By: Madla S.B. No. 609
A BILL TO BE ENTITLED
AN ACT
1-1 relating to the regulation of pharmacies and pharmacists; providing
1-2 a penalty.
1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-4 SECTION 1. Section 5, Texas Pharmacy Act (Article 4542a-1,
1-5 Vernon's Texas Civil Statutes), is amended to read as follows:
1-6 Sec. 5. DEFINITIONS. In this Act, unless the context of
1-7 its use clearly indicates otherwise:
1-8 (1) "A.C.P.E." means the American Council on
1-9 Pharmaceutical Education.
1-10 (2) "Administer" means the direct application of a
1-11 prescription drug by injection, inhalation, ingestion, or any other
1-12 means to the body of a patient by:
1-13 (A) a practitioner, an authorized agent under
1-14 his supervision, or other person authorized by law; or
1-15 (B) the patient at the direction of a
1-16 practitioner.
1-17 (3) "Administrative Procedure Act" means Chapter 2001,
1-18 Government Code [the Administrative Procedure and Texas Register
1-19 Act, as amended (Article 6252-13a, Vernon's Texas Civil Statutes)].
1-20 (4) "Board" means the Texas State Board of Pharmacy.
1-21 (5) "Class A pharmacy license" or "community pharmacy
1-22 license" means a license issued to a pharmacy dispensing drugs or
1-23 devices to the general public pursuant to a prescription drug
1-24 order.
2-1 (6) "Class B pharmacy license" or "nuclear pharmacy
2-2 license" means a license issued to a pharmacy dispensing or
2-3 providing radioactive drugs or devices for administration to an
2-4 ultimate user.
2-5 (7) "Class C pharmacy license" or "institutional
2-6 pharmacy license" means a license issued to a pharmacy located in a
2-7 hospital or other in-patient facility that is licensed under
2-8 Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental
2-9 Health Code (Article 5547-1 et seq., Vernon's Texas Civil
2-10 Statutes), to a hospice in-patient facility that is licensed under
2-11 Chapter 142, Health and Safety Code, or to a pharmacy located in a
2-12 hospital maintained or operated by the state.
2-13 (8) "Class D pharmacy license" or "clinic pharmacy
2-14 license" means a license issued to a pharmacy dispensing a limited
2-15 type of drugs or devices pursuant to a prescription drug order.
2-16 (9) "Class E pharmacy license" or "nonresident
2-17 pharmacy license" means a license issued under this Act to a
2-18 pharmacy located in a state of the United States other than this
2-19 state whose primary business is to dispense a prescription drug or
2-20 device under a prescription drug order and to deliver the drug or
2-21 device to a patient, including a patient in this state, by the
2-22 United States mail, a common carrier, or a delivery service.
2-23 (10) [(11)] "College of pharmacy" means a school,
2-24 university, or college of pharmacy that satisfies the accreditation
2-25 standards of A.C.P.E. as adopted by the board; or that has degree
2-26 requirements which meet the standards of accreditation set by the
2-27 board.
3-1 (11) [(12)] "Compounding" means the preparation,
3-2 mixing, assembling, packaging, or labeling of a drug or device:
3-3 (A) as the result of a practitioner's
3-4 prescription drug order or initiative based on the
3-5 practitioner-patient-pharmacist relationship in the course of
3-6 professional practice;
3-7 (B) in anticipation of prescription drug orders
3-8 based on routine, regularly observed prescribing patterns; or
3-9 (C) for the purpose of or as an incident to
3-10 research, teaching, or chemical analysis and not for sale or
3-11 dispensing.
3-12 (12) [(13)] "Confidential record" means any
3-13 health-related record that contains information that identifies an
3-14 individual and that is maintained by a pharmacy or pharmacist such
3-15 as a patient medication record, prescription drug order, or
3-16 medication order.
3-17 (13) [(14)] "Controlled substance" means a drug,
3-18 immediate precursor, or other substance listed in Schedules I-V or
3-19 Penalty Groups 1-4 of Chapter 481, Health and Safety Code, or a
3-20 drug, immediate precursor, or other substance included in Schedule
3-21 I, II, III, IV, or V of the Federal Comprehensive Drug Abuse
3-22 Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
3-23 (14) [(15)] "Controlled Substances Act" means Chapter
3-24 481, Health and Safety Code, or the Federal Comprehensive Drug
3-25 Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et
3-26 seq.).
3-27 (15) [(16)] "Dangerous drug" means any drug or device
4-1 that is not included in Penalty Groups 1-4 of the Controlled
4-2 Substances Act and that is unsafe for self-medication or any drug
4-3 or device that bears or is required to bear the legend:
4-4 (A) "Caution: federal law prohibits dispensing
4-5 without prescription"; or
4-6 (B) "Caution: federal law restricts this drug
4-7 to use by or on the order of a licensed veterinarian."
4-8 (16) [(17)] "Dangerous Drug Act" means Chapter 483,
4-9 Health and Safety Code.
4-10 (17) [(18)] "Deliver" or "delivery" means the actual,
4-11 constructive, or attempted transfer of a prescription drug or
4-12 device or controlled substance from one person to another, whether
4-13 or not for a consideration.
4-14 (18) [(19)] "Designated agent" means:
4-15 (A) a licensed nurse, physician assistant,
4-16 pharmacist, or other individual designated by a practitioner, and
4-17 for whom the practitioner assumes legal responsibility, who
4-18 communicates prescription drug orders to a pharmacist;
4-19 (B) a licensed nurse, physician assistant, or
4-20 pharmacist employed in a health care facility to whom the
4-21 practitioner communicates a prescription drug order; or
4-22 (C) a registered nurse or physician assistant
4-23 authorized by a practitioner to carry out a prescription drug order
4-24 for dangerous drugs under Subdivision (5) or (6), Subsection (d),
4-25 Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas
4-26 Civil Statutes).
4-27 (19) [(20)] "Device" means an instrument, apparatus,
5-1 implement, machine, contrivance, implant, in vitro reagent, or
5-2 other similar or related article, including any component part or
5-3 accessory, that is required under federal or state law to be
5-4 ordered or prescribed by a practitioner.
5-5 (20) [(21)] "Dispense" means preparing, packaging,
5-6 compounding, or labeling for delivery a prescription drug or device
5-7 in the course of professional practice to an ultimate user or his
5-8 agent by or pursuant to the lawful order of a practitioner.
5-9 (21) [(22)] "Distribute" means the delivery of a
5-10 prescription drug or device other than by administering or
5-11 dispensing.
5-12 (22) [(23)] "Drug" means:
5-13 (A) a substance recognized as drugs in the
5-14 current official United States Pharmacopoeia, official National
5-15 Formulary, official Homeopathic Pharmacopoeia, or other drug
5-16 compendium or any supplement to any of them;
5-17 (B) a substance intended for use in the
5-18 diagnosis, cure, mitigation, treatment, or prevention of disease in
5-19 man or other animals;
5-20 (C) a substance, other than food, intended to
5-21 affect the structure or any function of the body of man or other
5-22 animals;
5-23 (D) a substance intended for use as a component
5-24 of any articles specified in Paragraph (A), (B), or (C) of this
5-25 subdivision;
5-26 (E) a dangerous drug; or
5-27 (F) a controlled substance.
6-1 (23) [(24)] "Drug regimen review" includes the
6-2 following activities:
6-3 (A) evaluation of prescription drug or
6-4 medication orders and patient medication records for:
6-5 (i) known allergies;
6-6 (ii) rational therapy-contraindications;
6-7 (iii) reasonable dose and route of
6-8 administration; and
6-9 (iv) reasonable directions for use;
6-10 (B) evaluation of prescription drug or
6-11 medication orders and patient medication records for duplication of
6-12 therapy;
6-13 (C) evaluation of prescription drug or
6-14 medication orders and patient medication records for:
6-15 (i) drug-drug interactions;
6-16 (ii) drug-food interactions;
6-17 (iii) drug-disease interactions;
6-18 (iv) adverse drug reactions; and
6-19 (D) evaluation of prescription drug and
6-20 medication orders and patient medication records for proper
6-21 utilization, including overutilization or underutilization.
6-22 (24) [(25)] "Internship" means a practical experience
6-23 program that is approved by the board.
6-24 (25) [(26)] "Label" means written, printed, or graphic
6-25 matter on the immediate container of a drug or device.
6-26 (26) [(27)] "Labeling" means the process of affixing a
6-27 label including all information required by federal and state law
7-1 or regulation to any drug or device container. The term does not
7-2 include the labeling by a manufacturer, packer, or distributor of a
7-3 nonprescription drug or commercially packaged prescription drug or
7-4 device, or unit dose packaging.
7-5 (27) [(28)] "Manufacturing" means the production,
7-6 preparation, propagation, conversion, or processing of a drug or
7-7 device, either directly or indirectly, by extraction from
7-8 substances of natural origin or independently by means of chemical
7-9 or biological synthesis and includes any packaging or repackaging
7-10 of the substances or labeling or relabeling of the container and
7-11 the promotion and marketing of such drugs or devices.
7-12 Manufacturing also includes the preparation and promotion of
7-13 commercially available products from bulk compounds for resale by
7-14 pharmacies, practitioners, or other persons but does not include
7-15 compounding.
7-16 (28) [(29)] "Medication order" means an order from a
7-17 practitioner or a practitioner's designated agent for
7-18 administration of a drug or device.
7-19 (29) [(30)] "Nonprescription drug" means a nonnarcotic
7-20 drug or device that may be sold without a prescription and that is
7-21 labeled and packaged in compliance with applicable state or federal
7-22 law.
7-23 (30) [(31)] "Patient counseling" means the
7-24 communication by the pharmacist of information, as specified in the
7-25 rules of the board, to the patient or caregiver, in order to
7-26 improve therapy by ensuring proper use of drugs and devices.
7-27 (31) [(32)] "Person" means an individual, corporation,
8-1 government or governmental subdivision or agency, business trust,
8-2 estate, trust, partnership, association, or any other legal entity.
8-3 (32) [(33)] "Pharmaceutical care" is the provision of
8-4 drug therapy and other pharmaceutical services defined in the rules
8-5 of the board and intended to assist in the cure or prevention of a
8-6 disease, elimination or reduction of a patient's symptoms, or
8-7 arresting or slowing of a disease process.
8-8 (33) [(34)] "Pharmacist" means a person licensed by
8-9 the board to practice pharmacy.
8-10 (34) [(35)] "Pharmacist-in-charge" means the
8-11 pharmacist designated on a pharmacy license as the pharmacist who
8-12 has the authority or responsibility for a pharmacy's compliance
8-13 with laws and rules pertaining to the practice of pharmacy.
8-14 (35) [(36)] "Pharmacist-intern" means an undergraduate
8-15 student enrolled in the professional sequence of a college of
8-16 pharmacy approved by the board and participating in a school-based,
8-17 board-approved internship program or a graduate of a college of
8-18 pharmacy who is participating in a board-approved internship.
8-19 (36) [(37)] "Pharmacy" means a facility at which
8-20 prescription drug or medication orders are received, processed, or
8-21 dispensed under this Act, the Dangerous Drug Act, or the Controlled
8-22 Substances Act [licensed by the board pursuant to Section 29 of
8-23 this Act].
8-24 (37) "Pharmacy technician" means an individual
8-25 employed by a pharmacy whose responsibility is to provide technical
8-26 services that do not require professional judgment regarding the
8-27 preparation and distribution of drugs and who works under the
9-1 direct supervision of and is responsible to a pharmacist.
9-2 (38) "Practice of pharmacy" means:
9-3 (A) provision of those acts or services
9-4 necessary to provide pharmaceutical care;
9-5 (B) interpretation and evaluation of
9-6 prescription drug orders or medication orders;
9-7 (C) participation in drug and device selection
9-8 as authorized by law, drug administration, drug regimen review, or
9-9 drug or drug-related research;
9-10 (D) provision of patient counseling;
9-11 (E) responsibility for:
9-12 (i) dispensing of prescription drug orders
9-13 or distribution of medication orders;
9-14 (ii) compounding and labeling of drugs and
9-15 devices, except labeling by a manufacturer, repackager, or
9-16 distributor of nonprescription drugs and commercially packaged
9-17 prescription drugs and devices;
9-18 (iii) proper and safe storage of drugs and
9-19 devices; or
9-20 (iv) maintenance of proper records for
9-21 drugs and devices; and
9-22 (F) performance of a specific act of drug
9-23 therapy management for a patient delegated to a pharmacist by a
9-24 written protocol from a physician licensed in this state in
9-25 compliance with the Medical Practice Act (Article 4495b, Vernon's
9-26 Texas Civil Statutes).
9-27 (39) "Practitioner" means:
10-1 (A) a physician, dentist, podiatrist,
10-2 veterinarian, or other person licensed or registered to prescribe,
10-3 distribute, administer, or dispense a prescription drug or device
10-4 in the course of professional practice in this state;
10-5 (B) a person licensed by another state in a
10-6 health field in which, under Texas law, licensees in this state may
10-7 legally prescribe dangerous drugs or a person practicing in another
10-8 state and licensed by another state as a physician, dentist,
10-9 veterinarian, or podiatrist, having a current Federal Drug
10-10 Enforcement Administration registration number, and who may legally
10-11 prescribe Schedule II, III, IV, or V controlled substances in such
10-12 other state; or
10-13 (C) a person licensed in the Dominion of Canada
10-14 or the United Mexican States in a health field in which, under the
10-15 laws of this state, a licensee may legally prescribe dangerous
10-16 drugs. "Practitioner" does not include a person licensed under
10-17 this Act.
10-18 (40) "Preceptor" means a pharmacist [in good standing]
10-19 licensed in this state to practice pharmacy who meets the preceptor
10-20 requirements specified by rule and who is certified by the board to
10-21 supervise and be responsible for the activities and functions of a
10-22 pharmacist-intern in the internship program.
10-23 (41) "Prescription drug" means:
10-24 (A) a substance for which federal or state law
10-25 requires a prescription before it may be legally dispensed to the
10-26 public;
10-27 (B) a drug or device that under federal law is
11-1 required, prior to being dispensed or delivered, to be labeled with
11-2 either of the following statements:
11-3 (i) "Caution: federal law prohibits
11-4 dispensing without prescription"; or
11-5 (ii) "Caution: federal law restricts this
11-6 drug to use by or on the order of a licensed veterinarian"; or
11-7 (C) a drug or device that is required by any
11-8 applicable federal or state law or regulation to be dispensed on
11-9 prescription only or is restricted to use by a practitioner only.
11-10 (42) "Prescription drug order" means:
11-11 (A) an order from a practitioner or a
11-12 practitioner's designated agent to a pharmacist for a drug or
11-13 device to be dispensed; or
11-14 (B) an order pursuant to Subdivision (5) or (6),
11-15 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
11-16 Vernon's Texas Civil Statutes).
11-17 (43) "Prospective drug use review" means a review of
11-18 the patient's drug therapy and prescription drug order or
11-19 medication order, as defined in the rules of the board, prior to
11-20 dispensing or distributing the drug.
11-21 (44) "Provide" means to supply one or more unit doses
11-22 of a nonprescription drug or dangerous drug to a patient.
11-23 (45) "Radioactive drug" means a drug that exhibits
11-24 spontaneous disintegration of unstable nuclei with the emission of
11-25 nuclear particles or photons, including any nonradioactive reagent
11-26 kit or nuclide generator that is intended to be used in the
11-27 preparation of any such substance.
12-1 (46) "Substitution" means the dispensing of a drug or
12-2 a brand of drug other than that which is ordered or prescribed.
12-3 (47) "Texas trade association" means a nonprofit,
12-4 cooperative association of business or professional competitors in
12-5 this state whose purpose is to assist its members, industry, or
12-6 profession and whose members have joined voluntarily. ["Supportive
12-7 personnel" means those individuals utilized in pharmacies whose
12-8 responsibility it shall be to provide technical services that do
12-9 not require professional judgment concerned with the preparation
12-10 and distribution of drugs under the direct supervision of and
12-11 responsible to a pharmacist.]
12-12 (48) "Ultimate user" means a person who has obtained
12-13 and possesses a prescription drug or device for the person's own
12-14 use or for the use of a member of the person's household or for
12-15 administering to an animal owned by the person or by a member of
12-16 the person's household.
12-17 (49) "Unit dose packaging" means the ordered amount of
12-18 drug in a dosage form ready for administration to a particular
12-19 patient, by the prescribed route at the prescribed time, and
12-20 properly labeled with name, strength, and expiration date of the
12-21 drug.
12-22 (50) "Written protocol" means a physician's order,
12-23 standing medical order, standing delegation order, or other order
12-24 or protocol as defined by rule of the Texas State Board of Medical
12-25 Examiners under the Medical Practice Act (Article 4495b, Vernon's
12-26 Texas Civil Statutes).
12-27 SECTION 2. Subsection (a), Section 8, Texas Pharmacy Act
13-1 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
13-2 read as follows:
13-3 (a) A licensed pharmacist member of the board:
13-4 (1) may not be:
13-5 (A) a salaried faculty member at a college of
13-6 pharmacy; or
13-7 (B) an officer, employee, or paid consultant of
13-8 a Texas trade association in the field of health care or a spouse
13-9 of an officer, employee, or paid consultant; and
13-10 (2) must at the time of his appointment:
13-11 (A) [(1)] be a resident of this state;
13-12 (B) [(2)] be licensed for the five years
13-13 immediately preceding appointment and be in good standing to engage
13-14 in the practice of pharmacy in this state; and
13-15 (C) [(3)] be engaged in the practice of pharmacy
13-16 in this state.
13-17 SECTION 3. Section 8, Texas Pharmacy Act (Article 4542a-1,
13-18 Vernon's Texas Civil Statutes), is amended by adding Subsection (f)
13-19 to read as follows:
13-20 (f) The board shall provide to its members, as often as
13-21 necessary, information regarding their qualifications for office or
13-22 employment under this Act and their responsibilities under
13-23 applicable laws relating to standards of conduct for state officers
13-24 or employees.
13-25 SECTION 4. Subsection (c), Section 14, Texas Pharmacy Act
13-26 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
13-27 read as follows:
14-1 (c) Except as otherwise provided by this subsection, all
14-2 board meetings and hearings shall be open to the public. The board
14-3 may, in its discretion and in accordance with the open meetings
14-4 law, Chapter 551, Government Code, [Chapter 271, Acts of the 60th
14-5 Legislature, Regular Session, 1967, as amended (Article 6252-17,
14-6 Vernon's Texas Civil Statutes),] conduct any portion of its meeting
14-7 in executive session. The board may in its discretion conduct
14-8 deliberations relative to licensee disciplinary actions in
14-9 executive session. At the conclusion of its deliberations relative
14-10 to licensee disciplinary action, the board shall vote and announce
14-11 its decision relative to the licensee in open session. The board
14-12 in executive session may conduct disciplinary hearings relating to
14-13 a pharmacist or pharmacy student who is impaired because of
14-14 chemical abuse or mental or physical illness.
14-15 SECTION 5. Subsections (c), (d), and (f), Section 15, Texas
14-16 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
14-17 amended to read as follows:
14-18 (c) An officer, employee, or paid consultant of a Texas
14-19 trade association in the field of health care may not be an [a
14-20 member or] employee of the board who is exempt from the state's
14-21 position classification plan or is compensated at or above the
14-22 amount prescribed by the General Appropriations Act for step 1,
14-23 salary group 17, of the position classification salary schedule.
14-24 (d) A person who is the spouse of an officer, manager, or
14-25 paid consultant of a Texas trade association in the field of health
14-26 care may not be a [board member and may not be a] board employee
14-27 who is exempt from the state's position classification plan or is
15-1 compensated at or above the amount prescribed by the General
15-2 Appropriations Act for step 1, salary group 17, of the position
15-3 classification salary schedule.
15-4 (f) The board shall provide to its [members and] employees,
15-5 as often as necessary, information regarding their qualification
15-6 for office or employment under this Act and their responsibilities
15-7 under applicable laws relating to standards of conduct for state
15-8 officers or employees.
15-9 SECTION 6. Subsections (o) and (q), Section 17, Texas
15-10 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
15-11 amended to read as follows:
15-12 (o) The board:
15-13 (1) shall [may] establish rules for the use of
15-14 pharmacy technicians [supportive personnel] and the duties of those
15-15 technicians [personnel] in pharmacies licensed by the board,
15-16 provided that those technicians [personnel] are responsible to and
15-17 directly supervised by a pharmacist licensed by the board; provided
15-18 however that the board may not adopt rules or regulations
15-19 establishing ratios of pharmacists to pharmacy technicians
15-20 [supportive personnel] in Class C pharmacies; and
15-21 (2) may determine and issue standards for recognition
15-22 and approval of training programs for pharmacy technicians and
15-23 maintain a list of training programs that meet the standards.
15-24 (q) Board investigative files and all information and
15-25 materials compiled by the board in connection with an investigation
15-26 are confidential and are not subject to disclosure under Chapter
15-27 552, Government Code [424, Acts of the 63rd Legislature, Regular
16-1 Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil
16-2 Statutes)], and are not subject to disclosure, discovery, subpoena,
16-3 or other means of legal compulsion for their release to anyone
16-4 other than the board or its employees or agents involved in
16-5 licensee discipline except that this information may be disclosed
16-6 to:
16-7 (1) persons involved with the board in a disciplinary
16-8 action against the licensee;
16-9 (2) pharmacist or pharmacy licensing or disciplinary
16-10 authorities of other jurisdictions;
16-11 (3) a pharmaceutical peer review committee as outlined
16-12 in Section 27A of this Act;
16-13 (4) law enforcement agencies; and
16-14 (5) persons engaged in bona fide research, if all
16-15 individual-identifying information has been deleted.
16-16 SECTION 7. Subsection (a), Section 17D, Texas Pharmacy Act
16-17 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
16-18 read as follows:
16-19 (a) The board by rule shall adopt procedures governing:
16-20 (1) informal disposition of a contested case under
16-21 Chapter 2001, Government Code [Section 13(e), Administrative
16-22 Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas
16-23 Civil Statutes), and its subsequent amendments]; and
16-24 (2) informal proceedings held in compliance with
16-25 Chapter 2001, Government Code [Section 18(c), Administrative
16-26 Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas
16-27 Civil Statutes), and its subsequent amendments].
17-1 SECTION 8. Subsections (a), (f), and (g), Section 19, Texas
17-2 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
17-3 amended to read as follows:
17-4 (a) A person may not:
17-5 (1) dispense or distribute prescription drugs unless
17-6 he is a licensed pharmacist or is authorized by this Act to
17-7 dispense or distribute prescription drugs; or
17-8 (2) operate a pharmacy unless he first obtains a
17-9 license to operate a pharmacy.
17-10 (f) This Act does not apply to:
17-11 (1) a member of the faculty of a college of pharmacy
17-12 that is recognized by the board if the faculty member is a licensed
17-13 pharmacist and performs his services for the benefit of the college
17-14 only;
17-15 (2) [a pharmacist-intern;]
17-16 [(3)] a person who procures prescription drugs for
17-17 lawful research, teaching, or testing and not for resale; or
17-18 (3) [(4)] a home and community support services agency
17-19 that possesses a dangerous drug as authorized by Section 142.0061,
17-20 Health and Safety Code.
17-21 (g) Any person found by the board to have unlawfully engaged
17-22 in the practice of pharmacy or unlawfully operated a pharmacy is
17-23 subject to a civil penalty under Section 37A of this Act [fine to
17-24 be imposed by the board not to exceed $1,000 for each offense].
17-25 Each violation of this Act or the rules adopted under this Act
17-26 pertaining to unlawfully engaging in the practice of pharmacy or
17-27 unlawfully operating a pharmacy also constitutes a Class A
18-1 misdemeanor.
18-2 SECTION 9. Section 20, Texas Pharmacy Act (Article 4542a-1,
18-3 Vernon's Texas Civil Statutes), is amended to read as follows:
18-4 Sec. 20. PHARMACIST-INTERN REGISTRATION. (a) A person
18-5 must register with the board before beginning the board-approved
18-6 internship in this state. An application for the registration of a
18-7 pharmacist-intern must be on a form prescribed by the board.
18-8 Registration shall remain in effect as long as the person meets the
18-9 qualifications for internship as specified by rules adopted by the
18-10 board [during internship training and thereafter until the earlier
18-11 of the following occurs:]
18-12 [(1) the failure of the pharmacist-intern to take the
18-13 next regularly scheduled examination; or]
18-14 [(2) the failure to pass the next regularly scheduled
18-15 examination].
18-16 (b) The board may in its discretion refuse to issue a
18-17 registration to an applicant and may restrict, suspend, or revoke a
18-18 pharmacist-intern registration for any violation of this Act. In
18-19 enforcing Section 26(a)(4) of this Act, the board shall, on
18-20 probable cause, request a pharmacist-intern or pharmacist-intern
18-21 applicant to submit to a mental or physical examination by
18-22 physicians or other health care professionals designated by the
18-23 board. If the pharmacist-intern or applicant refuses to submit to
18-24 the examination, the board shall issue an order requiring the
18-25 pharmacist-intern or applicant to show cause why he will not submit
18-26 to the examination and shall schedule a hearing on the order within
18-27 30 days after notice is served on the pharmacist-intern or
19-1 applicant. The board shall notify the pharmacist-intern or
19-2 applicant by either personal service or certified mail with return
19-3 receipt requested. At the hearing, the pharmacist-intern or
19-4 applicant and an attorney are entitled to present any testimony and
19-5 other evidence to show why the pharmacist-intern or applicant
19-6 should not be required to submit to the examination. After the
19-7 hearing, the board shall issue an order either requiring the
19-8 pharmacist-intern or applicant to submit to the examination or
19-9 withdrawing the request for examination.
19-10 SECTION 10. Subsections (a) and (e), Section 21, Texas
19-11 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
19-12 amended to read as follows:
19-13 (a) To qualify for a license to practice pharmacy, an
19-14 applicant for licensing by examination must submit to the board a
19-15 license fee as determined by the board and a completed application
19-16 on a form prescribed by the board with satisfactory sworn evidence
19-17 that he:
19-18 (1) is at least 18 years old;
19-19 (2) is of good moral character;
19-20 (3) has completed a minimum of a 1,000-hour internship
19-21 or other program that has been approved by the board or has
19-22 demonstrated, to the board's satisfaction, experience in the
19-23 practice of pharmacy that meets or exceeds the minimum internship
19-24 requirements of the board;
19-25 (4) has graduated and received a [the first
19-26 professional undergraduate degree or the advanced] professional
19-27 practice degree, as defined by the rules adopted by the board, from
20-1 an accredited pharmacy degree program approved by the board;
20-2 (5) has passed the examination required by the board;
20-3 and
20-4 (6) has not had a pharmacist license granted by
20-5 another state suspended, revoked, canceled, surrendered, or
20-6 otherwise restricted for any reason.
20-7 (e) The [Within 30 days after the date a licensing
20-8 examination is administered under this Act, the] board shall notify
20-9 each examinee of the results of the examination[. However, if an
20-10 examination is graded or reviewed by a national testing service,
20-11 the board shall notify each examinee of the results of the
20-12 examination] within 30 days [two weeks] after the date the board
20-13 receives the results from a national [the] testing service. [If
20-14 the notice of the examination results will be delayed for more than
20-15 90 days after the examination date, the board shall notify the
20-16 examinee of the reason for the delay before the 90th day.]
20-17 SECTION 11. Subsection (a), Section 22, Texas Pharmacy Act
20-18 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
20-19 read as follows:
20-20 (a) To qualify for a license to practice pharmacy by
20-21 reciprocity, an applicant for licensing must:
20-22 (1) submit to the board a reciprocity fee as
20-23 determined by the board and a completed application given under
20-24 oath, in the form prescribed by the board;
20-25 (2) have good moral character;
20-26 (3) have graduated and received a [the first
20-27 professional undergraduate degree or the advanced] professional
21-1 practice degree, as defined by the rules adopted by the board, from
21-2 an accredited pharmacy degree program approved by the board;
21-3 (4) have possessed at the time of initial licensing as
21-4 a pharmacist other qualifications necessary to have been eligible
21-5 for licensing at that time in this state;
21-6 (5) have presented to the board proof of initial
21-7 licensing by examination and proof that the license and other
21-8 license or licenses granted to the applicant by any other state
21-9 have not been suspended, revoked, canceled, surrendered, or
21-10 otherwise restricted for any reason; and
21-11 (6) pass the Texas [Drug and] Pharmacy Jurisprudence
21-12 examination.
21-13 SECTION 12. Subsection (b), Section 26, Texas Pharmacy Act
21-14 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
21-15 read as follows:
21-16 (b) Grounds for Disciplining a Holder of a Pharmacy License:
21-17 The board shall refuse to issue a pharmacy license for failure to
21-18 meet the requirements of Section 29 or 30 of this Act. The board
21-19 may in its discretion refuse to issue or renew a license or may
21-20 assess a penalty, reprimand, revoke, restrict, cancel, or suspend
21-21 any license granted by the board, and may probate any license
21-22 suspension if the board finds that the applicant or licensee has:
21-23 (1) been convicted of a felony or a misdemeanor
21-24 involving moral turpitude, or if the applicant or licensee is a
21-25 legal entity such as an association, joint stock company,
21-26 partnership, or corporation, that a managing officer has been
21-27 convicted of a felony or a misdemeanor involving moral turpitude
22-1 under the law of this state, another state, or the United States;
22-2 (2) advertised any prescription drugs or devices in a
22-3 deceitful, misleading, or fraudulent manner;
22-4 (3) violated any provision of this Act or any rule
22-5 adopted under this Act or that any owner or employee of a pharmacy
22-6 has violated any provision of this Act or any rule adopted under
22-7 this Act;
22-8 (4) sold without legal authorization prescription
22-9 drugs or devices to persons other than:
22-10 (A) a pharmacy licensed by the board;
22-11 (B) a practitioner;
22-12 (C) a person who procures prescription drugs or
22-13 devices for the purpose of lawful research, teaching, or testing,
22-14 and not for resale;
22-15 (D) a manufacturer or wholesaler registered with
22-16 the commissioner of health as required by Chapter 431, Health and
22-17 Safety Code; or
22-18 (E) a carrier or warehouseman;
22-19 (5) allowed an employee who is not a licensed
22-20 pharmacist to practice pharmacy;
22-21 (6) sold adulterated or misbranded prescription or
22-22 nonprescription drugs;
22-23 (7) failed to engage in or ceased to engage in the
22-24 business described in the application for a license;
22-25 (8) failed to keep and maintain records as required by
22-26 this Act, the Controlled Substances Act, Dangerous Drug Act, or
22-27 rules adopted under this Act or the Dangerous Drug Act; [or]
23-1 (9) failed to establish and maintain effective
23-2 controls against diversion of prescription drugs into other than
23-3 legitimate medical, scientific, or industrial channels as provided
23-4 by this Act or other state or federal laws or rules; or
23-5 (10) engaged in any fraud, deceit, or
23-6 misrepresentation as defined by the rules adopted by the board in
23-7 operating a pharmacy or in seeking a license to operate a pharmacy.
23-8 SECTION 13. Subsection (c), Section 26A, Texas Pharmacy Act
23-9 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
23-10 read as follows:
23-11 (c) Any disciplinary action taken by the board under this
23-12 section is governed by the Administrative Procedure Act (Chapter
23-13 2001, Government Code [and Texas Register Act (Article 6252-13a,
23-14 Vernon's Texas Civil Statutes]) and the rules of practice and
23-15 procedure adopted by the board.
23-16 SECTION 14. Section 27, Texas Pharmacy Act (Article 4542a-1,
23-17 Vernon's Texas Civil Statutes), is amended to read as follows:
23-18 Sec. 27. PROCEDURE. Except as provided in Section 27A of
23-19 this Act, any disciplinary action taken by the board under Section
23-20 26, 26A, or 26B of this Act is governed by the Administrative
23-21 Procedure Act (Chapter 2001, Government Code [and Texas Register
23-22 Act (Article 6252-13a, Vernon's Texas Civil Statutes]) and the
23-23 rules of practice and procedure before the board.
23-24 SECTION 15. Subsection (d), Section 27A, Texas Pharmacy Act
23-25 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
23-26 read as follows:
23-27 (d) The records and proceedings of the board, its authorized
24-1 agents, or any pharmaceutical organization committee as set out in
24-2 Subsections (a) and (b) of this section shall be confidential and
24-3 are not considered open records for the purposes of Chapter 552,
24-4 Government Code [424, Acts of the 63rd Legislature, Regular
24-5 Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil
24-6 Statutes)]; provided, however, the board may disclose this
24-7 confidential information only:
24-8 (1) in a disciplinary hearing before the board or in a
24-9 subsequent trial or appeal of a board action or order;
24-10 (2) to the pharmacist licensing or disciplinary
24-11 authorities of other jurisdictions;
24-12 (3) pursuant to an order of a court of competent
24-13 jurisdiction; or
24-14 (4) pursuant to Subsection (j) of this section.
24-15 SECTION 16. Subsection (c), Section 27B, Texas Pharmacy Act
24-16 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
24-17 read as follows:
24-18 (c) The identity of a person who reports to or assists the
24-19 board under this section and any document that could disclose the
24-20 identity of that person is confidential and does not constitute
24-21 public information for the purposes of Chapter 552, Government Code
24-22 [424, Acts of the 63rd Legislature, Regular Session, 1973 (Article
24-23 6252-17a, Vernon's Texas Civil Statutes)].
24-24 SECTION 17. Subsection (a), Section 28, Texas Pharmacy Act
24-25 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
24-26 read as follows:
24-27 (a) On the finding of the existence of grounds for
25-1 discipline of any person holding a license or seeking a license or
25-2 a renewal license under this Act, the board may impose one or more
25-3 of the following penalties:
25-4 (1) suspension of the offender's license;
25-5 (2) revocation of the offender's license;
25-6 (3) restriction of the offender's license to prohibit
25-7 the offender from performing certain acts or from engaging in the
25-8 practice of pharmacy or operating a pharmacy in a particular manner
25-9 for a term and under conditions to be determined by the board;
25-10 (4) imposition of an administrative penalty under
25-11 Section 28B of this Act;
25-12 (5) refusal to issue or renew the offender's license;
25-13 (6) placement of the offender's license on probation
25-14 and supervision by the board for a period to be determined by the
25-15 board and imposition of a requirement that the licensee:
25-16 (A) report regularly to the board on matters
25-17 that are the basis of the probation;
25-18 (B) limit practice to the areas prescribed by
25-19 the board; [or]
25-20 (C) continue or review professional education
25-21 until the licensee attains a degree of skill satisfactory to the
25-22 board in those areas that are the basis of the probation; or
25-23 (D) pay the board a probation fee to defray the
25-24 costs of monitoring a licensee during the period of probation;
25-25 (7) reprimand;
25-26 (8) cancellation of the offender's license; or
25-27 (9) retirement of the offender's license as provided
26-1 by board rule[; or]
26-2 [(10) imposition of a civil penalty that does not
26-3 exceed $1,000 for each day of each violation and that may be
26-4 collected in a suit initiated by the board].
26-5 SECTION 18. Subsection (e), Section 29, Texas Pharmacy Act
26-6 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
26-7 read as follows:
26-8 (e) The board shall have the discretion to determine under
26-9 which classifications a pharmacy applicant may be licensed. With
26-10 respect to Class C pharmacies, the board may establish rules for
26-11 the use of pharmacy technicians [supportive personnel] and the
26-12 duties of those technicians [personnel] in Class C pharmacies
26-13 licensed by the board, provided that these technicians [personnel]
26-14 are responsible to and directly supervised by a pharmacist licensed
26-15 by the board; provided, however, the board may not adopt any rule
26-16 setting ratios with respect to pharmacists and pharmacy technicians
26-17 [supportive personnel] or limiting the number of pharmacy
26-18 technicians [supportive personnel] that may be utilized.
26-19 SECTION 19. Section 35, Texas Pharmacy Act (Article 4542a-1,
26-20 Vernon's Texas Civil Statutes), is amended to read as follows:
26-21 Sec. 35. UNLAWFUL USE OF "PHARMACY." (a) A person may
26-22 not display in or on any store or place of business the word
26-23 "pharmacy," either in English or any other language, any other word
26-24 or combination of words of the same or similar meaning, or any
26-25 graphic representation that would mislead or tend to mislead the
26-26 public unless it is a pharmacy licensed under this Act.
26-27 (b) A person may not advertise any store or place of
27-1 business as a pharmacy or provide pharmacy services unless the
27-2 facility is a pharmacy licensed under this Act.
27-3 SECTION 20. The Texas Pharmacy Act (Article 4542a-1,
27-4 Vernon's Texas Civil Statutes) is amended by adding Section 37A to
27-5 read as follows:
27-6 Sec. 37A. CIVIL PENALTY. (a) A person who violates the
27-7 license requirements of this Act is liable to the state for a civil
27-8 penalty of up to $1,000 for each day the violation continues.
27-9 (b) At the request of the board, the attorney general shall
27-10 institute an action to collect a civil penalty from a person who
27-11 has violated this Act or rules adopted under this Act.
27-12 (c) If the attorney general fails to take action within 30
27-13 days of referral from the board, the board shall refer the case to
27-14 the local district attorney, county attorney, or city attorney.
27-15 The district attorney, county attorney, or city attorney shall file
27-16 suit in a district court to collect and retain the penalty.
27-17 SECTION 21. Subdivisions (10) and (11), Section 483.001,
27-18 Health and Safety Code, are amended to read as follows:
27-19 (10) "Pharmacy" means a facility where prescription
27-20 drug or medication orders are received, processed, dispensed, or
27-21 distributed under this chapter, Chapter 481, and the Texas Pharmacy
27-22 Act (Article 4542a-1, Vernon's Texas Civil Statutes) [licensed by
27-23 the board pursuant to Section 29, Texas Pharmacy Act (Article
27-24 4542a-1, Vernon's Texas Civil Statutes)].
27-25 (11) "Practice of pharmacy" means:
27-26 (A) provision of those acts or services
27-27 necessary to provide pharmaceutical care;
28-1 (B) interpretation and evaluation of
28-2 prescription drug orders or medication orders;
28-3 (C) participation in drug and device selection
28-4 as authorized by law, drug administration, drug regimen review, or
28-5 drug or drug-related research;
28-6 (D) provision of patient counseling; [and]
28-7 (E) responsibility for:
28-8 (i) dispensing of prescription drug orders
28-9 or distribution of medication orders in the patient's best
28-10 interest;
28-11 (ii) compounding and labeling of drugs and
28-12 devices, except labeling by a manufacturer, repackager, or
28-13 distributor of nonprescription drugs and commercially packaged
28-14 prescription drugs and devices;
28-15 (iii) proper and safe storage of drugs and
28-16 devices; and
28-17 (iv) maintenance of proper records for
28-18 drugs and devices. In this subdivision, "device" has the meaning
28-19 assigned by the Texas Pharmacy Act (Article 4542a-1, Vernon's Texas
28-20 Civil Statutes); and
28-21 (F) performance of a specific act of drug
28-22 therapy management for a patient delegated to a pharmacist by a
28-23 written protocol from a physician licensed by the state under the
28-24 Medical Practice Act (Article 4495b, Vernon's Texas Civil
28-25 Statutes).
28-26 SECTION 22. Subsection (b), Section 483.003, Health and
28-27 Safety Code, is amended to read as follows:
29-1 (b) On making that finding, the Texas Board of Health
29-2 [board] may limit the availability of the abused drug by permitting
29-3 its dispensing only on the prescription of a practitioner described
29-4 by Section 483.001(12)(A) or (B).
29-5 SECTION 23. Subsection (e), Section 483.042, Health and
29-6 Safety Code, is amended to read as follows:
29-7 (e) The labeling provisions of Subsection (a) do not apply
29-8 to a dangerous drug prescribed or dispensed for administration to a
29-9 patient who is institutionalized. The board shall adopt rules for
29-10 the labeling of such a drug [food production animals in an
29-11 agricultural operation under a written medical directive or
29-12 treatment guideline from a veterinarian licensed under The
29-13 Veterinary Licensing Act (Article 8890, Revised Statutes) and its
29-14 subsequent amendments].
29-15 SECTION 24. Chapter 107, Acts of the 41st Legislature,
29-16 Regular Session, 1929 (Article 4542a, Vernon's Texas Civil
29-17 Statutes), is repealed.
29-18 SECTION 25. Subsection (b), Section 26A, Texas Pharmacy Act
29-19 (Article 4542a-1, Vernon's Texas Civil Statutes), as amended by
29-20 Section 7, Chapter 789, Acts of the 73rd Legislature, 1993, is
29-21 repealed.
29-22 SECTION 26. This Act takes effect September 1, 1997.
29-23 SECTION 27. (a) This Act applies only to a license issued
29-24 by the Texas State Board of Pharmacy on or after the effective date
29-25 of this Act. A license issued or renewed before that date is
29-26 governed by the law in effect on the date the license was issued or
29-27 renewed, and the former law is continued in effect for that
30-1 purpose.
30-2 (b) Section 37A, Texas Pharmacy Act (Article 4542a-1,
30-3 Vernon's Texas Civil Statutes), as added by this Act, applies only
30-4 to a violation of the licensing requirements of the Texas Pharmacy
30-5 Act (Article 4542a-1, Vernon's Texas Civil Statutes) that occurs on
30-6 or after the effective date of this Act.
30-7 SECTION 28. The importance of this legislation and the
30-8 crowded condition of the calendars in both houses create an
30-9 emergency and an imperative public necessity that the
30-10 constitutional rule requiring bills to be read on three several
30-11 days in each house be suspended, and this rule is hereby suspended.