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 sales transaction for the drug is conducted through an Internet site; and (2) such site fails to meet specified requirements regarding inclusion of a page (and links thereto) providing 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); and (6) the person received payment.
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 the 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 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2464 Introduced in Senate (IS)]
108th CONGRESS
2d Session
S. 2464
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
sale of prescription drugs through the Internet.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 20, 2004
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.
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:
``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; and
``(B) 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 are not intended to be accessed by purchasers or
prospective purchasers or that 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 (B) 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; the address
of the principal place of business of the
person with respect to sales of prescription
drugs through the Internet; and the telephone
number for such place of business.
``(ii) Each State in which the person is
authorized by law to dispense prescription
drugs.
``(iii) The name of each individual who
serves as a pharmacist for purposes of the
site; and each State in which the individual is
authorized by law to dispense prescription
drugs.
``(iv) 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.--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) 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 at least 1 in-person
medical evaluation of the patient has been conducted by
the 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.
``(3) Rules of construction.--
``(A) Individuals represented as practitioners.--A
person who is not a practitioner (as defined in
subsection (e)(1)) lacks legal capacity under this
section to have a qualifying medical relationship with
any patient.
``(B) Applicability of requirements.--Paragraph (2)
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) 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) 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.--
``(A) Venue.--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.
``(B) Service of process.--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) Effect of section.--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) Additional action.--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) 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.
``(e) Definitions.--For purposes of this section:
``(1) Practitioner.--The term `practitioner' means a
practitioner referred to in section 503(b)(1) with respect to
issuing a written or oral prescription.
``(2) Prescription drug.--The term `prescription drug'
means a drug that is subject to section 503(b)(1).
``(3) Qualifying medical relationship.--The term
`qualifying medical relationship', with respect to a
practitioner and a patient, has the meaning indicated for such
term in subsection (b).''.
(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)), 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) 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 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 (21 U.S.C. 371(a)). The preceding sentence may
not be construed as affecting the authority of such Secretary to
promulgate such a final rule.
SEC. 3. REPORTS REGARDING INTERNET-RELATED VIOLATIONS OF FEDERAL AND
STATE LAWS ON DISPENSING OF DRUGS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall, pursuant to
the submission of an application meeting the criteria of the Secretary,
award a grant or contract to the National Clearinghouse on Internet
Prescribing (operated by the Federation of State Medical Boards) for
the purpose of--
(1) identifying Internet sites that appear to be in
violation of Federal or State laws concerning the dispensing of
drugs;
(2) 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
(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) Authorization of Appropriations.--For the purpose of carrying
out subsection (a), there is authorized to be appropriated $100,000 for
each of the fiscal years 2004 through 2006.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S5983-5984)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line