[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4769 Introduced in House (IH)]







109th CONGRESS
  2d Session
                                H. R. 4769

   To amend the Federal Food, Drug, and Cosmetic Act, the Controlled 
Substances Import and Export Act, and the Public Health Service Act to 
    impose requirements respecting Internet pharmacies, to require 
manufacturers to implement chain-of-custody procedures, to restrict an 
   exemption respecting the importation of controlled substances for 
                 personal use, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 16, 2006

 Mr. Norwood (for himself and Mr. Strickland) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act, the Controlled 
Substances Import and Export Act, and the Public Health Service Act to 
    impose requirements respecting Internet pharmacies, to require 
manufacturers to implement chain-of-custody procedures, to restrict an 
   exemption respecting the importation of controlled substances for 
                 personal use, 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 ``Prescription Drug Abuse Elimination 
Act of 2006''.

SEC. 2. INTERNET PHARMACIES.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A 
the following:

``SEC. 503B. INTERNET SALE OF PRESCRIPTION DRUGS.

    ``(a) In General.--
            ``(1) Prohibitions.--Subject to paragraph (2), it is a 
        violation of this section--
                    ``(A) for any person to sell a prescription drug in 
                interstate commerce through an Internet site--
                            ``(i) if the Internet site is an illegal 
                        Internet pharmacy under subsection (b);
                            ``(ii) if the person fails to comply with 
                        the treating provider verification requirements 
                        of subsection (c); or
                            ``(iii) if the person fails to submit the 
                        notices required by subsection (d); or
                    ``(B) for any person to own or operate an illegal 
                Internet pharmacy in interstate commerce.
            ``(2) Exception.--Any person who sells a prescription drug 
        through an Internet site, or who owns or operates an Internet 
        pharmacy, is deemed to meet the requirements of this section 
        for purposes of such sale, ownership, or operation if the 
        Internet site or Internet pharmacy is certified by the National 
        Association of Boards of Pharmacy's Verified Internet Pharmacy 
        Practice Sites program.
    ``(b) Internet Pharmacy Requirements.--
            ``(1) In general.--For purposes of this section:
                    ``(A) The term `Internet pharmacy' means an 
                Internet site, inside or outside the State involved, 
                that--
                            ``(i) is used or attempted to be used to 
                        communicate with, or obtain information from, a 
                        person for the purpose of filling or refilling 
                        a prescription; or
                            ``(ii) is otherwise used in the practice of 
                        pharmacy, including dispensing, distributing or 
                        delivery of, or aiding in the delivery of, a 
                        prescription drug to a person.
                    ``(B) The term `illegal Internet pharmacy' means an 
                Internet pharmacy that fails to comply with this 
                subsection.
            ``(2) Requirements.--An Internet pharmacy shall provide to 
        any individual who accesses the pharmacy the following 
        information:
                    ``(A) The street address and telephone number of--
                            ``(i) the Internet pharmacy's place of 
                        business; and
                            ``(ii) the Internet pharmacy's supervising 
                        pharmacist.
                    ``(B) All States in which the Internet pharmacy is 
                licensed or otherwise authorized to dispense 
                prescription drugs.
                    ``(C) If the Internet pharmacy makes referrals to, 
                or solicits on behalf of, a practitioner or a group of 
                practitioners for prescription services--
                            ``(i) the name, street address, and 
                        telephone number of such practitioner or group; 
                        and
                            ``(ii) each State in which each 
                        practitioner involved is licensed or otherwise 
                        authorized to prescribe drugs.
                    ``(D) A statement that the Internet pharmacy will 
                dispense prescription drugs only upon a showing of a 
                prescription.
    ``(c) Treating Provider Verification Requirements.--The treating 
provider verification requirements of this subsection are as follows:
            ``(1) In general.--Subject to paragraph (2), a person may 
        sell a prescription drug in interstate commerce through an 
        Internet site only if--
                    ``(A) the sale is in accordance with a prescription 
                of the treating provider of the patient involved;
                    ``(B) the seller verifies the prescription in 
                accordance with paragraph (3);
                    ``(C) the seller maintains a record of direct 
                communications in accordance with paragraph (4); and
                    ``(D) the seller complies with the prohibition of 
                paragraph (5) against alteration of the prescription.
            ``(2) Limitation.--The treating provider verification 
        requirements of this subsection apply with respect to a 
        prescription drug only if--
                    ``(A) the prescription drug is included in schedule 
                II, III, or IV of section 202(c) of the Controlled 
                Substances Act; or
                    ``(B) the Secretary for purposes of this section 
                identifies the prescription drug as potentially subject 
                to abuse, diversion, and misuse.
            ``(3) Verification requirement.--
                    ``(A) Requirement.--A seller verifies a 
                prescription in accordance with this paragraph if--
                            ``(i) the patient involved or the patient's 
                        treating provider presents the prescription, 
                        directly or by facsimile or electronic mail, to 
                        the seller; or
                            ``(ii) the seller verifies the prescription 
                        by direct communication with the treating 
                        provider involved.
                    ``(B) Information.--When seeking verification of a 
                prescription under subparagraph (A)(ii), a seller shall 
                provide to the treating provider the following 
                information:
                            ``(i) Patient's full name and address.
                            ``(ii) Identification of the drug by a 
                        national drug code number.
                            ``(iii) Quantity to be dispensed.
                            ``(iv) Date of patient request.
                            ``(v) Date and time of verification 
                        request.
                            ``(vi) Name of contact person at seller's 
                        company, including facsimile and telephone 
                        number.
                    ``(C) Verification events.--A prescription is 
                verified under subparagraph (A)(ii) only if one of the 
                following occurs:
                            ``(i) The treating provider confirms the 
                        prescription is accurate by direct 
                        communication with the seller.
                            ``(ii) The treating provider informs the 
                        seller that the prescription is inaccurate and 
                        provides the accurate prescription.
                            ``(iii) The treating provider fails to 
                        communicate with the seller within 48 hours, or 
                        a similar time as defined by the Commissioner 
                        of Food and Drugs, after receiving from the 
                        seller the information described in 
                        subparagraph (B).
                    ``(D) Invalid prescription.--If a treating provider 
                informs a seller before the deadline under subparagraph 
                (C)(iii) that the prescription is inaccurate or 
                expired, the seller shall not fill the prescription. 
                The treating provider shall specify the basis for the 
                inaccuracy or invalidity of the prescription. If the 
                prescription communicated by the seller to the treating 
                provider is inaccurate, the treating provider shall 
                correct it.
            ``(4) Record requirement.--A seller shall maintain for at 
        least 2 years a record of all direct communications with a 
        treating provider regarding the sale of a prescription drug, 
        including verification of the prescription involved.
            ``(5) No alteration.--
                    ``(A) In general.--A seller may not alter a 
                prescription for a prescription drug.
                    ``(B) Exceptions.--Notwithstanding subparagraph 
                (A)--
                            ``(i) if the same prescription drug is 
                        manufactured by the same company and sold under 
                        multiple labels to individual providers, the 
                        seller may fill the prescription with a 
                        prescription drug manufactured by that company 
                        under another label; and
                            ``(ii) the seller may fill the prescription 
                        with a generic version of the prescription 
                        drug.
            ``(6) Definitions.--In this subsection:
                    ``(A) The term `direct communication' includes 
                communication by telephone, facsimile, or electronic 
                mail.
                    ``(B) The term `generic version of the prescription 
                drug' means, with respect to a prescription drug, a 
                drug for which an application is approved under section 
                505(j) and for which the relevant listed drug described 
                in section 505(j)(2) is such prescription drug.
                    ``(C) The term `seller' means a person that sells a 
                prescription drug in interstate commerce through an 
                Internet site.
                    ``(D) The term `treating provider' means a health 
                care provider (including a nurse) licensed by law to 
                administer the prescription drug involved who--
                            ``(i) has performed a documented patient 
                        evaluation of the individual involved 
                        (including a patient history and physical 
                        examination) to establish the diagnosis for 
                        which the prescription drug involved is 
                        prescribed, has discussed with the individual 
                        his or her treatment options and the risks and 
                        benefits of treatment, and maintains 
                        contemporaneous medical records on the 
                        individual;
                            ``(ii) is providing care in consultation 
                        with a health care provider described in clause 
                        (i) and who has access to the medical records 
                        of the patient involved; or
                            ``(iii) is providing care as part of an on-
                        call or cross-coverage arrangement with a 
                        health care provider described in clause (i).
    ``(d) State Notice Requirements.--A person that sells a 
prescription drug in interstate commerce through an Internet site shall 
provide to each State authority that licenses or otherwise authorizes 
the person to dispense the prescription drug the following information:
            ``(1) A statement that the person is selling prescription 
        drugs through an Internet site.
            ``(2) The name, Internet address, street address, and 
        telephone number of the person's business for selling such 
        drugs.
    ``(e) Definition.--In this section, the term `prescription drug' 
means a drug subject to section 503(b).''.
    (b) Inclusion as Prohibited Act.--Section 301 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by inserting after 
paragraph (k) the following:
    ``(l) The sale of a prescription drug, or the ownership or 
operation of an illegal Internet pharmacy, in violation of section 
503B.''.
    (c) Links to Illegal Internet Pharmacy.--Section 302 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 332) is amended by adding at 
the end the following:
    ``(c) In the case of a violation of section 503B relating to an 
illegal Internet pharmacy, the district courts of the United States and 
the United States courts of the Territories shall have jurisdiction to 
order a provider of an interactive computer service to remove, or 
disable access to, a site violating such section, or a link to a site 
violating such section, that resides on a computer server that such 
provider controls or operates. Such relief shall--
            ``(1) be available only after provision to the provider of 
        notice and an opportunity to appear;
            ``(2) not impose any obligation on the provider to monitor 
        its service or to affirmatively seek facts indicating activity 
        violating section 503B;
            ``(3) specify the provider to which the relief applies; and
            ``(4) specifically identify the location of the site or 
        link to be removed, or to which access is to be disabled.''.

SEC. 3. DISTRIBUTION AND LABELING OF DRUGS.

    (a) Drug Pedigrees.--With respect to any State that imposes a 
requirement on the manufacturer or distributor of a drug to provide 
information to persons receiving the drug regarding prior sales, 
purchases, or trades of the drug, the Secretary of Health and Human 
Services shall--
            (1) encourage the State to allow the manufacturer or 
        distributor to take advantage of technological advances, 
        including by providing such information electronically; and
            (2) at the request of the State, provide technical 
        assistance in implementing the requirement.
    (b) Chain-of-custody Requirements.--Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) (as amended by section 
2) is amended--
            (1) in section 502, by adding at the end the following:
    ``(x) If it is a drug with respect to which the manufacturer, 
importer, distributor, or retailer fails to comply with the chain-of-
custody requirements of section 503C.''; and
            (2) by inserting after section 503B (as added by section 2) 
        the following:

``SEC. 503C. CHAIN-OF-CUSTODY REQUIREMENTS.

    ``(a) In General.--Not later than January 1, 2007, the Secretary 
shall promulgate chain-of-custody requirements applicable to each 
manufacturer, importer, distributor, and retailer of a prescription 
drug.
    ``(b) Manufacturers.--The chain-of-custody requirements promulgated 
under this section shall require each manufacturer of a prescription 
drug--
            ``(1) to incorporate a unique identifier into the packaging 
        or labeling of the drug;
            ``(2) to track the drug through the point of delivery to 
        the retailer of the drug; and
            ``(3) to maintain, either directly or through a contractor, 
        a database on the movement of the drug.
    ``(c) Importers, Distributors, and Retailers.--The chain-of-custody 
requirements promulgated under this section shall require each 
importer, distributor, and retailer of a prescription drug to assist in 
the tracking of the drug under this section by reporting the receipt of 
the drug to the manufacturer.
    ``(d) Prescription Drug.--In this section, the term `prescription 
drug' means a drug subject to section 503(b).
    ``(e) Effective Date.--The chain-of-custody requirements 
promulgated by the Secretary under this section shall take effect on 
January 1, 2009.''.
    (c) Grants for Community Pharmacists.--The Secretary of Health and 
Human Services may make grants to community pharmacists to assist such 
pharmacists to comply with tracking requirements imposed on such 
pharmacists by drug manufacturers, importers, or distributors as a 
result of the amendments made by subsection (b).

SEC. 4. RESTRICTION ON PERSONAL USE EXEMPTION FOR IMPORTING CONTROLLED 
              SUBSTANCES.

    Paragraph (2) of section 1006(a) of the Controlled Substances 
Import and Export Act (21 U.S.C. 956(a)) is amended by striking ``may 
not import the controlled substance'' and all that follows and 
inserting: ``may not import the controlled substance into the United 
States--
            ``(1) in an amount that exceeds 50 dosage units of the 
        controlled substance; or
            ``(2) in the case of a controlled substance in schedule II, 
        III, or IV, more than 1 time during any 30-day period.''.

SEC. 5. WORKING GROUP ON PHARMACEUTICAL COUNTERFEITING.

    (a) Establishment.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall convene a working group (in this 
section referred to as the ``working group'') to conduct a study and 
submit a report on pharmaceutical counterfeiting.
    (b) Members.--The Secretary shall invite to serve as members of the 
working group representatives of the following:
            (1) Domestic regulatory agencies.
            (2) Domestic and international law enforcement officials.
            (3) Multinational organizations, such as the World Trade 
        Organization and the World Health Organization.
            (4) The United States Trade Representative.
            (5) The pharmaceutical industry.
            (6) Trade associations, including associations representing 
        each step of the pharmaceutical delivery system (including 
        representatives of drug manufacturers and pharmacists).
    (c) Study.--The study conducted by the working group on 
pharmaceutical counterfeiting shall consider the following:
            (1) How to enhance supply-chain security.
            (2) Consumer education on counterfeiting issues.
            (3) Employing technology designed to frustrate organized 
        and sophisticated criminals intent on compromising the world's 
        drug supply.
            (4) How industry could assist law enforcement by analyzing 
        suspected counterfeit drugs to determine authenticity.
            (5) How industry can collaborate on issues related to 
        pharmaceutical counterfeiting without revealing trade secrets 
        or other confidential information.
    (d) Report.--Not later than 2 years after the date of the enactment 
of this Act, the working group shall submit a report to the Congress on 
the results of the study conducted under this section, including 
recommendations on measures to reduce or eliminate problems associated 
with pharmaceutical counterfeiting.

SEC. 6. STUDY ON UNUSED CONTROLLED SUBSTANCES.

    (a) Study.--The Secretary of Health and Human Services (in this 
section referred to as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall conduct a study to determine the 
best methods to ensure that unused controlled substances are not 
diverted for unlawful use.
    (b) Consultation.--In conducting the study required by this 
section, the Secretary shall consult with the Administrator of the Drug 
Enforcement Administration, appropriate law enforcement 
representatives, the Administrator of the Environmental Protection 
Agency, States and municipalities (including State boards of pharmacy), 
and representatives of the pharmaceutical industry.
    (c) Report.--Not later than 2 years after the date of the enactment 
of this Act, the Secretary shall submit a report to the Congress on the 
results of the study conducted under this section.

SEC. 7. BASELINE RESEARCH ON PRESCRIPTION DRUG ABUSE.

    (a) Research.--The Secretary of Health and Human Services shall 
conduct research on issues related to prescription drug abuse, 
including the following:
            (1) Enhancing existing public use surveys and other sources 
        so as to provide appropriate baseline data and data on the 
        natural history and context of prescription drug use in order 
        to evaluate the extent and nature of potential problems and 
        guide corrective actions which reduce the problems without 
        unintentionally hindering patient access.
            (2) The phenomenon of iatrogenic addiction, including the 
        actual incidence and prevalence of iatrogenic addiction, the 
        factors that modulate the risk of such addiction, and the 
        extent to which concern about iatrogenic addiction impacts 
        health care delivery.
            (3) Development of postapproval surveillance approaches 
        that can detect and address potential risks of abuse and 
        misuse, including risks in diverse patient populations that did 
        not previously appear at risk for diversion or abuse, and in 
        geographic regions that have been relatively absent from risk.
            (4) Methods to better translate new ideas about 
        terminology, diagnosis, and management of addiction diseases 
        into clinical practice at the primary care and specialist 
        levels.
            (5) Reliable, useful assessment tools for addiction in the 
        clinical setting of initial and ongoing treatment of conditions 
        requiring the use of controlled substances.
            (6) Development of better methods of ensuring patient 
        adherence to prescribed drug regimens.
            (7) Relative contributions of genetic, psychosocial, 
        environmental, and behavioral factors to addiction to 
        prescription opioids.
    (b) Report.--Not later than 2 years after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall submit to 
the Congress a report on the results of the research conducted under 
this section.

SEC. 8. DATABASE FOR DRUG ABUSE MORTALITY REPORTING.

    Section 505 of the Public Health Service Act (42 U.S.C. 290aa-4) is 
amended--
            (1) in subparagraph (B) of subsection (c)(1), by striking 
        ``, as indicated in reports by coroners''; and
            (2) by adding at the end the following:
    ``(e) With respect to the activities of the Administrator under 
subsections (a) and (c)(1)(B) relating to the collection of data on the 
number of deaths occurring as a result of substance abuse, the 
Administrator--
            ``(1) shall expand and intensify collection activities to 
        maintain a comprehensive, national database on such deaths; and
            ``(2) shall require medical examiners, coroners, and other 
        appropriate persons to report to the Administrator for purposes 
        of collecting data on such deaths.''.
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