CHAPTER 560. LICENSING OF PHARMACIES
OCCUPATIONS CODE
TITLE 3. HEALTH PROFESSIONS
SUBTITLE J. PHARMACY AND PHARMACISTS
CHAPTER 560. LICENSING OF PHARMACIES
SUBCHAPTER A. LICENSE REQUIRED
Sec. 560.001. LICENSE REQUIRED. (a) A person may not operate a
pharmacy in this state unless the pharmacy is licensed by the
board.
(b) A pharmacy located in another state may not ship, mail, or
deliver to this state a prescription drug or device dispensed
under a prescription drug order to a resident of this state
unless the pharmacy is licensed by the board or is exempt under
Section 560.004.
(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.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2005, 79th Leg., Ch.
1345, Sec. 39, eff. September 1, 2005.
Sec. 560.002. USE OF "PHARMACY"; PROVIDING PHARMACY SERVICES
WITHOUT LICENSE. (a) A person may not display in or on a place
of business the word "pharmacy" or "apothecary" in any language,
any word or combination of words of the same or similar meaning,
or a graphic representation that would lead or tend to lead the
public to believe that the business is a pharmacy unless the
facility is a pharmacy licensed under this chapter.
(b) A person may not advertise a place of business as a pharmacy
or provide pharmacy services unless the facility is a pharmacy
licensed under this chapter.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1254, Sec. 4, eff. Sept. 1,
2001.
Sec. 560.003. PROHIBITED ADVERTISING OF PHARMACY. (a) A
pharmacy that is not licensed under this chapter may not
advertise the pharmacy's services in this state.
(b) A person who is a resident of this state may not advertise
the pharmacy services of a pharmacy that is not licensed by the
board if the pharmacy or person makes the advertisement with the
knowledge that the advertisement will or is likely to induce a
resident of this state to use the pharmacy to dispense a
prescription drug order.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 560.004. EXEMPTION. The board may grant an exemption from
the licensing requirements of this chapter on the application of
a pharmacy located in another state that restricts to isolated
transactions the pharmacy's dispensing of a prescription drug or
device to a resident of this state.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
SUBCHAPTER B. PHARMACY CLASSIFICATION
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) another classification established by the board under
Section 560.053.
(b) A Class A pharmacy license or community pharmacy license
authorizes a pharmacy to dispense a drug or device to the public
under a prescription drug order.
(c) A Class B pharmacy license or nuclear pharmacy license
authorizes a pharmacy to dispense a radioactive drug or device
for administration to an ultimate user.
(d) A Class C pharmacy license or institutional pharmacy license
may be issued to a pharmacy located in:
(1) an inpatient facility, including a hospital, licensed under
Chapter 241 or 577, Health and Safety Code;
(2) a hospital maintained or operated by the state;
(3) a hospice inpatient facility licensed under Chapter 142,
Health and Safety Code; or
(4) an ambulatory surgical center licensed under Chapter 243,
Health and Safety Code.
(e) A Class D pharmacy license or clinic pharmacy license
authorizes a pharmacy to dispense a limited type of drug or
device under a prescription drug order.
(f) A Class E pharmacy license or nonresident pharmacy license
may be issued to a pharmacy located in another state whose
primary business is to:
(A) dispense a prescription drug or device under a prescription
drug order; and
(B) deliver the drug or device to a patient, including a patient
in this state, by United States mail, common carrier, or delivery
service.
(g) The board may determine the classification under which a
pharmacy may be licensed.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.305(a), eff.
Sept. 1, 2001; Acts 2003, 78th Leg., ch. 941, Sec. 1, eff. Sept.
1, 2003.
Sec. 560.052. QUALIFICATIONS. (a) The board by rule shall
establish the standards that each pharmacy and the pharmacy's
employees involved in the practice of pharmacy must meet to
qualify for licensing as a pharmacy in each classification.
(b) To qualify for a pharmacy license, an applicant must submit
to the board:
(1) a license fee set by the board, except as provided by
Subsection (d); and
(2) a completed application that:
(A) is on a form prescribed by the board;
(B) is given under oath; and
(C) includes a statement of:
(i) the ownership;
(ii) the location of the pharmacy;
(iii) the license number of each pharmacist who is employed by
the pharmacy, if the pharmacy is located in this state, or who is
licensed to practice pharmacy in this state, if the pharmacy is a
Class E pharmacy;
(iv) the license number of the pharmacist-in-charge; and
(v) any other information the board determines necessary.
(c) To qualify for a Class E pharmacy license, an applicant, in
addition to satisfying the other requirements of this chapter,
must provide to the board:
(1) evidence that the applicant holds a pharmacy license,
registration, or permit in good standing issued by the state in
which the pharmacy is located;
(2) the name of the owner and pharmacist-in-charge of the
pharmacy for service of process;
(3) 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;
(4) an affidavit by the pharmacist-in-charge that states that
the pharmacist has read and understands the laws and rules
relating to a Class E pharmacy;
(5) proof of creditworthiness; and
(6) an inspection report issued:
(A) not more than two years before the date the license
application is received; and
(B) by the pharmacy licensing board in the state of the
pharmacy's physical location, except as provided by Subsection
(f).
(d) A pharmacy operated by the state or a local government that
qualifies for a Class D pharmacy license is not required to pay a
fee to obtain a license.
(e) With respect to a Class C pharmacy license, the board may
issue a license to a pharmacy on certification by the appropriate
agency that the facility in which the pharmacy is located has
substantially completed the requirements for licensing.
(f) A Class E pharmacy may submit an inspection report issued by
an entity other than the pharmacy licensing board of the state in
which the pharmacy is physically located if:
(1) the state's licensing board does not conduct inspections;
(2) the inspection is substantively equivalent to an inspection
conducted by the board, as determined by board rule; and
(3) the inspecting entity meets specifications adopted by the
board for inspecting entities.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.306(a), eff.
Sept. 1, 2001.
Amended by:
Acts 2005, 79th Leg., Ch.
1345, Sec. 18, eff. September 1, 2005.
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.
Added by Acts 2005, 79th Leg., Ch.
1345, Sec. 40, eff. September 1, 2005.
Sec. 560.053. ESTABLISHMENT OF ADDITIONAL PHARMACY
CLASSIFICATIONS. The board by rule may establish classifications
of pharmacy licenses in addition to the classifications under
Section 560.051 if the board determines that:
(1) the practice setting will provide pharmaceutical care
services to the public;
(2) the existing classifications of pharmacy licenses are not
appropriate for that practice setting; and
(3) establishment of a new classification of pharmacy license is
necessary to protect the public health, safety, and welfare.
Added by Acts 2003, 78th Leg., ch. 941, Sec. 2, eff. Sept. 1,
2003.
SUBCHAPTER C. RESTRICTIONS ON LICENSE
Sec. 560.101. LICENSE NOT TRANSFERABLE. A pharmacy license
issued under this chapter is not transferable or assignable.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 560.102. SEPARATE LICENSE FOR EACH LOCATION. (a) A
separate pharmacy license is required for each principal place of
business of a pharmacy.
(b) Only one pharmacy license may be issued for a specific
location.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
SUBCHAPTER D. CERTAIN PROHIBITED PRACTICES
Sec. 560.103. FALSE AFFIDAVIT. A person who falsely makes the
affidavit prescribed by Section 560.052 is guilty of fraudulent
and dishonorable conduct and malpractice.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.