(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 
505C 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 
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 2005,’’; 
(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. 
205. 
USE 
OF 
COUNTERFEIT-RESISTANT 
TECH-
NOLOGIES TO PREVENT COUNTERFEITING. 
(a) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352; deeming 
drugs and devices to be misbranded) is amended by adding 
at the end the following: 
‘‘(x) If it is a drug subject to section 503(b), unless 
the packaging of such drug complies with the require-
ments of section 505C 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 505B the following: 
‘‘SEC. 505C. 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.