IB
Union Calendar No. 327
107TH CONGRESS
2D SESSION
H. R. 4990
[Report No. 107–546]
To amend the Federal Food, Drug, and Cosmetic Act to establish require-
ments with respect to the sale of, or the offer to sell, prescription
drugs through the Internet, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JUNE 21, 2002
Mr. TAUZIN introduced the following bill; which was referred to the Committee
on Energy and Commerce
JUNE 26, 2002
Committed to the Committee of the Whole House on the State of the Union
and ordered to be printed
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
establish requirements with respect to the sale of, or
the offer to sell, prescription drugs through the Internet,
and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
Subtitle B—Internet Pharmacies
SEC. 911. FINDINGS.
The Congress finds as follows:
(1) Legitimate Internet sellers of prescription
drugs can offer substantial benefits to consumers.
These potential benefits include convenience, pri-
vacy, valuable information, competitive prices, and
personalized services.
(2) Unlawful Internet sellers of prescription
drugs may dispense inappropriate, contaminated,
counterfeit, or subpotent prescription drugs that
could put at risk the health and safety of consumers.
(3) Unlawful Internet sellers have exposed con-
sumers to significant health risks by knowingly fill-
ing invalid prescriptions, such as prescriptions based
solely on an online questionnaire, or by dispensing
prescription drugs without any prescription.
(4) Consumers may have difficulty distin-
guishing legitimate from unlawful Internet sellers, as
well as foreign from domestic Internet sellers, of
prescription drugs.
SEC. 912. AMENDMENT TO FEDERAL FOOD, DRUG, AND
COSMETIC ACT.
(a) IN GENERAL.—Chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 503A the following:
‘‘SEC. 503B. INTERNET PRESCRIPTION DRUG SALES.
‘‘(a) DEFINITIONS.—For purposes of this section:
‘‘(1) CONSUMER.—The term ‘consumer’ means
a person (other than an entity licensed or otherwise
authorized under Federal or State law as a phar-
macy or to dispense or distribute prescription drugs)
that purchases or seeks to purchase prescription
drugs through the Internet.
‘‘(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
collectively the myriad of computer and tele-
communications facilities, including equipment and
operating software, which comprise the inter-
connected worldwide network of networks that em-
ploy 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 con-
sumer via the Postal Service, or any private or
commercial 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 prescription drug
to a consumer, such as an interstate carrier
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 lo-
cated within 75 miles of the consumer.
‘‘(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 phar-
macy under State law.
‘‘(7) 
PRESCRIBER.—The 
term 
‘prescriber’
means an individual, licensed or otherwise author-
ized under applicable Federal and State law to issue
prescriptions for prescription drugs.
‘‘(8) PRESCRIPTION
DRUG.—The term ‘pre-
scription drug’ means a drug under section
503(b)(1).
‘‘(9) VALID
PRESCRIPTION.—The term ‘valid
prescription’ means a prescription that meets the re-
quirements 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 determined by Internet protocol numbers or
by a domain name.
‘‘(b) REQUIREMENTS FOR INTERSTATE INTERNET
SELLERS.—
‘‘(1) IN
GENERAL.—Each interstate Internet
seller shall comply with the requirements of this sub-
section 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 interstate 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 tele-
phone number of such place of business;
‘‘(B) each State in which the interstate
Internet seller is licensed or otherwise author-
ized as a pharmacy, 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 be-
half of a prescriber, the name of each pre-
scriber, the street address of each such pre-
scriber’s place of business, the telephone num-
ber of such place of business, each State in
which each such prescriber is licensed or other-
wise authorized to prescribe prescription drugs,
and the type of such license or authorization;
and
‘‘(D) a statement that the interstate Inter-
net seller 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 effec-
tive date of this section if the web site of such
seller is in operation as of such date; or
‘‘(B) on the date of the first day of oper-
ation of such seller’s web site if such site goes
into operation after such date.
‘‘(4) QUALIFYING STATEMENTS.—An interstate
Internet seller shall not indicate in any manner that
posting disclosure information on its web site sig-
nifies that the Federal Government has made any
determination on the legitimacy 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 au-
thorization 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 author-
ized to promulgate such regulations as are necessary
to carry out the provisions of this subsection. In
issuing such regulations, the Secretary—
‘‘(A) shall take into consideration disclo-
sure formats used by existing interstate Inter-
net seller certification programs; and
‘‘(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 amend-
ed by adding at the end the following:
‘‘(bb) The failure to post information required under
section 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 dan-
gers of purchasing prescription drugs from unlawful Inter-
net sources. The Secretary should educate the public
about effective public and private sector consumer protec-
tion 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 Congress a report providing recommendations for co-
ordinating the activities of Federal agencies regarding
interstate Internet sellers that operate from foreign coun-
tries and for coordinating the activities of the Federal
Government with the activities of governments of foreign
countries regarding such interstate Internet sellers.
SEC. 915. EFFECTIVE DATE.
The amendments made by this subtitle shall take ef-
fect 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 effec-
tive on the date of enactment of this Act.
Union Calendar No. 327
107TH CONGRESS
2D SESSION
H. R. 4990
[Report No. 107–546]
A BILL
To amend the Federal Food, Drug, and Cosmetic
Act to establish requirements with respect to the
sale of, or the offer to sell, prescription drugs
through the Internet, and for other purposes.
JUNE 26, 2002
Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed