[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.
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