Prescription Drug Abuse Elimination Act of 2006 -Amends the Federal Food, Drug, and Cosmetic Act to require Internet pharmacies to meet specified criteria, including: (1) providing individuals who access the pharmacy with certain information; (2) obtaining verification of a valid prescription in some circumstances; and (3) providing contact information of the individual dispensing prescription drugs on the site to each state that licenses or authorizes the person to dispense drugs. Prohibits the sale of a prescription drug, or the ownership or operation of an illegal Internet pharmacy, in violation of the requirements of this Act. Allows district courts to order Internet providers to remove access or links to sites that violate this Act.
Directs the Secretary of Health and Human Services to promulgate chain-of-custody requirements to track prescription drugs from the manufacturer through each importer, distributor, and retailer. Deems a drug misbranded if such requirements are not met.
Amends the Controlled Substances Import and Export Act to restrict the importation of a schedule II, III, or IV drug by a U.S. resident without a valid prescription to once during any 30-day period.
Requires the Secretary, acting through the Commissioner of Food and Drugs, to: (1) convene a working group to study and report on pharmaceutical counterfeiting; and (2) study the best methods to ensure that controlled substances are not diverted for unlawful use.
Requires the Secretary to conduct research and report on issues related to prescription drug abuse.
Requires the Administrator of the Substance Abuse and Mental Health Services Administration to maintain a comprehensive, national database on deaths occurring as a result of substance abuse.
[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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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