CHAPTER 554. BOARD POWERS AND DUTIES; RULEMAKING AUTHORITY

State Codes and Statutes

Statutes > Texas > Occupations-code > Title-3-health-professions > 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.

(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.

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

(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.

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.

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.

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).

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.

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.

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.

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.

State Codes and Statutes

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State Codes and Statutes

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