Internet sellers and the Federal agencies need addi-
tional enforcement tools to take effective action
against unlawful foreign Internet sellers.
(b) PURPOSE.—The purpose of this Act is to provide
Federal and State law enforcement with adequate tools to
take effective action against interstate Internet sellers of
prescription drugs who illegally sell such drugs to con-
sumers in the United States and to protect such con-
sumers against potential harms that may result from pur-
chasing such drugs from such sellers.
SEC. 3. AMENDMENT TO THE 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) STATE ENFORCEMENT OF FEDERAL LAW RE-
GARDING
INTERNET
SELLERS
OF
PRESCRIPTION
DRUGS.—Chapter III of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331 et seq.) is amended by add-
ing at the end the following:
‘‘STATE PROCEEDINGS REGARDING INTERNET SALES OF
PRESCRIPTION DRUGS
‘‘SEC. 310A. (a) IN GENERAL.—A State, through its
attorney general, may bring in its own name, and in an
appropriate district court of the United States, pro-
ceedings against an interstate Internet seller of a prescrip-
tion drug for the civil enforcement, or to restrain viola-
tions of section 503B(b), or paragraph (1) or (2) of sec-
tion 503(b), on behalf of consumers who reside in that
State and have been or are being adversely affected by
such violations. Through such proceedings, the State may
with respect to such violations—
‘‘(1) obtain a permanent nationwide injunction;
‘‘(2) enforce compliance; or
‘‘(3) obtain such other relief as the court may
find appropriate.
‘‘(b) NOTICE
TO SECRETARY
AND APPROPRIATE
FEDERAL AGENCIES.—A State—
‘‘(1) shall serve prior written notice of any civil
action under subsection (a) upon the Secretary and
the appropriate Federal agencies and provide to the
Secretary and such agencies a copy of its complaint,
except in any case where such prior notice is not fea-
sible, in which case the State shall serve such notice
immediately upon instituting such action; and
‘‘(2) may proceed with the civil action unless
another State attorney general or a Federal agency
has filed a complaint against the same party for the
same violations under this section prior to receiving
notice and the civil action brought by the State at-
torney general or such agency is still ongoing or
there has been a final judgment.
‘‘(c) RIGHTS OF PRESIDENT.—The President shall
have the right to intervene in any action brought under
subsection (a), and upon so intervening, to be heard in
all matters arising therein and to file notices of appeal.
‘‘(d) APPLICABILITY
OF SUBPOENAS.—Subpoenas
for witnesses who are required to attend a court of the
United States, in any district, may run into any other dis-
trict in any proceeding under this section.
‘‘(e) CONSTRUCTION.—For purposes of bringing any
civil action under subsection (a), nothing in this section
shall prevent a State attorney general 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 or other evidence or to
bring an action under the laws of such State to obtain
remedies under that State’s laws.
‘‘(f) DEFINITIONS.—For purposes of this section, the
terms ‘interstate Internet seller’, ‘Internet’, and ‘prescrip-
tion drug’ have the meanings given such terms in section
503B.’’.
(c) 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:
‘‘(aa) 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. 4. 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. 5. 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. 6. CIVIL ACTIONS REGARDING PROPERTY.
Section 303 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 333) is amended by adding at the end the
following subsection:
‘‘(i)(1) If a person is alienating or disposing of prop-
erty, or intends to alienate or dispose of property which
is obtained as a result of or is traceable to a violation by
an interstate Internet seller of paragraph (1) or (2) of sec-
tion 503(b), the President may commence a civil action
in any Federal court—
‘‘(A) to enjoin such alienation or disposition of
property; or
‘‘(B) for a restraining order to—
‘‘(i) prohibit any person from withdrawing,
transferring, removing, dissipating, or disposing
of any such property or property of equivalent
value; and
‘‘(ii) appoint a temporary receiver to ad-
minister such restraining order.
‘‘(2) Proceedings under paragraph (1) shall be car-
ried out in the same manner as apply under section 1345
of title 18, United States Code.’’.
SEC. 7. EFFECTIVE DATE.
The amendments made by this Act shall take effect
6 months 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.
SEC. 8. AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated to carry out
this Act such sums as may be necessary.
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