Law:Title 3. Health Professions. Subtitle J. Pharmacy And Pharmacists from Chapter 560. Licensing Of Pharmacies (Texas)

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Subtitle J. Pharmacy And Pharmacists

Contents

Chapter 560. Licensing Of Pharmacies

Subchapter A. License Required

Section  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.



Section  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.



Section  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.



Section  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

Section  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.



Section  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.



Section 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.



Section  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

Section  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.



Section  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

Section  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.


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