``(iii) Timing of submission of
application.--An application under section
505(b) required under clause (i) shall be
submitted to the Secretary not later than the
day on which the information referred to in
clause (ii)(II) is submitted to the government
of the permitted country.
``(iv) Notice of decision on application.--
The Secretary shall promptly notify registered
exporters, registered importers, the Federal
Trade Commission, and the Assistant Attorney
General of a determination to approve or to
disapprove an application under section 505(b)
required under clause (i).
``(v) Related active ingredients.--For
purposes of clause (i)(II), 2 active
ingredients are related if they are--
``(I) the same; or
``(II) different salts, esters, or
complexes of the same moiety.
``(3) Section 502; labeling.--
``(A) Importation by registered importer.--
``(i) In general.--In the case of a
qualifying drug that is imported or offered for
import by a registered importer, such drug
shall be considered to be in compliance with
section 502 if the drug bears--
``(I) a copy of the labeling
approved for the drug under section
505, without regard to whether the copy
bears the trademark involved;
``(II) the name of the manufacturer
and location of the manufacturer;
``(III) the lot number assigned by
the manufacturer; and
``(IV) the name, location, and
registration number of the importer.
``(ii) Request for copy of the labeling.--
The Secretary shall provide such copy to the
registered importer involved, upon request of
the importer.
``(B) Importation by individual.--In the case of a
qualifying drug that is imported or offered for import
by a registered exporter to an individual, such drug
shall be considered to be in compliance with section
502 if the drug bears a label providing the directions
for use by the consumer, and bears a copy of any
special labeling that would be required by the
Secretary had the drug been dispensed by a pharmacist
in the United States, without regard to whether the
special labeling bears the trademark involved. The
Secretary shall provide to the registered exporter
involved a copy of the special labeling, upon request
of the exporter.
``(4) Section 501; standards for refusing admission.--
``(A) In general.--For purposes of administrative
and judicial procedure, there is a presumption that a
drug proposed for export or import under subsection (a)
is in compliance with section 501 if the drug is in
compliance with subsection (c).
``(B) Standards for refusing admission.--A
qualifying drug exported under subsection (a) from a
registered exporter or imported by a registered
importer may be refused admission into the United
States if 1 or more of the following applies:
``(i) The shipping container appears
damaged in a way that may affect the strength,
quality, or purity of the drug.
``(ii) The Secretary becomes aware that--
``(I) the drug may be counterfeit;
``(II) the drug may have been
prepared, packed, or held under
insanitary conditions; or
``(III) the methods used in, or the
facilities or controls used for, the
manufacturing, processing, packing, or
holding of the drug do not conform to
good manufacturing practice.
``(iii) The Secretary has obtained an
injunction under section 302 that prohibits the
distribution of the drug in interstate
commerce.
``(iv) The Secretary has under section
505(e) withdrawn approval of the drug.
``(v) The manufacturer of the drug has
instituted a recall of the drug.
``(vi) If the qualifying drug is exported
from a registered exporter to an individual and
1 or more of the following applies:
``(I) The shipping container for
such drug does not bear the markings
required under subsection (d)(2).
``(II) The markings on the shipping
container appear to be counterfeit.
``(III) The shipping container or
markings appear to have been tampered
with.
``(h) Licensing as Pharmacist.--A registration condition is that
the exporter involved agrees that a qualifying drug will be exported to
an individual only if the Secretary has verified that--
``(1) the exporter is authorized under Canadian law to
dispense prescription drugs; and
``(2) the exporter employs persons that are licensed under
Canadian law to dispense prescription drugs in sufficient
number to dispense safely the qualifying drugs exported by the
exporter to individuals, and the exporter assigns to those
persons responsibility for dispensing such qualifying drugs to
individuals.
``(i) Individuals; Conditions for Importation From Canada.--
``(1) In general.--For purposes of subsection (a)(2)(B),
the importation of a qualifying drug by an individual is in
accordance with this subsection if the following conditions are
met:
``(A) The drug is accompanied by a copy of a
prescription for the drug, which prescription--
``(i) is valid under applicable Federal and
State laws; and
``(ii) was issued by a practitioner who,
under the law of a State of which the
individual is a resident, or in which the
individual receives care from the practitioner
who issues the prescription, is authorized to
administer prescription drugs.
``(B) The drug is accompanied by a copy of the
documentation that was required under the law or
regulations of Canada as a condition of dispensing the
drug to the individual.
``(C) The copies referred to in subparagraphs
(A)(i) and (B) are marked in a manner sufficient--
``(i) to indicate that the prescription,
and the equivalent document in Canada, have
been filled; and
``(ii) to prevent a duplicative filling by
another pharmacist.
``(D) The individual has provided to the registered
exporter a complete list of all drugs used by the
individual for review by the individuals who dispense
the drug.
``(E) The quantity of the drug does not exceed a
90-day supply.
``(F) The drug is not an ineligible subpart H drug.
For purposes of this section, a prescription drug is an
`ineligible subpart H drug' if the drug was approved by
the Secretary under subpart H of part 314 of title 21,
Code of Federal Regulations (relating to accelerated
approval), with restrictions under section 520 of such
part to assure safe use, and the Secretary has
published in the Federal Register a notice that the
Secretary has determined that good cause exists to
prohibit the drug from being imported pursuant to this
subsection.
``(2) Notice regarding drug refused admission.--If a
registered exporter ships a drug to an individual pursuant to
subsection (a)(2)(B) and the drug is refused admission to the
United States, a written notice shall be sent to the individual
and to the exporter that informs the individual and the
exporter of such refusal and the reason for the refusal.
``(j) Maintenance of Records and Samples.--A registration condition
is that the importer or exporter involved shall--
``(1) maintain records required under this section for not
less than 2 years; and
``(2) maintain samples of each lot of a drug required under
this section for not less than 2 years.
``(k) Drug Recalls.--
``(1) Manufacturers.--A person that manufactures a
prescription drug imported from a permitted country under this
section shall promptly inform the Secretary--
``(A) if the drug is recalled or withdrawn from the
market in a permitted country;
``(B) how the drug may be identified, including lot
number; and
``(C) the reason for the recall or withdrawal.
``(2) Secretary.--With respect to each permitted country,
the Secretary shall--
``(A) enter into an agreement with the government
of the country to receive information about recalls and
withdrawals of prescription drugs in the country; or
``(B) monitor recalls and withdrawals of
prescription drugs in the country using any information
that is available to the public in any media.
``(3) Notice.--The Secretary may notify, as appropriate,
registered exporters, registered importers, wholesalers,
pharmacies, or the public of a recall or withdrawal of a
prescription drug in a permitted country.''.
(b) Prohibited Acts.--The Federal Food, Drug, and Cosmetic Act is
amended--
(1) in section 301 (21 U.S.C. 331), by striking paragraph
(aa) and inserting the following:
``(aa)(1) The sale or trade by a pharmacist, or by a business
organization of which the pharmacist is a part, of a qualifying drug
that under section 804(a)(2)(A) was imported by the pharmacist, other
than--
``(A) a sale at retail made pursuant to dispensing the drug
to a customer of the pharmacist or organization; or
``(B) a sale or trade of the drug to a pharmacy or a
wholesaler registered to import drugs under section 804.
``(2) The sale or trade by an individual of a qualifying drug that
under section 804(a)(2)(B) was imported by the individual.
``(3) The making of a materially false, fictitious, or fraudulent
statement or representation, or a material omission, in a notice under
clause (i) of section 804(g)(2)(C) or in an application required under
section 804(g)(2)(G), or the failure to submit such a notice or
application.
``(4) The importation of a drug in violation of a requirement under
section 804.''; and
(2) in section 303(a) (21 U.S.C. 333(a)), by striking
paragraph (6) and inserting the following:
``(6) Notwithstanding subsection (a), any person that knowingly
violates section 301(aa) (3) or (4) shall be imprisoned not more than
10 years, or fined in accordance with title 18, United States Code, or
both.''.
(c) Implementation.--
(1) Rulemaking.--
(A) In general.--
(i) Promulgation by secretary.--Not later
than 90 days after the date of the enactment of
this Act, the Secretary of Health and Human
Services shall promulgate an interim rule for
implementing section 804 of the Federal Food,
Drug, and Cosmetic Act, as added by subsection
(a) of this section. Such rule shall be
developed and promulgated by the Secretary
without providing general notice of proposed
rulemaking. Not later than 1 year after the
date on which the interim rule is promulgated, the Secretary shall, in
accordance with procedures under section 553 of title 5, United States
Code, promulgate a final rule for implementing such section 804, which
may incorporate by reference provisions of the interim rule, to the
extent that such provisions are not modified.
(ii) Effect of rules.--The rules
promulgated under clause (i) shall permit the
importation of prescription drugs--
(I) from registered exporters by
individuals effective on the date of
the promulgation of the interim rule;
(II) from Canada by registered
importers effective on the date of the
promulgation of the interim rule; and
(III) from Australia, a member
country of the European Union as of
January 1, 2003, Japan, New Zealand, or
Switzerland by registered importers on
the date that is 1 year after the date
of the enactment of this Act.
(B) Certain exporters.--The interim rule under
subparagraph (A) shall provide that, in the review of
registrations submitted under subsection (b) of the
section 804 referred to in such subparagraph,
registrations submitted by entities in Canada that are
significant exporters of prescription drugs to
individuals in the United States as of the date of the
enactment of this Act will have priority during the
period in which the interim rule under subparagraph (A)
is in effect. During such period, the reference in
subsection (b)(2)(A) of such section 804 to 90 days
(relating to approval or disapproval of registrations)
is, as applied to such entities, deemed to be 30 days.
(C) Drugs for import from canada.--The notices with
respect to drugs to be imported from Canada that are
required under subsection (g)(2)(C)(i)(I) of such
section 804 and that require approval under subsection
(g)(2)(D) or (E) of such section 804 shall be submitted
to the Secretary not later than 30 days after the date
of enactment of this Act. The notices with respect to
drugs to be imported from Canada that are required
under subsection (g)(2)(C)(i) of such section 804 and
that do not require approval under subsection (g)(2)(D)
or (E) of such section 804 shall be submitted to the
Secretary not later than 90 days after the date of
enactment of this Act.
(D) Drugs for import from other countries.--The
notices with respect to drugs to be imported from
Australia, a member country of the European Union as of
January 1, 2003, Japan, New Zealand, or Switzerland
that are required under subsection (g)(2)(C)(i)(I) of
such section 804 and that require approval under
subsection (g)(2)(D) or (E) of such section 804 shall
be submitted to the Secretary not later than 180 days
after the date of enactment of this Act. The notices
with respect to drugs to be imported from such
countries that are required under subsection
(g)(2)(C)(i)(II) of such section 804 and that do not
require approval under subsection (g)(2)(D) or (E) of
such section 804 shall be submitted to the Secretary
not later than 270 days after the date of enactment of
this Act.
(2) Personal importation from canada.--Until the expiration
of the 60-day period beginning on the date on which the interim
rule under paragraph (1)(A) is promulgated, an individual may
import a prescription drug from Canada for personal use or for
the use of a family member of the individual (rather than for
resale), subject to compliance with the following conditions:
(A) The drug is not--
(i) a controlled substance, as defined in
section 102 of the Controlled Substances Act
(21 U.S.C. 802);
(ii) a biological product, as defined in
section 351 of the Public Health Service Act
(42 U.S.C. 262);
(iii) an infused drug, including a
peritoneal dialysis solution;
(iv) an intravenously injected drug;
(v) a drug that is inhaled during surgery;
or
(vi) a drug approved by the Secretary under
subpart H of part 314 of title 21, Code of
Federal Regulations (relating to accelerated
approval) with restrictions under section 520
of such part to assure safe use.
(B) The drug is dispensed by a person licensed in
Canada to dispense such drugs.
(C) The drug is accompanied by a copy of the
prescription for the drug, which prescription--
(i) is valid under applicable Federal and
State laws; and
(ii) was issued by a practitioner who,
under the law of a State of which the
individual is a resident, or in which the
individual receives care from the practitioner
who issues the prescription, is authorized to
administer prescription drugs.
(D) The drug is accompanied by a copy of the
document that was required in Canada as a condition of
dispensing the drug to the individual.
(E) The copies referred to in subparagraphs (C) and
(D) are marked in a manner sufficient--
(i) to indicate that the prescription, and
the equivalent document in Canada, have been
filled; and
(ii) to prevent a duplicative filling by
another pharmacist.
(F) The quantity of the drug does not exceed a 90-
day supply.
(3) Facilitation of canadian imports.--Not less than 15
days after the enactment of this Act and until the expiration
of the 60-day period that begins on the date on which the
interim rule under paragraph (1)(A) is promulgated, the
Secretary shall, through the Internet website of the Food and
Drug Administration, make readily available to the public a
list of persons licensed in Canada to dispense prescription
drugs who are willing to export drugs under paragraph (2) to
individuals in the United States.
(4) Effect of provisions.--The amendments made in
subsection (d), section 6, and section 7 of this Act shall have
no effect with respect to imports made under paragraph (2).
(d) Amendment of Certain Provision.--Section 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by striking
subsection (g) and inserting the following:
``(g) With respect to a prescription drug that is imported or
offered for import into the United States by an individual who is not
in the business of such importation, that is not shipped by a
registered exporter under section 804, and that is refused admission
under subsection (a), the Secretary shall notify the individual that--
``(1) the drug has been refused admission because the drug
was not a lawful import under section 804;
``(2) the drug is not otherwise subject to a waiver of the
requirements of subsection (a);
``(3) the individual may under section 804 lawfully import
certain prescription drugs from Canadian exporters registered
with the Secretary; and
``(4) the individual can find information about such
importation, including a list of registered exporters, on the
Internet website of the Food and Drug Administration.''.
(e) Anticompetitive Practices Relating to Importing and Exporting
Drugs to the United States.--
(1) In general.--The Clayton Act (15 U.S.C. 12 et seq.) is
amended by adding at the end the following:
``SEC. 27. RESTRAINT OF TRADE REGARDING PRESCRIPTION DRUGS.
``(a) In General.--It shall be unlawful for any person engaged in
commerce, directly or indirectly to--
``(1) charge a higher price for prescription drugs sold to
a registered exporter or other person that exports prescription
drugs to the United States under section 804 of the Federal
Food, Drug, and Cosmetic Act than the price that is charged to
another person that is in the same country and that does not
export prescription drugs into the United States under section
804 of such Act;
``(2) charge a higher price for prescription drugs sold to
a registered importer or other person that distributes, sells,
or uses prescription drugs imported to the United States under
section 804 of such Act than the price that is charged to
another person in the United States that does not import
prescription drugs under section 804 of such Act, or that does
not distribute, sell, or use such drugs;
``(3) deny supplies of prescription drugs to a registered
exporter or other person that exports prescription drugs to the
United States under section 804 of such Act or to a registered
importer or other person that distributes, sells, or uses
prescription drugs imported to the United States under section
804 of such Act;
``(4) publicly, privately, or otherwise refuse to do
business with a registered exporter or other person that
exports prescription drugs to the United States under section
804 of such Act or with a registered importer or other person
that distributes, sells, or uses prescription drugs imported to
the United States under section 804 of such Act;
``(5) specifically restrict supplies of prescription drugs
to a registered exporter or other person that exports
prescription drugs to the United States under section 804 of
such Act or to a registered importer or other person that
distributes, sells, or uses prescription drugs imported to the
United States under section 804 of such Act;
``(6) fail to submit a notice under subsection (g)(2)(C)(i)
of section 804 of such Act, fail to submit such a notice on or
before the date specified in subsection (g)(2)(C)(v) of section
804 of such Act, submit such a notice that makes a materially
false, fictitious, or fraudulent statement, or fail to provide
promptly any information requested by the Secretary of Health
and Human Services to review such a notice;
``(7) fail to submit an application required under
subsection (g)(2)(G) of section 804 of such Act, fail to submit
such an application on or before the date specified in
subsection (g)(2)(G)(ii) of section 804 of such Act, submit
such an application that makes a materially false, fictitious,
or fraudulent statement, or fail to provide promptly any
information requested by the Secretary of Health and Human
Services to review such an application;
``(8) cause there to be a difference (including a
difference in active ingredient, route of administration,
dosage form, strength, formulation, manufacturing
establishment, manufacturing process, or person that
manufactures the drug) between a prescription drug for
distribution in the United States and a prescription drug for
distribution in Australia, Canada, a member country of the
European Union as of January 1, 2003, Japan, New Zealand, or
Switzerland for the purpose of restricting importation of the
drug to the United States under section 804 of such Act;
``(9) refuse to allow an inspection authorized under
section 804 of such Act of an establishment that manufactures a
prescription drug that is offered for import under such
section;
``(10) fail to conform to the methods used in, or the
facilities used for, the manufacturing, processing, packing, or
holding of a prescription drug offered for import under section
804 to good manufacturing practice under such Act; or
``(11) engage in any other action that the Federal Trade
Commission determines to unfairly restrict competition under
section 804 of such Act.
``(b) Presumption.--A difference (including a difference in active
ingredient, route of administration, dosage form, strength,
formulation, manufacturing establishment, manufacturing process, or
person that manufactures the drug) between a prescription drug for
distribution in the United States and a prescription drug for
distribution in Australia, Canada, a member country of the European
Union as of January 1, 2003, Japan, New Zealand, or Switzerland made
after January 1, 2004, shall be presumed to be for the purpose of
restricting importation of the drug to the United States under section
804 of the Federal Food, Drug, and Cosmetic Act unless--
``(1) the person manufacturing the drug for distribution in
the United States proves that the difference was required by
the country in which the drug is distributed;
``(2) the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drug, determines that the
difference was necessary to improve the safety or efficacy of
the drug; or
``(3) the person manufacturing the drug for distribution in
the United States has given notice to the Secretary of Health
and Human Services under subsection (g)(2)(C)(i) of section 804
of such Act that the drug for distribution in the United States
is not different from a drug for distribution in not fewer than
half of those countries.
``(c) Affirmative Defense.--It shall be an affirmative defense to a
charge that a person has violated paragraph (1), (2), (3), (4), or (5)
of subsection (a) that the higher prices charged for prescription drugs
sold to a person, the denial of supplies of prescription drugs to a
person, the refusal to do business with a person, or the specific
restriction or delay of supplies to a person is not based, in whole or
in part, on--
``(1) the person exporting or importing prescription drugs
to the United States under section 804 of the Federal Food,
Drug, and Cosmetic Act; or
``(2) the person distributing, selling, or using
prescription drugs imported to the United States under section
804 of such Act.
``(d) Definitions.--In this section:
``(1) Prescription drug.--The term `prescription drug'
means a drug that is described in section 503(b)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)).
``(2) Registered importer.--The term `registered importer'
has the meaning given such term in section 804 of the Federal
Food, Drug, and Cosmetic Act.
``(3) Registered exporter.--The term `registered exporter'
has the same meaning as in section 804 of the Federal Food,
Drug, and Cosmetic Act.''.
(2) Applicability of amendments to importation under the
pharmaceutical market access and fair trade act of 2004.--
(A) Personal importation from canada.--Paragraphs
(1) through (5) and (11) of subsection (a) of section
27 of the Clayton Act (15 U.S.C. et seq.) (as amended
by paragraph (1)) shall apply with respect to the
importation of drugs from Canada under subsection
(c)(2).
(B) Notices respecting drug for import.--Paragraph
(6) of subsection (a) of section 27 of the Clayton Act
(15 U.S.C. et seq.) (as amended by paragraph (1)) shall
apply with respect to notices required under section
804(g)(2)(C)(i) of the Federal Food Drug and Cosmetic
Act (21 U.S.C. 384(g)(2)(C)(i)) that are not submitted
by the dates required under subsections (c)(1)(C) and
(D).
(f) Exhaustion.--
(1) In general.--Section 271 of title 35, United States
Code, is amended--
(A) by redesignating subsections (h) and (i) as (i)
and (j), respectively; and
(B) by inserting after subsection (g) the
following:
``(h) It shall not be an act of infringement to use, offer to sell,
or sell within the United States or to import into the United States
any patented invention under section 804 of the Federal Food, Drug, and
Cosmetic Act that was first sold abroad by or under authority of the
owner or licensee of such patent.''.
(2) Rule of construction.--Nothing in the amendment made by
paragraph (1) shall be construed to affect the ability of a
patent owner or licensee to enforce their patent, subject to
such amendment.
SEC. 5. ADDITIONAL WAIVERS REGARDING PERSONAL IMPORTATION; ENFORCEMENT
POLICIES OF SECRETARY.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the
following:
``(p)(1) Waivers under this subsection are in addition to, and
independent of, the waiver pursuant to section 804(a)(2)(B).
``(2) With respect to the standards referred to in subsection
(d)(1), the Secretary shall establish by regulation a waiver of such
standards in the case of the importation by an individual of a drug
into the United States in the following circumstances:
``(A) The drug was dispensed to the individual while the
individual was in the United States, the drug was dispensed by
a pharmacist or by a practitioner licensed by law to administer
the drug, and the individual traveled from the United States
with the drug.
``(B) The individual is entering the United States and the
drug accompanies the individual at the time of entry.
``(C) The drug does not appear to the Secretary to be
adulterated.
``(D) The quantity of the drug does not exceed a 90-day
supply.
``(E) The drug is accompanied by a statement that the
individual seeks to import the drug into the United States
under a personal importation waiver.
``(F) Such additional standards as the Secretary determines
to be appropriate to protect the public health.
``(3) With respect to the standards referred to in subsections (a)
and (d)(1), the Secretary shall establish by regulation a waiver of
such standards in the case of the importation by an individual of a
drug into the United States in the following circumstances:
``(A) The drug was dispensed to the individual while the
individual was in a foreign country, and the drug was dispensed
in accordance with the laws and regulations of such country.
``(B) The individual is entering the United States and the
drug accompanies the individual at the time of entry.
``(C) The drug is approved for commercial distribution in
the foreign country in which the drug was obtained.
``(D) The drug does not appear to the Secretary to be
adulterated.
``(E) The quantity of the drug does not exceed--
``(i) a 90-day supply if the drug is dispensed in
Australia, Canada, a member country of the European
Union as of January 1, 2003, Japan, New Zealand, or
Switzerland; or
``(ii) a 14-day supply otherwise.
``(F) The drug is accompanied by a statement that the
individual seeks to import the drug into the United States
under a personal importation waiver.
``(G) Such additional standards as the Secretary determines
to be appropriate to protect the public health.
``(q) The Secretary may not administer any enforcement policy that
has the effect of permitting the importation of a prescription drug
into the United States in violation of this Act or section 351 of the
Public Health Service Act.''.
(b) Additional Waiver.--This Act and the amendments made by this
Act shall not be construed as limiting the authority of the Secretary
of Health and Human Services to establish a waiver of the standards
referred to in section 801(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 381(a)) with respect to the importation by an individual
of a drug into the United States that does not meet such standards,
provided that such waiver is no more permissive than the guidance, as
in effect on January 1, 2004, that is provided in the item numbered 2
(relating to a specific situation, consisting of conditions (a) through
(d)) under the heading ``Drugs, Biologics, and Devices'' in chapter 9
of the FDA/ORA Regulatory Procedures Manual (relating to import
operations/actions), in the subchapter relating to coverage of personal
importations.
SEC. 6. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO UNITED
STATES.
(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section 3 of this
Act, is further amended by adding at the end the following section:
``SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.
``(a) In General.--The Secretary of Homeland Security shall refuse
admission to a shipment of drugs that is imported or offered for import
into the United States if the shipment has a declared value of less
than $10,000 and the drugs are in violation of any standard referred to
in section 801(a) or 801(d)(1), including any drugs imported or offered
for import under enforcement policies prohibited under section 801(q).
``(b) Importation Under Section 804.--In the case of a drug that
under section 804 is imported or offered for import from a registered
exporter, the reference in subsection (a) to standards referred to in
section 801(a) or 801(d)(1) shall be considered a reference to
standards referred to in section 804(g)(4)(B).
``(c) Destruction of Violative Shipments.--Drugs refused admission
under subsection (a) or (b) shall be destroyed, subject to subsection
(e). Section 801(b) does not authorize the delivery of the drugs
pursuant to the execution of a bond, and the drugs may not be exported.
``(d) Certain Procedures.--
``(1) In general.--The refusal of admission and destruction
of drugs under this section may be carried out without notice
to the importer, owner, or consignee of the drugs except as
required by section 801(g) or section 804(i)(2). The issuance
of receipts for the drugs, and recordkeeping activities
regarding the drugs, may be carried out on a summary basis.
``(2) Objective of procedures.--Procedures promulgated
under paragraph (1) shall be designed toward the objective of
ensuring that, with respect to efficiently utilizing Federal
resources available for carrying out this section, a
substantial majority of shipments of drugs subject to
subsection (a) or (b) are identified and refused admission and
destroyed.
``(e) Evidence Exception.--Drugs may not be destroyed under
subsection (c) to the extent that the Attorney General of the United
States determines that the drugs should be preserved as evidence or
potential evidence with respect to an offense against the United
States.
``(f) Rule of Construction.--This section may not be construed as
having any legal effect on applicable law with respect to a shipment of
drugs that is imported or offered for import into the United States and
has a declared value equal to or greater than $10,000.''.
(b) Procedures.--Procedures for carrying out section 805 of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall
be established not later than 90 days after the date of the enactment
of this Act.
SEC. 7. CIVIL ACTIONS REGARDING PROPERTY.
Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
333) is amended by adding at the end the following subsection:
``(g)(1) If a person is alienating or disposing of property, or
intends to alienate or dispose of property, that is obtained as a
result of or is traceable to a drug imported in violation of section
801(a) or 801(d), the Attorney General may commence a civil action in
any Federal court--
``(A) to enjoin such alienation or disposition of property;
or
``(B) for a restraining order to--
``(i) prohibit any person from withdrawing,
transferring, removing, dissipating, or disposing of
any such property or property of equivalent value; and
``(ii) appoint a temporary receiver to administer
such restraining order.
``(2) Proceedings under paragraph (1) shall be carried out in the
same manner as applies under section 1345 of title 18, United States
Code.''.
SEC. 8. WHOLESALE DISTRIBUTION OF DRUGS; STATEMENTS REGARDING PRIOR
SALE, PURCHASE, OR TRADE.
(a) Striking of Exemptions; Applicability to Registered
Exporters.--Section 503(e) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(e)) is amended--
(1) in paragraph (1)--
(A) by striking ``and who is not the manufacturer
or an authorized distributor of record of such drug'';
(B) by striking ``to an authorized distributor of
record or''; and
(C) by striking subparagraph (B) and inserting the
following:
``(B) The fact that a drug subject to subsection (b) is exported
from the United States does not with respect to such drug exempt any
person that is engaged in the business of the wholesale distribution of
the drug from providing the statement described in subparagraph (A) to
the person that receives the drug pursuant to the export of the drug.
``(C)(i) The Secretary may by regulation establish requirements
that supersede subparagraph (A) (referred to in this subparagraph as
`alternative requirements') to identify the chain of custody of a drug
subject to subsection (b) from the manufacturer of the drug throughout
the wholesale distribution of the drug to a pharmacist who intends to
sell the drug at retail if the Secretary determines that the
alternative requirements, which may include anti-counterfeiting or
track-and-trace technologies, will identify such chain of custody or
the identity of the drug with equal certainty to the requirements of
subparagraph (A), and that the alternative requirements are
economically and technically feasible.
``(ii) If the Secretary promulgates a final rule to establish such
alternative requirements, the final rule in addition shall, with
respect to the registration condition established in clause (i) of
section 804(c)(3)(B), establish a condition equivalent to the
alternative requirements, and such equivalent condition supersedes such
clause (i).'';
(2) in paragraph (2)(A), by adding at the end the
following: ``The preceding sentence may not be construed as
having any applicability with respect to a registered exporter
under section 804.''; and
(3) in paragraph (3), by striking ``and subsection (d)--''
in the matter preceding subparagraph (A) and all that follows
through ``the term `wholesale distribution' means'' in
subparagraph (B) and inserting the following: ``and subsection
(d), the term `wholesale distribution' means''.
(b) Conforming Amendment.--Section 503(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 353(d)) is amended by adding at the
end the following:
``(4) Each manufacturer of a drug subject to subsection (b) shall
maintain at its corporate offices a current list of the authorized
distributors of record of such drug.
``(5) For purposes of this subsection, the term `authorized
distributors of record' means those distributors with whom a
manufacturer has established an ongoing relationship to distribute such
manufacturer's products.''.
SEC. 9. REPEAL OF IMPORTATION EXEMPTION UNDER CONTROLLED SUBSTANCES
IMPORT AND EXPORT ACT.
Section 1006 of the Controlled Substances Import and Export Act (21
U.S.C. 956) is repealed.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S4227-4228)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 108-470.
Committee on the Judiciary. Hearings held.
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