Home > 108th Congressional Bills > H.R. 3871 (ih) To establish the United States-Israel Homeland Security Foundation to make grants to joint business ventures between United States and Israeli private corporate entities to develop products and services with applications related to homeland...H.R. 3871 (ih) To establish the United States-Israel Homeland Security Foundation to make grants to joint business ventures between United States and Israeli private corporate entities to develop products and services with applications related to homeland...
108th CONGRESS
2d Session
H. R. 3870
To amend the Public Health Service Act, the Federal Food, Drug, and
Cosmetic Act, and the Controlled Substances Import and Export Act to
provide grants to States to establish prescription drug monitoring
programs, 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
March 2, 2004
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 Public Health Service Act, the Federal Food, Drug, and
Cosmetic Act, and the Controlled Substances Import and Export Act to
provide grants to States to establish prescription drug monitoring
programs, 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 2004''.
SEC. 2. PRESCRIPTION DRUG MONITORING PROGRAM.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding after section 399N the following:
``SEC. 399O. PRESCRIPTION DRUG MONITORING PROGRAM.
``(a) Prescription Drug.--For purposes of this section, the term
`prescription drug' means--
``(1) a drug that is included in schedule II, III, or IV of
section 202(c) of the Controlled Substances Act; or
``(2) a drug that is--
``(A) subject to section 503(b) of the Federal
Food, Drug, and Cosmetic Act; and
``(B) identified for purposes of this section by
the Secretary as potentially subject to abuse,
diversion, and misuse.
``(b) Grants.--The Secretary shall make a grant to each State that
submits an application in accordance with subsection (k) for the
purpose of establishing a prescription drug monitoring program
described in this section.
``(c) Reporting Requirements.--A funding agreement for a grant
under this section is that the State involved shall comply with the
following:
``(1) The State shall require dispensers to report each
dispensing in the State of a prescription drug to an ultimate
user or research subject.
``(2) A State may exclude from the reporting requirement of
this section--
``(A) the direct application of a prescription drug
to the body of an ultimate user or research subject;
``(B) the dispensing of a prescription drug in a
quantity limited to an amount adequate to treat the
ultimate user or research subject involved for 48 hours
or less; or
``(C) the application or dispensing of a
prescription drug in accordance with an exclusion
identified by the Secretary under subsection (i)(2).
``(3) Subject to paragraph (5), the information to be
reported under this section with respect to the dispensing of a
prescription drug shall include the following:
``(A) Drug Enforcement Administration Registration
Number of the dispenser.
``(B) Drug Enforcement Administration Registration
Number and name of the practitioner who prescribed the
drug.
``(C) Name, address, and telephone number of the
ultimate user or research subject.
``(D) Identification of the drug by a national drug
code number.
``(E) Quantity dispensed.
``(F) Estimated number of days for which such
quantity should last.
``(G) Number of refills ordered.
``(H) Whether the drug was dispensed as a refill of
a prescription or as a first-time request.
``(I) Date of the dispensing.
``(J) Date of origin of the prescription.
``(4) The State shall specify an electronic format for the
reporting of information under this section and may waive the
requirement of such format with respect to an individual
dispenser.
``(5) The State may meet the requirements of paragraphs (3)
and (4) by requiring that information be reported under this
section in accordance with the current version of the
telecommunications format for controlled substances of the
American Society for Automation in Pharmacy.
``(d) Database.--A funding agreement for a grant under this section
is that the State involved shall comply with the following:
``(1) The State shall establish and maintain an electronic
database containing the information reported to the State under
this section.
``(2) The database must be searchable by any field or
combination of fields.
``(3) The State shall include reported information in the
database in a timely and efficient manner, with appropriate
safeguards for ensuring the accuracy and completeness of the
database.
``(4) The State shall take appropriate security measures to
protect the integrity of, and access to, the database.
``(e) Required Availability of Information.--Subject to subsection
(g), a funding agreement for a grant under this section is that the
State involved, with respect to the database established by the State
under subsection (d), shall comply with the following:
``(1) The State, taking into consideration the criteria
established by the Secretary under subsection (i)(1), shall
notify appropriate authorities responsible for drug diversion
investigation if information in the database indicates a
potential unlawful diversion or misuse of a prescription drug.
``(2) The State shall provide for sharing of information on
a specific individual in the database with each State that--
``(A) maintains a database established under
subsection (d); and
``(B) agrees to use the information in accordance
with the requirements of this section.
``(3) The State shall automatically share information
reported to the State under this section with another State
if--
``(A) such other State maintains a database under
subsection (d); and
``(B) the information concerns--
``(i) the dispensing of a prescription drug
to an ultimate consumer or research subject who
resides in such other State; or
``(ii) the dispensing of a prescription
drug prescribed by a practitioner whose
principal place of business is located in such
other State.
``(f) Optional Availability of Information.--Subject to subsection
(g), a funding agreement for a grant under this section is that the
State involved, with respect to the database established by the State
under subsection (d), may choose to comply with any of the following:
``(1) On request, the State may make available information
on a specific individual from the database to any dispenser or
practitioner who certifies that the requested information is
for the purpose of providing pharmaceutical or medical
treatment, or evaluating the need for such treatment, with
respect to a bona fide patient.
``(2) On request, the State may make available information
on a specific individual from the database to any local, State,
or Federal law enforcement authority responsible for
prescription drug diversion investigation that requests the
information and certifies that--
``(A) the requested information relates to an
active criminal investigation or proceeding involving
the unlawful diversion or misuse of a prescription
drug; and
``(B) the authority has reasonable cause to
conclude that such information will further the purpose
of the investigation or assist in the proceeding.
``(3) On request, the State may make available information
on a specific individual from the database to any health care
professional licensing authority that requests the information
and certifies that the requested information relates to an
active investigation or proceeding involving the unlawful
diversion or misuse of a prescription drug, and the authority
has reasonable cause to conclude that such information will
further the purpose of the investigation or assist in the
proceeding. Information made available to a health care
professional licensing authority under this paragraph shall be
limited to those individuals licensed, regulated, or
disciplined by the authority.
``(4) The State may make available information on a
specific individual from the database to dispensers,
practitioners, law enforcement authorities responsible for
prescription drug diversion investigation, and health care
professional licensing authorities in accordance with
paragraphs (1), (2), and (3), irrespective of whether such
dispensers, practitioners, or authorities are from another
State.
``(5) On request, the State may make available information
on a specific individual from the database to that specific
individual with appropriate identification and procedures.
``(g) Limitation.--With respect to information in a database
established under subsection (d), a funding agreement for a grant under
this section is that--
``(1) the State involved shall limit the release of
information pursuant to subsections (e) and (f) to the minimum
necessary to accomplish the intended purpose of such release;
``(2) after the passage of 18 months from the date of the
dispensing of a drug, the State involved will make information
on such dispensing available only to the extent required by
court order; and
``(3) except as inconsistent with the provisions of this
section, the State involved will comply with section 264(c) of
the Health Insurance Portability and Accountability Act of 1996
(Public Law 104-191; 110 Stat. 2033) (concerning the
confidentiality of individually identifiable health
information) and any regulation promulgated under such section.
``(h) Quality Improvement Program.--A funding agreement for a grant
under this section is that the State involved shall operate a
continuous quality improvement program to ensure the State's compliance
with this section and to improve the State's prescription drug
monitoring program.
``(i) Authority of Secretary.--
``(1) National criteria.--The Secretary shall establish
criteria for determining whether information in a database
established under subsection (d) indicates a potential unlawful
diversion or misuse of a prescription drug.
``(2) Exclusions.--The Secretary may identify instances (in
addition to those described in subparagraphs (A) and (B) of
subsection (c)(2)) in which a State may exclude from the
reporting requirement of this section the application or
dispensing of a prescription drug.
``(j) Advisory Council.--A funding agreement for a grant under this
section is that the State involved shall comply with the following:
``(1) The State shall establish an advisory council to
assist in the establishment and implementation of a
prescription drug monitoring program under this section.
``(2) The State shall ensure that the membership of the
advisory council includes the following:
``(A) A representative of the primary State agency
responsible for law enforcement.
``(B) A representative of the primary State agency
responsible for health care.
``(C) A health care practitioner with a specialty
in pain medicine licensed in the State to prescribe
drugs.
``(D) A pharmacist licensed in the State.
``(E) A prosecutor experienced in criminal
prosecution of drug diversion cases.
``(F) A member representing the public at large.
``(k) Application.--For purposes of subsection (b), an application
is in accordance with this subsection if--
``(1) the application contains each funding agreement in
this section;
``(2) with respect to such funding agreements, the
application provides assurances of compliance satisfactory to
the Secretary; and
``(3) the application is in such form, is made in such
manner, and contains such information as the Secretary
determines to be necessary to carry out this section.
``(l) Definitions.--For purposes of this section:
``(1) The term `bona fide patient' means an individual who
is a patient of the dispenser or practitioner involved.
``(2) The term `dispense' means to deliver a prescription
drug to an ultimate user or research subject by, or pursuant to
the lawful order of, a practitioner, irrespective of whether
the dispenser uses the Internet or other means to effect such
delivery.
``(3) The term `dispenser' means a physician, pharmacist,
or other individual who dispenses a prescription drug to an
ultimate user or research subject.
``(4) The term `ultimate user' means a person who has
lawfully obtained, and who possesses, a prescription drug for
his or her own use, for the use of a member of his or her
household, or for the use of an animal owned by him or her or
by a member of his or her household.
``(m) Authorization of Appropriations.--
``(1) In general.--There is authorized to be appropriated
to carry out this section $10,000,000 for fiscal year 2005 and
each subsequent fiscal year.
``(2) Startup grants.--For the purpose of awarding grants
under this section to assist with the initial costs of
establishing a prescription drug monitoring program, there is
authorized to be appropriated $25,000,000 for the period of
fiscal years 2005 through 2009. Such authorization of
appropriations is in addition to the authorization of
appropriations in paragraph (1).''.
SEC. 3. 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.--
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