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Amend SB 410 by adding the following appropriately numbered
SECTIONS to the bill and renumbering subsequent SECTIONS of the
bill accordingly:
SECTION ___. The legislature finds that:
(1) prescription drugs are expensive to the point that
some residents of this state have been forced to choose between
purchasing prescription drugs and paying for other essentials, such
as groceries or rent;
(2) prescription drugs can be purchased at much lower
costs in Canada;
(3) scams offering low-cost prescription drugs are
prevalent on the Internet and in spam e-mail, and these practices
make it difficult for consumers in this state to determine how and
where to purchase safe and effective prescription drugs at
affordable prices;
(4) the Regulatory Procedures Manual of the Federal
Drug Administration authorizes agency personnel to allow the
importation of products regulated by that agency when the quantity
and purpose are clearly for personal use and the product does not
present an unreasonable risk to the user; and
(5) other states and municipalities provide Internet
websites and other methods to allow residents of those states or
municipalities to safely purchase prescription drugs from Canada.
SECTION ___. Subchapter A, Chapter 554, Occupations Code,
is amended by adding Section 554.016 to read as follows:
Sec. 554.016. CANADIAN PHARMACY INSPECTION; DESIGNATION;
FEES; INFORMATION. (a) The board shall designate at least one and
not more than 10 Canadian pharmacies whose primary business is to
dispense prescription drugs under prescription drug orders to
Canadian residents, as having passed inspection by the board for
shipping, mailing, or delivering to this state a prescription
dispensed under a prescription drug order to a resident in this
state.
(b) The board by rule shall set fees in amounts reasonable
and necessary to cover the costs incurred by the board in inspecting
Canadian pharmacies as provided by Subsection (a).
(c) The board shall establish and maintain an Internet
website to provide information necessary to enable residents of
this state to conveniently order prescription drugs from Canadian
pharmacies designated by the board as having passed inspection to
dispense prescription drugs to residents in this state in
accordance with this subtitle and board rules. The board shall
include on the website a statement that the board is not liable for
any act or omission of a Canadian pharmacy designated as having
passed inspection to dispense prescription drugs to residents in
this state.
SECTION ___. Subchapter B, Chapter 556, Occupations Code,
is amended by adding Section 556.0555 to read as follows:
Sec. 556.0555. INSPECTIONS. (a) At least annually, the
board shall conduct random inspections of Canadian pharmacies
designated under Section 554.016 as necessary to ensure compliance
with the safety standards and other requirements of this subtitle
and board rules.
(b) Notwithstanding the requirements of this chapter, the
board by rule may establish the standards and procedures for
inspections under this section.
(c) The board may enter into a written agreement with
another state for an agency or employee of the state to perform
services for the board related to inspecting a Canadian pharmacy
designated by the board under Section 554.016 to dispense
prescription drugs to residents in this state. This subsection
does not apply to the initial inspection of the pharmacy.
SECTION ___. Section 560.001, Occupations Code, is amended
by adding Subsection (c) to read as follows:
(c) A pharmacy located in Canada may not ship, mail, or
deliver to this state a prescription drug dispensed under a
prescription drug order to a resident of this state unless the
pharmacy is designated by the board under Section 554.016.
SECTION ___. Subchapter B, Chapter 560, Occupations Code,
is amended by adding Section 560.0525 to read as follows:
Sec. 560.0525. ADDITIONAL QUALIFICATION REQUIREMENTS FOR
CANADIAN PHARMACIES. (a) To pass an inspection by the board, a
Canadian pharmacy must meet Texas licensing standards.
(b) In addition to satisfying the other requirements of this
chapter, to qualify for designation by the board under Section
554.016, a Canadian pharmacy applicant must submit to the board:
(1) evidence satisfactory to the board that the
applicant holds a pharmacy license, registration, or permit in good
standing issued by Canada or the Canadian province in which the
pharmacy is located and is not subject to any pending disciplinary
action or legal action by any regulatory authority;
(2) the name and address of the pharmacy's owner and
pharmacist-in-charge for service of process;
(3) evidence of the applicant's ability to provide to
the board, not later than 72 hours after the time the board requests
the record, a record of a prescription drug order authorizing the
pharmacy to dispense a prescription drug to a resident of this
state;
(4) an affidavit by the pharmacist-in-charge that
states the pharmacist has read and understands this subtitle and
the rules adopted under this subtitle that relate to a Canadian
pharmacy designated by the board as having passed inspection to
dispense prescription drugs to residents in this state;
(5) evidence satisfactory to the board that the
applicant meets the standards established by board rule to ensure
customer safety for each order filled and in the dispensing,
storing, packaging, shipping, and delivering of prescription
drugs; and
(6) evidence satisfactory to the board that the
applicant's employees hold the appropriate Canadian licenses
required to dispense prescription drugs in Canada.
(c) Before a Canadian pharmacy is designated as having
passed inspection to dispense prescription drugs to residents in
this state, a representative of the board shall visit the
pharmacy's facilities and review the pharmacy's compliance with the
requirements and safety standards established under this subtitle.
SECTION ___. Section 562.101, Occupations Code, is amended
by adding Subsection (f-1) to read as follows:
(f-1) A Canadian pharmacy designated by the board as having
passed inspection to dispense prescription drugs to residents in
this state is required to be under the continuous on-site
supervision of a pharmacist and shall designate one pharmacist
licensed to practice pharmacy by the regulatory or licensing agency
of Canada or of the Canadian province in which the Canadian pharmacy
is located to serve as the pharmacist-in-charge of the Canadian
pharmacy.
SECTION ___. Subchapter C, Chapter 562, Occupations Code,
is amended by adding Section 562.111 to read as follows:
Sec. 562.111. PRESCRIPTION DRUG ORDER FOR CONSUMER. (a) A
pharmacy in this state may order for a consumer a prescription drug
from a Canadian pharmacy designated by the board under Section
554.016 to dispense prescription drugs to residents in this state.
(b) A pharmacy may order a prescription drug under this
section only with the knowledge and clear consent of the consumer.
SECTION ___. Chapter 562, Occupations Code, is amended by
adding Subchapter E to read as follows:
SUBCHAPTER E. PRACTICE BY CANADIAN PHARMACY
Sec. 562.201. ADDITIONAL PRACTICE REQUIREMENTS. In
addition to complying with the other requirements of this chapter,
a Canadian pharmacy designated by the board under Section 554.016
shall:
(1) dispense a prescription drug to a resident of this
state only under the lawful order of a practitioner licensed in the
United States;
(2) dispense to a resident of this state only a
prescription drug that is approved by Canada's Therapeutic Products
Directorate for sale to residents of Canada;
(3) dispense to a resident of this state a
prescription drug in the original, unopened manufacturer's
packaging whenever possible; and
(4) dispense to a resident of this state only drugs
prescribed for long-term use.
Sec. 562.202. LIMITATIONS ON PRACTICE. A Canadian pharmacy
designated by the board under Section 554.016 to dispense
prescription drugs to residents in this state may not:
(1) dispense to a resident of this state a
prescription drug for which there is not an equivalent drug
approved by the United States Food and Drug Administration for sale
in the United States;
(2) dispense to a resident of this state a
prescription drug that cannot be safely shipped by mail, common
carrier, or delivery service;
(3) dispense in one order to a resident of this state a
quantity of a prescription drug that exceeds:
(A) a three-month supply; or
(B) the amount ordered by the practitioner;
(4) fill a prescription drug order for a consumer who
is a resident of this state that the consumer indicates is the
consumer's first prescription for that drug; or
(5) dispense to a resident of this state any of the
following:
(A) a substance designated as a controlled
substance under Chapter 481, Health and Safety Code (Texas
Controlled Substances Act);
(B) a biological product, as described by Section
351, Public Health Service Act (42 U.S.C. Section 262);
(C) an infused drug, including a peritoneal
dialysis solution;
(D) an intravenously injected drug; or
(E) a drug that is inhaled during surgery.
Sec. 562.203. COMPLAINT REPORT. A Canadian pharmacy
designated by the board under Section 554.016 to dispense
prescription drugs to residents in this state shall provide to the
board periodic reports in accordance with board rules on each
complaint received by the pharmacy from a consumer in this state who
purchases a prescription drug from the pharmacy.
Sec. 562.204. PRICE LIST. A Canadian pharmacy designated
by the board under Section 554.016 shall:
(1) compile and maintain a current price list for
prescription drugs provided to residents in this state; and
(2) guarantee those prices for not less than 30 days
from the date the list is effective.
SECTION ___. (a) Not later than the 30th day after the
effective date of this Act, the Texas State Board of Pharmacy shall
adopt the initial rules necessary to implement the changes in law
made by this Act to Subtitle J, Title 3, Occupations Code, in the
manner provided by law for adoption of emergency rules. This
subsection expires January 1, 2006.
(b) Not later than January 1, 2006, the Texas State Board of
Pharmacy shall adopt the rules necessary to implement the changes
in law made by this Act to Subtitle J, Title 3, Occupations Code.
(c) The requirements for a Canadian pharmacy to be
designated under Section 554.016, Occupations Code, as added by
this Act, to dispense prescription drugs in this state under
Subtitle J, Title 3, Occupations Code, as amended by this Act, take
effect March 1, 2006.