Reducing Fraudulent and Imitation Drugs Act of 2006 - Directs the Secretary of Health and Human Services to require prescription drug packaging to incorporate: (1) radio frequency tagging technology or similar trace and track technologies; (2) tamper-indicating technologies; and (3) blister security packaging when possible.
Directs the Secretary to: (1) require that such technologies be used exclusively to authenticate the pedigree of prescription drugs; and (2) prohibit such technologies from containing or transmitting any identifying information of a health care practitioner or consumer, or any advertisement or information about indications or off-label uses.
Requires the Secretary to encourage prescription drug manufacturers and distributors to incorporate: (1) overt optically variable counterfeit-resistant technologies into packaging; and (2) required prescription drug packaging technologies into multiple elements of the physical packaging of the drugs. Requires prescription drug shipments to include a label on the shipping container that incorporates packaging technologies.Deems a prescription drug to be misbranded if the packaging or labeling of the drug is in violation of a requirement or prohibition of this Act.
Requires the Secretary to publish the National Specified List of Susceptible Prescription Drugs, consisting of not less than 30 of the most frequently counterfeited prescription drugs in the United States.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4829 Introduced in House (IH)]
109th CONGRESS
2d Session
H. R. 4829
To direct the Secretary of Health and Human Services to require the
incorporation of counterfeit-resistant technologies into the packaging
of prescription drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 1, 2006
Mr. Burton of Indiana (for himself, Mr. Gutknecht, Mr. Sanders, Mr.
Emanuel, Ms. Herseth, Mrs. Northup, Mr. Jones of North Carolina, Mr.
DeFazio, and Mr. Souder) 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 technologies into the packaging
of prescription drugs, and for other purposes.
Be it enacted by the Senate and House of Representatives 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 2006''.
SEC. 2. COUNTERFEIT-RESISTANT TECHNOLOGIES FOR PRESCRIPTION DRUGS.
(a) Required Technologies.--The Secretary of Health and Human
Services shall require that the packaging of any prescription drug
incorporate--
(1) radio frequency identification (RFID) tagging
technology, or similar trace and track technologies 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 pedigree of prescription drugs, including
by--
(A) implementing inventory control;
(B) tracking and tracing prescription drugs;
(C) verifying shipment or receipt of prescription
drugs;
(D) authenticating finished prescription drugs; and
(E) electronically authenticating the pedigree of
prescription drugs.
(2) Privacy protection.--The Secretary shall prohibit
technologies required by subsection (a)(1) from containing or
transmitting any information that may be used to identify a
health care practitioner 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 prescription drugs to incorporate
into the packaging of such drugs, in addition to the technologies
required under subsection (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 Bureau of
Engraving and Printing to secure United States currency;
(3) are manufactured and distributed in a highly secure,
tightly controlled environment; and
(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
manufacturers 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 labels,
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 technologies described in
subsection (a)(1), so that members of the supply chain
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.
(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 susceptible 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 Services 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 Secretary).
(B) Revision.--Not less than annually through the
end of calendar year 2009, the Secretary shall review
and, as appropriate, revise the National Specified List
of Susceptible Prescription 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 subsections (a), (b), and
(d)--
(A) with respect to prescription drugs on the
National Specified List of Susceptible Prescription
Drugs, beginning not later than the earlier of--
(i) 1 year after the initial publication of
such List; or
(ii) December 31, 2007; and
(B) with respect to all prescription drugs,
beginning not later than December 31, 2010.
(3) Authorized uses during transitional period.--In lieu of
the requirements specified in subsection (b)(1), for the period
beginning on the effective date applicable under paragraph
(2)(A) and ending on the commencement of the effective date
applicable under paragraph (2)(B), the Secretary shall require
that technologies described in subsection (a)(1) be used
exclusively to verify the authenticity 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 involved to a
distributor or retailer of the drug (including the date
of the transaction and the names and addresses of all
parties to the transaction); and
(B) excludes information about the sale, purchase,
or trade of the drug to the drug consumer.
(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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line