CHAPTER 551. GENERAL PROVISIONS
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.
(c) The purpose of this subtitle is to promote, preserve, and
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;
(C) in anticipation of a prescription drug order based on a
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;
or
(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
(C) a registered nurse or physician assistant authorized by a
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;
(C) a substance, other than food, intended to affect the
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;
(C) a reasonable dose and route of administration;
(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;
(C) participating in drug or device selection as authorized by
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;
or
(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;
(C) a person practicing in another state and licensed by another
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
(C) a drug or device that is required by federal or state
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.
(c) This subtitle does not prevent the sale by a person, other
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;
or
(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.