By: Hochberg H.B. No. 173
A BILL TO BE ENTITLED
AN ACT
relating to the licensing of Canadian pharmacies to sell
prescription medicines to Texas residents.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. The Legislature finds that:
(1) Prescription drugs are expensive, to the point
that some Texas residents 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
cost in Canada.
(3) Scams offering low cost prescription drugs are
prevalent on the internet and in spam e-mail, which makes it
difficult for Texas consumers to know how and where to find safe and
effective prescription drugs at affordable prices.
(4) The Federal Drug Administration's Regulatory
Procedures Manual authorizes FDA personnel to use their discretion
to allow the importation of FDA regulated products when the
quantity and purpose are clearly for personal use and the product
does not present an unreasonable risk to the user.
(5) Other states and cities have provided websites and
other mechanisms for their residents to safely purchase
prescription drugs from Canada.
SECTION 2. Title 3, Subtitle J of the Occupations Code is
amended by adding Chapter 570 to read as follows:
CHAPTER 570. LICENSING OF CANADIAN PHARMACIES
Section 570.001. (a) The board shall license pharmacies
located and licensed in Canada to ship, mail, or deliver certain
prescription drugs under a prescription drug order to a resident of
this state.
(b) Pharmacies licensed under this section shall:
(1) meet Texas licensing standards;
(2) compile a price list for prescription drugs
provided under this section and guarantee those prices for a
minimum of 30 days;
(3) provide to the board:
(A) evidence that the applicant holds a pharmacy
license, registration, or permit in good standing issued by Canada
or the province in which the pharmacy is located;
(B) the name of the owner and
pharmacist-in-charge of the pharmacy for service of process;
(C) evidence of the applicant's ability to
provide to the board a record of a prescription drug order dispensed
by the applicant to a resident of this state not later than 72 hours
after the time the board requests the record; and
(D) an affidavit by the pharmacist-in-charge
that states that the pharmacist has read and understands the laws
and rules relating to a Class F pharmacy.
(4) meet standards established by board rule for order
fulfillment and drug dispensement, storage, packaging, shipping,
and delivery to assure customer safety.
(5) ensure that the pharmacy's employees have
necessary Canadian licenses;
(6) require a prescription drug order from a U.S.
physician;
(7) provide only drugs that are approved by the
Government of Canada's Therapeutic Products Directorate for sale to
residents of Canada;
(8) exclude drugs for which there is no equivalent
approved by the Food and Drug Administration for sale in the United
States and medicines that cannot be safely shipped via mail order;
(9) limit the amount of any one drug dispensed in any
one order to the lesser of a three-month supply or the amount
approved by the person's U.S. physician;
(10) use the unopened manufacturer's packaging
whenever possible;
(11) not fill prescription drug orders if the customer
indicates the purchase would represent his or her first use of that
drug and limit drugs to those prescribed for long-term use; and
(12) provide periodic reports to the board regarding
any complaints from Texas customers purchasing from the pharmacy.
(c) Before licensing a pharmacy under this section, the
board shall visit the pharmacy's facilities and review its
compliance with all applicable licensing requirements and safety
standards.
(d) The board shall conduct random inspections of
pharmacies licensed under this section at least yearly to ensure
continued compliance with all applicable licensing requirements
and safety standards.
Section 570.002. The board shall establish and maintain a
website that provides information about the Canadian pharmacies
licensed under Section 570.001 and provides a convenient mechanism
for Texas residents to order prescription drugs from those
pharmacies in accordance with this chapter and board rule.
Section 570.003. (a) A pharmacy located in Texas and
holding a pharmacy license issued by the board may order
prescription drugs from Canadian pharmacies licensed under Section
570.002 on behalf of their customers.
(b) A pharmacy ordering drugs under this section shall only
do so with the knowledge and clear consent of the customer.
SECTION 3. Section 551.003, Occupations Code is amended by
adding subdivision (8) to read as follows and by renumbering the
remaining subdivisions accordingly:
(8) "Class F pharmacy license" or "Canadian pharmacy
license" means a license described by Section 560.051.
SECTION 4. Section 560.051, Occupations Code is amended by
amending Subsection (a) and adding Subsection (f) to read as
follows:
Sec. 560.051. LICENSE CLASSIFICATIONS. (a) Each applicant
for a pharmacy license shall apply for a license in one or more of
the following classifications:
(1) Class A;
(2) Class B;
(3) Class C;
(4) Class D;
(5) Class E; [or]
(6) Class F; or
(7) [(6)] another classification established by the
board under Section 560.053.
(f) A Class F pharmacy license or Canadian pharmacy license
may be issued to a pharmacy located in Canada in accordance with
Chapter 570.
SECTION 5. The Texas State Board of Pharmacy shall adopt
emergency rules to implement this Act as soon as practicable after
the effective date of this Act and shall adopt permanent rules no
later than September 1, 2005.
SECTION 6. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2005.