By Van de Putte H.B. No. 1283
75R5098 SKB-D
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to the regulation of pharmacies and pharmacists; providing
1-3 a penalty.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Section 5, Texas Pharmacy Act (Article 4542a-1,
1-6 Vernon's Texas Civil Statutes), is amended to read as follows:
1-7 Sec. 5. DEFINITIONS. In this Act, unless the context of its
1-8 use clearly indicates otherwise:
1-9 (1) "A.C.P.E." means the American Council on
1-10 Pharmaceutical Education.
1-11 (2) "Administer" means the direct application of a
1-12 prescription drug by injection, inhalation, ingestion, or any other
1-13 means to the body of a patient by:
1-14 (A) a practitioner, an authorized agent under
1-15 his supervision, or other person authorized by law; or
1-16 (B) the patient at the direction of a
1-17 practitioner.
1-18 (3) "Administrative Procedure Act" means Chapter 2001,
1-19 Government Code [the Administrative Procedure and Texas Register
1-20 Act, as amended (Article 6252-13a, Vernon's Texas Civil Statutes)].
1-21 (4) "Board" means the Texas State Board of Pharmacy.
1-22 (5) "Class A pharmacy license" or "community pharmacy
1-23 license" means a license issued to a pharmacy dispensing drugs or
1-24 devices to the general public pursuant to a prescription drug
2-1 order.
2-2 (6) "Class B pharmacy license" or "nuclear pharmacy
2-3 license" means a license issued to a pharmacy dispensing or
2-4 providing radioactive drugs or devices for administration to an
2-5 ultimate user.
2-6 (7) "Class C pharmacy license" or "institutional
2-7 pharmacy license" means a license issued to a pharmacy located in a
2-8 hospital or other in-patient facility that is licensed under
2-9 Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental
2-10 Health Code (Article 5547-1 et seq., Vernon's Texas Civil
2-11 Statutes), to a hospice in-patient facility that is licensed under
2-12 Chapter 142, Health and Safety Code, or to a pharmacy located in a
2-13 hospital maintained or operated by the state.
2-14 (8) "Class D pharmacy license" or "clinic pharmacy
2-15 license" means a license issued to a pharmacy dispensing a limited
2-16 type of drugs or devices pursuant to a prescription drug order.
2-17 (9) "Class E pharmacy license" or "nonresident
2-18 pharmacy license" means a license issued under this Act to a
2-19 pharmacy located in a state of the United States other than this
2-20 state whose primary business is to dispense a prescription drug or
2-21 device under a prescription drug order and to deliver the drug or
2-22 device to a patient, including a patient in this state, by the
2-23 United States mail, a common carrier, or a delivery service.
2-24 (10) [(11)] "College of pharmacy" means a school,
2-25 university, or college of pharmacy that satisfies the accreditation
2-26 standards of A.C.P.E. as adopted by the board; or that has degree
2-27 requirements which meet the standards of accreditation set by the
3-1 board.
3-2 (11) [(12)] "Compounding" means the preparation,
3-3 mixing, assembling, packaging, or labeling of a drug or device:
3-4 (A) as the result of a practitioner's
3-5 prescription drug order or initiative based on the
3-6 practitioner-patient-pharmacist relationship in the course of
3-7 professional practice;
3-8 (B) in anticipation of prescription drug orders
3-9 based on routine, regularly observed prescribing patterns; or
3-10 (C) for the purpose of or as an incident to
3-11 research, teaching, or chemical analysis and not for sale or
3-12 dispensing.
3-13 (12) [(13)] "Confidential record" means any
3-14 health-related record that contains information that identifies an
3-15 individual and that is maintained by a pharmacy or pharmacist such
3-16 as a patient medication record, prescription drug order, or
3-17 medication order.
3-18 (13) [(14)] "Controlled substance" means a drug,
3-19 immediate precursor, or other substance listed in Schedules I-V or
3-20 Penalty Groups 1-4 of Chapter 481, Health and Safety Code, or a
3-21 drug, immediate precursor, or other substance included in Schedule
3-22 I, II, III, IV, or V of the Federal Comprehensive Drug Abuse
3-23 Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
3-24 (14) [(15)] "Controlled Substances Act" means Chapter
3-25 481, Health and Safety Code, or the Federal Comprehensive Drug
3-26 Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et
3-27 seq.).
4-1 (15) [(16)] "Dangerous drug" means any drug or device
4-2 that is not included in Penalty Groups 1-4 of the Controlled
4-3 Substances Act and that is unsafe for self-medication or any drug
4-4 or device that bears or is required to bear the legend:
4-5 (A) "Caution: federal law prohibits dispensing
4-6 without prescription"; or
4-7 (B) "Caution: federal law restricts this drug
4-8 to use by or on the order of a licensed veterinarian."
4-9 (16) [(17)] "Dangerous Drug Act" means Chapter 483,
4-10 Health and Safety Code.
4-11 (17) [(18)] "Deliver" or "delivery" means the actual,
4-12 constructive, or attempted transfer of a prescription drug or
4-13 device or controlled substance from one person to another, whether
4-14 or not for a consideration.
4-15 (18) [(19)] "Designated agent" means:
4-16 (A) a licensed nurse, physician assistant,
4-17 pharmacist, or other individual designated by a practitioner, and
4-18 for whom the practitioner assumes legal responsibility, who
4-19 communicates prescription drug orders to a pharmacist;
4-20 (B) a licensed nurse, physician assistant, or
4-21 pharmacist employed in a health care facility to whom the
4-22 practitioner communicates a prescription drug order; or
4-23 (C) a registered nurse or physician assistant
4-24 authorized by a practitioner to carry out a prescription drug order
4-25 for dangerous drugs under Subdivision (5) or (6), Subsection (d),
4-26 Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas
4-27 Civil Statutes).
5-1 (19) [(20)] "Device" means an instrument, apparatus,
5-2 implement, machine, contrivance, implant, in vitro reagent, or
5-3 other similar or related article, including any component part or
5-4 accessory, that is required under federal or state law to be
5-5 ordered or prescribed by a practitioner.
5-6 (20) [(21)] "Dispense" means preparing, packaging,
5-7 compounding, or labeling for delivery a prescription drug or device
5-8 in the course of professional practice to an ultimate user or his
5-9 agent by or pursuant to the lawful order of a practitioner.
5-10 (21) [(22)] "Distribute" means the delivery of a
5-11 prescription drug or device other than by administering or
5-12 dispensing.
5-13 (22) [(23)] "Drug" means:
5-14 (A) a substance recognized as drugs in the
5-15 current official United States Pharmacopoeia, official National
5-16 Formulary, official Homeopathic Pharmacopoeia, or other drug
5-17 compendium or any supplement to any of them;
5-18 (B) a substance intended for use in the
5-19 diagnosis, cure, mitigation, treatment, or prevention of disease in
5-20 man or other animals;
5-21 (C) a substance, other than food, intended to
5-22 affect the structure or any function of the body of man or other
5-23 animals;
5-24 (D) a substance intended for use as a component
5-25 of any articles specified in Paragraph (A), (B), or (C) of this
5-26 subdivision;
5-27 (E) a dangerous drug; or
6-1 (F) a controlled substance.
6-2 (23) [(24)] "Drug regimen review" includes the
6-3 following activities:
6-4 (A) evaluation of prescription drug or
6-5 medication orders and patient medication records for:
6-6 (i) known allergies;
6-7 (ii) rational therapy-contraindications;
6-8 (iii) reasonable dose and route of
6-9 administration; and
6-10 (iv) reasonable directions for use;
6-11 (B) evaluation of prescription drug or
6-12 medication orders and patient medication records for duplication of
6-13 therapy;
6-14 (C) evaluation of prescription drug or
6-15 medication orders and patient medication records for:
6-16 (i) drug-drug interactions;
6-17 (ii) drug-food interactions;
6-18 (iii) drug-disease interactions;
6-19 (iv) adverse drug reactions; and
6-20 (D) evaluation of prescription drug and
6-21 medication orders and patient medication records for proper
6-22 utilization, including overutilization or underutilization.
6-23 (24) [(25)] "Internship" means a practical experience
6-24 program that is approved by the board.
6-25 (25) [(26)] "Label" means written, printed, or graphic
6-26 matter on the immediate container of a drug or device.
6-27 (26) [(27)] "Labeling" means the process of affixing a
7-1 label including all information required by federal and state law
7-2 or regulation to any drug or device container. The term does not
7-3 include the labeling by a manufacturer, packer, or distributor of a
7-4 nonprescription drug or commercially packaged prescription drug or
7-5 device, or unit dose packaging.
7-6 (27) [(28)] "Manufacturing" means the production,
7-7 preparation, propagation, conversion, or processing of a drug or
7-8 device, either directly or indirectly, by extraction from
7-9 substances of natural origin or independently by means of chemical
7-10 or biological synthesis and includes any packaging or repackaging
7-11 of the substances or labeling or relabeling of the container and
7-12 the promotion and marketing of such drugs or devices.
7-13 Manufacturing also includes the preparation and promotion of
7-14 commercially available products from bulk compounds for resale by
7-15 pharmacies, practitioners, or other persons but does not include
7-16 compounding.
7-17 (28) [(29)] "Medication order" means an order from a
7-18 practitioner or a practitioner's designated agent for
7-19 administration of a drug or device.
7-20 (29) [(30)] "Nonprescription drug" means a nonnarcotic
7-21 drug or device that may be sold without a prescription and that is
7-22 labeled and packaged in compliance with applicable state or federal
7-23 law.
7-24 (30) [(31)] "Patient counseling" means the
7-25 communication by the pharmacist of information, as specified in the
7-26 rules of the board, to the patient or caregiver, in order to
7-27 improve therapy by ensuring proper use of drugs and devices.
8-1 (31) [(32)] "Person" means an individual, corporation,
8-2 government or governmental subdivision or agency, business trust,
8-3 estate, trust, partnership, association, or any other legal entity.
8-4 (32) [(33)] "Pharmaceutical care" is the provision of
8-5 drug therapy and other pharmaceutical services defined in the rules
8-6 of the board and intended to assist in the cure or prevention of a
8-7 disease, elimination or reduction of a patient's symptoms, or
8-8 arresting or slowing of a disease process.
8-9 (33) [(34)] "Pharmacist" means a person licensed by
8-10 the board to practice pharmacy.
8-11 (34) [(35)] "Pharmacist-in-charge" means the
8-12 pharmacist designated on a pharmacy license as the pharmacist who
8-13 has the authority or responsibility for a pharmacy's compliance
8-14 with laws and rules pertaining to the practice of pharmacy.
8-15 (35) [(36)] "Pharmacist-intern" means an undergraduate
8-16 student enrolled in the professional sequence of a college of
8-17 pharmacy approved by the board and participating in a school-based,
8-18 board-approved internship program or a graduate of a college of
8-19 pharmacy who is participating in a board-approved internship.
8-20 (36) [(37)] "Pharmacy" means a facility at which
8-21 prescription drug or medication orders are received, processed, or
8-22 dispensed under this Act, the Dangerous Drug Act, or the Controlled
8-23 Substances Act [licensed by the board pursuant to Section 29 of
8-24 this Act].
8-25 (37) "Pharmacy technician" means an individual
8-26 employed by a pharmacy whose responsibility is to provide technical
8-27 services that do not require professional judgment regarding the
9-1 preparation and distribution of drugs and who works under the
9-2 direct supervision of and is responsible to a pharmacist.
9-3 (38) "Practice of pharmacy" means:
9-4 (A) provision of those acts or services
9-5 necessary to provide pharmaceutical care;
9-6 (B) interpretation and evaluation of
9-7 prescription drug orders or medication orders;
9-8 (C) participation in drug and device selection
9-9 as authorized by law, drug administration, drug regimen review, or
9-10 drug or drug-related research;
9-11 (D) provision of patient counseling;
9-12 (E) responsibility for:
9-13 (i) dispensing of prescription drug orders
9-14 or distribution of medication orders;
9-15 (ii) compounding and labeling of drugs and
9-16 devices, except labeling by a manufacturer, repackager, or
9-17 distributor of nonprescription drugs and commercially packaged
9-18 prescription drugs and devices;
9-19 (iii) proper and safe storage of drugs and
9-20 devices; or
9-21 (iv) maintenance of proper records for
9-22 drugs and devices; and
9-23 (F) performance of a specific act of drug
9-24 therapy management for a patient delegated to a pharmacist by a
9-25 written protocol from a physician licensed in this state in
9-26 compliance with the Medical Practice Act (Article 4495b, Vernon's
9-27 Texas Civil Statutes).
10-1 (39) "Practitioner" means:
10-2 (A) a physician, dentist, podiatrist,
10-3 veterinarian, or other person licensed or registered to prescribe,
10-4 distribute, administer, or dispense a prescription drug or device
10-5 in the course of professional practice in this state;
10-6 (B) a person licensed by another state in a
10-7 health field in which, under Texas law, licensees in this state may
10-8 legally prescribe dangerous drugs or a person practicing in another
10-9 state and licensed by another state as a physician, dentist,
10-10 veterinarian, or podiatrist, having a current Federal Drug
10-11 Enforcement Administration registration number, and who may legally
10-12 prescribe Schedule II, III, IV, or V controlled substances in such
10-13 other state; or
10-14 (C) a person licensed in the Dominion of Canada
10-15 or the United Mexican States in a health field in which, under the
10-16 laws of this state, a licensee may legally prescribe dangerous
10-17 drugs. "Practitioner" does not include a person licensed under
10-18 this Act.
10-19 (40) "Preceptor" means a pharmacist [in good standing]
10-20 licensed in this state to practice pharmacy who meets the preceptor
10-21 requirements specified by rule and certified by the board to
10-22 supervise and be responsible for the activities and functions of a
10-23 pharmacist-intern in the internship program.
10-24 (41) "Prescription drug" means:
10-25 (A) a substance for which federal or state law
10-26 requires a prescription before it may be legally dispensed to the
10-27 public;
11-1 (B) a drug or device that under federal law is
11-2 required, prior to being dispensed or delivered, to be labeled with
11-3 either of the following statements:
11-4 (i) "Caution: federal law prohibits
11-5 dispensing without prescription"; or
11-6 (ii) "Caution: federal law restricts this
11-7 drug to use by or on the order of a licensed veterinarian"; or
11-8 (C) a drug or device that is required by any
11-9 applicable federal or state law or regulation to be dispensed on
11-10 prescription only or is restricted to use by a practitioner only.
11-11 (42) "Prescription drug order" means:
11-12 (A) an order from a practitioner or a
11-13 practitioner's designated agent to a pharmacist for a drug or
11-14 device to be dispensed; or
11-15 (B) an order pursuant to Subdivision (5) or (6),
11-16 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
11-17 Vernon's Texas Civil Statutes).
11-18 (43) "Prospective drug use review" means a review of
11-19 the patient's drug therapy and prescription drug order or
11-20 medication order, as defined in the rules of the board, prior to
11-21 dispensing or distributing the drug.
11-22 (44) "Provide" means to supply one or more unit doses
11-23 of a nonprescription drug or dangerous drug to a patient.
11-24 (45) "Radioactive drug" means a drug that exhibits
11-25 spontaneous disintegration of unstable nuclei with the emission of
11-26 nuclear particles or photons, including any nonradioactive reagent
11-27 kit or nuclide generator that is intended to be used in the
12-1 preparation of any such substance.
12-2 (46) "Substitution" means the dispensing of a drug or
12-3 a brand of drug other than that which is ordered or prescribed.
12-4 (47) "Texas trade association" means a nonprofit,
12-5 cooperative association of business or professional competitors in
12-6 this state whose purpose is to assist its members, industry, or
12-7 profession and whose members have joined voluntarily. ["Supportive
12-8 personnel" means those individuals utilized in pharmacies whose
12-9 responsibility it shall be to provide technical services that do
12-10 not require professional judgment concerned with the preparation
12-11 and distribution of drugs under the direct supervision of and
12-12 responsible to a pharmacist.]
12-13 (48) "Ultimate user" means a person who has obtained
12-14 and possesses a prescription drug or device for the person's own
12-15 use or for the use of a member of the person's household or for
12-16 administering to an animal owned by the person or by a member of
12-17 the person's household.
12-18 (49) "Unit dose packaging" means the ordered amount of
12-19 drug in a dosage form ready for administration to a particular
12-20 patient, by the prescribed route at the prescribed time, and
12-21 properly labeled with name, strength, and expiration date of the
12-22 drug.
12-23 (50) "Written protocol" means a physician's order,
12-24 standing medical order, standing delegation order, or other order
12-25 or protocol as defined by rule of the Texas State Board of Medical
12-26 Examiners under the Medical Practice Act (Article 4495b, Vernon's
12-27 Texas Civil Statutes).
13-1 SECTION 2. Section 8(a), Texas Pharmacy Act (Article
13-2 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
13-3 follows:
13-4 (a) A licensed pharmacist member of the board:
13-5 (1) may not be:
13-6 (A) a salaried faculty member at a college of
13-7 pharmacy; or
13-8 (B) an officer, employee, or paid consultant of
13-9 a Texas trade association in the field of health care or a spouse
13-10 of an officer, employee, or paid consultant; and
13-11 (2) must at the time of his appointment:
13-12 (A) [(1)] be a resident of this state;
13-13 (B) [(2)] be licensed for the five years
13-14 immediately preceding appointment and be in good standing to engage
13-15 in the practice of pharmacy in this state; and
13-16 (C) [(3)] be engaged in the practice of pharmacy
13-17 in this state.
13-18 SECTION 3. Section 8, Texas Pharmacy Act (Article 4542a-1,
13-19 Vernon's Texas Civil Statutes), is amended by adding Subsection (f)
13-20 to read as follows:
13-21 (f) The board shall provide to its members, as often as
13-22 necessary, information regarding their qualifications for office or
13-23 employment under this Act and their responsibilities under
13-24 applicable laws relating to standards of conduct for state officers
13-25 or employees.
13-26 SECTION 4. Section 14(c), Texas Pharmacy Act (Article
13-27 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
14-1 follows:
14-2 (c) Except as otherwise provided by this subsection, all
14-3 board meetings and hearings shall be open to the public. The board
14-4 may, in its discretion and in accordance with the open meetings
14-5 law, Chapter 551, Government Code, [Chapter 271, Acts of the 60th
14-6 Legislature, Regular Session, 1967, as amended (Article 6252-17,
14-7 Vernon's Texas Civil Statutes),] conduct any portion of its meeting
14-8 in executive session. The board may in its discretion conduct
14-9 deliberations relative to licensee disciplinary actions in
14-10 executive session. At the conclusion of its deliberations relative
14-11 to licensee disciplinary action, the board shall vote and announce
14-12 its decision relative to the licensee in open session. The board
14-13 in executive session may conduct disciplinary hearings relating to
14-14 a pharmacist or pharmacy student who is impaired because of
14-15 chemical abuse or mental or physical illness.
14-16 SECTION 5. Sections 15(c), (d), and (f), Texas Pharmacy Act
14-17 (Article 4542a-1, Vernon's Texas Civil Statutes), are amended to
14-18 read as follows:
14-19 (c) An officer, employee, or paid consultant of a Texas
14-20 trade association in the field of health care may not be an [a
14-21 member or] employee of the board who is exempt from the state's
14-22 position classification plan or is compensated at or above the
14-23 amount prescribed by the General Appropriations Act for step 1,
14-24 salary group 17, of the position classification salary schedule.
14-25 (d) A person who is the spouse of an officer, manager, or
14-26 paid consultant of a Texas trade association in the field of health
14-27 care may not be a [board member and may not be a] board employee
15-1 who is exempt from the state's position classification plan or is
15-2 compensated at or above the amount prescribed by the General
15-3 Appropriations Act for step 1, salary group 17, of the position
15-4 classification salary schedule.
15-5 (f) The board shall provide to its [members and] employees,
15-6 as often as necessary, information regarding their qualification
15-7 for office or employment under this Act and their responsibilities
15-8 under applicable laws relating to standards of conduct for state
15-9 officers or employees.
15-10 SECTION 6. Sections 17(a), (o), and (q), Texas Pharmacy Act
15-11 (Article 4542a-1, Vernon's Texas Civil Statutes), are amended to
15-12 read as follows:
15-13 (a) The board is responsible for the regulation of the
15-14 practice of pharmacy in this state, including the following:
15-15 (1) the licensing by examination or by reciprocity of
15-16 applicants who are qualified to engage in the practice of pharmacy
15-17 and the licensing of pharmacies under this Act;
15-18 (2) the renewal of licenses to engage in the practice
15-19 of pharmacy and licenses to operate pharmacies;
15-20 (3) the determination and issuance of standards for
15-21 recognition and approval of degree requirements of colleges of
15-22 pharmacy whose graduates shall be eligible for licensing in this
15-23 state and the specification and enforcement of requirements for
15-24 practical training, including internship;
15-25 (4) the enforcement of those provisions of this Act
15-26 relating to the conduct or competence of pharmacists practicing in
15-27 this state and the conduct of pharmacies operating in this state
16-1 and the suspension, revocation, fining, reprimanding, cancellation,
16-2 or restriction of licenses to engage in the practice of pharmacy or
16-3 to operate a pharmacy;
16-4 (5) the specifications of conditions under which a
16-5 pharmacist may administer medications which at a minimum shall
16-6 include the following:
16-7 (A) a licensed health care provider authorized
16-8 to administer the medication is not reasonably available to
16-9 administer the medication;
16-10 (B) failure to administer the medication might
16-11 result in a significant delay or interruption of a critical phase
16-12 of drug therapy;
16-13 (C) the pharmacist possesses the necessary skill
16-14 and education to administer the medication;
16-15 (D) the pharmacist notifies the appropriate
16-16 licensed health care provider responsible for the patient's care
16-17 within a reasonable time that the medication was administered;
16-18 (E) a pharmacist may not administer medications
16-19 to a patient where the patient resides, except in a licensed
16-20 nursing home or hospital;
16-21 (F) the authority of the pharmacist to
16-22 administer medications may not be delegated;
16-23 (G) nothing in this subdivision shall be
16-24 construed to prohibit a pharmacist from preparing or manipulating
16-25 biotechnological agents or devices; and
16-26 (H) nothing in this subdivision shall be
16-27 construed as prohibiting a pharmacist from performing an act
17-1 delegated by a physician in accordance with the provisions of
17-2 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
17-3 Vernon's Texas Civil Statutes), and the pharmacist performing such
17-4 a delegated medical act shall be considered to be performing a
17-5 medical act and not as engaged in the practice of pharmacy;
17-6 (6) the regulation of the training, qualifications,
17-7 and employment of pharmacist-interns; and
17-8 (7) the enforcement of this Act and any rules adopted
17-9 under this Act.
17-10 (o) The board:
17-11 (1) shall [may] establish rules for the use of
17-12 pharmacy technicians [supportive personnel] and the duties of those
17-13 technicians [personnel] in pharmacies licensed by the board,
17-14 provided that those technicians [personnel] are responsible to and
17-15 directly supervised by a pharmacist licensed by the board; provided
17-16 however that the board may not adopt rules or regulations
17-17 establishing ratios of pharmacists to pharmacy technicians
17-18 [supportive personnel] in Class C pharmacies; and
17-19 (2) may determine and issue standards for recognition
17-20 and approval of training programs for pharmacy technicians and
17-21 maintain a list of training programs that meet the standards.
17-22 (q) Board investigative files and all information and
17-23 materials compiled by the board in connection with an investigation
17-24 are confidential and are not subject to disclosure under Chapter
17-25 552, Government Code [424, Acts of the 63rd Legislature, Regular
17-26 Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil
17-27 Statutes)], and are not subject to disclosure, discovery, subpoena,
18-1 or other means of legal compulsion for their release to anyone
18-2 other than the board or its employees or agents involved in
18-3 licensee discipline except that this information may be disclosed
18-4 to:
18-5 (1) persons involved with the board in a disciplinary
18-6 action against the licensee;
18-7 (2) pharmacist or pharmacy licensing or disciplinary
18-8 authorities of other jurisdictions;
18-9 (3) a pharmaceutical peer review committee as outlined
18-10 in Section 27A of this Act;
18-11 (4) law enforcement agencies; and
18-12 (5) persons engaged in bona fide research, if all
18-13 individual-identifying information has been deleted.
18-14 SECTION 7. Section 17D(a), Texas Pharmacy Act (Article
18-15 4542a-1, Vernon's Texas Civil Statutes), is revised to read as
18-16 follows:
18-17 (a) The board by rule shall adopt procedures governing:
18-18 (1) informal disposition of a contested case under
18-19 Chapter 2001, Government Code [Section 13(e), Administrative
18-20 Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas
18-21 Civil Statutes), and its subsequent amendments]; and
18-22 (2) informal proceedings held in compliance with
18-23 Chapter 2001, Government Code [Section 18(c), Administrative
18-24 Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas
18-25 Civil Statutes), and its subsequent amendments].
18-26 SECTION 8. Sections 19(a), (f), and (g), Texas Pharmacy Act
18-27 (Article 4542a-1, Vernon's Texas Civil Statutes), are amended to
19-1 read as follows:
19-2 (a) A person may not:
19-3 (1) dispense or distribute prescription drugs unless
19-4 he is a licensed pharmacist or is authorized by this Act to
19-5 dispense or distribute prescription drugs; or
19-6 (2) operate a pharmacy unless he first obtains a
19-7 license to operate a pharmacy.
19-8 (f) This Act does not apply to:
19-9 (1) a member of the faculty of a college of pharmacy
19-10 that is recognized by the board if the faculty member is a licensed
19-11 pharmacist and performs his services for the benefit of the college
19-12 only;
19-13 (2) [a pharmacist-intern;]
19-14 [(3)] a person who procures prescription drugs for
19-15 lawful research, teaching, or testing and not for resale; or
19-16 (3) [(4)] a home and community support services agency
19-17 that possesses a dangerous drug as authorized by Section 142.0061,
19-18 Health and Safety Code.
19-19 (g) Any person found by the board to have unlawfully engaged
19-20 in the practice of pharmacy or unlawfully operated a pharmacy is
19-21 subject to a civil penalty under Section 37A [fine to be imposed
19-22 by the board not to exceed $1,000 for each offense]. Each
19-23 violation of this Act or the rules adopted under this Act
19-24 pertaining to unlawfully engaging in the practice of pharmacy or
19-25 unlawfully operating a pharmacy also constitutes a Class A
19-26 misdemeanor.
19-27 SECTION 9. Section 20, Texas Pharmacy Act (Article 4542a-1,
20-1 Vernon's Texas Civil Statutes), is amended to read as follows:
20-2 Sec. 20. PHARMACIST-INTERN REGISTRATION. (a) A person must
20-3 register with the board before beginning the board-approved
20-4 internship in this state. An application for the registration of a
20-5 pharmacist-intern must be on a form prescribed by the board.
20-6 Registration shall remain in effect as long as the person meets the
20-7 qualifications for internship as specified by rules adopted by the
20-8 board [during internship training and thereafter until the earlier
20-9 of the following occurs:]
20-10 [(1) the failure of the pharmacist-intern to take the
20-11 next regularly scheduled examination; or]
20-12 [(2) the failure to pass the next regularly scheduled
20-13 examination].
20-14 (b) The board may in its discretion refuse to issue a
20-15 registration to an applicant and may restrict, suspend, or revoke a
20-16 pharmacist-intern registration for any violation of this Act. In
20-17 enforcing Section 26(a)(4), the board shall, on probable cause,
20-18 request a pharmacist-intern or pharmacist-intern applicant to
20-19 submit to a mental or physical examination by physicians or other
20-20 health care professionals designated by the board. If the
20-21 pharmacist-intern or applicant refuses to submit to the
20-22 examination, the board shall issue an order requiring the
20-23 pharmacist-intern or applicant to show cause why he will not submit
20-24 to the examination and shall schedule a hearing on the order within
20-25 30 days after notice is served on the pharmacist-intern or
20-26 applicant. The board shall notify the pharmacist-intern or
20-27 applicant by either personal service or certified mail with return
21-1 receipt requested. At the hearing, the pharmacist-intern or
21-2 applicant and an attorney are entitled to present any testimony and
21-3 other evidence to show why the pharmacist-intern or applicant
21-4 should not be required to submit to the examination. After the
21-5 hearing, the board shall issue an order either requiring the
21-6 pharmacist-intern or applicant to submit to the examination or
21-7 withdrawing the request for examination.
21-8 SECTION 10. Sections 21(a) and (e), Texas Pharmacy Act
21-9 (Article 4542a-1, Vernon's Texas Civil Statutes), are amended to
21-10 read as follows:
21-11 (a) To qualify for a license to practice pharmacy, an
21-12 applicant for licensing by examination must submit to the board a
21-13 license fee as determined by the board and a completed application
21-14 on a form prescribed by the board with satisfactory sworn evidence
21-15 that he:
21-16 (1) is at least 18 years old;
21-17 (2) is of good moral character;
21-18 (3) has completed a minimum of a 1,000-hour internship
21-19 or other program that has been approved by the board or has
21-20 demonstrated, to the board's satisfaction, experience in the
21-21 practice of pharmacy that meets or exceeds the minimum internship
21-22 requirements of the board;
21-23 (4) has graduated and received a [the first
21-24 professional undergraduate degree or the advanced] professional
21-25 practice degree, as defined by the rules adopted by the board,
21-26 from an accredited pharmacy degree program approved by the board;
21-27 (5) has passed the examination required by the board;
22-1 and
22-2 (6) has not had a pharmacist license granted by
22-3 another state suspended, revoked, canceled, surrendered, or
22-4 otherwise restricted for any reason.
22-5 (e) The [Within 30 days after the date a licensing
22-6 examination is administered under this Act, the] board shall notify
22-7 each examinee of the results of the examination[. However, if an
22-8 examination is graded or reviewed by a national testing service,
22-9 the board shall notify each examinee of the results of the
22-10 examination] within 30 days [two weeks] after the date the board
22-11 receives the results from a national [the] testing service. [If
22-12 the notice of the examination results will be delayed for more than
22-13 90 days after the examination date, the board shall notify the
22-14 examinee of the reason for the delay before the 90th day.]
22-15 SECTION 11. Section 22(a), Texas Pharmacy Act (Article
22-16 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
22-17 follows:
22-18 (a) To qualify for a license to practice pharmacy by
22-19 reciprocity, an applicant for licensing must:
22-20 (1) submit to the board a reciprocity fee as
22-21 determined by the board and a completed application given under
22-22 oath, in the form prescribed by the board;
22-23 (2) have good moral character;
22-24 (3) have graduated and received a [the first
22-25 professional undergraduate degree or the advanced] professional
22-26 practice degree, as defined by the rules adopted by the board,
22-27 from an accredited pharmacy degree program approved by the board;
23-1 (4) have possessed at the time of initial licensing as
23-2 a pharmacist other qualifications necessary to have been eligible
23-3 for licensing at that time in this state;
23-4 (5) have presented to the board proof of initial
23-5 licensing by examination and proof that the license and other
23-6 license or licenses granted to the applicant by any other state
23-7 have not been suspended, revoked, canceled, surrendered, or
23-8 otherwise restricted for any reason; and
23-9 (6) pass the Texas [Drug and] Pharmacy Jurisprudence
23-10 examination.
23-11 SECTION 12. Section 26(b), Texas Pharmacy Act (Article
23-12 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
23-13 follows:
23-14 (b) Grounds for Disciplining a Holder of a Pharmacy License:
23-15 The board shall refuse to issue a pharmacy license for failure to
23-16 meet the requirements of Section 29 or 30 of this Act. The board
23-17 may in its discretion refuse to issue or renew a license or may
23-18 assess a penalty, reprimand, revoke, restrict, cancel, or suspend
23-19 any license granted by the board, and may probate any license
23-20 suspension if the board finds that the applicant or licensee has:
23-21 (1) been convicted of a felony or a misdemeanor
23-22 involving moral turpitude, or if the applicant or licensee is a
23-23 legal entity such as an association, joint stock company,
23-24 partnership, or corporation, that a managing officer has been
23-25 convicted of a felony or a misdemeanor involving moral turpitude
23-26 under the law of this state, another state, or the United States;
23-27 (2) advertised any prescription drugs or devices in a
24-1 deceitful, misleading, or fraudulent manner;
24-2 (3) violated any provision of this Act or any rule
24-3 adopted under this Act or that any owner or employee of a pharmacy
24-4 has violated any provision of this Act or any rule adopted under
24-5 this Act;
24-6 (4) sold without legal authorization prescription
24-7 drugs or devices to persons other than:
24-8 (A) a pharmacy licensed by the board;
24-9 (B) a practitioner;
24-10 (C) a person who procures prescription drugs or
24-11 devices for the purpose of lawful research, teaching, or testing,
24-12 and not for resale;
24-13 (D) a manufacturer or wholesaler registered with
24-14 the commissioner of health as required by Chapter 431, Health and
24-15 Safety Code; or
24-16 (E) a carrier or warehouseman;
24-17 (5) allowed an employee who is not a licensed
24-18 pharmacist to practice pharmacy;
24-19 (6) sold adulterated or misbranded prescription or
24-20 nonprescription drugs;
24-21 (7) failed to engage in or ceased to engage in the
24-22 business described in the application for a license;
24-23 (8) failed to keep and maintain records as required by
24-24 this Act, the Controlled Substances Act, Dangerous Drug Act, or
24-25 rules adopted under this Act or the Dangerous Drug Act; [or]
24-26 (9) failed to establish and maintain effective
24-27 controls against diversion of prescription drugs into other than
25-1 legitimate medical, scientific, or industrial channels as provided
25-2 by this Act or other state or federal laws or rules; or
25-3 (10) engaged in any fraud, deceit, or
25-4 misrepresentation as defined by the rules adopted by the board in
25-5 operating a pharmacy or in seeking a license to operate a pharmacy.
25-6 SECTION 13. Section 26A(c), Texas Pharmacy Act (Article
25-7 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
25-8 follows:
25-9 (c) Any disciplinary action taken by the board under this
25-10 section is governed by the Administrative Procedure Act (Chapter
25-11 2001, Government Code [and Texas Register Act (Article 6252-13a,
25-12 Vernon's Texas Civil Statutes]) and the rules of practice and
25-13 procedure adopted by the board.
25-14 SECTION 14. Section 27, Texas Pharmacy Act (Article 4542a-1,
25-15 Vernon's Texas Civil Statutes), is amended to read as follows:
25-16 Sec. 27. PROCEDURE. Except as provided in Section 27A of
25-17 this Act, any disciplinary action taken by the board under Section
25-18 26, 26A, or 26B of this Act is governed by the Administrative
25-19 Procedure Act (Chapter 2001, Government Code [and Texas Register
25-20 Act (Article 6252-13a, Vernon's Texas Civil Statutes]) and the
25-21 rules of practice and procedure before the board.
25-22 SECTION 15. Section 27A(d), Texas Pharmacy Act (Article
25-23 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
25-24 follows:
25-25 (d) The records and proceedings of the board, its authorized
25-26 agents, or any pharmaceutical organization committee as set out in
25-27 Subsections (a) and (b) of this section shall be confidential and
26-1 are not considered open records for the purposes of Chapter 552,
26-2 Government Code [424, Acts of the 63rd Legislature, Regular
26-3 Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil
26-4 Statutes)]; provided, however, the board may disclose this
26-5 confidential information only:
26-6 (1) in a disciplinary hearing before the board or in a
26-7 subsequent trial or appeal of a board action or order;
26-8 (2) to the pharmacist licensing or disciplinary
26-9 authorities of other jurisdictions;
26-10 (3) pursuant to an order of a court of competent
26-11 jurisdiction; or
26-12 (4) pursuant to Subsection (j) of this section.
26-13 SECTION 16. Section 27B(c), Texas Pharmacy Act (Article
26-14 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
26-15 follows:
26-16 (c) The identity of a person who reports to or assists the
26-17 board under this section and any document that could disclose the
26-18 identity of that person is confidential and does not constitute
26-19 public information for the purposes of Chapter 552, Government Code
26-20 [424, Acts of the 63rd Legislature, Regular Session, 1973 (Article
26-21 6252-17a, Vernon's Texas Civil Statutes)].
26-22 SECTION 17. Section 28(a), Texas Pharmacy Act (Article
26-23 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
26-24 follows:
26-25 (a) On the finding of the existence of grounds for
26-26 discipline of any person holding a license or seeking a license or
26-27 a renewal license under this Act, the board may impose one or more
27-1 of the following penalties:
27-2 (1) suspension of the offender's license;
27-3 (2) revocation of the offender's license;
27-4 (3) restriction of the offender's license to prohibit
27-5 the offender from performing certain acts or from engaging in the
27-6 practice of pharmacy or operating a pharmacy in a particular manner
27-7 for a term and under conditions to be determined by the board;
27-8 (4) imposition of an administrative penalty under
27-9 Section 28B of this Act;
27-10 (5) refusal to issue or renew the offender's license;
27-11 (6) placement of the offender's license on probation
27-12 and supervision by the board for a period to be determined by the
27-13 board and imposition of a requirement that the licensee:
27-14 (A) report regularly to the board on matters
27-15 that are the basis of the probation;
27-16 (B) limit practice to the areas prescribed by
27-17 the board; [or]
27-18 (C) continue or review professional education
27-19 until the licensee attains a degree of skill satisfactory to the
27-20 board in those areas that are the basis of the probation; or
27-21 (D) pay the board a probation fee to defer the
27-22 costs of monitoring a licensee during the period of probation;
27-23 (7) reprimand;
27-24 (8) cancellation of the offender's license; or
27-25 (9) retirement of the offender's license as provided
27-26 by board rule[; or]
27-27 [(10) imposition of a civil penalty that does not
28-1 exceed $1,000 for each day of each violation and that may be
28-2 collected in a suit initiated by the board].
28-3 SECTION 18. Section 29(e), Texas Pharmacy Act (Article
28-4 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
28-5 follows:
28-6 (e) The board shall have the discretion to determine under
28-7 which classifications a pharmacy applicant may be licensed. With
28-8 respect to Class C pharmacies, the board may establish rules for
28-9 the use of pharmacy technicians [supportive personnel] and the
28-10 duties of those technicians [personnel] in Class C pharmacies
28-11 licensed by the board, provided that these technicians [personnel]
28-12 are responsible to and directly supervised by a pharmacist licensed
28-13 by the board; provided, however, the board may not adopt any rule
28-14 setting ratios with respect to pharmacists and pharmacy technicians
28-15 [supportive personnel] or limiting the number of pharmacy
28-16 technicians [supportive personnel] that may be utilized.
28-17 SECTION 19. Section 35, Texas Pharmacy Act (Article 4542a-1,
28-18 Vernon's Texas Civil Statutes), is amended to read as follows:
28-19 Sec. 35. UNLAWFUL USE OF "PHARMACY." (a) A person may not
28-20 display in or on any store or place of business the word
28-21 "pharmacy," either in English or any other language, any other word
28-22 or combination of words of the same or similar meaning, or any
28-23 graphic representation that would mislead or tend to mislead the
28-24 public unless it is a pharmacy licensed under this Act.
28-25 (b) A person may not advertise any store or place of
28-26 business as a pharmacy or provide pharmacy services unless the
28-27 facility is a pharmacy licensed under this Act.
29-1 SECTION 20. The Texas Pharmacy Act (Article 4542a-1,
29-2 Vernon's Texas Civil Statutes) is amended by adding Section 37A to
29-3 read as follows:
29-4 Sec. 37A. CIVIL PENALTY. (a) A person who violates the
29-5 license requirements of this Act is liable to the state for a civil
29-6 penalty of $1,000 for each day the violation continues.
29-7 (b) The attorney general, district attorney, county
29-8 attorney, or city attorney may sue in a district court of Travis
29-9 County to collect the penalty.
29-10 SECTION 21. Section 40(h), Texas Pharmacy Act (Article
29-11 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
29-12 follows:
29-13 (h) A pharmacist may dispense a generically equivalent drug
29-14 if the practitioner does not write by hand on the face of his or
29-15 her written prescription the words "brand medically necessary" or
29-16 analogous words. [No written prescription issued by a practitioner,
29-17 as such term is defined in Section 5(39)(A) of this Act, may be
29-18 dispensed unless it is ordered on a form containing two signature
29-19 lines of equal prominence, side by side, at the bottom of the form.
29-20 Under either signature line shall be printed clearly the words
29-21 "product selection permitted," and under the other signature line
29-22 shall be printed clearly the words "dispense as written." The
29-23 practitioner shall communicate dispensing instructions to the
29-24 pharmacist by signing on the appropriate line. If the
29-25 practitioner's signature does not clearly indicate that the
29-26 prescription must be dispensed as written, generically equivalent
29-27 drug selection is permitted. No prescription form furnished a
30-1 practitioner shall contain a preprinted order for a drug product by
30-2 brand name, generic name, or manufacturer.]
30-3 SECTION 22. Sections 483.001(10) and (11), Health and Safety
30-4 Code, are amended to read as follows:
30-5 (10) "Pharmacy" means a facility where prescription
30-6 drug or medication orders are received, processed, dispensed, or
30-7 distributed under this chapter, Chapter 481, and the Texas Pharmacy
30-8 Act (Article 4542a-1, Vernon's Texas Civil Statutes) [licensed by
30-9 the board pursuant to Section 29, Texas Pharmacy Act (Article
30-10 4542a-1, Vernon's Texas Civil Statutes)].
30-11 (11) "Practice of pharmacy" means:
30-12 (A) provision of those acts or services
30-13 necessary to provide pharmaceutical care;
30-14 (B) interpretation and evaluation of
30-15 prescription drug orders or medication orders;
30-16 (C) participation in drug and device selection
30-17 as authorized by law, drug administration, drug regimen review, or
30-18 drug or drug-related research;
30-19 (D) provision of patient counseling; [and]
30-20 (E) responsibility for:
30-21 (i) dispensing of prescription drug orders
30-22 or distribution of medication orders in the patient's best
30-23 interest;
30-24 (ii) compounding and labeling of drugs and
30-25 devices, except labeling by a manufacturer, repackager, or
30-26 distributor of nonprescription drugs and commercially packaged
30-27 prescription drugs and devices;
31-1 (iii) proper and safe storage of drugs and
31-2 devices; and
31-3 (iv) maintenance of proper records for
31-4 drugs and devices. In this subdivision, "device" has the meaning
31-5 assigned by the Texas Pharmacy Act (Article 4542a-1, Vernon's Texas
31-6 Civil Statutes); and
31-7 (F) performance of a specific act of drug
31-8 therapy management for a patient delegated to a pharmacist by a
31-9 written protocol from a physician licensed by the state under the
31-10 Medical Practice Act (Article 4495b, Vernon's Texas Civil
31-11 Statutes).
31-12 SECTION 23. Section 483.003(b), Health and Safety Code, is
31-13 amended to read as follows:
31-14 (b) On making that finding, the Texas Board of Health
31-15 [board] may limit the availability of the abused drug by permitting
31-16 its dispensing only on the prescription of a practitioner described
31-17 by Section 483.001(12)(A) or (B).
31-18 SECTION 24. Section 483.042(e), Health and Safety Code, is
31-19 amended to read as follows:
31-20 (e) The labeling provisions of Subsection (a) do not apply
31-21 to a dangerous drug prescribed or dispensed for administration to a
31-22 patient who is institutionalized. The board shall adopt rules for
31-23 the labeling of such a drug [food production animals in an
31-24 agricultural operation under a written medical directive or
31-25 treatment guideline from a veterinarian licensed under The
31-26 Veterinary Licensing Act (Article 8890, Revised Statutes) and its
31-27 subsequent amendments].
32-1 SECTION 25. Chapter 107, Acts of the 41st Legislature,
32-2 Regular Session, 1929 (Article 4542a, Vernon's Texas Civil
32-3 Statutes), is repealed.
32-4 SECTION 26. Section 26A(b), Texas Pharmacy Act (Article
32-5 4542a-1, Vernon's Texas Civil Statutes), as amended by Section 7,
32-6 Chapter 789, Acts of the 73rd Legislature, Regular Session, 1993,
32-7 is repealed.
32-8 SECTION 27. This Act takes effect September 1, 1997.
32-9 SECTION 28. (a) This Act applies only to a license issued
32-10 by the Texas State Board of Pharmacy on or after the effective date
32-11 of this Act. A license issued or renewed before that date is
32-12 governed by the law in effect on the date the license was issued or
32-13 renewed, and the former law is continued in effect for that
32-14 purpose.
32-15 (b) Section 37A, Texas Pharmacy Act (Article 4542a-1,
32-16 Vernon's Texas Civil Statutes), as added by this Act, applies only
32-17 to a violation of the licensing requirements of the Texas Pharmacy
32-18 Act (Article 4542a-1, Vernon's Texas Civil Statutes) that occurs on
32-19 or after the effective date of this Act.
32-20 SECTION 29. The importance of this legislation and the
32-21 crowded condition of the calendars in both houses create an
32-22 emergency and an imperative public necessity that the
32-23 constitutional rule requiring bills to be read on three several
32-24 days in each house be suspended, and this rule is hereby suspended.