Safe Importation of Medical Products and Other Rx Therapies Act of 2004 or Safe IMPORT Act of 2004 - Amends the Federal Food, Drug, and Cosmetic Act to allow individuals to import Food and Drug Administration (FDA)-approved prescription drugs from Canada for personal use.
Permits the importation of prescription drugs from Canada by registered Internet pharmacies, pharmacies, or wholesalers in one year under specified conditions, including meeting proper labeling on all dispensed drugs to indicate that the drug has been imported. Allows the Secretary of Health and Human Services to designate additional countries from which to allow importation in three years.
Requires the Secretary to give high priority to improving the information management systems of the FDA to improve the detection of intentionally adulterated prescription drugs.
Sets forth Internet pharmacy licensing requirements and procedures. Makes providers of interactive computer and advertising services liable for violations under this Act if such providers accept advertising: (1) for a prescription drug from an unlicensed Internet pharmacy; or (2) stating that an individual does not need a prescription to obtain a prescription drug.
Requires the Secretary to promulgate regulations requiring designated payment systems, including credit card companies, to prevent sales by unlicensed Internet pharmacies.
Allows the FDA to detain or temporarily hold prescription drug shipments based on credible information that a drug presents a risk to the public health.
Allows the Secretary to: (1) suspend or debar importation of a particular drug or dosage that poses such a risk or by a particular importer who violates Act requirements; (2) require owners of prescription drugs that have been refused admission into the United States to indicate that information on the drug containers; and (3) authorize other Federal and State officials to conduct inspections to enforce compliance with this Act
Deems to be misbranded a prescription drug offered for importation that has previously been refused admission, unless the person reoffering the drug affirmatively establishes that it complies with applicable requirements.
Sets forth anti-counterfeiting provisions.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2493 Introduced in Senate (IS)]
108th CONGRESS
2d Session
S. 2493
To amend the Federal Food, Drug, and Cosmetic Act to protect the public
health from the unsafe importation of prescription drugs and from
counterfeit prescription drugs, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 2, 2004
Mr. Gregg (for himself, Mr. Smith, Ms. Collins, Mr. Coleman, Mr.
Sessions, Mr. Lott, and Mr. Enzi) 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 to protect the public
health from the unsafe importation of prescription drugs and from
counterfeit 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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Safe Importation
of Medical Products and Other Rx Therapies Act of 2004'' or the ``Safe
IMPORT Act of 2004''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Importation.
Sec. 3. Protection against adulterated prescription drugs.
Sec. 4. Internet pharmacies.
Sec. 5. Administrative detention and temporary hold.
Sec. 6. Suspension.
Sec. 7. Debarment for repeated or serious prescription drug importation
violations.
Sec. 8. Registration of prescription drug importation facilities.
Sec. 9. Maintenance and inspection of records for prescription drugs.
Sec. 10. Advance notice of imported prescription drug shipments.
Sec. 11. Authority to mark prescription drugs refused admission into
the United States.
Sec. 12. Prohibition of port shopping.
Sec. 13. Authority to commission other Federal and State officials to
conduct inspections.
Sec. 14. User fees relating to prescription drug importation.
Sec. 15. Anticounterfeiting provisions.
Sec. 16. Conforming amendments.
SEC. 2. IMPORTATION.
(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.) is amended--
(1) by inserting after the chapter heading the following:
``SUBCHAPTER A--GENERAL PROVISIONS''; and
(2) by adding at the end the following:
``SUBCHAPTER B--IMPORTATION OF PRESCRIPTION DRUGS
``SEC. 811. DEFINITIONS.
``In this subchapter:
``(1) Drug importation facility.--The term `drug
importation facility' means a person, other than an individual
importing a prescription drug under section 812, located
outside the United States (other than a transporter) that
engages in the distribution or dispensing of a prescription
drug that is imported or offered for importation into the
United States.
``(2) Internet pharmacy.--The term `Internet pharmacy'
means a person, other than an individual importing a
prescription drug under section 812, that offers to dispense in
the United States a prescription drug through an Internet
website in interstate commerce, regardless of whether the
physical location of the principal place of business of the
Internet pharmacy is in the United States or in another
country.
``(3) Pharmacy.--The term `pharmacy' means a person, other
than an individual importing a prescription drug under section
812, licensed by a State to dispense prescription drugs or to
provide pharmaceutical care.
``(4) Permitted country.--
``(A) In general.--The term `permitted country'
means a country that--
``(i) was a member of the European Union as
of December 31, 2003; and
``(ii) is designated by the Secretary as a
permitted country under subparagraph (B).
``(B) Report.--Three years after the date of
enactment of this subchapter, the Secretary shall
submit to the Committee on Health, Education, Labor,
and Pensions of the Senate and to the Committee on
Energy and Commerce of the House of Representatives a
report that includes--
``(i) a list of countries under
subparagraph (A)(i) designated by the Secretary
from which a prescription drug shall be
permitted to be imported into the United States
under this subchapter, and the basis for the
Secretary's determination that the importation
of a prescription drug from such countries
would not present an increased risk to the
public health;
``(ii) a list of countries under
subparagraph (A)(i) from which a prescription
drug shall not be permitted to be imported into
the United States under this subchapter, and
the basis for Secretary's determination that
the importation of a prescription drug from
such countries would present an increased risk
to the public health;
``(iii) for countries identified in clause
(i), any additional measures that could be
taken to ensure that there will be no increased
risk to the public health; and
``(iv) for countries identified in clause
(ii), any additional measures that could be
taken to a avoid, reduce, or mitigate such
increased risk to the public health.
``(C) Determination.--The Secretary may determine
whether to designate a permitted country at any time
after submission of the report under subparagraph (B).
``(5) Prescription drug.--
``(A) In general.--The term `prescription drug'
means a drug described in section 503(b) that is
approved by the Secretary under section 505.
``(B) Exclusions.--The term `prescription drug'
does not include--
``(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;
``(vi) a parenteral drug;
``(vii) a drug manufactured through 1 or
more biotechnology processes, including--
``(I) a therapeutic DNA plasmid
product;
``(II) a therapeutic synthetic
peptide product of not more than 40
amino acids;
``(III) a monoclonal antibody
product for in vivo use; and
``(IV) a therapeutic recombinant
DNA-derived product;
``(viii) a drug required to be refrigerated
at any time during manufacturing, packing,
processing, or holding; or
``(ix) a photoreactive drug.
``(6) Treating provider.--The term `treating provider'
means a licensed health care provider that--
``(A)(i) performs a documented patient evaluation
(including a patient history and physical examination)
of an individual to establish the diagnosis for which a
prescription drug is prescribed;
``(ii) discusses with the individual the treatment
options of the individual and the risks and benefits of
treatment; and
``(iii) maintains contemporaneous medical records
concerning the individual; or
``(B) provides care to an individual as part of an
on-call or cross-coverage arrangement with a health
care provider described in subparagraph (A).
``(7) Wholesaler.--
``(A) In general.--The term `wholesaler' means a
person licensed as a wholesaler or distributor of
prescription drugs in the United States as described in
section 503(e)(2).
``(B) Exclusion.--The term `wholesaler' does not
include--
``(i) a person authorized to import drugs
under section 801(d)(1); or
``(ii) an individual importing a
prescription drug under section 812.
``SEC. 812. PERSONAL IMPORTATION.
``(a) In General.--An individual may import a prescription drug
from Canada or a permitted country into the United States for personal
use (not for resale), subject to subsections (b) and (c).
``(b) Importation.--An individual may import a prescription drug
if--
``(1) the prescription drug is purchased from a licensed
pharmacy in Canada or a licensed pharmacy in a permitted
country and dispensed in compliance with the applicable laws of
Canada or the permitted country regarding the practice of
pharmacy;
``(2) the prescription drug is imported for personal use
(not for resale) by the individual;
``(3) the prescription drug is imported from Canada or a
permitted country into the United States;
``(4) the prescription drug is imported by the individual
on the person of the individual;
``(5) the quantity of the prescription drug imported does
not exceed a 90-day supply during any 90-day period; and
``(6) the prescription drug is accompanied by--
``(A) a copy of a prescription valid in a State and
cosigned by a prescribing physician in Canada or the
permitted country; or
``(B) if the prescription drug is available in
Canada or the permitted country without a prescription,
a copy of the valid prescription signed by a pharmacist
licensed in Canada or the permitted country.
``(c) Compassionate Use.--The Secretary may permit an individual to
import an up to a 90-day supply of a drug that is not approved by the
Secretary under section 505 if the importation is for continuation of
personal use by the individual for treatment, begun in a foreign
country, of a serious medical condition.
``SEC. 813. PHARMACY AND WHOLESALER IMPORTATION OF PRESCRIPTION DRUGS.
``(a) In General.--
``(1) Importation.--A drug importation facility, pharmacy,
Internet pharmacy, or wholesaler may import a prescription drug
from Canada or a permitted country into the United States for
dispensing in the United States in accordance with this
subchapter.
``(2) Limitation to certain ports.--The Secretary may limit
the ports of entry in the United States through which a
prescription drug may be imported under this section to a
reasonable number of ports designated by the Secretary.
``(b) Requirements.--Each prescription drug imported under this
subchapter shall--
``(1) be approved under section 505;
``(2) comply with sections 501 and 502;
``(3) be in a container that bears a label stating, in
prominent and conspicuous type--
``(A) the lot number of the prescription drug;
``(B) the name, address and phone number of the
drug importation facility;
``(C) the following: `This drug has been imported
from _____.', with the name of the permitted country
from which the prescription drug is imported in the
blank space; and
``(D) a unique identifier code provided by the
Secretary that modifies the national drug code of the
prescription drug to indicate that the drug has been
imported; and
``(4) comply with any other applicable requirement of this
Act.
``(c) Approved Labeling.--
``(1) In general.--A drug importation facility that offers
for importation a prescription drug under this subchapter shall
submit to the Secretary an application for approval that
demonstrates that the labeling of the prescription drug to be
imported into the United States complies with the requirements
of sections 502 and 503.
``(2) Procedure.--Not later than 60 days after receipt of a
completed application under paragraph (1), the Secretary
shall--
``(A) approve or deny the application consistent
with the requirements of sections 502 and 503; and
``(B) notify the applicant of the decision of the
Secretary and, if the application is denied, the reason
for the denial.
``(3) Lists.--
``(A) Applications.--The Secretary shall maintain
an updated list of applications pending, applications
approved, and applications denied under this
subsection.
``(B) Ports.--The Secretary shall maintain an
updated list of ports through which a prescription drug
may be imported under this section and make the list
available to the public on an Internet website.
``(d) Prohibition of Importation of a Prescription Drug That Enters
Other Countries.--
``(1) In general.--A drug importation facility, pharmacy,
Internet pharmacy, or wholesaler shall not import a
prescription drug if, during any period in which the
prescription drug was not in the control of the manufacturer,
the prescription drug entered a country other than--
``(A) Canada; or
``(B) subject to paragraph (2), a country that was
a member of the European Union as of December 31, 2003.
``(2) Limitation.--The Secretary may exclude 1 or more of
the countries under subparagraph (B) of paragraph (1) from the
application of that subparagraph if the Secretary determines
that allowing a prescription drug to be imported into the
United States after having entered that country outside control
of a manufacturer would present a risk to the public health.
``(e) Prohibition of Commingling.--
``(1) In general.--A drug importation facility, pharmacy,
Internet pharmacy, or wholesaler shall not commingle a
prescription drug imported into the United States under this
subchapter with a prescription drug that is not imported from
Canada or a permitted country.
``(2) Label.--A pharmacy or Internet pharmacy that
dispenses a prescription drug imported from Canada or a
permitted country shall affix on each dispensed container of
the prescription drug the label required under subsection
(b)(3) unless such a label is already affixed to the container.
``(f) Drug Recalls.--On receipt of notification from the
manufacturer of a prescription drug imported from Canada or a permitted
country under this section that the prescription drug has been recalled
or withdrawn from the market in Canada or a permitted country, a drug
importation facility shall promptly provide the Secretary and any
person to whom the prescription drug was distributed a notice that the
drug has been recalled or withdrawn from the market and that includes--
``(1) information (including the lot number) that
identifies the prescription drug; and
``(2) a statement of the reason for the recall or
withdrawal.
``(g) Charitable Contributions.--Notwithstanding any other
provision of this section, section 801(d)(1) continues to apply to a
prescription drug that is donated or otherwise supplied at no charge or
a nominal charge by the manufacturer of the prescription drug to a
charitable or humanitarian organization (including the United Nations
and affiliates) or to a government of a foreign country.
``(h) Jurisdiction.--The district courts of the United States shall
have jurisdiction in an action brought by the United States against a
person importing or offering for importation a prescription drug in
violation of the requirements of this section.
``(i) Effect of Section.--Nothing in this section limits the
authority of the Secretary relating to the importation of prescription
drugs (including the interdiction of prescription drugs that are
unapproved, adulterated, or misbranded), other than with respect to
section 801(d)(1) as provided in subsection (g).''.
(b) Regulations.--
(1) Personal importation.--
(A) In general.--The Secretary of Health and Human
Services may promulgate regulations to carry out
section 812 of the Federal Food, Drug, and Cosmetic Act
(as added by this section).
(B) Effective date.--Section 812 of the Federal
Food, Drug, and Cosmetic Act shall take effect on the
date of enactment of this Act, without regard to
whether the Secretary of Health and Human Services has
promulgated regulations under paragraph (1).
(2) Pharmacy and wholesaler importation of prescription
drugs.--
(A) In general.--The Secretary of Health and Human
Services shall promulgate interim final regulations to
carry out section 813 of the Federal Food, Drug, and
Cosmetic Act (as added by this section).
(B) Effective date.--Section 813 of the Federal
Food, Drug, and Cosmetic Act shall take effect on the
date that is 1 year after the date of enactment of this
Act, without regard to whether the Secretary of Health
and Human Services has promulgated regulations under
paragraph (1).
(c) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(hh) Dispensing or offering to dispense a prescription drug
imported into the United States in violation of the requirements of
section 813.''.
SEC. 3. PROTECTION AGAINST ADULTERATED PRESCRIPTION DRUGS.
Section 801(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381(h)) is amended--
(1) in paragraph (2)--
(A) by inserting ``and prescription drugs'' after
``related to foods'';
(B) by inserting ``and of prescription drugs''
after ``adulteration of food,''; and
(C) by inserting ``and prescription drugs'' after
``importation of food''; and
(2) in paragraph (3), by inserting ``and for ensuring the
safety of imported prescription drugs'' after ``food safety''.
SEC. 4. INTERNET PHARMACIES.
(a) Internet Pharmacies.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after
section 510 the following:
``SEC. 511. INTERNET PHARMACIES.
``(a) Definitions.--In this section:
``(1) Advertising service provider.--The term `advertising
service provider' means an advertising company that contracts
with a provider of an interactive computer service (as defined
in section 230(f) of the Communications Act of 1934 (47 U.S.C.
230(f)) to provide advertising on the Internet.
``(2) Designated payment system.--
``(A) In general.--The term `designated payment
system' means a system used by a person to effect a
credit transaction, electronic transfer, or money
transmitting service described in subparagraph (B) that
the Federal functional regulators determine, by
regulation or order, could be used in connection with,
or to facilitate, a restricted transaction.
``(B) Persons described.--A person referred to in
subparagraph (A) is--
``(i) a creditor;
``(ii) a credit card issuer;
``(iii) a financial institution;
``(iv) an operator of a terminal at which
an electronic fund transfer may be initiated;
``(v) a money transmitting business; or
``(vi)(I) an international, national,
regional, or local network used to effect a
credit transaction, electronic fund transfer,
or money transmitting service; or
``(II) any participant in a network
described in subclause (I).
``(3) Federal functional regulator.--The term `Federal
functional regulator' has the meaning given the term in section
509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809).
``(4) Prescription drug.--The term `prescription drug'
means a drug described in section 503(b) that is approved by
the Secretary under section 505.
``(5) Internet pharmacy.--The term `Internet pharmacy'
means a person that dispenses or offers to dispense a
prescription drug through an Internet website in interstate
commerce in the United States regardless of whether the
physical location of the principal place of business of the
Internet pharmacy is in the United States or in another
country.
``(6) Restricted transaction.--The term `restricted
transaction' means a transaction or transmittal, on behalf of a
individual who places an unlawful Internet pharmacy request to
any person engaged in the operation of an unlicensed Internet
pharmacy, of--
``(A) credit, or the proceeds of credit, extended
to or on behalf of the individual who placed the
unlawful Internet request (including credit extended
through the use of a credit card);
``(B) an electronic fund transfer or funds
transmitted by or through a money transmitting
business, or the proceeds of an electronic fund
transfer or money transmitting service, from or on
behalf of the individual who placed the unlawful
Internet request;
``(C) a check, draft, or similar instrument which
is drawn by or on behalf of the individual who placed
the unlawful Internet request and is drawn on or
payable at or through any financial institution; or
``(D) the proceeds of any other form of financial
transaction (identified by the Federal functional
regulators by regulation) that involves a financial
institution as a payor or financial intermediary on
behalf of or for the benefit of the individual who
placed the unlawful Internet request.
``(7) Unlawful internet pharmacy request.--The term
`unlawful Internet pharmacy request' means the request, or
transmittal of a request, made to an unlicensed Internet
pharmacy for a prescription drug by mail (including a private
carrier), facsimile, phone, or electronic mail, or by a means
that involves the use, in whole or in part, of the Internet.
``(8) Other definitions.--
``(A) Credit; creditor; credit card.--The terms
`credit', `creditor'; and `credit card' have the
meanings given the terms in section 103 of the Truth in
Lending Act (15 U.S.C. 1602).
``(B) Electronic fund transfer.--The term
`electronic fund transfer'--
``(i) has the meaning given the term in
section 903 of the Electronic Fund Transfer Act
(15 U.S.C. 1693a); and
``(ii) includes any fund transfer covered
under Article 4A of the Uniform Commercial
Code, as in effect in any State.
``(C) Financial institution.--The term `financial
institution'--
``(i) has the meaning given the term in
section 903 of the Electronic Transfer Fund Act
(15 U.S.C. 1693a); and
``(ii) includes a financial institution (as
defined in section 509 of the Gramm-Leach-
Bliley Act (15 U.S.C. 6809)).
``(D) Money transmitting business; money
transmitting service.--The terms `money transmitting
business' and `money transmitting service' have the
meaning given the terms in section 5330(d) of title 31,
United States Code.
``(b) In General.--An Internet pharmacy may only dispense or offer
to dispense a prescription drug to a person in the United States in
accordance with this section.
``(c) Licensing of Internet Pharmacies.--
``(1) In general.--To be licensed under this section an
Internet pharmacy shall--
``(A) have its principal place of business in the
United States, Canada, or a permitted country; and
``(B) be licensed by the Secretary in accordance
with this section prior to dispensing a prescription
drug to an individual.
``(2) Conditions for licensing.--
``(A) Application requirements.--An Internet
pharmacy shall submit to the Secretary an application
that includes--
``(i)(I) in the case of an Internet
pharmacy located in the United States,
verification that, in each State in which the
Internet pharmacy engages in dispensing or
offering to dispense prescription drugs, the
Internet pharmacy, and all employees and agents
of the Internet pharmacy, is in compliance with
applicable Federal and State laws regarding--
``(aa) the practice of pharmacy,
including licensing laws and inspection
requirements; and
``(bb) the manufacturing and
distribution of controlled substances,
including with respect to mailing or
shipping controlled substances to
consumers; or
``(II) in the case of an Internet pharmacy
located in Canada or a permitted country,
verification that--
``(aa) all employees and agents of
the Internet pharmacy are in compliance
with applicable laws of Canada or the
permitted country regarding the
practice of pharmacy, including
licensing laws and inspection
requirements; and
``(bb) the Internet pharmacy is in
compliance with applicable Federal and
State laws regarding the practice of
pharmacy, including licensing laws and
inspection requirements;
``(ii) verification that the person that
owns the Internet pharmacy has not had a
license for an Internet pharmacy terminated by
the Secretary, and that no other Internet
pharmacy owned by the person has had a license
under this subsection that has been terminated
by the Secretary;
``(iii) verification from the person that
owns the Internet pharmacy that the person will
permit inspection of the facilities and
business practices of the Internet pharmacy by
the Secretary to the extent necessary to
determine whether the Internet pharmacy is in
compliance with this subsection; and
``(iv) in the case of an agreement between
a patient and an Internet pharmacy that
releases the Internet pharmacy, and any
employee or agent of the Internet pharmacy,
from liability for damages arising out of the
negligence of the Internet pharmacy, an
assurance that such a limitation of liability
shall be null and void.
``(B) Identification requirements.--An Internet
pharmacy shall provide to any person that accesses the
Internet pharmacy website, on each page of the website
of the Internet pharmacy or by a link to a separate
page, the following information:
``(i) The street address, city, ZIP Code or
comparable mail code, State (or comparable
entity), country, and telephone number of--
``(I) each place of business of the
Internet pharmacy; and
``(II) the name of the supervising
pharmacist of the Internet pharmacy and
each individual who serves as a
pharmacist for purposes of the Internet
pharmacy website.
``(ii) The names of all States or
countries, as appropriate, in which the
Internet pharmacy and the pharmacists employed
by the Internet pharmacy are licensed or
otherwise authorized to dispense prescription
drugs.
``(iii) If the Internet pharmacy makes
referrals to, or solicits on behalf of, a
health care practitioner or group of
practitioners in the United States for
prescription services--
``(I) the name, street address,
city, ZIP Code or comparable mail code,
State, and telephone number of the
practitioner or group; and
``(II) the name of each State in
which each practitioner is licensed or
otherwise authorized to prescribe
drugs.
``(iv) A statement that the Internet
pharmacy will dispense prescription drugs only
after receipt of a valid prescription.
``(C) Professional services requirements.--An
Internet pharmacy shall carry out the following:
``(i) Maintain patient medication profiles
and other related data in a readily accessible
format organized to facilitate consultation
with treating providers, caregivers, and
patients.
``(ii) Conduct prospective drug use reviews
before dispensing medications or medical
devices.
``(iii) Ensure patient confidentiality and
the protection of patient identity and patient-
specific information, in accordance with the
regulations promulgated under section 264(c) of
the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2
note).
``(iv) Offer interactive and meaningful
consultation by a licensed pharmacist to the
caregiver or patient prior to and subsequent to
the time at which the Internet pharmacy
dispenses the drug.
``(v)(I) Establish a mechanism for patients
to report errors and suspected adverse drug
reactions.
``(II) Document in the reporting mechanism
the response of the Internet pharmacy to those
reports.
``(vi) Develop a system to inform
caregivers and patients about drug recalls.
``(vii) Educate caregivers and patients
about the appropriate means of disposing of
expired, damaged, or unusable medications.
``(viii) Assure that the sale of a
prescription drug is in accordance with a
prescription from the treating provider of the
individual.
``(ix)(I) Verify the validity of the
prescription of an individual by using 1 of the
following methods:
``(aa) Receiving from the
individual or treating provider of the
individual the prescription of the
individual by mail (including a private
carrier), or receiving from the
treating provider of the individual the
prescription of the individual by
electronic mail.
``(bb) If the prescription is for a
controlled substance (as defined in
section 102 of the Controlled
Substances Act (21 U.S.C. 802)),
confirming with the treating provider
the information in subclause (II).
``(II) When seeking verification of a
prescription of an individual under subclause
(I)(bb), an Internet pharmacy shall provide to
the treating provider the following
information:
``(aa) The full name and address of
the individual.
``(bb) Identification of the
prescription drug.
``(cc) The quantity of the
prescription drug to be dispensed.
``(dd) The date on which the
individual presented the prescription
to the Internet pharmacy.
``(ee) The date and time of the
verification request.
``(ff) The name of a contact person
at the Internet pharmacy, including a
voice telephone number, electronic mail
address, and facsimile telephone
number.
``(III) A prescription is verified under
subclause (I)(bb) only if 1 of the following
occurs:
``(aa) The treating provider
confirms, by direct communication with
the Internet pharmacy, that the
prescription is accurate.
``(bb) The treating provider
informs the Internet pharmacy that the
prescription is inaccurate and provides
the accurate prescription.
``(IV) An Internet pharmacy shall not fill
a prescription if--
``(aa) a treating provider informs
the Internet pharmacy within 72 hours
after receipt of a communication under
subclause (I)(bb) that the prescription
is inaccurate or expired; or
``(bb) the treating provider does
not respond within that time.
``(x) Maintain, for such period of time as
the Secretary shall prescribe by regulation, a
record of all direct communications with a
treating provider regarding the dispensing of a
prescription drug, including verification of
the prescription.
``(3) Licensure procedure.--
``(A) Action by secretary.--On receipt of a
completed licensing application under paragraph (3),
the Secretary shall--
``(i) assign an identification number to
each Internet pharmacy;
``(ii) notify the applicant of the receipt
of the licensure application; and
``(iii) not later than 60 days after
receipt of the licensure application, issue a
license if the Internet pharmacy is in
compliance with conditions under paragraph (3).
``(B) Electronic filing.--
``(i) In general.--For the purpose of
reducing paperwork and reporting burdens, the
Secretary shall require the use of electronic
methods of submitting to the Secretary a
licensure application required under this
section and provide for electronic methods of
receiving the applications.
``(ii) Authentication.--In providing for
the electronic submission of such licensure
applications under this section, the Secretary
shall ensure that adequate authentication
protocols are used to allow identification of
the Internet pharmacy and validation of the
data as appropriate.
``(4) List.--
``(A) In general.--The Secretary shall compile,
maintain, and periodically update a list of licensees.
``(B) Availability.--The Secretary shall make the
list described under subparagraph (A) and information
submitted by the licensee under paragraph (2)(B)
available to the public on an Internet website and
through a toll-free telephone number.
``(5) Licensing fee.--The Secretary shall establish a
licensing fee that an Internet pharmacy licensed by the
Secretary under this section shall be required to pay to the
Secretary.
``(A) Collection.--
``(i) Collection of initial year licensing
fee.--A licensing fee of $5,000 shall be
payable for the fiscal year in which the
Internet pharmacy first submits a licensing
application under this section.
``(ii) Collection in subsequent years.--
After the licensing fee is paid for the first
fiscal year, the fee, as modified under
subparagraph (B), shall be payable on or before
October 1 of each year.
``(iii) One fee per Internet pharmacy.--The
licensing fee shall be paid only once for each
Internet pharmacy for a fiscal year in which
the fee is payable.
``(B) Fee amount.--The amount of the licensing fee
shall be determined each year by the Secretary based on
the anticipated costs to the Secretary of enforcing the
requirements of this section in the subsequent fiscal
year.
``(C) Annual fee determination.--
``(i) In general.--Not later than 60 days
before the beginning of each fiscal year
beginning after September 30, 2004, the
Secretary shall determine the licensing fee for
that fiscal year.
``(ii) Publication of fee amount.--Not
later than 60 days before each fiscal year, the
Secretary shall publish the licensing fee under
this section for that fiscal year and provide
for a period of 30 days for the public to
provide written comments on the fee.
``(D) Use of fees.--The licensing fees collected
under this section shall be used, without further
appropriation, to carry out this section.
``(E) Failure to pay fee.--
``(i) Due date.--A licensing fee payable
under this section shall be paid by the date
that is 30 days after the date on which the fee
is due.
``(ii) Failure to pay.--If an Internet
pharmacy subject to a fee under this section
fails to pay the fee by the date specified
under clause (i), the Secretary shall not
permit the Internet pharmacy to engage in the
dispensing of drugs as described under this
section until all such fees owed by the
Internet pharmacy are paid.
``(F) Reports.--Beginning with fiscal year 2005,
not later than 60 days after the end of each fiscal
year during which licensing fees are collected under
this section, the Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives a report that describes--
``(i) implementation of the licensing fee
authority during the fiscal year; and
``(ii) the use by the Secretary of the
licensing fees collected during the fiscal year
for which the report is made.
``(6) Termination of license.--The Secretary, upon the
initiative of the Secretary, may terminate a license issued
under subsection (c), after notice to the Internet pharmacy and
an opportunity for a hearing, and if the Secretary determines
that an Internet pharmacy--
``(A) has demonstrated a pattern of noncompliance
with this section;
``(B) has made an untrue statement of material fact
in its license application; or
``(C) is in violation of any applicable Federal or
State law relating to the dispensing of a prescription
drug.
``(7) Renewal evaluation.--
``(A) In general.--Before renewing a license of an
Internet pharmacy under this subsection pursuant to the
submission of a renewal application, the Secretary
shall conduct an evaluation to determine whether the
Internet pharmacy is in compliance with this section.
``(B) Evaluation.--At the discretion of the
Secretary and as applicable, an evaluation under
subparagraph (A) may include testing of the Internet
pharmacy website or other systems through which the
Internet pharmacy communicates with consumers, and a
physical inspection of the records and premises of the
pharmacy.
``(8) Contract for operation of program.--
``(A) In general.--The Secretary may award a
contract under this subsection for the operation of the
licensing program.
``(B) Term.--The duration of a contract under
subparagraph (A) shall not exceed 5 years and may be
renewable.
``(C) Performance review.--The Secretary shall
annually review performance under a contract under
subparagraph (A).
``(d) Providers of Interactive Computer Services or Advertising
Services.--A provider of interactive computer services (as defined in
section 230(f) of the Communications Act of 1934 (47 U.S.C. 230(f))) or
an advertising service provider shall be liable under this section for
dispensing or selling prescription drugs in violation of this section
on account of another person's selling or dispensing of a prescription
drug if the provider of the service--
``(1) accepts advertising for a prescription drug from an
unlicensed Internet pharmacy; or
``(2) accepts advertising stating that an individual does
not need a physician's prescription to obtain a prescription
drug.
``(e) Policies and Procedures Required To Prevent Payments for
Unlawful Internet Pharmacy Requests.--
``(1) Regulations.--Not later than 1 year after the date of
enactment of this section, the Federal functional regulators
shall promulgate regulations requiring a person described in
subsection (a)(2) to prevent restricted transactions by
establishing policies and procedures that--
``(A)(i) are reasonably designed to allow the
payment system and any person involved in the payment
system to identify restricted transactions by means of
codes in authorization messages or by other means; and
``(ii) are reasonably designed to block restricted
transactions identified as a result of the policies and
procedures developed under clause (i); or
``(B) prevent the acceptance of the products or
services of the payment system in connection with a
restricted transaction.
``(2) Requirements for policies and procedures.--In
promulgating regulations under paragraph (1), the Federal
functional regulators shall--
``(A) identify types of policies and procedures,
including nonexclusive examples, that shall be
considered to be reasonably designed to identify and
reasonably designed to block or to prevent the
acceptance of the products or services in connection
with each type of restricted transaction, including--
``(i) identifying transactions by a code or
codes in the authorization message; and
``(ii) denying authorization of a credit
card transaction in response to an
authorization message; and
``(B) to the extent practicable, permit any
participant in a designated payment system to choose
among alternative means of identifying and blocking, or
otherwise preventing the acceptance of the products or
services of the designated payment system or
participant in connection with, restricted
transactions.
``(3) Compliance with payment system policies and
procedures.--A person described in subsection (a)(2)(B) meets
the requirement of paragraph (1) if--
``(A) the person relies on and complies with the
policies and procedures of a designated payment system
of which the person is a member or in which the person
is a participant, to--
``(i) identify and block restricted
transactions; or
``(ii) otherwise prevent the acceptance of
the products or services of the payment system,
member, or participant in connection with
restricted transactions; and
``(B) such policies and procedures of the
designated payment system comply with the requirements
of regulations promulgated under paragraph (1).
``(4) No liability for blocking or refusing to honor
restricted transaction.--A person that is subject to a
regulation or an order issued under this section and blocks or
otherwise refuses to honor a restricted transaction (or a
transaction that such person reasonably believes to be a
restricted transaction) or as a member of a designated payment
system, relies on the policies and procedures of the payment
system in an effort to comply with regulations promulgated
under this section, shall not be liable to any party for such
action.
``(5) Enforcement.--
``(A) In general.--This section shall be enforced
by the Federal functional regulators and the Federal
Trade Commission under applicable law in the manner
provided in section 505(a) of the Gramm-Leach-Bliley
Act (21 U.S.C. 6805(a)).
``(B) Factors to be considered.--In considering any
enforcement action under this subsection against a
payment system or person described in subsection
(a)(2)(B), the Federal functional regulators and the
Federal Trade Commission shall consider the following
factors:
``(i) The extent to which the person is
extending credit or transmitting funds knowing
the transaction is in connection with an
unlawful Internet pharmacy request.
``(ii) The history of the person in
extending credit or transmitting funds knowing
the transaction is in connection with an
unlawful Internet pharmacy request.
``(iii) The extent to which the person has
established and is maintaining policies and
procedures in compliance with regulations
prescribed under this subsection.
``(iv) The feasibility that any specific
remedy prescribed can be implemented by the
person without substantial deviation from
normal business practice.
``(v) The costs and burdens the specific
remedy will have on the person.
``(f) Reports Regarding Internet-Related Violations of Federal and
State Laws on Dispensing of Drugs.--The Secretary shall, pursuant to
the submission of an application meeting criteria prescribed by the
Secretary, make an award of a grant or contract to an entity with
experience in developing and maintaining systems for the purpose of--
``(1) identifying Internet pharmacy websites that are not
licensed or that appear to be operating in violation of Federal
or State laws concerning the dispensing of drugs;
``(2) reporting such Internet pharmacy websites to State
medical licensing boards and State pharmacy licensing boards,
and to the Attorney General and the Secretary, for further
investigation; and
``(3) submitting, for each fiscal year for which the award
under this subsection is made, a report to the Secretary
describing investigations undertaken with respect to violations
described in paragraph (1).''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) (as amended by section 2(b)) is amended by
adding at the end the following:
``(ii) The sale of a prescription drug, or the ownership or
operation of an Internet pharmacy, in violation of section 511.
``(jj) The representation by advertisement, sales presentation,
direct communication (including telephone, facsimile, or electronic
mail), or otherwise by an Internet pharmacy, that a prescription drug
may be obtained from the Internet pharmacy without a prescription, in
violation of section 511.
``(kk) The acceptance of an advertisement from an Internet pharmacy
by the provider of an interactive computer service, unless the provider
has on file a copy of the license issued to the Internet pharmacy under
section 511.''.
(c) Links to Illegal Internet Pharmacies.--Section 302 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) is amended by
adding at the end the following:
``(c)(1) In the case of a violation of section 511 relating to an
illegal Internet pharmacy, the district courts of the United States and
the United States courts of the territories shall have jurisdiction to
order a provider of an interactive computer service to remove, or
disable access to, a website violating that section that resides on a
computer server that the provider controls or operates.
``(2) Relief under paragraph (1)--
``(A) shall be available only after provision to the
provider of notice and an opportunity to appear;
``(B) shall not impose any obligation on the provider to
monitor its service or to affirmatively seek facts indicating
activity violating section 511; and
``(C) shall specify the provider to which the relief
applies.''.
(d) Regulations.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall promulgate interim final regulations that are
consistent with the Verified Internet Pharmacy Sites
certification program developed by the National Association of
Boards of Pharmacy to carry out the amendments made by this
section.
(2) Effective date.--The requirement of licensure under
section 511 of the Federal Food, Drug, and Cosmetic Act (as
added by this section) shall take effect on the date determined
by the Secretary of Health and Human Services but in no event
later than 90 days after the effective date of the interim
final regulations under paragraph (1).
(e) Return to Sender.--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) Unlicensed Internet Pharmacy.--If an Internet pharmacy is not
licensed by the Secretary in accordance with section 511, any shipment
of a prescription drug from such an Internet pharmacy to an individual
shall be refused admission into the United States and the Secretary
shall return the prescription drug, other than a prescription drug that
is required to be destroyed, to the Internet pharmacy at the expense of
the Internet pharmacy.
``(q) Licensed Internet Pharmacy.--If a shipment of a prescription
drug from an Internet pharmacy licensed by the Secretary in accordance
with section 511 to an individual is refused admission into the United
States, the Secretary shall--
``(1) return the prescription drug, other than a
prescription drug that is required to be destroyed, to the
Internet pharmacy at the expense of the Internet pharmacy; and
``(2) provide the individual and the Internet pharmacy with
a written notice that informs the individual and the Internet
pharmacy of the refusal and of the reason for the refusal.''.
SEC. 5. ADMINISTRATIVE DETENTION AND TEMPORARY HOLD.
(a) In General.--The Federal Food, Drug, and Cosmetic Act is
amended by adding after section 815 (as added by section 9) the
following:
``SEC. 816. ADMINISTRATIVE DETENTION.
``(a) Administrative Detention of Prescription Drugs.--
``(1) Detention authority.--
``(A) In general.--An officer or qualified employee
of the Food and Drug Administration may order the
detention, in accordance with this subsection, of any
prescription drug that is found during an inspection,
examination, or investigation under this Act conducted
by the officer or qualified employee, if the officer or
qualified employee has credible evidence or information
indicating that the prescription drug presents a risk
to the public health.
``(B) Approval.--A prescription drug may be
detained under subparagraph (A) only if the Secretary
or an official designated by the Secretary approves the
order of detention.
``(2) Period of detention.--A prescription drug may be
detained under paragraph (1) for a reasonable period, not to
exceed 20 days, unless a greater period, not to exceed 30 days,
is necessary, to enable the Secretary to commence an action
under this subsection or section 302.
``(3) Security of detained article.--
``(A) In general.--An order under paragraph (1)
with respect to a prescription drug--
``(i) may require that the prescription
drug be labeled or marked as detained; and
``(ii) shall require that the prescription
drug be removed to a secure facility, as
appropriate.
``(B) No transfer.--A prescription drug subject to
an order under paragraph (1) shall not be transferred
by any person from the place at which the prescription
drug is ordered detained or from the place to which the
prescription drug is removed, until released by the
Secretary or until the expiration of the detention
period applicable under the order, whichever occurs
first.
``(C) Effect of paragraph.--This paragraph does not
authorize the delivery of a prescription drug pursuant
to the execution of a bond while the prescription drug
is subject to an order under paragraph (1).
``(D) Effect of bonding provision.--Section 801(b)
does not authorize the delivery of a prescription drug
pursuant to the execution of a bond while the
prescription drug is subject to an order under
paragraph (1).
``(4) Appeal of detention order.--
``(A) In general.--With respect to a prescription
drug detained under paragraph (1), any person that
would be entitled to be a claimant for the prescription
drug if the prescription drug were seized under
paragraph (1) may appeal the order of detention to the
Secretary.
``(B) Action by the secretary.--Not later than 5
days after an appeal is filed, the Secretary, after
providing opportunity for an informal hearing, shall
confirm or terminate the order, and confirmation by the
Secretary shall be considered to be a final agency
action for purposes of section 702 of title 5, United
States Code.
``(C) Failure to act.--If, during the 5-day period
specified in subparagraph (B), the Secretary fails to
provide an opportunity for hearing or to confirm or
terminate the order, the order shall be deemed to be
terminated.
``(D) Effect of commencement of court action.--The
process under this paragraph for the appeal of an order
under paragraph (1) with respect to a prescription drug
terminates if the Secretary commences an action under
subsection (a) or section 302 regarding the
prescription drug.
``(b) Effect of Section.--Nothing in this section applies to a
prescription drug imported by an individual under section 812 or to a
commercial transaction conducted between an Internet pharmacy and an
individual.''.
(b) Temporary Hold at Port of Entry.--Section 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381) (as amended by section
4(e)) is amended by adding at the end the following:
``(r) Temporary Hold at Port of Entry.--
``(1) In general.--If an officer or qualified employee of
the Food and Drug Administration has credible evidence or
information indicating that a prescription drug presents a risk
to the public health, and the officer or qualified employee is
unable to inspect, examine, or investigate the prescription
drug upon the prescription drug's being offered for import at a
port of entry into the United States, the officer or qualified
employee shall request the Secretary of the Treasury to hold
the prescription drug at the port of entry for a reasonable
period of time, not to exceed 24 hours, for the purpose of
enabling the Secretary to inspect, examine, or investigate the
prescription drug as appropriate.
``(2) Approval.--
``(A) In general.--An officer or qualified employee
of the Food and Drug Administration may make a request
under paragraph (1) only if the Secretary or an
official designated by the Secretary approves the
request.
``(B) Designees.--An official may not be designated
under subparagraph (A) unless the official is the
director of the district under this Act in which the
prescription drug is located, or is an official senior
to that director.
``(3) Notification.--With respect to a prescription drug
for which a request under paragraph (1) is made, the Secretary,
promptly after the request is made, shall notify the State in
which the port of entry involved is located that the request
has been made, and as applicable, that the prescription drug,
is being held under this subsection.
``(4) Removal.--A prescription drug held under paragraph
(1) shall be removed to a secure facility, as appropriate.
``(5) No transfer.--During the period in which a
prescription drug is held under this subsection, the
prescription drug shall not be transferred by any person from
the port of entry into the United States for the prescription
drug or from the secure facility to which the prescription drug
has been removed.
``(6) Effect of bonding provision.--Subsection (b) does not
authorize the delivery of a prescription drug held under this
subsection pursuant to the execution of a bond while the
prescription drug is held under this subsection.
``(7) Effect of subsection.--Nothing in this subsection
applies to a prescription drug imported by an individual under
section 812 or to a commercial transaction conducted between an
Internet pharmacy and an individual.''.
(c) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) (as amended by section 4(b)) is amended by
adding at the end the following:
``(ll) The transfer of a prescription drug in violation of an order
under section 816, or the removal or alteration of any mark or label
required by the order to identify the prescription drug as detained.''.
SEC. 6. SUSPENSION.
(a) In General.--The Federal Food, Drug, and Cosmetic Act is
amended by adding after section 816 (as added by section 5) the
following:
``SEC. 817. SUSPENSION OF IMPORTATION.
``(a) Prescription Drug.--If the Secretary determines that the
importation of a particular prescription drug or particular dosage form
of a prescription drug into the United States presents a risk to the
public health, the Secretary may immediately order the suspension of
the importation of the particular prescription drug or particular
dosage form of the prescription drug.
``(b) Suspension.--If the Secretary determines that a drug
importation facility, pharmacy, Internet pharmacy, or wholesaler is
engaged in a pattern of importing or offering for importation a
prescription drug into the United States in violation of any of the
requirements of this Act, the Secretary may immediately order the
suspension of that person from engaging in the importation or offering
for importation of prescription drugs into the United States.
``(c) Canada or Permitted Country.--If the Secretary determines
that there is a pattern of prescription drugs being imported or offered
for importation into the United States from Canada or a permitted
country in violation of any of the requirements of this Act, the
Secretary may immediately order the suspension of the importation or
offering for importation into the United States of prescription drugs
from Canada or that permitted country, as appropriate.
``(d) Appeal of Suspension Order.--
``(1) In general.--
``(A) Prescription drugs.--With respect to the
importation of a prescription drug, the importation of
which is suspended under subsection (a), any person
that would be entitled to be a claimant for the
prescription drug may appeal the suspension order to
the Secretary.
``(B) Suspended persons.--With respect to a drug
importation facility, pharmacy, Internet pharmacy, or
wholesaler subject to a suspension order under
subsection (b) or (c), the drug importation facility,
pharmacy, Internet pharmacy or wholesaler may appeal
the suspension order to the Secretary.
``(2) Action by the secretary.--Not later than 30 days
after an appeal is filed, the Secretary, after providing
opportunity for an informal hearing, shall confirm or terminate
the order.
``(3) Failure to act.--If, during the 30-day period
specified in paragraph (2), the Secretary fails to provide an
opportunity for a hearing or to confirm or terminate the order,
the order shall be deemed to be terminated.
``(e) No Judicial Review.--An order under this section shall not be
subject to judicial review.
``(f) Effect of Section.--Nothing in this section applies to a
prescription drug imported by an individual under section 812 or to a
commercial transaction conducted between an Internet pharmacy and an
individual.''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) (as amended by section 5(c)) is amended by
adding at the end the following:
``(mm) The importation or offering for importation of a
prescription drug in violation of an order under section 817.''.
SEC. 7. DEBARMENT FOR REPEATED OR SERIOUS PRESCRIPTION DRUG IMPORTATION
VIOLATIONS.
(a) Debarment Authority.--
(1) Permissive debarment.--Section 306(b)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is
amended--
(A) in subparagraph (B), by striking ``or'' at the
end;
(B) in subparagraph (C), by striking the period at
the end and inserting ``, or''; and
(C) by adding at the end the following:
``(D) a person from importing a prescription drug
or offering a prescription drug for importation into
the United States.''.
(2) Amendment regarding debarment grounds.--Section 306(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b))
is amended--
(A) by redesignating paragraph (4) as paragraph
(5); and
(B) by inserting after paragraph (3) the following:
``(4) Persons subject to permissive debarment; prescription
drug importation.--
``(A) In general.--A person is subject to debarment
under paragraph (1)(D) if--
``(i) the person has been convicted of a
felony for conduct relating to the importation
into the United States of any prescription
drug; or
``(ii) the person has engaged in a pattern
of importing or offering for import a
prescription drug that presents a risk to the
public health.
``(B) Effect of paragraph.--Nothing in this
paragraph applies to a prescription drug imported by an
individual under section 812 or to a commercial
transaction conducted between an Internet pharmacy and
an individual.''.
(b) Conforming Amendments.--Section 306 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a) is amended--
(1) in subsection (b), by striking the subsection heading
and inserting the following:
``(b) Permissive Debarment; Certain Drug Applications; Imports.--
'';
(2) in subsection (c)(2)(A)(iii), by striking ``paragraph
(2) or (3) of subsection (b)'' and inserting ``paragraph (2),
(3), or (4) of subsection (b)''; and
(3) in subsection (d)(3)--
(A) in subparagraph (A)(i), by striking ``or
paragraph (2)(A) or (3) of subsection (b)'' and
inserting ``paragraph (2)(A), (3), or (4) of subsection
(b)'';
(B) in clauses (i) and (ii) of subparagraph (B), by
striking ``or subsection (b)(3)'' and inserting
``paragraph (3) or (4) of subsection (b)''; and
(C) in subparagraph (B)(ii), by striking ``or the
food importation process, as the case may be'' and
inserting ``, or the food or prescription drug
importation process, as the case may be''.
(c) Effective Date.--Section 306(l)(2) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a(l)(2)) is amended--
(1) in the first sentence, by striking ``and subsection
(b)(3)(A)'' and inserting ``subsection (b)(3)(A), and
subsection (b)(4)(A)''; and
(2) in the second sentence, by inserting ``, subsection
(b)(4)(B),'' after ``subsection (b)(3)(B)''.
(d) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) (as amended by section 6(b)) is amended by
adding at the end the following:
``(nn) The importing or offering for importation into the United
States of a prescription drug by, with the assistance of, or at the
direction of a person debarred under section 306(b)(4).''.
(e) Importation by Debarred Persons.--Section 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381) (as amended by section
5(b)) is amended by adding at the end the following:
``(s) Importation of Prescription Drugs by Debarred Persons.--
``(1) In general.--If a prescription drug is imported or
offered for importation into the United States, and the
importer, owner, or consignee of the prescription drug is a
person that has been debarred under section 306(b)(4), the
prescription drug--
``(A) shall be held at the port of entry for the
prescription drug; and
``(B) may not be delivered to the person.
``(2) Effect of bonding provision.--Subsection (b) does not
authorize the delivery of a prescription drug pursuant to the
execution of a bond while the prescription drug is held under
this subsection.
``(3) Removal.--A prescription drug held under this
subsection shall be removed to a secure facility, as
appropriate.
``(4) No transfer.--During a period in which a prescription
drug is held under this subsection, the prescription drug shall
not be transferred by any person from the port of entry into
the United States for the prescription drug or from the secure
facility to which the prescription drug has been removed.
``(5) Permissible delivery.--A prescription drug held under
this subsection may be delivered to a person that is not a
debarred person under section 306(b)(4) if the person
affirmatively establishes, at the expense of the person, that
the prescription drug complies with the requirements of this
Act, as determined by the Secretary.''.
SEC. 8. REGISTRATION OF PRESCRIPTION DRUG IMPORTATION FACILITIES.
(a) Registration of Certain Importers.--The Federal Food, Drug, and
Cosmetic Act is amended by adding after section 813 (as added by
section 2) the following:
``SEC. 814. REGISTRATION OF CERTAIN IMPORTERS.
``(a) In General.--A drug importation facility, pharmacy, Internet
pharmacy, or wholesaler engaged in the importation or offering for
importation of prescription drugs into the United States, or in the
dispensing of such drugs, shall register with the Secretary in
accordance with this section.
``(b) Registration.--
``(1) In general.--To register, the owner, operator, or
agent in charge of a drug importation facility, pharmacy,
Internet pharmacy, or wholesaler shall submit to the Secretary
a registration that discloses--
``(A) the name and address of each drug importation
facility, pharmacy, Internet pharmacy, or wholesaler at
which, and all trade names under which, the registrant
conducts business;
``(B) the name of each prescription drug to be
imported into the United States by each drug
importation facility, pharmacy, Internet pharmacy, or wholesaler; and
``(C) the name and address of an agent for service
of process in the United States.
``(2) Change in information.--The registrant shall notify
the Secretary in a timely manner of any change in the
information provided under paragraph (1).
``(3) Procedure.--Not later than 60 days after receipt of a
completed registration under paragraph (1), the Secretary
shall--
``(A) assign a registration number to each
registered drug importation facility, pharmacy,
Internet pharmacy, and wholesaler; and
``(B) notify the registrant of the receipt of the
registration.
``(4) List.--
``(A) In general.--The Secretary shall compile,
maintain, and periodically update a list of
registrants.
``(B) Availability.--The Secretary shall make the
list described under subparagraph (A) and information
submitted by a registrant under paragraph (1) available
to the public on an Internet website and through a
toll-free telephone number.
``(c) Electronic Filing.--
``(1) In general.--For the purpose of reducing paperwork
and reporting burdens, the Secretary shall provide for, and
require the use of, electronic methods of submitting to the
Secretary registrations required under this section and shall
provide for electronic methods of receiving the registrations.
``(2) Authentication.--In providing for the electronic
submission of such registrations under this section, the
Secretary shall ensure that adequate authentication protocols
are used to allow identification of the registrant and
validation of the data as appropriate.
``(d) Effect of Section.--
``(1) Authority.--Nothing in this section
authorizes the Secretary to require an application,
review, or licensing process for a drug importation
facility, pharmacy, or wholesaler.
``(2) Importation by individuals.--Nothing in this
section applies to a prescription drug imported by an
individual under section 812 or to a commercial
transaction conducted between an Internet pharmacy and
an individual.''.
(b) Regulations.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall promulgate regulations to carry out section 814
of the Federal Food, Drug, and Cosmetic Act (as added by this
section).
(2) Effective date.--The requirement of registration under
section 814 of the Federal Food, Drug, and Cosmetic Act takes
effect--
(A) on the effective date of the final regulations
under paragraph (1); or
(B) if the final regulations have not been made
effective as of the expiration of that period, on the
date that is 1 year after the date of enactment of this
Act, subject to compliance with the final regulations
when the final regulations are made effective.
(c) Importation; Failure to Register.--Section 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381) (as amended by section
7(e)) is amended by adding at the end the following:
``(t) Failure to Register.--
``(1) In general.--If a drug importation facility,
pharmacy, Internet pharmacy, or wholesaler engaged in the
importation or offering for importation of prescription drugs
into the United States has not submitted a registration to the
Secretary in accordance with section 814, a prescription drug
that is being imported or offered for importation into the
United States shall not be delivered to the importer, owner, or
consignee of the prescription drug until the drug importation
facility, pharmacy, Internet pharmacy, or wholesaler is
registered in accordance with section 814.
``(2) Effect of subsection (b).--Subsection (b) does not
authorize the delivery of the prescription drug pursuant to the
execution of a bond while the prescription drug is held under
this subsection.
``(3) Removal.--A prescription drug held under this
subsection shall be removed to a secure facility, as
appropriate.
``(4) No transfer.--During the period in which a
prescription drug is held under this subsection, the
prescription drug shall not be transferred by any person from
the port of entry into the United States for the prescription
drug or from the secure facility to which the prescription drug
has been removed.''.
(d) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) (as amended by section 7(d)) is amended by
adding at the end the following:
``(oo) The failure of a drug importation facility, pharmacy,
Internet pharmacy, or wholesaler engaged in the importation or offering
for importation of prescription drugs into the United States, or in the
dispensing of such drugs, to register in accordance with section
814.''.
SEC. 9. MAINTENANCE AND INSPECTION OF RECORDS FOR PRESCRIPTION DRUGS.
The Federal Food, Drug, and Cosmetic Act is amended by adding after
section 814 (as added by section 8) the following:
``SEC. 815. MAINTENANCE AND INSPECTION OF RECORDS FOR PRESCRIPTION
DRUGS.
``(a) In General.--The Secretary may by regulation establish
requirements relating to the establishment and maintenance, for not
longer than 2 years, of records by--
``(1) a drug importation facility, pharmacy, Internet
pharmacy, or wholesaler engaged in the importation of
prescription drugs into the United States, or in the dispensing
of such drugs; and
``(2) any person that processes, packages, distributes,
receives, holds, or transports a prescription drug imported
under this subchapter.
``(b) Inspection.--
``(1) In general.--If the Secretary has reason to believe
that a prescription drug imported under this subchapter
presents a risk to the public health, the drug importation
facility, pharmacy, Internet pharmacy, or wholesaler that
imports the prescription drug, and each person that processes,
packages, distributes, receives, holds, or transports the
prescription drug shall, at the request of an officer or
employee duly designated by the Secretary, permit the officer
or employee, upon presentation of appropriate credentials and a
written notice to such pharmacy or person, at reasonable times,
within reasonable limits and in a reasonable manner, to have
access to and copy all records relating to the prescription
drug that are needed to enable the Secretary to determine
whether the prescription drug presents a risk to the public
health.
``(2) Applicability.--Paragraph (1) applies to all records
maintained by or on behalf of the drug importation facility,
pharmacy, Internet pharmacy, or wholesaler or such other person
in any format (including paper and electronic formats) and at
any location.
``(c) Protection of Sensitive Information.--The Secretary shall
take appropriate measures to ensure that there are in effect effective
procedures to prevent the unauthorized disclosure of any trade secret
or confidential information that is obtained by the Secretary under
this section or any commercial or financial information that is
privileged or confidential.
``(d) Effect of Section.--Nothing in this section applies to a
prescription drug imported by an individual under section 812 or to a
commercial transaction conducted between an Internet pharmacy and an
individual.''.
SEC. 10. ADVANCE NOTICE OF IMPORTED PRESCRIPTION DRUG SHIPMENTS.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (as amended by section 8(b)) is amended by adding at the
end the following:
``(u) Advance Notice of Imported Prescription Drug Shipments.--
``(1) In general.--For purposes of enabling the Secretary
to inspect at ports of entry a prescription drug that is being
imported or offered for importation into the United States, the
person importing or offering for importation the prescription
drug shall, in advance, provide to the Secretary a notice that
includes--
``(A) the established name (as defined by section
502(e)), dosage form, and quantity of the prescription
drug;
``(B) the name of the shipper of the prescription
drug;
``(C) the name of the country from which the
prescription drug originates;
``(D) the country from which the prescription drug
is shipped;
``(E) the name of the port of entry of the
prescription drug;
``(F) documentation from the drug importation
facility located in Canada or a permitted country
specifying--
``(i) the original source of the
prescription drug; and
``(ii) the quantity of each lot of the
prescription drug originally received by the
facility from that source;
``(G) the lot or control number assigned to the
prescription drug by the manufacturer of the
prescription drug;
``(H) the name, address, telephone number, and
professional license number of the drug importation
facility located in Canada or a permitted country; and
``(I) certification from the drug importation
facility located in a foreign country or from the
manufacturer of the prescription drug that the
prescription drug--
``(i) is approved for marketing in the
United States and is not adulterated or
misbranded; and
``(ii) meets all labeling requirements
under this Act.
``(2) Refusal of admission.--A prescription drug imported
or offered for importation without submission of a notice under
paragraph (1) shall be refused admission into the United
States.
``(3) Period of advance notice.--The period in which the
notice under paragraph (1) is required to be made in advance of
the time of the importation of a prescription drug or the
offering of a prescription drug for importation shall be not
less than 24 hours and not more than 5 days.
``(4) Failure to provide notice.--
``(A) In general.--If a prescription drug is being
imported or offered for importation into the United
States and notice is not provided in advance in
accordance with paragraph (1), the prescription drug
shall be held at the port of entry for the prescription
drug, and may not be delivered to the importer, owner,
or consignee of the prescription drug, until the notice
is submitted to the Secretary and the Secretary
examines the notice and determines that the notice is
in accordance with the requirements under paragraph
(1).
``(5) Effect of bonding provision.--Subsection (b) does not
authorize the delivery of a prescription drug pursuant to the
execution of a bond while the prescription drug is held under
this subsection.
``(6) Removal.--A prescription drug held under this
subsection shall be removed to a secure facility, as
appropriate.
``(7) No transfer.--During a period in which a prescription
drug is held under this subsection, the prescription drug shall
not be transferred by any person from the port of entry into
the United States for the article or from the secure facility
to which the prescription drug has been removed.
``(8) Effect of subsection.--
``(A) Authority.--This subsection does not limit
the authority of the Secretary to obtain information
under any other provision of this Act.
``(B) Importation by individuals.--Nothing in this
subsection applies to a prescription drug imported by
an individual under section 812 or to a commercial
transaction conducted between an Internet pharmacy and
an individual.''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) (as amended by section 8(c)) is amended by
adding at the end the following:
``(pp) The failure to submit prior notice of the importation of a
prescription drug in violation of section 801(s).''.
SEC. 11. AUTHORITY TO MARK PRESCRIPTION DRUGS REFUSED ADMISSION INTO
THE UNITED STATES.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) (as amended by section 10(a)) is amended
by adding at the end the following:
``(v) Prescription Drugs Refused Admission.--
``(1) In general.--If a prescription drug has been refused
admission under subsection (a), other than such a prescription
drug that is required to be destroyed, the Secretary may
require the owner or consignee of the prescription drug to
affix to the container of the prescription drug a label that
clearly and conspicuously bears the statement: `UNITED STATES:
REFUSED ENTRY'.
``(2) Expenses.--All expenses in connection with affixing a
label under paragraph (1)--
``(A) shall be paid by the owner or consignee of
the prescription drug; and
``(B) in default of such payment, shall constitute
a lien against future importations made by the owner or
consignee.
``(3) Effective period.--A requirement under paragraph (1)
with respect to a prescription drug remains in effect until the
Secretary determines that the prescription drug has been
brought into compliance with this Act.
``(4) Effect of subsection.--Nothing in this subsection
applies to a prescription drug imported by an individual under
section 812 or to a commercial transaction conducted between an
Internet pharmacy and an individual.''.
(b) Misbranded Prescription Drugs.--Section 502 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at
the end the following:
``(w) If--
``(1) it is a prescription drug refused admission into the
United States that fails to bear a label required by the
Secretary under section 801(v);
``(2) the Secretary finds that the prescription drug
presents a risk to the public health; and
``(3) on or after notifying the owner or consignee of the
prescription drug that the label is required under section
801(v), the Secretary informs the owner or consignee that the
prescription drug presents such a risk.''.
(c) Rule of Construction.--With respect to a prescription drug that
is imported or offered for importation into the United States, nothing
in this section limits the authority of the Secretary of Health and
Human Services or the Secretary of the Treasury to require the marking
of prescription drugs refused admission under any other provision of
law.
SEC. 12. PROHIBITION OF PORT SHOPPING.
Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352) (as amended by section 11(b)) is amended by adding at the end the
following:
``(x) Port Shopping.--
``(1) In general.--If--
``(A) it is a prescription drug imported or offered
for importation into the United States; and
``(B) the prescription drug has previously been
refused admission under section 801(a);
unless the person reoffering the prescription drug
affirmatively establishes, at the expense of the owner or
consignee of the prescription drug, that the prescription drug
complies with the applicable requirements of this Act, as
determined by the Secretary.
``(2) Effect of paragraph.--Nothing in this paragraph
applies to importation of a prescription drug under section 812
or to a commercial transaction conducted between an Internet
pharmacy and an individual.''.
SEC. 13. AUTHORITY TO COMMISSION OTHER FEDERAL AND STATE OFFICIALS TO
CONDUCT INSPECTIONS.
Section 702(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 372(a)) is amended--
(1) by redesignating paragraphs (3) and (4) as paragraphs
(5) and (6), respectively; and
(2) inserting after paragraph (2) the following:
``(3)(A) The Secretary, pursuant to a memorandum of
understanding between the Secretary and the head of another
Federal agency, may conduct examinations and investigations for
the purposes of enforcing compliance with the amendments made
by the Safe IMPORT Act of 2004 through the officers and
employees of the other agency.
``(B) A memorandum of understanding under subparagraph (A)
shall include--
``(i) provisions to ensure adequate training of
officers and employees to conduct the examinations and
investigations; and
``(ii) provisions regarding reimbursement that may,
in the discretion of the head of the other agency,
require reimbursement, in whole or in part, from the
Secretary for the examinations or investigations
performed under this paragraph by the officers or
employees of the other agency.
``(C) A memorandum of understanding under subparagraph (A)
shall be effective only with respect to examinations or
inspections at facilities or other locations that are jointly
regulated by the Secretary and the other agency.
``(D) Not later than 60 days after the end of each fiscal
year in which the head a Federal agency carries out 1 or more
examinations or inspections under a memorandum of understanding
under subparagraph (A), the Secretary and the agency head shall
submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and to the Committee on Energy and
Commerce of the House of Representatives, a report that
discloses, for that year--
``(i) the number of officers or employees that
carried out 1 or more programs, projects, or activities
under the memorandum of understanding;
``(ii) the number of additional articles that were
inspected or examined as a result of the memorandum of
understanding; and
``(iii) the number of additional examinations or
investigations that were carried out pursuant to the
memorandum of understanding.
``(4)(A) The Secretary may enter into a contract with a
State to use the State Board of Pharmacy personnel of the State
to conduct examinations and inspection for the purpose of
carrying out the amendments made by the Safe IMPORT Act of
2004.
``(B) A contract entered into under subparagraph (A)
shall--
``(i) ensure adequate training of officers and
employees to conduct the examinations and
investigations; and
``(ii) be effective only with respect to
examinations or inspections of drug importation
facilities, pharmacies, Internet pharmacies, and
wholesalers located in the State.''.
SEC. 14. USER FEES RELATING TO PRESCRIPTION DRUG IMPORTATION.
Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 397f et seq.) is amended by adding at the end the
following:
``PART 5--FEES RELATING TO PRESCRIPTION DRUG IMPORTATION
``SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IMPORTATION.
``(a) Registration Fee.--The Secretary shall establish a user fee
program under which a drug importation facility, pharmacy, Internet
pharmacy, or wholesaler registering with the Secretary under section
814 shall be required to pay a fee to the Secretary.
``(b) Collection.--
``(1) Collection on initial registration.--A fee under this
section shall be payable for the fiscal year in which the drug
importation facility, pharmacy, Internet pharmacy, or
wholesaler first registers under section 814 (or reregisters
under that section if that person has withdrawn its
registration and subsequently reregisters).
``(2) Collection in subsequent years.--After the fee is
paid for that fiscal year, the fee shall be payable on or
before October 1 of each year.
``(3) One fee per facility.--The fee shall be paid only
once for each drug importation facility, pharmacy, Internet
pharmacy, or wholesaler registered for a fiscal year in which
the fee is payable.
``(c) Fee Amount.--The amount of the fee shall be determined each
year by the Secretary and shall be based on the anticipated costs to
the Secretary of enforcing the amendments made by the Safe IMPORT Act
of 2004 in the subsequent fiscal year.
``(d) Use of Fees.--The fees collected under this section shall be
used, without further appropriation, to enforce the amendments made by
the Safe IMPORT Act of 2004.
``(e) Annual Fee Setting.--The Secretary shall establish, 60 days
before the beginning of each fiscal year beginning after September 30,
2004, for that fiscal year, registration fees.
``(f) Effect of Failure To Pay Fees.--
``(1) Due date.--A fee payable under this section shall be
paid by the date that is 30 days after the date on which the
fee is due.
``(2) Failure to pay.--If a registered drug importation
facility, pharmacy, Internet pharmacy, or wholesaler subject to
a fee under this section fails to pay the fee, the Secretary
shall not permit the drug importation facility pharmacy,
Internet pharmacy, or wholesaler to engage in importation or
offering for importation prescription drugs under this Act
until all such fees owed by that person are paid.
``(g) Reports.--
``(1) Fee establishment.--Not later than 60 days before
each fiscal year, the Secretary shall--
``(A) publish user fees under this section for that
fiscal year;
``(B) hold a meeting at which the public may
comment on the recommendations; and
``(C) provide for a period of 30 days for the
public to provide written comments on the
recommendations.
``(2) Performance and fiscal report.--Beginning with fiscal
year 2005, not later than 60 days after the end of each fiscal
year during which fees are collected under this section, the
Secretary shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report that
describes--
``(A) implementation of the user fee authority
during the fiscal year; and
``(B) the use by the Secretary of the fees
collected during the fiscal year for which the report
is made.''.
SEC. 15. ANTICOUNTERFEITING PROVISIONS.
(a) Required Records.--Section 503(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(e)) is amended by striking paragraph
(1) and inserting the following: ``(1) A distributor of record that is
engaged in the wholesale distribution of a drug subject to subsection
(b), shall--
``(A) before each wholesale distribution of the drug--
``(i) with respect to each wholesale distribution
of a drug subject to subsection (b), provide the person
that receives the drug a statement that identifies the
immediately previous distributor of record from which
the drug was purchased; and
``(ii) with respect to a drug subject to subsection
(b) that is imported to the United States, provide the
person that receives the drug a statement (in such form
and containing such information as the Secretary may
require) identifying each prior sale, purchase, or
trade of the drug (including the date of transmission
and the names and addresses of all parties to the
transaction); and
``(B) create, maintain for 2 years, and make available to
the Secretary for inspection at reasonable time, records that--
``(i) with respect to each wholesale distribution
of a drug subject to subsection (b), identifies--
``(I) the immediately previous distributor
of record from which the drug was purchased;
and
``(II) the immediately subsequent
distributor of record to which the drug was
sold or otherwise transferred; and
``(ii) with respect to a drug subject to subsection
(b) that is imported to the United States, identifies--
``(I) each previous distributor of record
from which the drug was purchased or otherwise
transferred; and
``(II) each subsequent distributor of
record to which the drug was sold or otherwise
transferred, to the extent feasible.''.
(b) Electronic Track and Trace Technology.--Not later than December
31, 2007, the Secretary of Health and Human Services shall require the
adoption and use of electronic track and trace technology for a
prescription drug at the case and pallet level that will identify each
sale, purchase, or trade of that case or pallet (including the date of
transmission and the names and addresses of all parties to the
transaction) .
(c) Distributors of Record.--Section 503(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 353(e)) is amended by striking
paragraph (3) and inserting the following:
``(3) For the purposes of this subsection and subsection (d)--
``(A) the term `distributor of record'--
``(i) means a person that takes title to or
possession of a drug subject to subsection (b) from
manufacture to retail sale;
``(ii) includes a person that manufacturers,
processes, packs, distributes, receives, holds,
imports, or offers for importation a drug subject to
subsection (b); and
``(iii) does not include a transporter;
``(B) the term `transporter' means the United States Postal
Service, or equivalent governmental service of a foreign
country, or a private carrier engaged in the business of
transporting packages for hire; and
``(C) the term `wholesale distribution' means the
distribution of a drug subject to subsection (b) to other than
the consumer or patient but not including an intracompany sale
or distribution of a drug described in subsection (c)(3)(B).''.
(d) Anticounterfeiting Programs.--Section 503(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) is amended by adding at
the end the following:
``(4) The Secretary shall--
``(A) establish a network to be known as the `Counterfeit
Alert Network' for the purpose of providing prompt notification
to health professionals and the public of counterfeit drugs
subject to subsection (b);
``(B)(i) develop and publish an Internet accessible-
reference document to facilitate the positive identification by
health professionals and regulatory agency personnel of
prescription drugs marketed in the United States and Canada;
and
``(ii) update the materials described under clause (i)
quarterly and when a new permitted country is designated by the
Secretary;
``(C) develop and publish educational materials to health
professionals and consumers identify and report cases of
counterfeit drugs subject to subsection (b);
``(D) develop and publish secure business practice
guidelines for the sale and distribution of such drugs in
cooperation with members of a drug supply chain; and
``(E) in cooperation with the National Association of
Boards of Pharmacy, develop and publish revised model rules for
licensure of drug wholesalers for adoption by the States.''.
SEC. 16. CONFORMING AMENDMENTS.
(a) Section 1006 of the Controlled Substances Import and Export
Act (21 U.S.C. 956) is repealed.
(b) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) is amended--
(1) in section 301(aa)--
(A) by striking ``section 804'' and inserting
``subchapter B of chapter VIII''; and
(B) by striking ``such section'' each place it
appears and inserting ``that subchapter'';
(2) in section 801(d)(1), by striking ``section 804'' and
inserting ``subchapter B''; and
(3) by striking section 804.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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