I 
110TH CONGRESS 
1ST SESSION H. R. 2716 
To direct the Secretary of Health and Human Services to require the incorpo-
ration of counterfeit-resistant technologies into the packaging of prescrip-
tion drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 14, 2007 
Mr. BURTON of Indiana introduced the following bill; which was referred to 
the Committee on Energy and Commerce 
A BILL 
To direct the Secretary of Health and Human Services to 
require the incorporation of counterfeit-resistant tech-
nologies into the packaging of prescription 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, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Reducing Fraudulent 
and Imitation Drugs Act of 2007’’. 
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SEC. 2. COUNTERFEIT-RESISTANT TECHNOLOGIES FOR 
PRESCRIPTION DRUGS. 
(a) REQUIRED TECHNOLOGIES.—The Secretary of 
Health and Human Services shall require that the pack-
aging of any prescription drug incorporate— 
(1) radio frequency identification (RFID) tag-
ging technology, or similar trace and track tech-
nologies that have an equivalent function; 
(2) tamper-indicating technologies; and 
(3) blister security packaging when possible. 
(b) USE OF TECHNOLOGIES.— 
(1) AUTHORIZED
USES.—The Secretary shall 
require that technologies described in subsection 
(a)(1) be used exclusively to authenticate the pedi-
gree of prescription drugs, including by— 
(A) implementing inventory control; 
(B) tracking and tracing prescription 
drugs; 
(C) verifying shipment or receipt of pre-
scription drugs; 
(D) authenticating finished prescription 
drugs; and 
(E) electronically authenticating the pedi-
gree of prescription drugs. 
(2) PRIVACY PROTECTION.—The Secretary shall 
prohibit technologies required by subsection (a)(1) 
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from containing or transmitting any information 
that may be used to identify a health care practi-
tioner or the prescription drug consumer. 
(3) PROHIBITION AGAINST ADVERTISING.—The 
Secretary shall prohibit technologies required by 
subsection (a)(1) from containing or transmitting 
any advertisement or information about prescription 
drug indications or off-label prescription drug uses. 
(c) RECOMMENDED TECHNOLOGIES.—The Secretary 
shall encourage the manufacturers and distributors of pre-
scription drugs to incorporate into the packaging of such 
drugs, in addition to the technologies required under sub-
section (a), overt optically variable counterfeit-resistant 
technologies that— 
(1) are visible to the naked eye, providing for 
visual identification of prescription drug authenticity 
without the need for readers, microscopes, lighting 
devices, or scanners; 
(2) are similar to technologies used by the Bu-
reau of Engraving and Printing to secure United 
States currency; 
(3) are manufactured and distributed in a high-
ly secure, tightly controlled environment; and 
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(4) incorporate additional layers of non-visible 
covert security features up to and including forensic 
capability. 
(d) STANDARDS FOR PACKAGING.— 
(1) MULTIPLE ELEMENTS.—For the purpose of 
making it more difficult to counterfeit the packaging 
of prescription drugs, the Secretary shall require 
manufacturers of prescription drugs to incorporate 
the technologies described in paragraphs (1), (2), 
and (3) of subsection (a), and shall encourage manu-
facturers and distributors of prescription drugs to 
incorporate the technologies described in subsection 
(c), into multiple elements of the physical packaging 
of the drugs, including— 
(A) blister packs, shrink wrap, package la-
bels, package seals, bottles, and boxes; and 
(B) at the item level. 
(2) LABELING
OF
SHIPPING
CONTAINER.— 
Shipments of prescription drugs shall include a label 
on the shipping container that incorporates the tech-
nologies described in subsection (a)(1), so that mem-
bers of the supply chain inspecting the packages will 
be able to determine the authenticity of the ship-
ment. Chain of custody procedures shall apply to 
such labels and shall include procedures applicable 
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to contractual agreements for the use and distribu-
tion of the labels, methods to audit the use of the 
labels, and database access for the relevant govern-
mental agencies for audit or verification of the use 
and distribution of the labels. 
(e) PENALTY.—A prescription drug is deemed to be 
misbranded for purposes of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) if the packaging or 
labeling of the drug is in violation of a requirement or 
prohibition applicable to the drug under subsection (a), 
(b), or (d). 
(f) 
TRANSITIONAL
PROVISIONS; 
EFFECTIVE 
DATES.— 
(1) NATIONAL
SPECIFIED
LIST
OF
SUSCEP-
TIBLE PRESCRIPTION DRUGS.— 
(A) INITIAL PUBLICATION.—Not later than 
180 days after the date of the enactment of this 
Act, the Secretary of Health and Human Serv-
ices shall publish in the Federal Register a list, 
to be known as the National Specified List of 
Susceptible Prescription Drugs, consisting of 
not less than 30 of the prescription drugs that 
are most frequently subject to counterfeiting in 
the United States (as determined by the Sec-
retary). 
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(B) REVISION.—Not less than annually 
through the end of calendar year 2010, the Sec-
retary shall review and, as appropriate, revise 
the National Specified List of Susceptible Pre-
scription Drugs. The Secretary may not revise 
the List to include fewer than 30 prescription 
drugs. 
(2) EFFECTIVE
DATES.—The Secretary shall 
implement the requirements and prohibitions of sub-
sections (a), (b), and (d)— 
(A) with respect to prescription drugs on 
the National Specified List of Susceptible Pre-
scription Drugs, beginning not later than the 
earlier of— 
(i) 1 year after the initial publication 
of such List; or 
(ii) December 31, 2008; and 
(B) with respect to all prescription drugs, 
beginning not later than December 31, 2011. 
(3) AUTHORIZED USES DURING TRANSITIONAL 
PERIOD.—In lieu of the requirements specified in 
subsection (b)(1), for the period beginning on the ef-
fective date applicable under paragraph (2)(A) and 
ending on the commencement of the effective date 
applicable under paragraph (2)(B), the Secretary 
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shall require that technologies described in sub-
section (a)(1) be used exclusively to verify the au-
thenticity of prescription drugs. 
(g) DEFINITIONS.—In this Act: 
(1) The term ‘‘pedigree’’— 
(A) means the history of each prior sale, 
purchase, or trade of the prescription drug in-
volved to a distributor or retailer of the drug 
(including the date of the transaction and the 
names and addresses of all parties to the trans-
action); and 
(B) excludes information about the sale, 
purchase, or trade of the drug to the drug con-
sumer. 
(2) The term ‘‘prescription drug’’ means a drug 
subject to section 503(b)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)). 
(3) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
Æ 
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