BILL NUMBER: SB 1149 ENROLLED
BILL TEXT
PASSED THE SENATE AUGUST 27, 2004
PASSED THE ASSEMBLY AUGUST 26, 2004
AMENDED IN ASSEMBLY JULY 19, 2004
AMENDED IN ASSEMBLY JUNE 21, 2004
AMENDED IN ASSEMBLY JUNE 8, 2004
AMENDED IN SENATE MAY 24, 2004
AMENDED IN SENATE APRIL 19, 2004
AMENDED IN SENATE APRIL 1, 2004
AMENDED IN SENATE MARCH 16, 2004
AMENDED IN SENATE MARCH 1, 2004
INTRODUCED BY Senator Ortiz
(Coauthor: Senator Murray)
JANUARY 26, 2004
An act to add Sections 4001.4 and 4001.6 to, and to add and
repeal Sections 4001.2 and 4001.3 of, the Business and Professions
Code, relating to pharmacy, and making an appropriation therefor.
LEGISLATIVE COUNSEL'S DIGEST
SB 1149, Ortiz. Dangerous drugs: Canadian pharmacies: foreign
suppliers.
Existing law, the Pharmacy Law, establishes the California State
Board of Pharmacy and makes it responsible for licensing and
regulating pharmacy practices, including the furnishing of dangerous
drugs, as defined.
This bill would require the board to develop and disseminate
information identifying pharmacies in Canada that meet recognized
standards for the safe acquisition, shipment, handling, and
dispensing of dangerous drugs to California residents. The bill
would require each pharmacy located in Canada that seeks to be
identified for these purposes to apply to the board. The bill would
authorize the board to enter into contracts with these pharmacies if
certain requirements are satisfied, including paying the board an
annual fee of $1,500. The bill would require the board to collect,
publish, and post on an Internet Web site information concerning
suppliers of dangerous drugs that are located and operating outside
of the United States that have violated safe shipment, handling, and
processing standards. The bill would also authorize the board to
provide Internet Web site links to other sources of information about
obtaining affordable prescription medications and cost comparisons
for those medications. The bill would repeal these provisions on
January 1, 2008.
The bill would create the Access to Affordable Prescription Drugs
Fund where fees and voluntary contributions to support those
activities would be deposited. The bill would make implementation of
its provisions subject to sufficient moneys in the fund for those
purposes. The bill would appropriate$71,500 to the board from the
fund for the 2004-05 fiscal year and would make additional moneys
available in subsequent fiscal years subject to appropriation in the
annual Budget Act.
Appropriation: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature finds all of the following:
(a) Prescription medications are an essential part of health care
delivery and have contributed to increasing the life expectancy of
patients and treating their diseases and conditions.
(b) Despite this, due to the high cost of prescription
medications, many Californians, especially elderly, disabled, and
low-income persons, face difficulty accessing the medications they
need to maintain their health.
(c) As one means of accessing affordable prescription medications,
increasing numbers of Californians are purchasing prescription
medications from foreign countries, in many cases through an Internet
Web site.
(d) California consumers currently have few ways of determining
which outlets and suppliers of prescription medications in foreign
countries are safe and reliable, particularly those offering their
products through an Internet Web site.
(e) Canadian pharmacies that are licensed by the provinces in
which they are located generally meet safety standards for the
acquisition, distribution, and dispensing of prescription medications
that are as stringent as those in California.
(f) In order to help ensure access to prescription medications,
there is a need to provide consumers with information about safe and
reliable Canadian pharmacies and about fraudulent and unsafe
suppliers or outlets of prescription medications whose practices may
potentially harm consumers, and there is a need to assist consumers
in making informed choices for obtaining prescription medications for
their health care needs.
SEC. 2. Section 4001.2 is added to the Business and Professions
Code, to read:
4001.2. (a) The board shall develop and disseminate information
identifying Canadian pharmacies that have established that they meet
recognized standards for the safe acquisition, shipment, handling,
and dispensing of dangerous drugs to persons in California. As part
of this requirement, the board shall establish an interactive
Internet Web site that links consumers to, or provides information
about, Canadian pharmacies that the board has determined meet
recognized standards for the safe acquisition, shipment, handling,
and dispensing of dangerous drugs to persons in California.
(b) For the purposes of this section, a Canadian pharmacy that
meets recognized standards for the safe acquisition, shipment,
handling, and dispensing of dangerous drugs means a pharmacy that is
located in Canada and meets all of the following requirements:
(1) Is licensed as a pharmacy by the province in which it is
located and its license is not revoked, suspended, or subject to
other disciplinary action.
(2) Notifies the board within three business days of any change in
its licensure status and any pending disciplinary action against it.
(3) Is accredited by the Internet and Mail Order Pharmacy
Accreditation Commission, another organization approved by the board,
or is a member of the Canadian International Pharmacy Association.
(4) Establishes that it meets pharmacy management standards
applicable to licensed pharmacies.
(5) Does not require a consumer to sign a waiver of liability or a
release of liability for a negligent act by the pharmacy.
(6) Requires a valid prescription from a physician and surgeon
licensed to practice in the United States before selling the
prescribed drug.
(7) Maintains a service department to respond to all consumer
inquiries.
(8) Discloses, on its Internet Web site and in packaging
accompanying any shipped drugs, that the consumer may file a
complaint regarding the pharmacy with the relevant Canadian
provincial licensing authority and with the pharmacy, and provides
the contact information for filing the complaint.
(9) Does not furnish any of the following types of drugs:
(A) Narcotics and other controlled substances.
(B) Drugs for which there is no equivalent drug approved for sale
in the United States by the federal Food and Drug Administration.
(C) Drugs that are not approved by the Canadian Therapeutic
Products Directorate for sale in Canada.
(D) Drugs that require refrigeration or that cannot be safely
shipped by mail.
(E) A biological product, as defined in Section 351 of the Public
Health Service Act (42 U.S.C. Sec. 262).
(F) An intravenously injected drug.
(G) An infused drug, including a peritoneal dialysis solution.
(H) A drug that is inhaled during surgery.
(10) Ensures that all physicians and surgeons, pharmacists, and
technicians in its employ are properly licensed according to Canadian
laws and their licenses are not revoked, suspended, or subject to
other disciplinary action.
(11) Complies with all personal health and medical information
privacy laws applicable to a pharmacy located in California.
(12) Does not exceed the prescribed amount and does not exceed a
three-month supply of the prescribed drug.
(13) Complies with all Canadian laws applicable to furnishing
drugs.
(14) Does not furnish a drug if the consumer indicates he or she
has not previously taken that drug.
(15) Does not repackage the drug from the original packaging by
the drug manufacturer unless the amount prescribed is a smaller
quantity.
(16) Dispense all medications in containers with child-proof caps
unless requested otherwise by a consumer.
(17) Complies with the requirements of subdivisions (c), (e), and
(f) of Section 4112.
(c) Each Canadian pharmacy that wishes to be identified by the
board pursuant to this section may apply to the board to enter into a
contract to be designated to provide the specified services. The
board may enter into contracts with Canadian pharmacies that it
determines meet the requirements of this section. Each contract may
be renewed upon payment of the fee specified in subdivision (e).
(d) The board shall have the ability to terminate any contract
with, and to discontinue providing information to consumers and
providing Internet Web site links to, any pharmacy that the board
determines does not meet the requirements of this section.
(e) Each pharmacy located in Canada that seeks to be identified by
the board pursuant to this section shall pay the board an annual fee
of one thousand five hundred dollars ($1,500). The fees shall be
deposited into the Access to Affordable Prescription Drugs Fund
created by Section 4001.4.
(f) The board may provide Internet Web site links to other sources
of information about obtaining affordable prescription medications,
including discount programs offered by public entities or
pharmaceutical companies, and cost comparisons of prescription
medications.
(g) This section shall remain in effect only until January 1,
2008, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2008, deletes or extends
that date.
SEC. 3. Section 4001.3 is added to the Business and Professions
Code, to read:
4001.3. (a) The board shall collect, publish, and post on an
Internet Web site created pursuant to Section 4001.2, information
concerning suppliers of dangerous drugs that are located and
operating outside of the United States that have been found to have
violated recognized standards for the safe shipment, handling, and
processing of dangerous drugs.
(b) In carrying out this section, the board may rely on
information made available by regulatory and law enforcement bodies,
including, but not limited to, the federal Food and Drug
Administration, the United States Customs Service, prescription drug
regulatory bodies of foreign countries, the Attorney General, the
United States Department of Justice, the boards of pharmacy of other
states, and the National Association of Boards of Pharmacy.
(c) The board is not required to conduct surveillance activities
or its own investigations in order to carry out the requirements of
this section, but is authorized to engage in those activities to the
extent its resources permit.
(d) This section shall remain in effect only until January 1,
2008, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2008, deletes or extends
that date.
SEC. 4. Section 4001.4 is added to the Business and Professions
Code, to read:
4001.4. (a) The board may receive voluntary contributions to
support its activities pursuant to Sections 4001.2 and 4001.3. The
contributions shall be deposited into the Access to Affordable
Prescription Drugs Fund which is hereby created in the State
Treasury. The revenue in the fund shall be made available to the
board for expenditure solely for the purpose of supporting the board'
s activities pursuant to Sections 4001.2 and 4001.3. The sum of
seventy-one thousand five hundred dollars ($71,500) is hereby
appropriated to the board from the fund for the 2004-05 fiscal year
to implement Sections 4001.2 and 4001.3. In subsequent fiscal years,
additional moneys shall be made available upon appropriation by the
Legislature in the annual Budget Act.
(b) The board may contract for any resources needed to implement
this section and Sections 4001.2 and 4001.3.
(c) Sections 4001.2 and 4001.3 shall be implemented only to the
extent that sufficient moneys are available in the Access to
Affordable Prescription Drugs Fund for those purposes.
SEC. 5. Section 4001.6 is added to the Business and Professions
Code, to read:
4001.6. (a) The board shall include in any Web site and in any
materials developed pursuant to Section 4001.2 a notice that informs
consumers about current laws regarding importation and reimportation
of prescription drugs and the Food and Drug Administration's policy
regarding personal importation. The notice shall also inform
consumers that the pharmacies included in the Web site or materials
developed by the board are licensed in the Canadian provinces in
which they reside and that the board has the right to remove them
from the Web site or materials if they violate the terms of the
agreement between the board and the pharmacy or if the board elects
to cancel the contract established pursuant to Section 4001.2. In
addition, the notice shall include a statement that the state accepts
no legal liability with respect to any product offered or
pharmaceutical care provided by the pharmacies listed on the Web site
and materials.
(b) Any information, including the identity of any Canadian
pharmacy, to be posted or included on the Web site or in other
materials developed by the board pursuant to Section 4001.2 shall
first be reviewed and approved by the board's staff before it is
posted or included.
(c) The board shall review, within 30 business days of receipt,
any information that it receives concerning any pharmacy's compliance
with the terms and conditions contained in Section 4001.2. The
board shall also determine, as part of the review, whether the
information the board has received constitutes grounds for
cancellation of the contract specified in Section 4001.2 between the
pharmacy and the board, removal of the pharmacy from the Web site, or
other action.