CHAPTER 554. BOARD POWERS AND DUTIES; RULEMAKING AUTHORITY
OCCUPATIONS CODE
TITLE 3. HEALTH PROFESSIONS
SUBTITLE J. PHARMACY AND PHARMACISTS
CHAPTER 554. BOARD POWERS AND DUTIES; RULEMAKING AUTHORITY
SUBCHAPTER A. POWERS AND DUTIES
Sec. 554.001. GENERAL POWERS AND DUTIES OF BOARD. (a) The
board shall:
(1) administer and enforce this subtitle and rules adopted under
this subtitle and enforce other laws relating to the practice of
pharmacy and other powers and duties granted under other law;
(2) cooperate with other state and federal agencies in the
enforcement of any law relating to the practice of pharmacy or
any drug or drug-related law;
(3) maintain an office in which permanent records are kept; and
(4) preserve a record of the board's proceedings.
(b) The board may:
(1) join a professional organization or association organized to
promote the improvement of the standards of the practice of
pharmacy for protecting the health and welfare of the public; and
(2) appoint committees from the board's membership, an advisory
committee from the pharmacy profession, and any other group to
assist in administering this subtitle.
(c) The board may:
(1) issue a duplicate copy of a license to practice pharmacy or
a license renewal certificate on a request from the holder and on
payment of a fee determined by the board; and
(2) inspect a facility licensed under this subtitle for
compliance with this subtitle.
(d) The board may be represented by counsel, including the
attorney general, district attorney, or county attorney, if
necessary in a legal action taken under this subtitle.
(e) The board shall develop formal policies outlining the
structure, role, and responsibilities of each committee
established under Subsection (b)(2) that contains board members.
The board may adopt rules to implement this subsection.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2005, 79th Leg., Ch.
1345, Sec. 8, eff. September 1, 2005.
Sec. 554.002. REGULATION OF PRACTICE OF PHARMACY. The board
shall regulate the practice of pharmacy in this state by:
(1) issuing a license after examination or by reciprocity to an
applicant qualified to practice pharmacy and issuing a license to
a pharmacy under this subtitle;
(2) renewing a license to practice pharmacy and a license to
operate a pharmacy;
(3) determining and issuing standards for recognizing and
approving degree requirements of colleges of pharmacy whose
graduates are eligible for a license in this state;
(4) specifying and enforcing requirements for practical
training, including an internship;
(5) enforcing the provisions of this subtitle relating to:
(A) the conduct or competence of a pharmacist practicing in this
state and the conduct of a pharmacy operating in this state; and
(B) the suspension, revocation, retirement, or restriction of a
license to practice pharmacy or to operate a pharmacy or the
imposition of an administrative penalty or reprimand on a license
holder;
(6) regulating the training, qualifications, and employment of a
pharmacist-intern and pharmacy technician; and
(7) determining and issuing standards for recognizing and
approving a pharmacy residency program for purposes of Subchapter
W, Chapter 61, Education Code.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.301(a), eff.
Sept. 1, 2001.
Sec. 554.0021. RECOGNITION AND APPROVAL OF PHARMACIST
CERTIFICATION PROGRAMS. (a) The board shall determine and issue
standards for recognizing and approving pharmacist certification
programs.
(b) In adopting standards under Subsection (a), the board shall
include a requirement that a pharmacist may not use the
designation "board certified" unless the pharmacist has
successfully completed a certification program that meets the
board's standards.
Added by Acts 2001, 77th Leg., ch. 1420, Sec. 14.301(c), eff.
Sept. 1, 2001.
Sec. 554.003. PROCEDURES. The board by rule shall specify:
(1) the licensing procedures to be followed, including
specification of forms to be used, in applying for a pharmacy
license; and
(2) fees for filing an application for a pharmacy license.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 554.004. ADMINISTRATION OF MEDICATION. (a) The board
shall specify conditions under which a pharmacist may administer
medication, including an immunization and vaccination. The
conditions must ensure that:
(1) a licensed health care provider authorized to administer the
medication is not reasonably available to administer the
medication;
(2) failure to administer the medication, other than an
immunization or vaccination, might result in a significant delay
or interruption of a critical phase of drug therapy;
(3) the pharmacist possesses the necessary skill, education, and
certification as specified by the board to administer the
medication;
(4) within a reasonable time after administering medication, the
pharmacist notifies the licensed health care provider responsible
for the patient's care that the medication was administered;
(5) the pharmacist may not administer medication to a patient at
the patient's residence, except at a licensed nursing home or
hospital;
(6) the pharmacist administers an immunization or vaccination
under a physician's written protocol and meets the standards
established by the board; and
(7) the authority of a pharmacist to administer medication may
not be delegated.
(b) This section does not prohibit a pharmacist from preparing
or manipulating a biotechnological agent or device.
(c) This section does not prohibit a pharmacist from performing
an act delegated by a physician in accordance with Chapter 157.
The pharmacist performing a delegated medical act under that
chapter is considered to be performing a medical act and not to
be engaging in the practice of pharmacy.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 554.005. PRESCRIPTION DRUGS AND DEVICES. (a) In
regulating the practice of pharmacy and the use in this state of
prescription drugs and devices in the diagnosis, mitigation, or
treatment or prevention of injury, illness, or disease, the board
shall:
(1) regulate the delivery or distribution of a prescription drug
or device;
(2) specify minimum standards for the professional environment,
technical equipment, and security in a prescription dispensing
area;
(3) specify minimum standards for:
(A) drug storage;
(B) maintenance of prescription drug records; and
(C) procedures for the:
(i) delivering and dispensing in a suitable, appropriately
labeled container;
(ii) providing of prescription drugs or devices;
(iii) monitoring of drug therapy; and
(iv) counseling of patients on proper use of a prescription drug
or device in the practice of pharmacy;
(4) adopt rules regulating a prescription drug order or
medication order transmitted by electronic means; and
(5) register a balance used for compounding drugs in a pharmacy
licensed in this state and periodically inspect the balance to
verify accuracy.
(b) In implementing Subsection (a)(1), the board may, after
notice and hearing, seize any prescription drug or device that
poses a hazard to the public health and welfare.
(c) In implementing Subsection (a)(1), the board may not
regulate:
(1) any manufacturer's representative or employee acting in the
normal course of business;
(2) a person engaged in the wholesale drug business and licensed
by the commissioner of public health as provided by Chapter 431,
Health and Safety Code; or
(3) an employee of a person described by Subdivision (2) if the
employee is acting in the normal course of business.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.301(d), eff.
Sept. 1, 2001.
Sec. 554.006. FEES. The board by rule shall establish
reasonable and necessary fees so that the fees, in the aggregate,
produce sufficient revenue to cover the cost of administering
this subtitle.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 554.007. FUNDS. (a) The board shall deposit revenue
collected under this subtitle to the credit of the general
revenue fund.
(b) The board may receive and spend money from a party, other
than the state, in addition to money collected under Subsection
(a), in accordance with state law.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2005, 79th Leg., Ch.
1345, Sec. 9, eff. September 1, 2005.
Sec. 554.009. LEASE OR PURCHASE OF VEHICLES. (a) The board may
lease or purchase vehicles for use in official board business.
(b) A vehicle acquired under Subsection (a) is exempt from a
requirement to bear state government identification.
(c) The board may register a vehicle with the Texas Department
of Motor Vehicles in an alias name only for investigative
personnel.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2009, 81st Leg., R.S., Ch.
933, Sec. 3I.01, eff. September 1, 2009.
Sec. 554.010. PEACE OFFICERS. (a) The board may commission as
a peace officer to enforce this subtitle an employee who has been
certified as qualified to be a peace officer by the Commission on
Law Enforcement Officer Standards and Education.
(b) An employee commissioned as a peace officer under this
subtitle has the powers, privileges, and immunities of a peace
officer while carrying out duties as a peace officer under this
subtitle.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2009, 81st Leg., R.S., Ch.
1361, Sec. 1, eff. June 19, 2009.
Sec. 554.011. PILOT AND DEMONSTRATION RESEARCH PROJECTS. (a)
The board may approve pilot and demonstration research projects
for innovative applications in the practice of pharmacy.
(b) The board shall specify the procedures to be followed in
applying for approval of a project.
(c) The approval may include a provision granting an exception
to any rule adopted under this subtitle. The board may extend the
time an exception to a rule is granted as necessary for the board
to adopt an amendment or modification of the rule. The board may
condition approval of a project on compliance with this section
and rules adopted under this section.
(d) A project may not include therapeutic substitution or
substitution of a medical device used in patient care.
(e) This section does not expand the definition of pharmacy
under this subtitle.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.302(a), eff.
Sept. 1, 2001.
Sec. 554.012. NOTIFICATION RELATING TO THERAPEUTIC OPTOMETRISTS.
The board shall inform each holder of a license to practice
pharmacy and each holder of a license to operate a pharmacy of
the authority of a therapeutic optometrist to prescribe a drug
under Section 351.357 by annually mailing to each license holder
a notice that:
(1) describes the authority of a therapeutic optometrist to
prescribe a drug; and
(2) lists each drug that a therapeutic optometrist may lawfully
prescribe.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 554.013. ANNUAL REPORT. (a) The board shall file annually
with the governor and the presiding officer of each house of the
legislature a complete and detailed written report accounting for
all funds received or disbursed by the board during the preceding
fiscal year.
(b) The report must be in the form and reported in the time
provided by the General Appropriations Act.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 554.014. INFORMATION PROVIDED TO LICENSE HOLDERS. At least
once each biennium, the board shall provide to license holders
information on:
(1) prescribing and dispensing pain medications, with particular
emphasis on Schedule II and Schedule III controlled substances;
(2) abusive and addictive behavior of certain persons who use
prescription pain medications;
(3) common diversion strategies employed by certain persons who
use prescription pain medications, including fraudulent
prescription patterns; and
(4) the appropriate use of pain medications and the differences
between addiction, pseudo-addiction, tolerance, and physical
dependence.
Added by Acts 2003, 78th Leg., ch. 1163, Sec. 7, eff. Sept. 1,
2003.
Sec. 554.015. POISON CONTROL CENTER INFORMATION. The board
shall provide to license holders information regarding the
services provided by poison control centers.
Added by Acts 2003, 78th Leg., ch. 1163, Sec. 7, eff. Sept. 1,
2003.
Sec. 554.016. CANADIAN PHARMACY INSPECTION; DESIGNATION; FEES;
INFORMATION. (a) The board shall designate at least one and not
more than 10 Canadian pharmacies whose primary business is to
dispense prescription drugs under prescription drug orders to
Canadian residents, as having passed inspection by the board for
shipping, mailing, or delivering to this state a prescription
dispensed under a prescription drug order to a resident in this
state.
(b) The board by rule shall set fees in amounts reasonable and
necessary to cover the costs incurred by the board in inspecting
Canadian pharmacies as provided by Subsection (a).
(c) The board shall establish and maintain an Internet website
to provide information necessary to enable residents of this
state to conveniently order prescription drugs from Canadian
pharmacies designated by the board as having passed inspection to
dispense prescription drugs to residents in this state in
accordance with this subtitle and board rules. The board shall
include on the website a statement that the board is not liable
for any act or omission of a Canadian pharmacy designated as
having passed inspection to dispense prescription drugs to
residents in this state.
Added by Acts 2005, 79th Leg., Ch.
1345, Sec. 37, eff. September 1, 2005.
Sec. 554.017. LIST OF PHARMACISTS AUTHORIZED TO SIGN
PRESCRIPTION DRUG ORDERS. The board shall provide on its
Internet website a list of pharmacists who are authorized to sign
a prescription drug order under Section 157.101(b-1), including
the name of the pharmacist's delegating physician under the
protocol required under that subsection.
Added by Acts 2009, 81st Leg., R.S., Ch.
271, Sec. 2, eff. September 1, 2009.
SUBCHAPTER B. RULEMAKING
Sec. 554.051. RULEMAKING: GENERAL POWERS AND DUTIES. (a) The
board shall adopt rules consistent with this subtitle for the
administration and enforcement of this subtitle.
(b) If the board determines it necessary to protect the health
and welfare of the citizens of this state, the board may make a
rule concerning the operation of a licensed pharmacy located in
this state applicable to a pharmacy licensed by the board that is
located in another state.
(c) The board shall adopt rules regarding records to be
maintained by a pharmacist performing a specific act under a
written protocol.
(d) The board by rule shall specify minimum standards for
professional responsibility in the conduct of a pharmacy.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 554.052. IMMUNIZATIONS AND VACCINATIONS; PHYSICIAN
SUPERVISION. (a) The board by rule shall require a pharmacist
to notify a physician who prescribes an immunization or
vaccination within 24 hours after the pharmacist administers the
immunization or vaccination.
(b) The board shall establish minimum education and continuing
education standards for a pharmacist who administers an
immunization or vaccination. The standards must include Centers
for Disease Control and Prevention training, basic life support
training, and hands-on training in techniques for administering
immunizations and vaccinations.
(c) Supervision by a physician is adequate if the delegating
physician:
(1) is responsible for formulating or approving an order or
protocol, including the physician's order, standing medical
order, or standing delegation order, and periodically reviews the
order or protocol and the services provided to a patient under
the order or protocol;
(2) except as provided by Subsection (c-1), has established a
physician-patient relationship with each patient under 14 years
of age and referred the patient to the pharmacist;
(3) is geographically located to be easily accessible to the
pharmacy where an immunization or vaccination is administered;
(4) receives, as appropriate, a periodic status report on the
patient, including any problem or complication encountered; and
(5) is available through direct telecommunication for
consultation, assistance, and direction.
(c-1) A pharmacist may administer an influenza vaccination to a
patient over seven years of age without an established
physician-patient relationship.
(d) The Texas Medical Board by rule shall establish the minimum
content of a written order or protocol. The order or protocol
may not permit delegation of medical diagnosis.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2009, 81st Leg., R.S., Ch.
375, Sec. 1, eff. September 1, 2009.
Sec. 554.053. RULEMAKING: PHARMACY TECHNICIAN. (a) The board
shall establish rules for the use and the duties of a pharmacy
technician in a pharmacy licensed by the board. A technician
shall be responsible to and must be directly supervised by a
pharmacist.
(b) The board may not adopt a rule establishing a ratio of
pharmacists to pharmacy technicians in a Class C pharmacy or
limiting the number of pharmacy technicians that may be used in a
Class C pharmacy.
(c) The board shall determine and issue standards for
recognition and approval of a training program for pharmacy
technicians and maintain a list of board-approved training
programs that meet those standards.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.303(a), eff.
Sept. 1, 2001.
Sec. 554.054. RULES RESTRICTING ADVERTISING OR COMPETITIVE
BIDDING. (a) The board may not adopt rules restricting
advertising or competitive bidding by a person regulated by the
board except to prohibit false, misleading, or deceptive
practices by that person.
(b) The board may not include in rules to prohibit false,
misleading, or deceptive practices by a person regulated by the
board a rule that:
(1) restricts the use of any advertising medium;
(2) restricts the person's personal appearance or use of the
person's voice in an advertisement;
(3) relates to the size or duration of an advertisement used by
the person; or
(4) restricts the use of a trade name in advertising by the
person.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 554.055. RULEMAKING; ELECTRONIC MEDIA. The board shall
adopt rules regarding the sale and delivery of drugs by use of
electronic media, including the Internet.
Added by Acts 2001, 77th Leg., ch. 972, Sec. 1, eff. Sept. 1,
2001.
Sec. 554.056. RULEMAKING; ADDITION OF FLAVORING TO COMMERCIAL
PRODUCT. The board may adopt rules governing the procedures for
a pharmacist, as part of compounding, to add flavoring to a
commercial product at the request of a patient or a patient's
agent.
Added by Acts 2007, 80th Leg., R.S., Ch.
550, Sec. 1, eff. September 1, 2007.
Sec. 554.057. RULEMAKING; IMPLEMENTATION OF DRUG THERAPY UNDER
PROTOCOL. The board, with the advice of the Texas Medical Board,
shall adopt rules that allow a pharmacist to implement or modify
a patient's drug therapy pursuant to a physician's delegation
under Section 157.101(b-1).
Added by Acts 2009, 81st Leg., R.S., Ch.
271, Sec. 3, eff. September 1, 2009.