SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Pharmaceutical Mar-
ket Access Act of 2003’’.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Americans unjustly pay up to 1000 percent
more to fill their prescriptions than consumers in
other countries.
(2) The United States is the world’s largest
market for pharmaceuticals yet consumers still pay
the world’s highest prices.
(3) An unaffordable drug is neither safe nor ef-
fective. Allowing and structuring the importation of
prescription drugs ensures access to affordable
drugs, thus providing a level of safety to American
consumers they do not currently enjoy.
(4) According to the Congressional Budget Of-
fice, American seniors alone will spend $1.8 trillion
dollars on pharmaceuticals over the next ten years.
(5) Allowing open pharmaceutical markets
could save American consumers at least $635 billion
of their own money each year.
SEC. 3. PURPOSES.
The purposes of this Act are as follows:
(1) To give all Americans immediate relief from
the outrageously high cost of pharmaceuticals.
(2) To reverse the perverse economics of the
American pharmaceutical markets.
(3) To allow the importation of drugs only if
the drugs and the facilities where they are manufac-
tured are approved by the Food and Drug Adminis-
tration, and to exclude pharmaceutical narcotics.
(4) To require that imported prescription drugs
be packaged and shipped using counterfeit-resistant
technologies approved by the Bureau of Engraving
and Printing (technologies similar to those used to
secure United States currency).
SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS.
Section 804 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 384) is amended—
(1) in subsection (a)—
(A) by striking ‘‘The Secretary’’ and in-
serting ‘‘Not later than 180 days after the date
of the enactment of the Pharmaceutical Market
Access Act of 2003, the Secretary’’; and
(B) by striking ‘‘pharmacists and whole-
salers’’ and inserting ‘‘pharmacists, wholesalers,
and qualifying individuals’’;
(2) in subsection (b)—
(A) by amending paragraph (1) to read as
follows:
‘‘(1) require that each covered product imported
pursuant to such subsection complies with sections
501, 502, and 505, and other applicable require-
ments of this Act; and’’;
(B) in paragraph (2), by striking ‘‘, includ-
ing subsection (d); and’’ and inserting a period;
and
(C) by striking paragraph (3);
(3) in subsection (c), by inserting ‘‘by phar-
macists and wholesalers (but not qualifying individ-
uals)’’ after ‘‘importation of covered products’’;
(4) in subsection (d)—
(A) by striking paragraphs (3) and (10);
(B) in paragraph (5), by striking ‘‘, includ-
ing the professional license number of the im-
porter, if any’’;
(C) in paragraph (6)—
(i) in subparagraph (C), by inserting
‘‘(if required under subsection (e))’’ before
the period;
(ii) in subparagraph (D), by inserting
‘‘(if required under subsection (e))’’ before
the period; and
(iii) in subparagraph (E), by striking
‘‘labeling’’;
(D) in paragraph (7)—
(i) in subparagraph (A), by inserting
‘‘(if required under subsection (e))’’ before
the period; and
(ii) by amending subparagraph (B) to
read as follows:
‘‘(B) Certification from the importer or
manufacturer of such product that the product
meets all requirements of this Act.’’; and
(E) 
by 
redesignating 
paragraphs 
(4)
through (9) as paragraphs (3) through (8), re-
spectively;
(5) by amending subsection (e) to read as fol-
lows:
‘‘(e) TESTING.—
‘‘(1) IN GENERAL.—Subject to paragraph (2),
regulations under subsection (a) shall require that
testing referred to in paragraphs (5) through (7) of
subsection (d) be conducted by the importer of the
covered product, unless the covered product is a pre-
scription drug subject to the requirements of section
505B for counterfeit-resistant technologies.
‘‘(2) EXCEPTION.—The testing requirements of
paragraphs (5) through (7) of subsection (d) shall
not apply to an importer unless the importer is a
wholesaler.’’;
(6) in subsection (f), by striking ‘‘or designated
by the Secretary, subject to such limitations as the
Secretary determines to be appropriate to protect
the public health’’;
(7) in subsection (g)—
(A) by striking ‘‘counterfeit or’’; and
(B) by striking ‘‘and the Secretary deter-
mines that the public is adequately protected
from counterfeit and violative covered products
being imported pursuant to subsection (a)’’;
(8) in subsection (i)(1)—
(A) by amending subparagraph (A) to read
as follows:
‘‘(A) IN
GENERAL.—The Secretary shall
conduct, or contract with an entity to conduct,
a study on the imports permitted pursuant to
subsection (a), including consideration of the
information received under subsection (d). In
conducting such study, the Secretary or entity
shall evaluate the compliance of importers with
regulations under subsection (a), and the inci-
dence of shipments pursuant to such sub-
section, if any, that have been determined to be
drugs and devices to be misbranded) is amended by adding
at the end the following:
‘‘(w) If it is a drug subject to section 503(b), unless
the packaging of such drug complies with the require-
ments of section 505B for counterfeit-resistant tech-
nologies.’’.
(b) REQUIREMENTS.—Title V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 505A the following:
‘‘SEC. 505B. COUNTERFEIT-RESISTANT TECHNOLOGIES.
‘‘(a) INCORPORATION OF COUNTERFEIT-RESISTANT
TECHNOLOGIES
INTO
PRESCRIPTION
DRUG
PACK-
AGING.—The Secretary shall require that the packaging
of any drug subject to section 503(b) incorporate—
‘‘(1) overt optically variable counterfeit-resist-
ant technologies that are described in subsection (b)
and comply with the standards of subsection (c); or
‘‘(2) technologies that have an equivalent func-
tion of security, as determined by the Secretary.
‘‘(b) ELIGIBLE TECHNOLOGIES.—Technologies de-
scribed in this subsection—
‘‘(1) shall be visible to the naked eye, providing
for visual identification of product authenticity with-
out the need for readers, microscopes, lighting de-
vices, or scanners;
‘‘(2) shall be similar to that used by the Bureau
of Engraving and Printing to secure United States
currency;
‘‘(3) shall be manufactured and distributed in a
highly secure, tightly controlled environment; and
‘‘(4) should incorporate additional layers of
non-visible covert security features up to and includ-
ing forensic capability.
‘‘(c) STANDARDS FOR PACKAGING.—
‘‘(1) MULTIPLE ELEMENTS.—For the purpose
of making it more difficult to counterfeit the pack-
aging of drugs subject to section 503(b), manufac-
turers of the drugs shall incorporate the technologies
described in subsection (b) into multiple elements of
the physical packaging of the drugs, including blister
packs, shrink wrap, package labels, package seals,
bottles, and boxes.
‘‘(2) LABELING
OF
SHIPPING
CONTAINER.—
Shipments of drugs described in subsection (a) shall
include a label on the shipping container that incor-
porates the technologies described in subsection (b),
so that officials inspecting the packages will be able
to determine the authenticity of the shipment. Chain
of custody procedures shall apply to such labels and
shall include procedures applicable to contractual
agreements for the use and distribution of the labels,
methods to audit the use of the labels, and database
access for the relevant governmental agencies for
audit or verification of the use and distribution of
the labels.’’.
Passed the House of Representatives July 25 (legis-
lative day, July 24), 2003.
Attest:
Clerk.
108TH CONGRESS
1ST SESSION
H. R. 2427
AN ACT
To authorize the Secretary of Health and Human
Services to promulgate regulations for the re-
importation of prescription drugs, and for other
purposes.