IIB 
108TH CONGRESS 
1ST SESSION H. R. 2427
IN THE SENATE OF THE UNITED STATES 
JULY 25 (legislative day, JULY 21), 2003
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
To authorize the Secretary of Health and Human Services 
to promulgate regulations for the reimportation of pre-
scription drugs, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
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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.
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(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:
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‘‘(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’’;
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(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
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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
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misbranded or adulterated, and determine how 
such compliance contrasts with the incidence of 
shipments of prescription drugs transported 
within the United States that have been deter-
mined to be misbranded or adulterated.’’; and 
(B) in subparagraph (B), by striking ‘‘Not 
later than 2 years after the effective date of 
final regulations under subsection (a),’’ and in-
serting ‘‘Not later than 18 months after the 
date of the enactment of the Pharmaceutical 
Market Access Act of 2003,’’; 
(9) in subsection (k)(2)—
(A) by redesignating subparagraphs (D) 
and (E) as subparagraphs (E) and (F), respec-
tively; and 
(B) by inserting after subparagraph (C) 
the following: 
‘‘(D) The term ‘qualifying individual’ 
means an individual who is not a pharmacist or 
a wholesaler. ’’; and 
(10) by striking subsections (l) and (m). 
SEC. 5. USE OF COUNTERFEIT-RESISTANT TECHNOLOGIES 
TO PREVENT COUNTERFEITING. 
(a) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352; deeming
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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;
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‘‘(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