1.Short title; table of
contentsThis Act may be cited
as the Safe Internet Pharmacy Act of
2007
.
2.
(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 providerThe 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 described in subparagraph (B) to effect a credit
transaction, electronic fund transfer, or money transmitting service that the
Board determines, by regulation or order, is regularly used in connection with,
or to facilitate restricted transactions.
(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)a participant in
an international, national, regional, or local network constructed primarily to
effect a credit transaction, electronic fund transfer, or money transmitting
service.
(3)Federal
functional regulatorThe 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 Internet pharmacy means a person
that offers to dispense or dispenses 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.
(5)The term prescription drug means a drug
described in section 503(b) that is approved by the Secretary under section
505.
(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 for the purpose
of 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 for the purpose of the unlawful Internet
request;
(C)a check, draft,
or similar instrument which is drawn by or on behalf of the individual for the
purpose of 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 Board by regulation)
that involves a financial institution as a payor or financial intermediary on
behalf of or for the benefit of the individual for the purpose of the unlawful
Internet request.
(7)The term treating provider means a health
care provider licensed in the United States who is authorized to prescribe
medications and who—
(A)(i)performs a documented
patient evaluation (including a patient history and physical examination) of an
individual, portions of which may be conducted by other health
professionals;
(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).
(8)Unlawful
internet pharmacy requestThe 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, telephone, or electronic mail, or by a means that
involves the use, in whole or in part, of the Internet.
(9)Unlicensed
internet pharmacyThe term unlicensed Internet
pharmacy means an Internet pharmacy that is not licensed under this
section.
(10)
(A)The
term Board means the Board of Governors of the Federal Reserve
System.
(B)Credit;
creditor; credit cardThe 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).
(C)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.
(D)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)).
(E)Money
transmitting business; money transmitting serviceThe terms
money transmitting business and money transmitting
service have the meanings 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)An Internet pharmacy shall be licensed by the Secretary
in accordance with this section prior to offering to dispense or 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
whose principal place of business is located outside the United States,
verification that—
- (aa)all employees and agents of the
Internet pharmacy are in compliance with applicable Federal and State laws
regarding the practice of pharmacy, including licensing laws and inspection
requirements;
- (bb)the Internet pharmacy is in
compliance with applicable Federal and State laws regarding the practice of
pharmacy, including licensing laws and inspection requirements;
- (cc)the Internet pharmacy expressly and
affirmatively agrees to provide and maintain an agent for service of process in
the United States;
- (dd)the Internet pharmacy expressly and
affirmatively agrees to be subject to the jurisdiction of the United States and
any of its States or territories where it engages in commerce; and
- (ee)the Internet pharmacy agrees to affix
to each shipping container of drugs to be shipped in the United States such
markings as the Secretary determines to be necessary to identify that the
shipment is from a licensed Internet pharmacy, which may include
anticounterfeiting or track-and-trace technologies;
(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;
(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;
(v)verification that
the Internet pharmacy expressly and affirmatively agrees to provide the
Secretary with the identity of any providers of interactive computer services
that provide host services or advertising services for the Internet pharmacy;
and
(vi)assurance that
the Internet pharmacy will comply with the requirements under subparagraphs (B)
and (C).
(B)Identification
requirementsAn Internet pharmacy shall post in a clear and
visible manner, 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 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 from a treating provider.
(v)A
distinctive tamper resistant seal to identify that the Internet pharmacy is
licensed.
(C)Professional
services requirementsAn 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.
(iv)Offer
interactive and meaningful consultation by a licensed pharmacist to the
caregiver or patient before and after 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.
(III)Submit those reports within 3 days of
receipt and the response of the Internet pharmacy to the Food and Drug
Administration in a manner determined appropriate by the Secretary.
(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 valid 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)If the prescription for any drug
other than a controlled substance (as defined in section 102 of the
Controlled Substances Act (21 U.S.C.
802)) is received from an individual or the treating provider of the individual
by mail (including a private carrier), or from the treating provider of the
individual by electronic mail, the validity of the prescription shall be
confirmed in accordance with all applicable Federal and State laws.
- (bb)If the prescription is for a
controlled substance (as defined in section 102 of the
Controlled Substances Act), the
validity of the prescription shall be confirmed with the treating provider as
described 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 complete licensing application from an
Internet pharmacy under paragraph (2), the Secretary shall—
(i)assign an
identification number to the Internet pharmacy;
(ii)notify the
applicant of the receipt of the licensing application; and
(iii)if the Internet
pharmacy is in compliance with the conditions under paragraph (2), issue a
license not later than 60 days after receipt of a licensing application from
the Internet pharmacy.
(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 licensing application required under this section
and provide for electronic methods of receiving the applications.
(ii)In
providing for the electronic submission of such licensing 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 database of the Internet pharmacies licensed under this
section.
(B)The
Secretary shall make the database 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)
(A)
(i)licensing
application feeThe Secretary shall establish a licensing
application fee to be paid by all applicants.
(ii)The Secretary shall establish a yearly renewal fee to be paid
by all Internet pharmacies licensed under this section.
(B)
(i)Collection of
licensing application feeA licensing application fee payable for
the fiscal year in which the Internet pharmacy submits a licensing application,
as established under subparagraph (C), shall be payable upon the submission to
the Secretary of such licensing application.
(ii)Collection of
renewal feesAfter the licensing application fee is paid for the
first fiscal year of licensure, the yearly renewal fee, as established under
subparagraph (C), shall be payable on or before October 1 of each subsequent
fiscal year.
(iii)One fee per
internet pharmacyThe licensing application fee and yearly
renewal fee shall be paid only once for each Internet pharmacy for a fiscal
year in which the fee is payable.
(C)The amount of the licensing application fee and the yearly
renewal fee for an Internet pharmacy 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.
(D)
(i)Not later than 60 days before the beginning of each
fiscal year beginning after September 30, 2007, the Secretary shall determine
the amount of the licensing application fee and the yearly renewal fee for that
fiscal year.
(ii)Publication of
fee amountNot later than 60 days before each fiscal year, the
Secretary shall publish the amount of the licensing application fee and the
yearly renewal 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
fees.
(E)The fees collected under this section shall be used, without
further appropriation, to carry out this section.
(F)
(i)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.
(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.
(G)Beginning
with fiscal year 2008, not later than 60 days after the end of each fiscal year
during which licensing application 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)
(A)If the Secretary determines that an Internet pharmacy is
engaged in a pattern of violations of any of the requirements of this Act, the
Secretary may immediately order the suspension of the license of the Internet
pharmacy.
(B)Appeal of
suspension orderAn Internet pharmacy subject to a suspension
order under subparagraph (A) may appeal the suspension order to the Secretary.
Not later than 30 days after an appeal is filed, the Secretary, after providing
opportunity for an informal hearing, shall affirm or terminate the
order.
(C)If, during the 30-day period specified in subparagraph (B),
the Secretary fails to provide an opportunity for a hearing or to affirm or
terminate the order, the order shall be deemed to be terminated.
(D)An order under this paragraph shall not be subject to
judicial review.
(7)The Secretary may terminate a license issued under this
subsection, after notice to the Internet pharmacy and an opportunity for a
hearing, and if the Secretary determines that the Internet pharmacy—
(A)has demonstrated
a pattern of noncompliance with this section;
(B)has made an
untrue statement of material fact in its licensing application; or
(C)is in violation
of any applicable Federal or State law relating to the dispensing of a
prescription drug.
(8)
(A)Before renewing a license of an Internet pharmacy under
this subsection, the Secretary shall conduct an evaluation to determine whether
the Internet pharmacy is in compliance with this section.
(B)Evaluation of
internet pharmaciesAt 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.
(9)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 ServicesNo 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
on account of another person’s selling or dispensing of a prescription drug, so
long as the provider of the interactive computer service or the advertising
service provider does not own or exercise corporate control over such
person.
(e)Policies and
Procedures Required To Prevent Payments for Unlawful Internet Pharmacy
Requests
(1)Not
later than 180 days after designating a system under subsection (a)(2), the
Board shall promulgate regulations that require—
(A)an operator of a
credit card system that is a designated payment system, an operator of an
international, national, or local network used to effect a credit transaction,
electronic fund transfer, or money transmitting service that is a designated
payment system, and an operator of any other designated payment system
specified by the Board that is centrally managed and is primarily engaged in
the transmission and settlement of credit transactions, electronic transfers,
or money transmitting services where at least 1 party to the transaction or
transfer is an individual; and
(B)in the case of a
designated payment system, other than a designated payment system described in
subparagraph (A), a person described in subsection (a)(2)(B);
to
establish policies and procedures that are reasonably designed to prevent the
introduction of restricted transactions into a designated payment system or the
completion of restricted transactions using a designated payment system.(2)Requirements
for policies and proceduresIn promulgating regulations under
paragraph (1), the Board 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
prevent the introduction of a restricted transaction in a designated payment or
the completion of restricted transactions using a designated payment system;
and
(B)to the extent
practicable, permit any designated payment system, or person described in
subsection (a)(2)(B), as applicable, to choose among alternative means of
preventing the introduction or completion of restricted transactions.
(3)No liability
for blocking or refusing to honor restricted transaction
(A)A designated payment system, or a person described in
subsection (a)(2)(B), that is subject to a regulation or an order issued under
this subsection, and any participant in such payment system, that—
(i)prevents or
otherwise refuses to honor restricted transactions, in an effort to implement
the policies and procedures required under this subsection or to otherwise
comply with this section, shall not be liable to any party for such action;
and
(ii)prevents or
otherwise refuses to honor a nonrestricted transaction in an effort to
implement the policies and procedures under this subsection or to otherwise
comply with this section, shall not be liable to any party for such
action.
(B)Compliance with
this subsectionA person described in subsection (a)(2)(B) meets
the requirements of this subsection, if any, if 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, and such
policies and procedures of the designated payment system comply with the
requirements of the regulations under paragraph (1)(B).
(4)
(A)This subsection 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 payment system or person knowingly permits restricted
transactions.
(ii)The history of
the payment system or person in connection with permitting restricted
transactions.
(iii)The extent to
which the payment system or 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 payment system or
person without substantial deviation from normal business practice.
(v)The costs and
burdens the specific remedy will have on the payment system or person.
(f)Reports
Regarding Internet-related Violations of Federal and State Laws on Dispensing
of DrugsThe 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).
(g)A designated payment system or person subject to a
regulation or an order issued under subsection (e) may engage in transactions
with licensed and unlicensed Internet pharmacies in connection with
investigating violations or potential violations of any rule or requirement
adopted by the payment system or person in connection with complying with
subsection (e). A person subject to a regulation or an order issued under
subsection (e) and the agents and employees of that person shall not be found
to be in violation of, or liable under, any Federal, State, or other law for
engaging in any such transaction.
(h)No requirement, prohibition, or liability may be
imposed on a designated payment system or person subject to a regulation or an
order issued under subsection (e) under the laws of any State with respect to
any payment transaction by an individual because the payment transaction
involves a payment to an Internet pharmacy.
(i)A designated payment system or a person subject to a
regulation under subsection (e) shall adopt policies and procedures reasonably
designed to comply with any regulations required under subsection (e) not later
than 180 days after the date on which such final regulations are
issued.
.
(b)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)(1)The sale, under section
511, of a drug that is not a prescription drug, the sale of such a prescription
drug without a valid prescription from a treating provider, or the ownership or
operation of an Internet pharmacy, in violation of section 511.
(2)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.
(3)The advertisement related to a
prescription drug through any media including sales presentation, direct
communication (including telephone, facsimile, or electronic mail), by an
unlicensed Internet pharmacy.
(4)The provision of an untrue statement
of material fact in the licensing application of an Internet pharmacy.
(5)For purposes of this subsection, any
term used in this subsection that is also used in section 511 shall have the
meaning given that term in section
511.
.
(c)Links to
unlicensed Internet pharmaciesSection 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 unlicensed Internet pharmacy (as
defined in such section 511), 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,
links 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;
(C)shall specify the provider to which
the relief applies; and
(D)shall specifically identify the
location of the website to be removed or to which access is to be
disabled.
.
(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 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 303 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 333) is amended by adding at the end the following:
(g)Notwithstanding
subsection (a), any person who knowingly violates paragraph (1), (2), (3), or
(4) of section 301(hh) shall be imprisoned for not more than 10 years or fined
in accordance with title 18, United States Code, or
both.
.