Internet Pharmacy Consumer Protection Act or the Ryan Haight Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to prohibit any person from dispensing a prescription drug pursuant to a sale if: (1) any part of the transaction is conducted through an Internet site; (2) the person dispenses the drug by mailing or shipping the drug to the purchaser; and (3) such site fails to provide the identities and licensing information of the seller, pharmacists, or medical consultants.
Prohibits a person from selling or dispensing a prescription drug if: (1) the purchaser communicated with the person through the Internet; (2) the purchaser did not have a valid prescription when the communication began; (3) the person provided for the involvement of a practitioner; (4) the practitioner issued a prescription for the drug that was purchased; (5) the person knew that no qualifying medical relationship existed (defines "qualifying medical relationship" as requiring an in-person medical evaluation or a medical evaluation as a covering practitioner); and (6) the person received payment. Excludes certain acts involving telemedicine, group practices, and practices that promote the public health.
Allows States to bring civil actions against a person for violations of this Act.
Prevents Internet providers from being held liable for dispensing or selling prescriptions drugs on account of another person's activities.
Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under FFDCA.
Requires the Secretary of Health and Human Services to award a grant or contract to the National Clearinghouse on Internet Prescribing to identify and report Internet sites that violate Federal or State laws concerning the dispensing of drugs.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 399 Introduced in Senate (IS)]
109th CONGRESS
1st Session
S. 399
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
sale of prescription drugs through the Internet, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 16, 2005
Mr. Coleman (for himself and Mrs. Feinstein) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
sale of prescription drugs through the Internet, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Internet Pharmacy Consumer
Protection Act'' or the ``Ryan Haight Act''.
SEC. 2. INTERNET SALES OF PRESCRIPTION DRUGS.
(a) In General.--Chapter 5 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A
the following section:
``SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.
``(a) Requirements Regarding Information on Internet Site.--
``(1) In general.--A person may not dispense a prescription
drug pursuant to a sale of the drug by such person if--
``(A) the purchaser of the drug submitted the
purchase order for the drug, or conducted any other
part of the sales transaction for the drug, through an
Internet site;
``(B) the person dispenses the drug to the
purchaser by mailing or shipping the drug to the
purchaser; and
``(C) such site, or any other Internet site used by
such person for purposes of sales of a prescription
drug, fails to meet each of the requirements specified
in paragraph (2), other than a site or pages on a site
that--
``(i) are not intended to be accessed by
purchasers or prospective purchasers; or
``(ii) provide an Internet information
location tool within the meaning of section
231(e)(5) of the Communications Act of 1934 (47
U.S.C. 231(e)(5)).
``(2) Requirements.--With respect to an Internet site, the
requirements referred to in subparagraph (C) of paragraph (1)
for a person to whom such paragraph applies are as follows:
``(A) Each page of the site shall include either
the following information or a link to a page that
provides the following information:
``(i) The name of such person.
``(ii) Each State in which the person is
authorized by law to dispense prescription
drugs.
``(iii) The address and telephone number of
each place of business of the person with
respect to sales of prescription drugs through
the Internet, other than a place of business
that does not mail or ship prescription drugs
to purchasers.
``(iv) The name of each individual who
serves as a pharmacist for prescription drugs
that are mailed or shipped pursuant to the
site, and each State in which the individual is
authorized by law to dispense prescription
drugs.
``(v) If the person provides for medical
consultations through the site for purposes of
providing prescriptions, the name of each
individual who provides such consultations;
each State in which the individual is licensed
or otherwise authorized by law to provide such
consultations or practice medicine; and the
type or types of health professions for which
the individual holds such licenses or other
authorizations.
``(B) A link to which paragraph (1) applies shall
be displayed in a clear and prominent place and manner,
and shall include in the caption for the link the words
`licensing and contact information'.
``(b) Internet Sales Without Appropriate Medical Relationships.--
``(1) In general.--Except as provided in paragraph (2), a
person may not dispense a prescription drug, or sell such a
drug, if--
``(A) for purposes of such dispensing or sale, the
purchaser communicated with the person through the
Internet;
``(B) the patient for whom the drug was dispensed
or purchased did not, when such communications began,
have a prescription for the drug that is valid in the
United States;
``(C) pursuant to such communications, the person
provided for the involvement of a practitioner, or an
individual represented by the person as a practitioner,
and the practitioner or such individual issued a
prescription for the drug that was purchased;
``(D) the person knew, or had reason to know, that
the practitioner or the individual referred to in
subparagraph (C) did not, when issuing the
prescription, have a qualifying medical relationship
with the patient; and
``(E) the person received payment for the
dispensing or sale of the drug.
For purposes of subparagraph (E), payment is received if money
or other valuable consideration is received.
``(2) Exceptions.--Paragraph (1) does not apply to--
``(A) the dispensing or selling of a prescription
drug pursuant to telemedicine practices sponsored by--
``(i) a hospital that has in effect a
provider agreement under title XVIII of the
Social Security Act (relating to the Medicare
program); or
``(ii) a group practice that has not fewer
than 100 physicians who have in effect provider
agreements under such title; or
``(B) the dispensing or selling of a prescription
drug pursuant to practices that promote the public
health, as determined by the Secretary by regulation.
``(3) Qualifying medical relationship.--
``(A) In general.--With respect to issuing a
prescription for a drug for a patient, a practitioner
has a qualifying medical relationship with the patient
for purposes of this section if--
``(i) at least one in-person medical
evaluation of the patient has been conducted by
the practitioner; or
``(ii) the practitioner conducts a medical
evaluation of the patient as a covering
practitioner.
``(B) In-person medical evaluation.--A medical
evaluation by a practitioner is an in-person medical
evaluation for purposes of this section if the
practitioner is in the physical presence of the patient
as part of conducting the evaluation, without regard to
whether portions of the evaluation are conducted by
other health professionals.
``(C) Covering practitioner.--With respect to a
patient, a practitioner is a covering practitioner for
purposes of this section if the practitioner conducts a
medical evaluation of the patient at the request of a
practitioner who has conducted at least one in-person
medical evaluation of the patient and is temporarily
unavailable to conduct the evaluation of the patient. A
practitioner is a covering practitioner without regard
to whether the practitioner has conducted any in-person
medical evaluation of the patient involved.
``(4) Rules of construction.--
``(A) Individuals represented as practitioners.--A
person who is not a practitioner (as defined in
subsection (d)(1)) lacks legal capacity under this
section to have a qualifying medical relationship with
any patient.
``(B) Standard practice of pharmacy.--Paragraph (1)
may not be construed as prohibiting any conduct that is
a standard practice in the practice of pharmacy.
``(C) Applicability of requirements.--Paragraph (3)
may not be construed as having any applicability beyond
this section, and does not affect any State law, or
interpretation of State law, concerning the practice of
medicine.
``(c) Actions by States.--
``(1) In general.--Whenever an attorney general of any
State has reason to believe that the interests of the residents
of that State have been or are being threatened or adversely
affected because any person has engaged or is engaging in a
pattern or practice that violates section 301(l), the State may
bring a civil action on behalf of its residents in an
appropriate district court of the United States to enjoin such
practice, to enforce compliance with such section (including a
nationwide injunction), to obtain damages, restitution, or
other compensation on behalf of residents of such State, to
obtain reasonable attorneys fees and costs if the State
prevails in the civil action, or to obtain such further and
other relief as the court may deem appropriate.
``(2) Notice.--The State shall serve prior written notice
of any civil action under paragraph (1) or (5)(B) upon the
Secretary and provide the Secretary with a copy of its
complaint, except that if it is not feasible for the State to
provide such prior notice, the State shall serve such notice
immediately upon instituting such action. Upon receiving a
notice respecting a civil action, the Secretary shall have the
right--
``(A) to intervene in such action;
``(B) upon so intervening, to be heard on all
matters arising therein; and
``(C) to file petitions for appeal.
``(3) Construction.--For purposes of bringing any civil
action under paragraph (1), nothing in this chapter shall
prevent an attorney general of a State from exercising the
powers conferred on the attorney general by the laws of such
State to conduct investigations or to administer oaths or
affirmations or to compel the attendance of witnesses or the
production of documentary and other evidence.
``(4) Venue; service of process.--Any civil action brought
under paragraph (1) in a district court of the United States
may be brought in the district in which the defendant is found,
is an inhabitant, or transacts business or wherever venue is
proper under section 1391 of title 28, United States Code.
Process in such an action may be served in any district in
which the defendant is an inhabitant or in which the defendant
may be found.
``(5) Actions by other state officials.--
``(A) Nothing contained in this section shall
prohibit an authorized State official from proceeding
in State court on the basis of an alleged violation of
any civil or criminal statute of such State.
``(B) In addition to actions brought by an attorney
general of a State under paragraph (1), such an action
may be brought by officers of such State who are
authorized by the State to bring actions in such State
on behalf of its residents.
``(d) General Definitions.--For purposes of this section:
``(1) The term `practitioner' means a practitioner referred
to in section 503(b)(1) with respect to issuing a written or
oral prescription.
``(2) The term `prescription drug' means a drug that is
subject to section 503(b)(1).
``(3) The term `qualifying medical relationship', with
respect to a practitioner and a patient, has the meaning
indicated for such term in subsection (b).
``(e) Internet-Related Definitions.--
``(1) In general.--For purposes of this section:
``(A) The term `Internet' means collectively the
myriad of computer and telecommunications facilities,
including equipment and operating software, which
comprise the interconnected world-wide network of
networks that employ the transmission control protocol/
internet protocol, or any predecessor or successor
protocols to such protocol, to communicate information
of all kinds by wire or radio.
``(B) The term `link', with respect to the
Internet, means one or more letters, words, numbers,
symbols, or graphic items that appear on a page of an
Internet site for the purpose of serving, when
activated, as a method for executing an electronic
command--
``(i) to move from viewing one portion of a
page on such site to another portion of the
page;
``(ii) to move from viewing one page on
such site to another page on such site; or
``(iii) to move from viewing a page on one
Internet site to a page on another Internet
site.
``(C) The term `page', with respect to the
Internet, means a document or other file accessed at an
Internet site.
``(D)(i) The terms `site' and `address', with
respect to the Internet, mean a specific location on
the Internet that is determined by Internet Protocol
numbers. Such term includes the domain name, if any.
``(ii) The term `domain name' means a method of
representing an Internet address without direct
reference to the Internet Protocol numbers for the
address, including methods that use designations such
as `.com', `.edu', `.gov', `.net', or `.org'.
``(iii) The term `Internet Protocol numbers'
includes any successor protocol for determining a
specific location on the Internet.
``(2) Authority of secretary.--The Secretary may by
regulation modify any definition under paragraph (1) to take
into account changes in technology.
``(f) Interactive Computer Service; Advertising.--No provider of an
interactive computer service, as defined in section 230(f)(2) of the
Communications Act of 1934 (47 U.S.C. 230(f)(2)), or of advertising
services 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 such drugs, provided that the provider
of the interactive computer service or of advertising services does not
own or exercise corporate control over such person.''.
(b) Inclusion as Prohibited Act.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by inserting after
paragraph (k) the following:
``(l) The dispensing or selling of a prescription drug in violation
of section 503B.''.
(c) Internet Sales of Prescription Drugs; Consideration by
Secretary of Practices and Procedures for Certification of Legitimate
Businesses.--In carrying out section 503B of the Federal Food, Drug,
and Cosmetic Act (as added by subsection (a) of this section), the
Secretary of Health and Human Services shall take into consideration
the practices and procedures of public or private entities that certify
that businesses selling prescription drugs through Internet sites are
legitimate businesses, including practices and procedures regarding
disclosure formats and verification programs.
(d) Reports Regarding Internet-Related Violations of State and
Federal Laws on Dispensing of Drugs.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary'') shall,
pursuant to the submission of an application meeting the
criteria of the Secretary, make an award of a grant or contract
to the National Clearinghouse on Internet Prescribing (operated
by the Federation of State Medical Boards) for the purpose of--
(A) identifying Internet sites that appear to be in
violation of State or Federal laws concerning the
dispensing of drugs;
(B) reporting such sites to State medical licensing
boards and State pharmacy licensing boards, and to the
Attorney General and the Secretary, for further
investigation; and
(C) 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 subparagraph (A).
(2) Authorization of appropriations.--For the purpose of
carrying out paragraph (1), there is authorized to be
appropriated $100,000 for each of the fiscal years 2005 through
2007.
(e) Effective Date.--The amendments made by subsections (a) and (b)
take effect upon the expiration of the 60-day period beginning on the
date of the enactment of this Act, without regard to whether a final
rule to implement such amendments has been promulgated by the Secretary
of Health and Human Services under section 701(a) of the Federal Food,
Drug, and Cosmetic Act. The preceding sentence may not be construed as
affecting the authority of such Secretary to promulgate such a final
rule.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S1531-1532)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1532-1534)
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