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.