1.
Short title; table of contents
(a)
This Act may be cited as the
Safe Importation of Medical Products
and Other Rx Therapies Act of 2005
or the
Safe IMPORT Act of
2005
.
(b)
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.
2.
(a)
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:
A
;
and
(2)
by adding at the end the
following:
B
Importation of prescription drugs
811.
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)
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)
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)
(A)
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)
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)
The Secretary may determine
whether to designate a permitted country at any time after submission of the
report under subparagraph (B).
(5)
(A)
The term prescription
drug means a drug described in section 503(b) that is approved by the
Secretary under section 505.
(B)
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)
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)
(A)
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)
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.
812.
(a)
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)
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)
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.
813.
Pharmacy and wholesaler importation of prescription
drugs
(a)
(1)
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)
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)
(1)
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)
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)
(A)
The Secretary shall
maintain an updated list of applications pending, applications approved, and
applications denied under this subsection.
(B)
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)
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)
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)
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)
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)
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)
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)
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)
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)
(1)
(A)
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)
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)
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)
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)
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.
.
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
.
4.
(a)
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:
511.
(a)
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)
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)
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)
The term prescription
drug means a drug described in section 503(b) that is approved by the
Secretary under section 505.
(5)
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)
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)
(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)
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)
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)
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)
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)
(A)
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)
(A)
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)
(i)
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)
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)
(A)
The Secretary shall
compile, maintain, and periodically update a list of licensees.
(B)
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)
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)
(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)
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)
(i)
Not later than 60 days
before the beginning of each fiscal year beginning after September 30, 2005,
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)
The licensing fees
collected under this section shall be used, without further appropriation, to
carry out this section.
(E)
(i)
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)
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)
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)
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)
(A)
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)
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)
The Secretary may award a
contract under this subsection for the operation of the licensing
program.
(B)
The duration of a contract
under subparagraph (A) shall not exceed 5 years and may be renewable.
(C)
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)
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)
(A)
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)
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)
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)
(1)
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)
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)
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.
.
5.
Administrative detention and temporary hold
(a)
The
Federal Food, Drug, and Cosmetic Act
is amended by adding after section 815 (as added by section 9) the
following:
816.
(a)
Administrative detention of prescription drugs
(1)
(A)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
(A)
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)
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)
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)
A prescription drug held
under paragraph (1) shall be removed to a secure facility, as
appropriate.
(5)
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)
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)
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.
.
6.
(a)
The
Federal Food, Drug, and Cosmetic Act
is amended by adding after section 816 (as added by section 5) the
following:
817.
Suspension of importation
(a)
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)
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)
(A)
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)
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)
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)
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)
An order under this section
shall not be subject to judicial review.
(f)
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)
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.
.
7.
Debarment for repeated or serious prescription drug importation
violations
(a)
(1)
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)
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)
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)
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)
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)
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)
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)
A prescription drug held
under this subsection shall be removed to a secure facility, as
appropriate.
(4)
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)
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.
.
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:
814.
Registration of certain importers
(a)
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)
(1)
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)
The registrant shall notify
the Secretary in a timely manner of any change in the information provided
under paragraph (1).
(3)
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)
(A)
The Secretary shall
compile, maintain, and periodically update a list of registrants.
(B)
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)
(1)
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)
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)
(1)
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)
(1)
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)
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)
(1)
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)
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)
A prescription drug held
under this subsection shall be removed to a secure facility, as
appropriate.
(4)
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)
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.
.
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:
815.
Maintenance and inspection of records for prescription
drugs
(a)
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)
(1)
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)
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)
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.
.
10.
Advance notice of imported prescription drug shipments
(a)
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)
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)
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)
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)
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)
A prescription drug held
under this subsection shall be removed to a secure facility, as
appropriate.
(7)
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)
(A)
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)
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).
.
11.
Authority to mark prescription drugs refused admission into the
United States
(a)
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)
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)
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)
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)
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)
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.
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)
(1)
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)
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.
.
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 2005
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 2005.
(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.
.
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:
5
Fees relating to prescription drug importation
740A.
Fees relating to prescription drug importation
(a)
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)
(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)
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)
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 2005 in the subsequent fiscal year.
(d)
The fees collected under
this section shall be used, without further appropriation, to enforce the
amendments made by the Safe IMPORT Act of 2005.
(e)
The Secretary shall
establish, 60 days before the beginning of each fiscal year beginning after
September 30, 2005, for that fiscal year, registration fees.
(f)
Effect of failure To pay fees
(1)
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)
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)
(1)
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
2006, 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.
.
15.
Anticounterfeiting provisions
(a)
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)
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.
.
16.
(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.