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‘‘(2) HOME PAGE.—The term ‘home page’ means the
entry point or main web page for an Internet site.
‘‘(3) INTERNET.—The term ‘Internet’ means collec-
tively the myriad of computer and telecommunications fa-
cilities, including equipment and operating software, which
comprise the interconnected worldwide 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, including electronic mail.
‘‘(4) INTERSTATE INTERNET SELLER.—
‘‘(A) IN GENERAL.—The term ‘interstate Internet
seller’ means a person whether in the United States or
abroad, that engages in, offers to engage in, or causes
the delivery or sale of a prescription drug through the
Internet and has such drug delivered directly to the
consumer via the Postal Service, or any private or com-
mercial interstate carrier to a consumer in the United
States who is residing in a State other than the State
in which the seller’s place of business is located. This
definition excludes a person who only delivers a pre-
scription drug to a consumer, such as an interstate car-
rier service.
‘‘(B) EXEMPTION.—With respect to the consumer
involved, the term ‘interstate Internet seller’ does not
include a person described in subparagraph (A) whose
place of business is located within 75 miles of the con-
sumer.
‘‘(5) LINK.—The term ‘link’ means either a textual or
graphical marker on a web page that, when clicked on,
takes the consumer to another part of the Internet, such
as to another web page or a different area on the same web
page, or from an electronic message to a web page.
‘‘(6) PHARMACY.—The term ‘pharmacy’ means any
place licensed or otherwise authorized as a pharmacy under
State law.
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‘‘(7) PRESCRIBER.—The term ‘prescriber’ means an
individual, licensed or otherwise authorized under applica-
ble Federal and State law to issue prescriptions for pre-
scription drugs.
‘‘(8) PRESCRIPTION
DRUG.—The term ‘prescription
drug’ means a drug under section 503(b)(1).
‘‘(9) VALID PRESCRIPTION.—The term ‘valid prescrip-
tion’ means a prescription that meets the requirements of
section 503(b)(1) and other applicable Federal and State
law.
‘‘(10) WEB
SITE; SITE.—The terms ‘web site’ and
‘site’ mean a specific location on the Internet that is deter-
mined by Internet protocol numbers or by a domain name.
‘‘(b) REQUIREMENTS FOR INTERSTATE INTERNET SELL-
ERS.—
‘‘(1) IN
GENERAL.—Each interstate Internet seller
shall comply with the requirements of this subsection with
respect to the sale of, or the offer to sell, prescription drugs
through the Internet and shall at all times display on its
web site information in accordance with paragraph (2).
‘‘(2) WEB SITE DISCLOSURE INFORMATION.—An inter-
state Internet seller shall post in a visible and clear manner
(as determined by regulation) on the home page of its web
site, or on a page directly linked to such home page—
‘‘(A) the street address of the interstate Internet
seller’s place of business, and the telephone number of
such place of business;
‘‘(B) each State in which the interstate Internet
seller is licensed or otherwise authorized as a phar-
macy, or if the interstate Internet seller is not licensed
or otherwise authorized by a State as a pharmacy, each
State in which the interstate Internet seller is licensed
or otherwise authorized to dispense prescription drugs,
and the type of State license or authorization;
‘‘(C) in the case of an interstate Internet seller
that makes referrals to or solicits on behalf of a pre-
scriber, the name of each prescriber, the street address
242
of each such prescriber’s place of business, the tele-
phone number of such place of business, each State in
which each such prescriber is licensed or otherwise au-
thorized to prescribe prescription drugs, and the type
of such license or authorization; and
‘‘(D) a statement that the interstate Internet sell-
er will dispense prescription drugs only upon a valid
prescription.
‘‘(3) DATE OF POSTING.—Information required to be
posted under paragraph (2) shall be posted by an interstate
Internet seller—
‘‘(A) not later than 90 days after the effective date
of this section if the web site of such seller is in oper-
ation as of such date; or
‘‘(B) on the date of the first day of operation of
such seller’s web site if such site goes into operation
after such date.
‘‘(4) QUALIFYING STATEMENTS.—An interstate Inter-
net seller shall not indicate in any manner that posting dis-
closure information on its web site signifies that the Fed-
eral Government has made any determination on the legit-
imacy of the interstate Internet seller or its business.
‘‘(5) DISCLOSURE TO STATE LICENSING BOARDS.—An
interstate Internet seller licensed or otherwise authorized to
dispense prescription drugs in accordance with applicable
State law shall notify each State entity that granted such
licensure or authorization that it is an interstate Internet
seller, the name of its business, the Internet address of its
business, the street address of its place of business, and the
telephone number of such place of business.
‘‘(6) REGULATIONS.—The Secretary is authorized to
promulgate such regulations as are necessary to carry out
the provisions of this subsection. In issuing such regula-
tions, the Secretary—
‘‘(A) shall take into consideration disclosure for-
mats used by existing interstate Internet seller certifi-
cation programs; and
243
‘‘(B) shall in defining the term ‘place of business’
include provisions providing that such place is a single
location at which employees of the business perform job
functions, and not a post office box or similar locale.’’.
(b) PROHIBITED ACTS.—Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding
at the end the following:
‘‘(bb) The failure to post information required under sec-
tion 503B(b)(2) or for knowingly making a materially false
statement when posting such information as required under
such section or violating section 503B(b)(4).’’.
SEC. 913. PUBLIC EDUCATION.
The Secretary of Health and Human Services shall engage
in activities to educate the public about the dangers of pur-
chasing prescription drugs from unlawful Internet sources. The
Secretary should educate the public about effective public and
private sector consumer protection efforts, as appropriate, with
input from the public and private sectors, as appropriate.
SEC. 914. STUDY REGARDING COORDINATION OF REGU-
LATORY ACTIVITIES.
Not later than 180 days after the date of enactment of
this Act, the Secretary of Health and Human Services, after
consultation with the Attorney General, shall submit to Con-
gress a report providing recommendations for coordinating the
activities of Federal agencies regarding interstate Internet sell-
ers that operate from foreign countries and for coordinating the
activities of the Federal Government with the activities of gov-
ernments of foreign countries regarding such interstate Inter-
net sellers.
SEC. 915. EFFECTIVE DATE.
The amendments made by this subtitle shall take effect 1
year after the date of enactment of this Act, except that the
authority of the Secretary of Health and Human Services to
commence the process of rulemaking is effective on the date of
enactment of this Act.
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Subtitle C—Promotion of Electronic
Prescription
SEC. 921. PROGRAM OF GRANTS TO HEALTH CARE PRO-
VIDERS TO IMPLEMENT ELECTRONIC PRE-
SCRIPTION DRUG PROGRAMS.
Part P of title III of the Public Health Service Act is
amended by inserting after section 399N the following new sec-
tion:
‘‘SEC. 399O. GRANTS TO HEALTH CARE PROVIDERS TO
IMPLEMENT 
ELECTRONIC 
PRESCRIPTION
DRUG PROGRAMS
‘‘(a) IN GENERAL.—The Secretary is authorized to make
grants for the purpose of assisting health care providers who
prescribe drugs and biologicals in implementing electronic pre-
scription programs described in section 1860C(d)(3) of the So-
cial Security Act.
‘‘(b) APPLICATION.—No grant may be made under this
section except pursuant to a grant application that is submitted
in a time, manner, and form approved by the Secretary.
‘‘(c) AUTHORIZATION
OF APPROPRIATIONS.—There are
authorized to be appropriated for fiscal year 2004, such sums
as may be appropriate to carry out this section.’’.
Subtitle D—Treatment of Rare
Diseases
SEC. 931. NIH OFFICE OF RARE DISEASES AT NATIONAL
INSTITUTES OF HEALTH.
Title IV of the Public Health Service Act (42 U.S.C. 281
et seq.), as amended by Public Law 107–84, is amended by in-
serting after section 404E the following:
‘‘OFFICE OF RARE DISEASES
‘‘SEC. 404F. (a) ESTABLISHMENT.—There is established
within the Office of the Director of NIH an office to be known
as the Office of Rare Diseases (in this section referred to as
the ‘Office’), which shall be headed by a Director (in this sec-
tion referred to as the ‘Director’), appointed by the Director of
NIH.
‘‘(b) DUTIES.—