CHAPTER 551. GENERAL PROVISIONS

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OCCUPATIONS CODE

TITLE 3. HEALTH PROFESSIONS

SUBTITLE J. PHARMACY AND PHARMACISTS

CHAPTER 551. GENERAL PROVISIONS

Sec. 551.001. SHORT TITLE. The chapters of this subtitle, other

than Chapter 567, may be cited as the Texas Pharmacy Act.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 551.002. LEGISLATIVE DECLARATION; PURPOSE. (a) This

subtitle shall be liberally construed to regulate in the public

interest the practice of pharmacy in this state as a professional

practice that affects the public health, safety, and welfare.

(b) It is a matter of public interest and concern that the

practice of pharmacy merits and receives the confidence of the

public and that only qualified persons be permitted to engage in

the practice of pharmacy in this state.

protect the public health, safety, and welfare through:

(1) effectively controlling and regulating the practice of

pharmacy; and

(2) licensing pharmacies engaged in the sale, delivery, or

distribution of prescription drugs and devices used in diagnosing

and treating injury, illness, and disease.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 551.003. DEFINITIONS. In Chapters 551-566:

(1) "Administer" means to directly apply a prescription drug to

the body of a patient by any means, including injection,

inhalation, or ingestion, by:

(A) a person authorized by law to administer the drug, including

a practitioner or an authorized agent under a practitioner's

supervision; or

(B) the patient at the direction of a practitioner.

(2) "Board" means the Texas State Board of Pharmacy.

(3) "Class A pharmacy license" or "community pharmacy license"

means a license described by Section 560.051.

(4) "Class B pharmacy license" or "nuclear pharmacy license"

means a license described by Section 560.051.

(5) "Class C pharmacy license" or "institutional pharmacy

license" means a license described by Section 560.051.

(6) "Class D pharmacy license" or "clinic pharmacy license"

means a license described by Section 560.051.

(7) "Class E pharmacy license" or "nonresident pharmacy license"

means a license described by Section 560.051.

(8) "College of pharmacy" means a school, university, or college

of pharmacy that:

(A) satisfies the accreditation standards of the American

Council on Pharmaceutical Education as adopted by the board; or

(B) has degree requirements that meet the standards of

accreditation set by the board.

(9) "Compounding" means the preparation, mixing, assembling,

packaging, or labeling of a drug or device:

(A) as the result of a practitioner's prescription drug order

based on the practitioner-patient-pharmacist relationship in the

course of professional practice;

(B) for administration to a patient by a practitioner as the

result of a practitioner's initiative based on the

practitioner-patient-pharmacist relationship in the course of

professional practice;

routine, regularly observed prescribing pattern; or

(D) for or as an incident to research, teaching, or chemical

analysis and not for selling or dispensing, except as allowed

under Section 562.154 or Chapter 563.

(10) "Confidential record" means a health-related record,

including a patient medication record, prescription drug order,

or medication order, that:

(A) contains information that identifies an individual; and

(B) is maintained by a pharmacy or pharmacist.

(11) "Controlled substance" means a substance, including a drug:

(A) listed in Schedule I, II, III, IV, or V, as established by

the commissioner of public health under Chapter 481, Health and

Safety Code, or in Penalty Group 1, 1-A, 2, 3, or 4, Chapter 481;

(B) included in Schedule I, II, III, IV, or V of the

Comprehensive Drug Abuse Prevention and Control Act of 1970 (21

U.S.C. Section 801 et seq.).

(12) "Dangerous drug" means a drug or device that:

(A) is not included in Penalty Group 1, 2, 3, or 4, Chapter 481,

Health and Safety Code, and is unsafe for self-medication; or

(B) bears or is required to bear the legend:

(i) "Caution: federal law prohibits dispensing without

prescription" or "Rx only" or another legend that complies with

federal law; or

(ii) "Caution: federal law restricts this drug to use by or on

the order of a licensed veterinarian."

(13) "Deliver" or "delivery" means the actual, constructive, or

attempted transfer of a prescription drug or device or controlled

substance from one person to another, with or without

consideration.

(14) "Designated agent" means:

(A) an individual, including a licensed nurse, physician

assistant, or pharmacist:

(i) who is designated by a practitioner and authorized to

communicate a prescription drug order to a pharmacist; and

(ii) for whom the practitioner assumes legal responsibility;

(B) a licensed nurse, physician assistant, or pharmacist

employed in a health care facility to whom a practitioner

communicates a prescription drug order; or

practitioner to administer a prescription drug order for a

dangerous drug under Subchapter B, Chapter 157.

(15) "Device" means an instrument, apparatus, implement,

machine, contrivance, implant, in vitro reagent, or other similar

or related article, including a component part or accessory, that

is required under federal or state law to be ordered or

prescribed by a practitioner.

(16) "Dispense" means to prepare, package, compound, or label,

in the course of professional practice, a prescription drug or

device for delivery to an ultimate user or the user's agent under

a practitioner's lawful order.

(17) "Distribute" means to deliver a prescription drug or device

other than by administering or dispensing.

(18) "Drug" means:

(A) a substance recognized as a drug in a drug compendium,

including the current official United States Pharmacopoeia,

official National Formulary, or official Homeopathic

Pharmacopoeia, or in a supplement to a drug compendium;

(B) a substance intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of disease in a human or

another animal;

structure or a function of the body of a human or another animal;

(D) a substance intended for use as a component of a substance

specified in Paragraph (A), (B), or (C);

(E) a dangerous drug; or

(F) a controlled substance.

(19) "Drug regimen review" includes evaluation of prescription

drug or medication orders and a patient medication record for:

(A) a known allergy;

(B) a rational therapy-contraindication;

(D) reasonable directions for use;

(E) duplication of therapy;

(F) a drug-drug interaction;

(G) drug-food interaction;

(H) drug-disease interaction;

(I) adverse drug reaction; and

(J) proper use, including overuse or underuse.

(20) "Internship" means a practical experience program that is

approved by the board.

(21) "Label" means written, printed, or graphic matter on the

immediate container of a drug or device.

(22) "Labeling" means the process of affixing a label, including

all information required by federal and state statute or

regulation, to a drug or device container. The term does not

include:

(A) the labeling by a manufacturer, packer, or distributor of a

nonprescription drug or commercially packaged prescription drug

or device; or

(B) unit dose packaging.

(23) "Manufacturing" means the production, preparation,

propagation, conversion, or processing of a drug or device,

either directly or indirectly, by extraction from a substance of

natural origin or independently by a chemical or biological

synthesis. The term includes packaging or repackaging a substance

or labeling or relabeling a container and promoting and marketing

the drug or device and preparing and promoting a commercially

available product from a bulk compound for resale by a person,

including a pharmacy or practitioner. The term does not include

compounding.

(24) "Medication order" means an order from a practitioner or a

practitioner's designated agent for administration of a drug or

device.

(25) "Nonprescription drug" means a nonnarcotic drug or device

that may be sold without a prescription and that is labeled and

packaged in compliance with state or federal law.

(26) "Patient counseling" means communication by a pharmacist of

information, as specified by board rule, to a patient or

caregiver to improve therapy by ensuring proper use of a drug or

device.

(27) "Pharmaceutical care" means providing drug therapy and

other pharmaceutical services defined by board rule and intended

to assist in curing or preventing a disease, eliminating or

reducing a patient's symptom, or arresting or slowing a disease

process.

(28) "Pharmacist" means a person licensed by the board to

practice pharmacy.

(29) "Pharmacist-in-charge" means the pharmacist designated on a

pharmacy license as the pharmacist who has the authority or

responsibility for the pharmacy's compliance with statutes and

rules relating to the practice of pharmacy.

(30) "Pharmacist-intern" means:

(A) an undergraduate student who is enrolled in the professional

sequence of a college of pharmacy approved by the board and who

is participating in a board-approved internship program; or

(B) a graduate of a college of pharmacy who is participating in

a board-approved internship.

(31) "Pharmacy" means a facility at which a prescription drug or

medication order is received, processed, or dispensed under this

subtitle, Chapter 481 or 483, Health and Safety Code, or the

Comprehensive Drug Abuse Prevention and Control Act of 1970 (21

U.S.C. Section 801 et seq.). The term does not include a narcotic

drug treatment program that is regulated under Chapter 466,

Health and Safety Code.

(32) "Pharmacy technician" means an individual employed by a

pharmacy whose responsibility is to provide technical services

that do not require professional judgment regarding preparing and

distributing drugs and who works under the direct supervision of

and is responsible to a pharmacist.

(33) "Practice of pharmacy" means:

(A) providing an act or service necessary to provide

pharmaceutical care;

(B) interpreting or evaluating a prescription drug order or

medication order;

law, and participating in drug administration, drug regimen

review, or drug or drug-related research;

(D) providing patient counseling;

(E) being responsible for:

(i) dispensing a prescription drug order or distributing a

medication order;

(ii) compounding or labeling a drug or device, other than

labeling by a manufacturer, repackager, or distributor of a

nonprescription drug or commercially packaged prescription drug

or device;

(iii) properly and safely storing a drug or device; or

(iv) maintaining proper records for a drug or device;

(F) performing for a patient a specific act of drug therapy

management delegated to a pharmacist by a written protocol from a

physician licensed in this state in compliance with Subtitle B;

(G) administering an immunization or vaccination under a

physician's written protocol.

(34) "Practitioner" means:

(A) a person licensed or registered to prescribe, distribute,

administer, or dispense a prescription drug or device in the

course of professional practice in this state, including a

physician, dentist, podiatrist, or veterinarian but excluding a

person licensed under this subtitle;

(B) a person licensed by another state, Canada, or the United

Mexican States in a health field in which, under the law of this

state, a license holder in this state may legally prescribe a

dangerous drug;

state as a physician, dentist, veterinarian, or podiatrist, who

has a current federal Drug Enforcement Administration

registration number and who may legally prescribe a Schedule II,

III, IV, or V controlled substance, as specified under Chapter

481, Health and Safety Code, in that other state; or

(D) an advanced practice nurse or physician assistant to whom a

physician has delegated the authority to carry out or sign

prescription drug orders under Section 157.0511, 157.052,

157.053, 157.054, 157.0541, or 157.0542.

(35) "Preceptor" has the meaning assigned by Section 558.057.

(36) "Prescription drug" means:

(A) a substance for which federal or state law requires a

prescription before the substance may be legally dispensed to the

public;

(B) a drug or device that under federal law is required, before

being dispensed or delivered, to be labeled with the statement:

(i) "Caution: federal law prohibits dispensing without

prescription" or "Rx only" or another legend that complies with

federal law; or

(ii) "Caution: federal law restricts this drug to use by or on

the order of a licensed veterinarian"; or

statute or regulation to be dispensed on prescription or that is

restricted to use by a practitioner only.

(37) "Prescription drug order" means:

(A) an order from a practitioner or a practitioner's designated

agent to a pharmacist for a drug or device to be dispensed; or

(B) an order under Subchapter B, Chapter 157.

(38) "Prospective drug use review" means the review of a

patient's drug therapy and prescription drug order or medication

order, as defined by board rule, before dispensing or

distributing a drug to the patient.

(39) "Provide" means to supply one or more unit doses of a

nonprescription drug or dangerous drug to a patient.

(40) "Radioactive drug" means a drug that exhibits spontaneous

disintegration of unstable nuclei with the emission of nuclear

particles or photons, including a nonradioactive reagent kit or

nuclide generator that is intended to be used in the preparation

of the substance.

(41) "Substitution" means the dispensing of a drug or a brand of

drug other than the drug or brand of drug ordered or prescribed.

(42) "Texas trade association" means a cooperative and

voluntarily joined statewide association of business or

professional competitors in this state designed to assist its

members and its industry or profession in dealing with mutual

business or professional problems and in promoting their common

interest.

(42-a) "Therapeutic contact lens" means a contact lens that

contains one or more drugs and that delivers the drugs into the

wearer's eye.

(43) "Ultimate user" means a person who obtains or possesses a

prescription drug or device for the person's own use or for the

use of a member of the person's household or for administering to

an animal owned by the person or by a member of the person's

household.

(44) "Unit dose packaging" means the ordered amount of drug in a

dosage form ready for administration to a particular patient, by

the prescribed route at the prescribed time, and properly labeled

with the name, strength, and expiration date of the drug.

(45) "Written protocol" means a physician's order, standing

medical order, standing delegation order, or other order or

protocol as defined by rule of the Texas State Board of Medical

Examiners under Subtitle B.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Amended by Acts 2001, 77th Leg., ch. 112, Sec. 5, eff. May 11,

2001; Acts 2001, 77th Leg., ch. 1188, Sec. 10, eff. Sept. 1,

2001; Acts 2001, 77th Leg., ch. 1254, Sec. 1, eff. Sept. 1, 2001;

Acts 2003, 78th Leg., ch. 88, Sec. 8, eff. May 20, 2003.

Amended by:

Acts 2005, 79th Leg., Ch.

28, Sec. 1, eff. September 1, 2005.

Acts 2005, 79th Leg., Ch.

1345, Sec. 2, eff. September 1, 2005.

Acts 2009, 81st Leg., R.S., Ch.

396, Sec. 1, eff. June 19, 2009.

Sec. 551.004. APPLICABILITY OF SUBTITLE. (a) This subtitle

does not apply to:

(1) a practitioner licensed by the appropriate state board who

supplies a patient of the practitioner with a drug in a manner

authorized by state or federal law and who does not operate a

pharmacy for the retailing of prescription drugs;

(2) a member of the faculty of a college of pharmacy recognized

by the board who is a pharmacist and who performs the

pharmacist's services only for the benefit of the college;

(3) a person who procures prescription drugs for lawful

research, teaching, or testing and not for resale; or

(4) a home and community support services agency that possesses

a dangerous drug as authorized by Section 142.0061, 142.0062, or

142.0063, Health and Safety Code.

(b) This subtitle does not prevent a practitioner from

administering a drug to a patient of the practitioner.

than a pharmacist, firm, joint stock company, partnership, or

corporation, of:

(1) a nonprescription drug that is harmless if used according to

instructions on a printed label on the drug's container and that

does not contain a narcotic;

(2) an insecticide, a fungicide, or a chemical used in the arts

if the insecticide, fungicide, or chemical is properly labeled;

(3) an insecticide or fungicide that is mixed or compounded only

for an agricultural purpose.

(d) A wholesaler or manufacturer may distribute a prescription

drug as provided by state or federal law.

(e) This subtitle does not prevent a physician or therapeutic

optometrist from dispensing and charging for therapeutic contact

lenses. This subsection does not authorize a therapeutic

optometrist to prescribe, administer, or dispense a drug that is

otherwise outside the therapeutic optometrist's scope of

practice.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Amended by:

Acts 2009, 81st Leg., R.S., Ch.

396, Sec. 2, eff. June 19, 2009.

Sec. 551.005. APPLICATION OF SUNSET ACT. The Texas State Board

of Pharmacy is subject to Chapter 325, Government Code (Texas

Sunset Act). Unless continued in existence as provided by that

chapter, the board is abolished and this subtitle expires

September 1, 2017.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Amended by:

Acts 2005, 79th Leg., Ch.

1345, Sec. 1, eff. September 1, 2005.

State Codes and Statutes

State Codes and Statutes

State Codes and Statutes

State Codes and Statutes

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