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79R5081 YDB-F
By: Ellis S.B. No. 518
A BILL TO BE ENTITLED
AN ACT
relating to the licensing and regulation of Canadian pharmacies for
the dispensing of prescription drugs in this state.
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 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 2. Section 551.003, Occupations Code, is amended by
adding Subdivision (7-a) to read as follows:
(7-a) "Class F pharmacy license" means a license
described by Section 560.051.
SECTION 3. Subchapter A, Chapter 554, Occupations Code, is
amended by adding Section 554.016 to read as follows:
Sec. 554.016. CANADIAN PHARMACY INFORMATION. The board
shall establish and maintain an Internet website to provide
information about Class F pharmacies necessary to enable residents
of this state to conveniently order prescription drugs from those
pharmacies in accordance with this subtitle and board rules.
SECTION 4. Subchapter B, Chapter 556, Occupations Code, is
amended by adding Section 556.0555 to read as follows:
Sec. 556.0555. INSPECTIONS. (a) The board shall conduct
random inspections of Class F pharmacies at least annually as
necessary to ensure compliance with the safety standards and the
licensing 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.
SECTION 5. 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 licensed by the board.
SECTION 6. Section 560.051, Occupations Code, is amended by
amending Subsection (a) and adding Subsection (f-1) to read as
follows:
(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) another classification established by the board
under Section 560.053.
(f-1) A Class F pharmacy license may be issued to a pharmacy
located in Canada whose primary business is to dispense a
prescription drug under a prescription drug order to Canadian
residents. The board shall issue a Class F pharmacy license to each
Canadian pharmacy that applies and is qualified for the license
under this subtitle.
SECTION 7. Subchapter B, Chapter 560, Occupations Code, is
amended by adding Section 560.0525 to read as follows:
Sec. 560.0525. ADDITIONAL QUALIFICATIONS AND LICENSING
REQUIREMENTS FOR CANADIAN PHARMACIES. (a) A Class F pharmacy shall
meet Texas licensing standards.
(b) In addition to satisfying the other requirements of this
chapter, to qualify for a Class F pharmacy license, an 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;
(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 Class F
pharmacy;
(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 issuing a Class F pharmacy license, a
representative of the board shall visit the pharmacy's facilities
and review the pharmacy's compliance with the licensing
requirements and safety standards established under this subtitle.
SECTION 8. Section 562.101, Occupations Code, is amended by
adding Subsection (f-1) to read as follows:
(f-1) A Class F pharmacy 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
Class F pharmacy is located to serve as the pharmacist-in-charge of
the Class F pharmacy.
SECTION 9. 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 a prescription drug from a Class F
pharmacy for a consumer.
(b) A pharmacy may order a prescription drug under this
section only with the knowledge and clear consent of the consumer.
SECTION 10. 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 Class F pharmacy 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 only a prescription drug that is approved
by Canada's Therapeutic Products Directorate for sale to residents
of Canada;
(3) dispense a prescription drug in the original,
unopened manufacturer's packaging whenever possible; and
(4) dispense only drugs prescribed for long-term use.
Sec. 562.202. LIMITATIONS ON PRACTICE. A Class F pharmacy
may not:
(1) dispense 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 a prescription drug that cannot be safely
shipped by mail, common carrier, or delivery service;
(3) dispense in one order a quantity of a prescription
drug that exceeds:
(A) a three-month supply; or
(B) the amount ordered by the practitioner; or
(4) fill a prescription drug order that a consumer
indicates is the consumer's first prescription for that drug.
Sec. 562.203. COMPLAINT REPORT. A Class F pharmacy 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 Class F pharmacy 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 11. (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 licensing requirements for a Canadian pharmacy
under Subtitle J, Title 3, Occupations Code, as amended by this Act,
take effect March 1, 2006. A Canadian pharmacy is not required to
comply with the licensing requirements under Subtitle J, Title 3,
Occupations Code, as amended by this Act, before March 1, 2006.
SECTION 12. 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.