Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004
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Read twice and referred to the Committee on Finance.
April 8, 2004
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Introduced in Senate
April 8, 2004
Sponsor introductory remarks on measure. (CR S4042-4046)
April 8, 2004
Read twice and referred to the Committee on Finance.
April 8, 2004
Floor Debate
21 membersWhat members said about S. 2307 on the floor




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Floor Debate
21 membersWhat members said about S. 2307 on the floor
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Bill Text
Latest available legislative text
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2307 Introduced in Senate (IS)]
108th CONGRESS
2d Session
S. 2307
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
importation of prescription drugs by importers, and by individuals for
personal use, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 8, 2004
Mr. Grassley introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
importation of prescription drugs by importers, and by individuals for
personal use, 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 ``Reliable Entry for Medicines at
Everyday Discounts through Importation with Effective Safeguards Act of
2004''.
SEC. 2. 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.), as amended by section 1121(a) of Public Law 108-173 (117
Stat. 2464), is amended by striking section 804.
SEC. 3. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF CERTAIN IMPORT
RESTRICTIONS.
(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act, as amended by section 2 of this Act, is amended by
inserting after section 803 the following section:
``SEC. 804. WAIVERS REGARDING COMMERCIAL AND PERSONAL IMPORTATION OF
PRESCRIPTION DRUGS; REGISTERED FOREIGN EXPORTERS.
``(a) Waivers.--
``(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--
``(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 an importer and the
importation is in accordance with subsection (h); or
``(B) the drug is imported by an individual for
personal use or for the use of a family member of the
individual (rather than for resale), and the
importation is in accordance with subsection (i).
``(3) Rule of construction.--This section has legal effect
only with respect to a drug that is imported or offered for
import into the United States from a registered exporter.
``(4) Definitions.--
``(A) Importer.--The term `importer' means a
pharmacist or wholesaler.
``(B) Permitted country.--
``(i) In general.--For purposes of this
section, the term `permitted country' means--
``(I) Canada;
``(II) 180 days after the date of
publication of the report under clause
(ii)--
``(aa) Australia;
``(bb) a member country of
the European Union or the
European Free Trade
Association;
``(cc) Japan; and
``(dd) New Zealand; and
``(III) any country designated as a
permitted country under clause (iii).
``(ii) Report.--
``(I) In general.--Not later than
18 months after the date of enactment
of this section, the Secretary shall
submit to Congress a report subject to
subclauses (II) and (III).
``(II) Contents of report.--The
report under subclause (I) shall--
``(aa) describe the impact
of the drug importation system
established under this section
on--
``(AA) the safety
and integrity of the
Nation's prescription
drug distribution
system;
``(BB) the
prevalence of
counterfeit,
adulterated, or
misbranded drugs in the
United States; and
``(CC) patient drug
therapy;
``(bb) describe the
potential impact of expanding
the system to allow importation
from additional countries; and
``(cc) include proposed
legislation to improve the
safety, efficiency, and
efficacy of the drug
reimportation system;
``(III) Consultation with the
federal trade commission.--The
Secretary, in consultation with the
Chairman of the Federal Trade
Commission, shall include in the report
under subclause (I)--
``(aa) an evaluation of the
extent to which this section
advances the objective of
introducing lower-priced
competition in the United
States market for prescription
drugs; and
``(bb) recommendations for
improving the operation and
effectiveness of this section
to meet that objective.
``(iii) Additional countries.--The
Secretary may designate an additional country
as a permitted country if the country meets the
requirements of section 802(b)(1)(B) as that
section relates to drugs.
``(C) Pharmacist.--The term `pharmacist' means a
person licensed by a State to practice pharmacy,
including the dispensing and selling of prescription
drugs.
``(D) Registered exporter.--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 `registration condition'
means a condition for a registration under
subsection (b) to be approved.
``(E) Qualifying drug.--For purposes of this
section, the term `qualifying drug' means a covered
prescription drug, other than any of the following:
``(i) A controlled substance, as defined in
section 102 of the Controlled Substances Act.
``(ii) A biological product, as defined in
section 351 of the Public Health Service Act.
``(iii) An infused drug, including a
peritoneal dialysis solution.
``(iv) An intravenously injected drug.
``(v) A drug that is inhaled during
surgery.
``(F) Wholesaler.--
``(i) In general.--The term `wholesaler'
means a person licensed as a wholesaler or
distributor of prescription drugs in the United
States under section 503(e)(2)(A).
``(ii) Exclusion.--The term `wholesaler'
does not include a person authorized to import
drugs under section 801(d)(1).
``(G) Other definitions.--For purposes of this
section:
``(i) The term `covered prescription drug'
means an approved drug under section 505(b)(1)
that is subject to section 503(b)(1).
``(ii) The term `exporter' means a person
who is in the business of exporting a drug to
the United States or who, pursuant to
submitting a registration under subsection (b),
seeks to be in such business.
``(b) Registration of Foreign Exporters.--
``(1) In general.--A registration condition is that the
exporter involved submits to the Secretary a registration
containing the following:
``(A) The name of the exporter and an
identification of all 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.
``(B) Such information as the Secretary determines
to be necessary to demonstrate that the exporter is in
compliance with registration conditions under
subsections (c), (d), (e), (f), and (g) (relating to
the sources of exported drugs; the monitoring of
foreign facilities and the marking of compliant
shipments; the payment of fees; being licensed as a
pharmacy (in the case of importation by individuals);
and compliance with the standards referred to in
section 801(a)).
``(C) An agreement by the exporter that the
exporter will not under subsection (a) export any drug
that is not a qualifying drug.
``(D) An agreement by the exporter that a
qualifying drug will not under subsection (a) be
exported to any person not authorized pursuant to
subsection (a)(2) to be an importer of such drug.
``(E) An agreement by the exporter that the
exporter submits to the jurisdiction of the courts of
the United States for the purpose of adjudication of
any action arising out of the activities of the
exporter under this section with the name and address
of an agent in the United States for service of
process.
``(F) An agreement by the exporter 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.
``(G) A plan describing the manner in which the
exporter will comply with the agreement under
subparagraph (F).
``(H) An agreement by the exporter to notify the
Secretary of--
``(i) any change that the exporter intends
to make regarding information provided under
subparagraph (A) or (B); and
``(ii) any change that the exporter intends
to make in the compliance plan under
subparagraph (G).
``(I) Such other provisions as the Secretary may
require to protect the public health while permitting
the importation 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 an exporter submits to the Secretary a
registration under paragraph (1), the Secretary shall
notify the exporter whether the registration is
approved or is disapproved. The Secretary shall
disapprove a registration if there is reason to believe
that the exporter is not in compliance with one or more
registration conditions, and shall notify the exporter
of such reason. In the case of a disapproved
registration, the Secretary shall subsequently notify
the exporter that the registration is approved if the
Secretary determines that the exporter 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 registered exporter, the
Secretary shall determine whether the change involved
affects the approval of the registration of the
exporter under paragraph (1), and shall inform the
exporter of the determination.
``(3) Publication of contact information for registered
exporters.--Through the Internet site of the Food and Drug
Administration, the Secretary shall make available to the
public a list of registered exporters, including contact
information for the exporters. Such list shall be posted on
such site in a manner that will assist the public in readily obtaining
the list. Promptly after the approval of a registration submitted under
paragraph (1), the Secretary shall update the site accordingly,
including, if requested by the exporter, providing a link to an
Internet site of the exporter.
``(4) Suspension and termination.--
``(A) Suspension.--With respect to the
effectiveness of a registration submitted under
paragraph (1) by an exporter:
``(i) Subject to clause (ii), if the
Secretary determines, after notice and
opportunity for a hearing, that the exporter
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 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)(E), 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 exporter involved 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 exporter 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 an exporter if the
Secretary determines that the exporter has engaged in a
pattern or practice of violating one or more
registration conditions, or if on one or more occasions
the Secretary has under subparagraph (A)(ii) suspended
the registration of the exporter. The Secretary may
make the termination permanent, or for a fixed period
of not less than one year. During the period in which
the registration is terminated, any registration
submitted under paragraph (1) by the exporter or a
person who is a partner in the export enterprise or a
principal officer in such enterprise, and any
registration prepared with the assistance of the
exporter or such a person, has no legal effect under
this section.
``(c) Sources of Exported Qualifying Drugs.--A registration
condition is that the exporter involved agrees that a qualifying drug
will under subsection (a) be exported to the United States only if, as
verified by the Secretary under subsection (d)(3)(A), there is
compliance with the following:
``(1) The drug was manufactured in an establishment
required to register under subsection (h) or (i) of section
510.
``(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 and for distribution
in one or more foreign countries specified in paragraph (4)
(without regard to whether in addition the drug was
manufactured for distribution in foreign countries not so
specified).
``(3) The exporter obtained the drug--
``(A) directly from the establishment; or
``(B) directly from an entity that, by contract
with the exporter--
``(i) provides to the exporter 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 any of the States; and
``(iv) has ensured, through such
contractual relationships as may be necessary,
that the Secretary has the same authorities
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 exporter will
export the drug is a permitted country.
``(5) 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.
``(d) Monitoring of Facilities; Marking of Shipments.--
``(1) Monitoring 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 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, on a day-to-day
basis, to records of the exporter that relate
to the export of such drugs, including
financial records;
``(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, with the permission of the
exporter, has assigned one or more employees of the
Secretary to carry out the functions described in this
subsection for the Secretary--
``(i) on a day-to-day basis on the premises
of places of businesses referred to in
subparagraph (A)(i), and such an assignment
remains in effect on a continuous basis; or
``(ii) on a periodic basis on the premises
of places of businesses referred to in
subparagraph (A)(i), if the Secretary
determines that the exporter has a sufficient
history of compliance with the registration
conditions.
``(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.--Duties of the Secretary under
paragraphs (1) and (2) regarding an exporter include the
following:
``(A) Verifying the chain of custody of each
qualifying drug from the manufacturer of the drug to
the exporter.
``(B) If one or more qualifying drugs are exported
to individuals under subsection (a)(2)(B), randomly
selecting samples of such exports for the purpose of
determining whether the drugs are being imported by the
individuals in accordance with the conditions under
subsection (i). Such sampling 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).
``(e) Fees.--
``(1) In general.--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 on which the exporter first submits a registration
under subsection (b).
``(2) Amount of fee.--
``(A) Aggregate total of fees.--The Secretary shall
ensure that the aggregate total of fees collected under
paragraph (1) for a fiscal year from all exporters is
sufficient to pay the costs of administering this
section for a fiscal year, including monitoring foreign
facilities under subsection (d); developing,
implementing, and maintaining under such subsection a
system to mark shipments to indicate compliance with
all registration conditions; and conducting under such
subsection inspections within the United States to
determine compliance with conditions under subsections
(h) and (i); except that, during the 12-month period
beginning on the date of the promulgation of the
interim final rule for implementing this section, the
Secretary may collect a lesser aggregate total of fees,
taking into account the number of registered exporters
and the capacity of such exporters as a group to pay
such administrative costs.
``(B) Individual exporter fee.--Subject to the
exception described in subparagraph (A), a fee under
paragraph (1) for an exporter shall be an amount that
is a reasonable estimate by the Secretary of the
semiannual pro rata share of the exporter of the costs
referred to in subparagraph (A). Such pro rata share
shall take into account the number of employees that
the Secretary has under subsection (d)(1)(B) assigned
to the exporter.
``(3) Use of fees.--Subject to appropriations Acts, fees
collected by the Secretary under paragraph (1) are available to
the Secretary for paying the costs referred to in paragraph
(2)(A).
``(f) Licensing as a Pharmacy.--A registration condition is that
the exporter involved agrees that a qualifying drug will under
subsection (a)(2)(B) be exported to an individual only if the Secretary
has determined that--
``(1) (A) the exporter is authorized under foreign law to
dispense drugs that are only safe for use under the supervision
of a practitioner authorized by law to administer such drugs;
and
``(B) the foreign country that issued such authorization
for the exporter did so under a regulatory program that, with
respect to the training of persons who dispense such drugs but
do not administer the drugs, protects the public health in a
manner comparable to programs of the States that regulate
pharmacists; or
``(2) in any case in which the exporter does not meet the
condition described in paragraph (1), the exporter employs a
sufficient number of individuals that are licensed as a
pharmacist under the law of one of the States, and the exporter
assigns to such pharmacist responsibility for dispensing
qualifying drugs under subsection (a)(2)(B).
``(g) Compliance With Section 801(a).--
``(1) In general.--A registration condition is that each
qualifying drug exported under subsection (a) by the exporter
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) and (3) and subsection (j).
``(2) Approval status.--
``(A) Importation.--Subject to subparagraphs (C)
and (D), a drug may, in accordance with the other
subsections of this section, be imported into the
United States if the following criteria are met:
``(i) The Secretary has with respect to the
drug verified compliance with subsection (c),
including verifying that the drug is approved
for commercial distribution in a foreign
country specified in paragraph (4) of such
subsection, and that the establishment that
manufactured the drug also manufactures the
drug for distribution in the United States
(referred to in this paragraph as a `U.S. label
drug').
``(ii) As compared to the U.S. label drug,
the drug has the same active ingredient or
ingredients, route of administration, dosage
form, and strength, according to information
provided by the labeling of the drug.
``(B) Petition by manufacturer; general
provisions.--
``(i) In general.--A person who
manufactures a drug imported under subsection
(a) may in accordance with this paragraph file
with the Secretary a petition that requests the
Secretary to order that importation of the drug
under such subsection cease. Such a petition
may be accepted for filing only if the petition
claims that the drug is changed from the U.S.
label drug and the change would require the
submission of a supplemental application if
made to the U.S. label drug, and only if the
petition claims that--
``(I) the change could, under
section 314.70 of title 21, Code of
Federal Regulations, be made before the
approval of such application; or
``(II) (aa) the change could not,
under such section 314.70, be made
before the approval of such
application; and
``(bb) the change raises a
bioequivalence consideration described
in subparagraph (E)(i).
``(ii) Certifications.--The Secretary may
not accept a petition under clause (i) for
filing unless the chief executive officer, the
chief legal counsel, and the chief medical
officer of the manufacturer involved each
certifies in the petition that the information
provided in the petition is complete and true.
``(iii) Certain claims.--With respect to a
drug being imported under subsection (a) for
which a claim is made in a petition under
clause (i) (referred to in this paragraph as a
`petition drug'), the Secretary may not accept
the petition for filing under clause (i) if the
Secretary determines that any of the changes
from the U.S. label drug described in the
petition is--
``(I) a variation provided for in
the approved application under section
505(b)(1) for the U.S. label drug; or
``(II) a change for which, under
section 314.70 of title 21, Code of
Federal Regulations, a supplemental
application would not be required.
``(iv) Fee.--The Secretary may not accept a
petition under clause (i) for filing unless the
person submitting the petition pays 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), except that the
fee may not be required for a petition that,
under clause (i)(II)(bb), makes a
nonequivalence claim (as defined in
subparagraph (E)(i)). Subject to appropriations
Acts, fees collected by the Secretary under the
preceding sentence are available to the
Secretary for paying the costs referred to in
subsection (e)(2)(A).
``(v) Review by secretary.--The Secretary
shall grant or deny a petition under clause (i)
not later than 180 days after the date on which
the petition is filed.
``(C) Petition; drug changes not requiring prior
approval.--In the case of a petition under subparagraph
(B)(i)(I):
``(i) During the period in which the
petition is being reviewed by the Secretary,
the authority under subsection (a) to import
the petition drug involved continues in effect,
subject to clause (ii).
``(ii) Such authority is, during such
period, subject to the condition that--
``(I) any importer importing the
petition drug under subsection
(a)(2)(A) inform individuals to whom
the importer sells or dispenses the
drug that the manufacturer is making a
claim that the drug is different than
the U.S. label drug; and
``(II) the registered exporter
involved notify any individuals
importing the petition drug from the
exporter under subsection (a)(2)(B)
that the manufacturer is making such a
claim.
``(iii) If the Secretary determines that
the supplemental application referred to in
subparagraph (C)(i)(I) regarding the U.S. label
drug would not be approved, the Secretary shall
grant the petition and order that importation
of the petition drug under subsection (a) cease.
``(D) Petition; drug changes requiring prior
approval.--
``(i) Bioequivalence considerations.--For
purposes of subparagraph (B)(i)(II)(bb), a
claim that a change in a petition drug raises a
bioequivalence consideration is a claim that--
``(I) the change creates the
possibility that such drug is not
bioequivalent to the U.S. label drug
(in this paragraph referred to as a
`possible- nonequivalence claim'); or
``(II) the petition drug is not
bioequivalent to the U.S. label drug
(referred to in this paragraph as a
`nonequivalence claim').
``(ii) Information regarding foreign
government.--The Secretary may not accept a
petition for filing under subparagraph (B)(i)
that makes a possible-nonequivalence claim or a
nonequivalence claim unless the following
conditions are met with respect to the foreign
country that approved the petition drug for
commercial distribution:
``(I) The person filing the
petition submits with the petition
information demonstrating that the
person has notified the government of
the foreign country in writing that the
person is submitting to the Secretary a
claim under clause (i), which notice
describes the claim.
``(II) Such person submits with the
petition the information the person
submitted to the government of the
foreign country for purposes of
obtaining approval for commercial
distribution of the petition drug in
the country.
``(iii) Possible-nonequivalence claim.--In
the case of a petition under subparagraph
(C)(i) that makes a possible-nonequivalence
claim:
``(I) Clauses (i) and (ii) of
subparagraph (C) apply to the same
extent and in the same manner as such
clauses apply to a petition under
subparagraph (B)(i) that makes a claim
described in subclause (I) of such
subparagraph.
``(II) If the Secretary determines
that the petition drug is not
bioequivalent to the U.S. label drug,
the Secretary shall grant the petition
and order that importation of the
petition drug under subsection (a)
cease.
``(iv) Nonequivalence claim.--In the case
of a petition under subparagraph (B)(i) that
makes a nonequivalence claim:
``(I) Promptly after the petition
is filed, the Secretary shall order
that the importation of the petition
drug involved cease during the period
in which the petition is under review
by the Secretary.
``(II) If the Secretary determines
that the petition drug is not
bioequivalent to the U.S. label drug,
the Secretary shall grant the petition
and provide that the order under
subclause (I) remains in effect.
``(v) Drugs approved on or after january 1,
2004.--In the case of a petition under
subparagraph (C)(i) that makes a possible-
nonequivalence claim or a nonequivalence claim,
if the petition drug involved for commercial
distribution was approved by the foreign
government on or after January 1, 2004, or if
the U.S. label drug was approved by the
Secretary on or after such date:
``(I) The Secretary may not accept
the petition for filing unless the
person submitting the petition submits
with the petition information
demonstrating that--
``(aa) the difference
between the petition drug and
the U.S. label drug is due to a
difference between the legal
requirements for approval of
the drug in the foreign country
and for approval by the
Secretary; or
``(bb) the person has
submitted a supplemental
application to the government
of the foreign country, or to
the Secretary, that will, if approved, remove the difference between
the petition drug and the U.S. label drug.
``(II) If under clause (iii)(II) or
(iv)(II) the Secretary has ordered that
importation of the petition drug under
subsection (a) cease, the Secretary
shall rescind the order promptly after
the approval of a supplemental
application referred to in subclause
(I)(bb) of this clause.
``(vi) False statements.--The Secretary
shall rescind an order under clause (iii)(II)
or (iv)(II) promptly after determining that a
materially false, fictitious, or fraudulent
statement or representation in the petition
involved was a material factor in the decision
of the Secretary to grant the petition.
``(3) Labeling.--
``(A) Importation by importer.--In the case of a
qualifying drug that under subsection (a)(2)(A) is
imported or offered for import with respect to an
importer, such drug shall be considered to be in
compliance with section 502 if the drug bears a copy of
the labeling approved for the drug under section 505,
without regard to whether the copy bears the trademark
involved. The Secretary shall provide such copy to the
registered exporter involved, upon request of the
exporter.
``(B) Importation by individual.--In the case of a
qualifying drug that under subsection (a)(2)(B) is
imported or offered for import with respect 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.
``(h) Importers; Conditions for Importation.--
``(1) In general.--For purposes of subsection (a)(2)(A),
the importation of a qualifying drug by an importer is in
accordance with this subsection if the following conditions are
met:
``(A) The importer, or a business organization of
which the importer is a part, takes delivery directly
from the mail, from a common carrier, or from a vehicle
or aircraft owned by the importer or such business
organization.
``(B) From the port of entry for the drug to the
delivery of the drug to the importer or such business
organization--
``(i) all transport of the drug was by one
or more of the modes of transport specified in
subparagraph (A); and
``(ii) personnel of the transporting
entities involved had exclusive custody of the
drug, without the custodial involvement of any
other type of entity, including a person in the
business of the wholesale distribution of
drugs.
``(2) Rule of construction.--Paragraph (1) may not be
construed as prohibiting a person in the business of the
wholesale distribution of drugs, or any other entity that is
not an importer, or a business organization referred to in
paragraph (1)(A), from negotiating the purchase price of
qualifying drugs from a registered exporter or from otherwise
being involved in the process of purchasing such drugs from
such exporters, if such person or other entity does not at any
point have custody of such drugs.
``(i) Personal Use; Conditions for Importation.--
``(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--
``(i) 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, is
authorized to administer prescription
drugs; and
``(ii) a statement that provides
information sufficient for the Secretary to
determine whether the prescription meets the
requirement of clause (i), including with
respect to the licensure of the practitioner
who issued the prescription.
``(B) With respect to the foreign country from
which the registered exporter involved dispensed the
drug, the drug is accompanied by a copy of the
documentation that was required under the law or
regulations of such country 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 the foreign
country involved, have been filled; and
``(ii) to prevent a duplicative filling by
another pharmacist.
``(D) The quantity of the drug does not exceed a
90-day supply.
``(E) 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 personal entry.--A registration
condition is that the exporter involved agrees that, in
providing a qualifying drug to an individual under subsection
(a)(2)(B) in circumstances in which the drug will accompany the
individual as the individual enters the United States, the
exporter will notify the individual that the drug is authorized
to be imported under such subsection only if the shipping
container for the drug is intact and bears the marking affixed
under subsection (d)(2).
``(3) Presumption.--In the case of importation under this
subsection, for purposes of judicial and administrative
procedure, there is a presumption that a drug proposed for
export under subsection (a) is an approved drug under section
505(b)(1) if the criteria described in subsection (g)(A)(i) and
(ii) are met.
``(j) Standards for Refusing Admission.--A qualifying drug exported
under subsection (a) from a registered exporter may be refused
admission into the United States only if one or more of the following
applies:
``(1) The shipping container for such drug does not bear
the markings required subsection (d)(2).
``(2) Such markings appear to be counterfeit.
``(3) The shipping container or markings appear to have
been tampered with.
``(4) The shipping container appears damaged in a way that
may affect the strength, quality, or purity of the drug.
``(5) After the shipment leaves the custody of the
registered exporter, the Secretary becomes aware that--
``(A) the drug may be counterfeit;
``(B) the drug may have been prepared, packed, or
held under insanitary conditions whereby it may have
been contaminated with filth; or
``(C) 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.
``(6) The Secretary has obtained an injunction under
section 302 that prohibits the distribution of the drug in
interstate commerce.
``(7) The Secretary has under section 505(e) withdrawn
approval of the drug.
``(8) The manufacturer of the drug has instituted a recall
of the drug.
``(k) Charitable Contributions.--Notwithstanding any other
provision of this section, this section does not authorize the
importation into the United States of a qualifying drug donated or
otherwise supplied for free or at nominal cost 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.''
(b) Prohibited Acts.--The Federal Food, Drug, and Cosmetic Act, as
amended by section 1121(b) of Public Law 108-173 (117 Stat. 2469), is
amended--
(1) in section 301 (21 U.S.C. 331), by amending paragraph
(aa) to read as follows:
``(aa)(1) The sale or trade by an importer, or by a business
organization of which the importer is a part, of a qualifying drug that
under section 804(a)(2)(A) was imported by the importer, other than--
``(A) a sale at retail made pursuant to dispensing the drug
to a customer of the importer or organization; or
``(B) a sale or trade of the drug to the registered
exporter from which the importer imported the drug.
``(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 knowing making of a materially false, fictitious, or
fraudulent statement or representation in a petition under clause (i)
of section 804(g)(2)(C). Such a petition that is not accepted for
filing by reason of clause (iii) of such section shall be considered to
contain such a statement or representation.''; and
(2) in section 303(a) (21 U.S.C. 333(a)), by amending
paragraph (6) to read as follows:
``(6) Notwithstanding subsection (a), any person who violates
section 301(aa)(3) shall be imprisoned not more than 10 years, or fined
in accordance with title 18, United States Code, or both.''.
(c) Civil Penalty.--
(1) Technical amendments.--
(A) In general.--Section 303 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333) is amended in
the last subsection by striking the subsection
designation and all that follows through ``Except as
provided'' in paragraph (1)(A) and inserting the
following:
``(f)(1)(A) Except as provided''.
(B) Certain acts.--The amendments made by the
following provisions of law are deemed to have been
made to subsection (f) of section 303 of the Federal
Food, Drug, and Cosmetic Act, as amended by
subparagraph (A) of this paragraph:
(i) section 407 of the Food Quality
Protection Act of 1996 (110 Stat. 1535); and
(ii) section 201(c) of the Medical Device
User Fee and Modernization Act of 2002 (116
Stat. 1609).
(2) Civil penalties.--
(A) In general.--Section 303 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333), as amended by
paragraph (1) of this subsection, is amended in
subsection (f)--
(i) by redesignating paragraphs (3) through
(5) as paragraphs (4) through (6),
respectively; and
(ii) by inserting after paragraph (2) the
following paragraph:
``(3) Any person who knowingly violates section 301(aa)(3)
and whose statement or representation described in such section
was a material factor in the decision of the Secretary to issue
an order under clause (iii)(II) or (iv)(II) of section
804(g)(2)(E) shall be liable to the United States for a civil
penalty in an amount not to exceed a reasonable estimate of the
gross revenue that, pursuant to section 804, would have been
collected by the register exporter involved for sales of the
qualifying drug involved to importers and individuals in the
United States during the period for which the order was in
effect.''.
(B) Conforming amendments.--Section 303(f) of the
Federal Food, Drug, and Cosmetic Act, as amended by
subparagraph (A), is amended--
(i) in paragraph 5 (as redesignated) by
striking ``paragraph (3)(A)'' and inserting
``paragraph (4)(A)''; and
(ii) in paragraph 6 (as redesignated) by
striking ``paragraph (4)'' each place it
appears and inserting ``paragraph (5)''.
(d) Implementation.--
(1) Rulemaking.--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 final 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, and
the rule may be made effective immediately upon promulgation of
the rule. Not later than one year after the date on which the
interim final 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 final rule, to the extent that such provisions are
not modified.
(2) Personal importation from canada.--Until the expiration
of the 45-day period beginning on the date on which the interim
final 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 each of the following
conditions:
(A) The drug is not--
(i) a controlled substance, as defined in
section 102 of the Controlled Substances Act;
(ii) a biological product, as defined in
section 351 of the Public Health Service Act;
(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, 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.
(e) Amendment of Certain Provision.--Section 801(g) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended--
(1) in the matter preceding clause (i), by striking ``With
respect to'' and all that follows through ``may not send'' and
inserting the following: ``With respect to a qualifying drug
that is imported or offered for import in the United States by
an individual pursuant to section 804(a)(2)(B), the Secretary
may not send'';
(2) by redesignating clause (iv) as clause (v);
(3) in clause (iii), by striking ``or'' at the end; and
(4) by inserting after clause (iii) the following:
``(iv) importation is not in accordance with
section 804; or''.
SEC. 4. 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 subsections:
``(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 may 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 30-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) The importation complies with 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 may 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 a 10-day
supply.
``(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) The importation complies with 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 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. 5. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO UNITED
STATES.
(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act, as amended by section 3 of this Act, is amended by adding
at the end the following section:
``SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.
``(a) In General.--A shipment of drugs that is imported or offered
for import into the United States shall be refused admission 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(j).
``(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. 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.
``(g) Administration.--This section may be not be construed as
transferring to the Secretary responsibility for carrying out this
section.''.
(b) Procedures.--Procedures for carrying out section 805 of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of
this subsection, shall be established not later than 30 days after the
date of the enactment of this Act.
SEC. 6. 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 subsection
(a) or (d) of section 801 or section 804, 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. 7. 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''
and inserting ``, other than a registered exporter
under section 804,'';
(B) by striking ``to an authorized distributor of
record or''; and
(C) by striking subparagraph (B) and inserting the
following subparagraphs:
``(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 who is engaged in the business of the wholesale distribution of
the drug from providing the statement described in subparagraph (A) to
the person who 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 an importer who intends to
sell the drug at retail if the Secretary determines that the
alternative requirements will identify such chain of custody or the
identity of the drug with greater certainty than 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 paragraphs:
``(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. 8. 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.
SEC. 9. ENFORCEMENT THROUGH DENIAL OF DEDUCTION FOR CERTAIN ADVERTISING
EXPENSES.
(a) In General.--Part IX of subchapter B of chapter 1 of the
Internal Revenue Code of 1986 (relating to items not deductible) is
amended by adding at the end the following new section:
``SEC. 280L. ADVERTISING EXPENDITURES OF TAXPAYERS WHO DISCRIMINATE
AGAINST FOREIGN SELLERS OF PRESCRIPTION DRUGS TO DOMESTIC
CONSUMERS.
``(a) In General.--No deduction otherwise allowable under this
chapter shall be allowed for any amount paid or incurred for
advertising for the taxable year by any taxpayer unless the taxpayer
certifies that the taxpayer has not taken any action, directly or
indirectly, during such taxable year to prevent the authorized
importation of a qualifying drug into the United States from a
registered exporter to a pharmacy or individual pursuant to section
804(a) of the Federal Food, Drug, and Cosmetic Act or has otherwise
conditioned the terms by which a qualifying drug is imported into the
United States from a registered exporter under such section. Such
certification shall be made in such manner as the Secretary determines
and shall be accompanied by such fees as the Secretary determines
necessary to cover the costs of confirming such certification.
``(b) Advertising.--For purposes of this section, the term
`advertising' includes direct to consumer advertising and any activity
designed to promote the use of a prescription drug directed to
providers or others who may make decisions about the use of
prescription drugs (other than the provision of free samples).''.
(b) Clerical Amendment.--The table of sections for part IX of
subchapter B of chapter 1 of such Code is amended by adding at the end
thereof the following new item:
``Sec. 280L. Advertising expenditures of taxpayers who discriminate
against foreign sellers of prescription
drugs to domestic consumers.''.
(c) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after the date of the enactment of
this Act.
SEC. 10. COMPLIANCE THROUGH ALLOWANCE OF RESEARCH AND DEVELOPMENT TAX
CREDIT.
(a) In General.--Section 41 of the Internal Revenue Code of 1986
(relating to credit for increasing research activities) is amended by
adding at the end the following new subsection:
``(i) Increase in Credit for Certain Taxpayers.--The amount of the
credit otherwise determined under this section for any taxable year
shall be increased by 20 percent if the taxpayer certifies that the
taxpayer has not taken any action, directly or indirectly, during such
taxable year to prevent the authorized importation of a qualifying drug
into the United States from a registered exporter to a pharmacy or
individual pursuant to section 804(a) of the Federal Food, Drug, and
Cosmetic Act or has otherwise conditioned the terms by which a
qualifying drug is imported into the United States from a registered
exporter under such section. Such certification shall be made in such
manner as the Secretary determines and shall be accompanied by such
fees as the Secretary determines necessary to cover the costs of
confirming such certification.''.
(b) Effective Date.--The amendment made by this section shall apply
to taxable years beginning after the date of the enactment of this Act.
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