1-1 By: Madla S.B. No. 609
1-2 (In the Senate - Filed February 14, 1997; February 20, 1997,
1-3 read first time and referred to Committee on Health and Human
1-4 Services; April 1, 1997, reported favorably, as amended, by the
1-5 following vote: Yeas 10, Nays 0; April 1, 1997, sent to printer.)
1-6 COMMITTEE AMENDMENT NO. 1 By: Madla
1-7 Amend S.B. No. 609 in SECTION 21 of the bill (filed version, page
1-8 11, line 55) by striking Subsection (h) in its entirety and
1-9 substituting the following:
1-10 (h) No written prescription issued by a practitioner, as
1-11 such term is defined in Section 5(39)(A) of this Act, may be
1-12 dispensed unless it is ordered on a form containing two signature
1-13 lines of equal prominence, side by side, at the bottom of the form.
1-14 Under either signature line shall be printed clearly the words
1-15 "product selection permitted," and under the other signature line
1-16 shall be printed clearly the words "dispense as written." The
1-17 practitioner shall communicate dispensing instructions to the
1-18 pharmacist by signing on the appropriate line. If the
1-19 practitioner's signature does not clearly indicate that the
1-20 prescription must be dispensed as written, generically equivalent
1-21 drug selection is permitted. No prescription form furnished a
1-22 practitioner shall contain a preprinted order for a drug product by
1-23 brand name, generic name, or manufacturer.
1-24 A BILL TO BE ENTITLED
1-25 AN ACT
1-26 relating to the regulation of pharmacies and pharmacists; providing
1-27 a penalty.
1-28 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-29 SECTION 1. Section 5, Texas Pharmacy Act (Article 4542a-1,
1-30 Vernon's Texas Civil Statutes), is amended to read as follows:
1-31 Sec. 5. DEFINITIONS. In this Act, unless the context of
1-32 its use clearly indicates otherwise:
1-33 (1) "A.C.P.E." means the American Council on
1-34 Pharmaceutical Education.
1-35 (2) "Administer" means the direct application of a
1-36 prescription drug by injection, inhalation, ingestion, or any other
1-37 means to the body of a patient by:
1-38 (A) a practitioner, an authorized agent under
1-39 his supervision, or other person authorized by law; or
1-40 (B) the patient at the direction of a
1-41 practitioner.
1-42 (3) "Administrative Procedure Act" means Chapter 2001,
1-43 Government Code [the Administrative Procedure and Texas Register
1-44 Act, as amended (Article 6252-13a, Vernon's Texas Civil Statutes)].
1-45 (4) "Board" means the Texas State Board of Pharmacy.
1-46 (5) "Class A pharmacy license" or "community pharmacy
1-47 license" means a license issued to a pharmacy dispensing drugs or
1-48 devices to the general public pursuant to a prescription drug
1-49 order.
1-50 (6) "Class B pharmacy license" or "nuclear pharmacy
1-51 license" means a license issued to a pharmacy dispensing or
1-52 providing radioactive drugs or devices for administration to an
1-53 ultimate user.
1-54 (7) "Class C pharmacy license" or "institutional
1-55 pharmacy license" means a license issued to a pharmacy located in a
1-56 hospital or other in-patient facility that is licensed under
1-57 Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental
1-58 Health Code (Article 5547-1 et seq., Vernon's Texas Civil
1-59 Statutes), to a hospice in-patient facility that is licensed under
1-60 Chapter 142, Health and Safety Code, or to a pharmacy located in a
1-61 hospital maintained or operated by the state.
1-62 (8) "Class D pharmacy license" or "clinic pharmacy
1-63 license" means a license issued to a pharmacy dispensing a limited
1-64 type of drugs or devices pursuant to a prescription drug order.
2-1 (9) "Class E pharmacy license" or "nonresident
2-2 pharmacy license" means a license issued under this Act to a
2-3 pharmacy located in a state of the United States other than this
2-4 state whose primary business is to dispense a prescription drug or
2-5 device under a prescription drug order and to deliver the drug or
2-6 device to a patient, including a patient in this state, by the
2-7 United States mail, a common carrier, or a delivery service.
2-8 (10) [(11)] "College of pharmacy" means a school,
2-9 university, or college of pharmacy that satisfies the accreditation
2-10 standards of A.C.P.E. as adopted by the board; or that has degree
2-11 requirements which meet the standards of accreditation set by the
2-12 board.
2-13 (11) [(12)] "Compounding" means the preparation,
2-14 mixing, assembling, packaging, or labeling of a drug or device:
2-15 (A) as the result of a practitioner's
2-16 prescription drug order or initiative based on the
2-17 practitioner-patient-pharmacist relationship in the course of
2-18 professional practice;
2-19 (B) in anticipation of prescription drug orders
2-20 based on routine, regularly observed prescribing patterns; or
2-21 (C) for the purpose of or as an incident to
2-22 research, teaching, or chemical analysis and not for sale or
2-23 dispensing.
2-24 (12) [(13)] "Confidential record" means any
2-25 health-related record that contains information that identifies an
2-26 individual and that is maintained by a pharmacy or pharmacist such
2-27 as a patient medication record, prescription drug order, or
2-28 medication order.
2-29 (13) [(14)] "Controlled substance" means a drug,
2-30 immediate precursor, or other substance listed in Schedules I-V or
2-31 Penalty Groups 1-4 of Chapter 481, Health and Safety Code, or a
2-32 drug, immediate precursor, or other substance included in Schedule
2-33 I, II, III, IV, or V of the Federal Comprehensive Drug Abuse
2-34 Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
2-35 (14) [(15)] "Controlled Substances Act" means Chapter
2-36 481, Health and Safety Code, or the Federal Comprehensive Drug
2-37 Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et
2-38 seq.).
2-39 (15) [(16)] "Dangerous drug" means any drug or device
2-40 that is not included in Penalty Groups 1-4 of the Controlled
2-41 Substances Act and that is unsafe for self-medication or any drug
2-42 or device that bears or is required to bear the legend:
2-43 (A) "Caution: federal law prohibits dispensing
2-44 without prescription"; or
2-45 (B) "Caution: federal law restricts this drug
2-46 to use by or on the order of a licensed veterinarian."
2-47 (16) [(17)] "Dangerous Drug Act" means Chapter 483,
2-48 Health and Safety Code.
2-49 (17) [(18)] "Deliver" or "delivery" means the actual,
2-50 constructive, or attempted transfer of a prescription drug or
2-51 device or controlled substance from one person to another, whether
2-52 or not for a consideration.
2-53 (18) [(19)] "Designated agent" means:
2-54 (A) a licensed nurse, physician assistant,
2-55 pharmacist, or other individual designated by a practitioner, and
2-56 for whom the practitioner assumes legal responsibility, who
2-57 communicates prescription drug orders to a pharmacist;
2-58 (B) a licensed nurse, physician assistant, or
2-59 pharmacist employed in a health care facility to whom the
2-60 practitioner communicates a prescription drug order; or
2-61 (C) a registered nurse or physician assistant
2-62 authorized by a practitioner to carry out a prescription drug order
2-63 for dangerous drugs under Subdivision (5) or (6), Subsection (d),
2-64 Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas
2-65 Civil Statutes).
2-66 (19) [(20)] "Device" means an instrument, apparatus,
2-67 implement, machine, contrivance, implant, in vitro reagent, or
2-68 other similar or related article, including any component part or
2-69 accessory, that is required under federal or state law to be
3-1 ordered or prescribed by a practitioner.
3-2 (20) [(21)] "Dispense" means preparing, packaging,
3-3 compounding, or labeling for delivery a prescription drug or device
3-4 in the course of professional practice to an ultimate user or his
3-5 agent by or pursuant to the lawful order of a practitioner.
3-6 (21) [(22)] "Distribute" means the delivery of a
3-7 prescription drug or device other than by administering or
3-8 dispensing.
3-9 (22) [(23)] "Drug" means:
3-10 (A) a substance recognized as drugs in the
3-11 current official United States Pharmacopoeia, official National
3-12 Formulary, official Homeopathic Pharmacopoeia, or other drug
3-13 compendium or any supplement to any of them;
3-14 (B) a substance intended for use in the
3-15 diagnosis, cure, mitigation, treatment, or prevention of disease in
3-16 man or other animals;
3-17 (C) a substance, other than food, intended to
3-18 affect the structure or any function of the body of man or other
3-19 animals;
3-20 (D) a substance intended for use as a component
3-21 of any articles specified in Paragraph (A), (B), or (C) of this
3-22 subdivision;
3-23 (E) a dangerous drug; or
3-24 (F) a controlled substance.
3-25 (23) [(24)] "Drug regimen review" includes the
3-26 following activities:
3-27 (A) evaluation of prescription drug or
3-28 medication orders and patient medication records for:
3-29 (i) known allergies;
3-30 (ii) rational therapy-contraindications;
3-31 (iii) reasonable dose and route of
3-32 administration; and
3-33 (iv) reasonable directions for use;
3-34 (B) evaluation of prescription drug or
3-35 medication orders and patient medication records for duplication of
3-36 therapy;
3-37 (C) evaluation of prescription drug or
3-38 medication orders and patient medication records for:
3-39 (i) drug-drug interactions;
3-40 (ii) drug-food interactions;
3-41 (iii) drug-disease interactions;
3-42 (iv) adverse drug reactions; and
3-43 (D) evaluation of prescription drug and
3-44 medication orders and patient medication records for proper
3-45 utilization, including overutilization or underutilization.
3-46 (24) [(25)] "Internship" means a practical experience
3-47 program that is approved by the board.
3-48 (25) [(26)] "Label" means written, printed, or graphic
3-49 matter on the immediate container of a drug or device.
3-50 (26) [(27)] "Labeling" means the process of affixing a
3-51 label including all information required by federal and state law
3-52 or regulation to any drug or device container. The term does not
3-53 include the labeling by a manufacturer, packer, or distributor of a
3-54 nonprescription drug or commercially packaged prescription drug or
3-55 device, or unit dose packaging.
3-56 (27) [(28)] "Manufacturing" means the production,
3-57 preparation, propagation, conversion, or processing of a drug or
3-58 device, either directly or indirectly, by extraction from
3-59 substances of natural origin or independently by means of chemical
3-60 or biological synthesis and includes any packaging or repackaging
3-61 of the substances or labeling or relabeling of the container and
3-62 the promotion and marketing of such drugs or devices.
3-63 Manufacturing also includes the preparation and promotion of
3-64 commercially available products from bulk compounds for resale by
3-65 pharmacies, practitioners, or other persons but does not include
3-66 compounding.
3-67 (28) [(29)] "Medication order" means an order from a
3-68 practitioner or a practitioner's designated agent for
3-69 administration of a drug or device.
4-1 (29) [(30)] "Nonprescription drug" means a nonnarcotic
4-2 drug or device that may be sold without a prescription and that is
4-3 labeled and packaged in compliance with applicable state or federal
4-4 law.
4-5 (30) [(31)] "Patient counseling" means the
4-6 communication by the pharmacist of information, as specified in the
4-7 rules of the board, to the patient or caregiver, in order to
4-8 improve therapy by ensuring proper use of drugs and devices.
4-9 (31) [(32)] "Person" means an individual, corporation,
4-10 government or governmental subdivision or agency, business trust,
4-11 estate, trust, partnership, association, or any other legal entity.
4-12 (32) [(33)] "Pharmaceutical care" is the provision of
4-13 drug therapy and other pharmaceutical services defined in the rules
4-14 of the board and intended to assist in the cure or prevention of a
4-15 disease, elimination or reduction of a patient's symptoms, or
4-16 arresting or slowing of a disease process.
4-17 (33) [(34)] "Pharmacist" means a person licensed by
4-18 the board to practice pharmacy.
4-19 (34) [(35)] "Pharmacist-in-charge" means the
4-20 pharmacist designated on a pharmacy license as the pharmacist who
4-21 has the authority or responsibility for a pharmacy's compliance
4-22 with laws and rules pertaining to the practice of pharmacy.
4-23 (35) [(36)] "Pharmacist-intern" means an undergraduate
4-24 student enrolled in the professional sequence of a college of
4-25 pharmacy approved by the board and participating in a school-based,
4-26 board-approved internship program or a graduate of a college of
4-27 pharmacy who is participating in a board-approved internship.
4-28 (36) [(37)] "Pharmacy" means a facility at which
4-29 prescription drug or medication orders are received, processed, or
4-30 dispensed under this Act, the Dangerous Drug Act, or the Controlled
4-31 Substances Act [licensed by the board pursuant to Section 29 of
4-32 this Act].
4-33 (37) "Pharmacy technician" means an individual
4-34 employed by a pharmacy whose responsibility is to provide technical
4-35 services that do not require professional judgment regarding the
4-36 preparation and distribution of drugs and who works under the
4-37 direct supervision of and is responsible to a pharmacist.
4-38 (38) "Practice of pharmacy" means:
4-39 (A) provision of those acts or services
4-40 necessary to provide pharmaceutical care;
4-41 (B) interpretation and evaluation of
4-42 prescription drug orders or medication orders;
4-43 (C) participation in drug and device selection
4-44 as authorized by law, drug administration, drug regimen review, or
4-45 drug or drug-related research;
4-46 (D) provision of patient counseling;
4-47 (E) responsibility for:
4-48 (i) dispensing of prescription drug orders
4-49 or distribution of medication orders;
4-50 (ii) compounding and labeling of drugs and
4-51 devices, except labeling by a manufacturer, repackager, or
4-52 distributor of nonprescription drugs and commercially packaged
4-53 prescription drugs and devices;
4-54 (iii) proper and safe storage of drugs and
4-55 devices; or
4-56 (iv) maintenance of proper records for
4-57 drugs and devices; and
4-58 (F) performance of a specific act of drug
4-59 therapy management for a patient delegated to a pharmacist by a
4-60 written protocol from a physician licensed in this state in
4-61 compliance with the Medical Practice Act (Article 4495b, Vernon's
4-62 Texas Civil Statutes).
4-63 (39) "Practitioner" means:
4-64 (A) a physician, dentist, podiatrist,
4-65 veterinarian, or other person licensed or registered to prescribe,
4-66 distribute, administer, or dispense a prescription drug or device
4-67 in the course of professional practice in this state;
4-68 (B) a person licensed by another state in a
4-69 health field in which, under Texas law, licensees in this state may
5-1 legally prescribe dangerous drugs or a person practicing in another
5-2 state and licensed by another state as a physician, dentist,
5-3 veterinarian, or podiatrist, having a current Federal Drug
5-4 Enforcement Administration registration number, and who may legally
5-5 prescribe Schedule II, III, IV, or V controlled substances in such
5-6 other state; or
5-7 (C) a person licensed in the Dominion of Canada
5-8 or the United Mexican States in a health field in which, under the
5-9 laws of this state, a licensee may legally prescribe dangerous
5-10 drugs. "Practitioner" does not include a person licensed under
5-11 this Act.
5-12 (40) "Preceptor" means a pharmacist [in good standing]
5-13 licensed in this state to practice pharmacy who meets the preceptor
5-14 requirements specified by rule and who is certified by the board to
5-15 supervise and be responsible for the activities and functions of a
5-16 pharmacist-intern in the internship program.
5-17 (41) "Prescription drug" means:
5-18 (A) a substance for which federal or state law
5-19 requires a prescription before it may be legally dispensed to the
5-20 public;
5-21 (B) a drug or device that under federal law is
5-22 required, prior to being dispensed or delivered, to be labeled with
5-23 either of the following statements:
5-24 (i) "Caution: federal law prohibits
5-25 dispensing without prescription"; or
5-26 (ii) "Caution: federal law restricts this
5-27 drug to use by or on the order of a licensed veterinarian"; or
5-28 (C) a drug or device that is required by any
5-29 applicable federal or state law or regulation to be dispensed on
5-30 prescription only or is restricted to use by a practitioner only.
5-31 (42) "Prescription drug order" means:
5-32 (A) an order from a practitioner or a
5-33 practitioner's designated agent to a pharmacist for a drug or
5-34 device to be dispensed; or
5-35 (B) an order pursuant to Subdivision (5) or (6),
5-36 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
5-37 Vernon's Texas Civil Statutes).
5-38 (43) "Prospective drug use review" means a review of
5-39 the patient's drug therapy and prescription drug order or
5-40 medication order, as defined in the rules of the board, prior to
5-41 dispensing or distributing the drug.
5-42 (44) "Provide" means to supply one or more unit doses
5-43 of a nonprescription drug or dangerous drug to a patient.
5-44 (45) "Radioactive drug" means a drug that exhibits
5-45 spontaneous disintegration of unstable nuclei with the emission of
5-46 nuclear particles or photons, including any nonradioactive reagent
5-47 kit or nuclide generator that is intended to be used in the
5-48 preparation of any such substance.
5-49 (46) "Substitution" means the dispensing of a drug or
5-50 a brand of drug other than that which is ordered or prescribed.
5-51 (47) "Texas trade association" means a nonprofit,
5-52 cooperative association of business or professional competitors in
5-53 this state whose purpose is to assist its members, industry, or
5-54 profession and whose members have joined voluntarily. ["Supportive
5-55 personnel" means those individuals utilized in pharmacies whose
5-56 responsibility it shall be to provide technical services that do
5-57 not require professional judgment concerned with the preparation
5-58 and distribution of drugs under the direct supervision of and
5-59 responsible to a pharmacist.]
5-60 (48) "Ultimate user" means a person who has obtained
5-61 and possesses a prescription drug or device for the person's own
5-62 use or for the use of a member of the person's household or for
5-63 administering to an animal owned by the person or by a member of
5-64 the person's household.
5-65 (49) "Unit dose packaging" means the ordered amount of
5-66 drug in a dosage form ready for administration to a particular
5-67 patient, by the prescribed route at the prescribed time, and
5-68 properly labeled with name, strength, and expiration date of the
5-69 drug.
6-1 (50) "Written protocol" means a physician's order,
6-2 standing medical order, standing delegation order, or other order
6-3 or protocol as defined by rule of the Texas State Board of Medical
6-4 Examiners under the Medical Practice Act (Article 4495b, Vernon's
6-5 Texas Civil Statutes).
6-6 SECTION 2. Subsection (a), Section 8, Texas Pharmacy Act
6-7 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
6-8 read as follows:
6-9 (a) A licensed pharmacist member of the board:
6-10 (1) may not be:
6-11 (A) a salaried faculty member at a college of
6-12 pharmacy; or
6-13 (B) an officer, employee, or paid consultant of
6-14 a Texas trade association in the field of health care or a spouse
6-15 of an officer, employee, or paid consultant; and
6-16 (2) must at the time of his appointment:
6-17 (A) [(1)] be a resident of this state;
6-18 (B) [(2)] be licensed for the five years
6-19 immediately preceding appointment and be in good standing to engage
6-20 in the practice of pharmacy in this state; and
6-21 (C) [(3)] be engaged in the practice of pharmacy
6-22 in this state.
6-23 SECTION 3. Section 8, Texas Pharmacy Act (Article 4542a-1,
6-24 Vernon's Texas Civil Statutes), is amended by adding Subsection (f)
6-25 to read as follows:
6-26 (f) The board shall provide to its members, as often as
6-27 necessary, information regarding their qualifications for office or
6-28 employment under this Act and their responsibilities under
6-29 applicable laws relating to standards of conduct for state officers
6-30 or employees.
6-31 SECTION 4. Subsection (c), Section 14, Texas Pharmacy Act
6-32 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
6-33 read as follows:
6-34 (c) Except as otherwise provided by this subsection, all
6-35 board meetings and hearings shall be open to the public. The board
6-36 may, in its discretion and in accordance with the open meetings
6-37 law, Chapter 551, Government Code, [Chapter 271, Acts of the 60th
6-38 Legislature, Regular Session, 1967, as amended (Article 6252-17,
6-39 Vernon's Texas Civil Statutes),] conduct any portion of its meeting
6-40 in executive session. The board may in its discretion conduct
6-41 deliberations relative to licensee disciplinary actions in
6-42 executive session. At the conclusion of its deliberations relative
6-43 to licensee disciplinary action, the board shall vote and announce
6-44 its decision relative to the licensee in open session. The board
6-45 in executive session may conduct disciplinary hearings relating to
6-46 a pharmacist or pharmacy student who is impaired because of
6-47 chemical abuse or mental or physical illness.
6-48 SECTION 5. Subsections (c), (d), and (f), Section 15, Texas
6-49 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
6-50 amended to read as follows:
6-51 (c) An officer, employee, or paid consultant of a Texas
6-52 trade association in the field of health care may not be an [a
6-53 member or] employee of the board who is exempt from the state's
6-54 position classification plan or is compensated at or above the
6-55 amount prescribed by the General Appropriations Act for step 1,
6-56 salary group 17, of the position classification salary schedule.
6-57 (d) A person who is the spouse of an officer, manager, or
6-58 paid consultant of a Texas trade association in the field of health
6-59 care may not be a [board member and may not be a] board employee
6-60 who is exempt from the state's position classification plan or is
6-61 compensated at or above the amount prescribed by the General
6-62 Appropriations Act for step 1, salary group 17, of the position
6-63 classification salary schedule.
6-64 (f) The board shall provide to its [members and] employees,
6-65 as often as necessary, information regarding their qualification
6-66 for office or employment under this Act and their responsibilities
6-67 under applicable laws relating to standards of conduct for state
6-68 officers or employees.
6-69 SECTION 6. Subsections (o) and (q), Section 17, Texas
7-1 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
7-2 amended to read as follows:
7-3 (o) The board:
7-4 (1) shall [may] establish rules for the use of
7-5 pharmacy technicians [supportive personnel] and the duties of those
7-6 technicians [personnel] in pharmacies licensed by the board,
7-7 provided that those technicians [personnel] are responsible to and
7-8 directly supervised by a pharmacist licensed by the board; provided
7-9 however that the board may not adopt rules or regulations
7-10 establishing ratios of pharmacists to pharmacy technicians
7-11 [supportive personnel] in Class C pharmacies; and
7-12 (2) may determine and issue standards for recognition
7-13 and approval of training programs for pharmacy technicians and
7-14 maintain a list of training programs that meet the standards.
7-15 (q) Board investigative files and all information and
7-16 materials compiled by the board in connection with an investigation
7-17 are confidential and are not subject to disclosure under Chapter
7-18 552, Government Code [424, Acts of the 63rd Legislature, Regular
7-19 Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil
7-20 Statutes)], and are not subject to disclosure, discovery, subpoena,
7-21 or other means of legal compulsion for their release to anyone
7-22 other than the board or its employees or agents involved in
7-23 licensee discipline except that this information may be disclosed
7-24 to:
7-25 (1) persons involved with the board in a disciplinary
7-26 action against the licensee;
7-27 (2) pharmacist or pharmacy licensing or disciplinary
7-28 authorities of other jurisdictions;
7-29 (3) a pharmaceutical peer review committee as outlined
7-30 in Section 27A of this Act;
7-31 (4) law enforcement agencies; and
7-32 (5) persons engaged in bona fide research, if all
7-33 individual-identifying information has been deleted.
7-34 SECTION 7. Subsection (a), Section 17D, Texas Pharmacy Act
7-35 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
7-36 read as follows:
7-37 (a) The board by rule shall adopt procedures governing:
7-38 (1) informal disposition of a contested case under
7-39 Chapter 2001, Government Code [Section 13(e), Administrative
7-40 Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas
7-41 Civil Statutes), and its subsequent amendments]; and
7-42 (2) informal proceedings held in compliance with
7-43 Chapter 2001, Government Code [Section 18(c), Administrative
7-44 Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas
7-45 Civil Statutes), and its subsequent amendments].
7-46 SECTION 8. Subsections (a), (f), and (g), Section 19, Texas
7-47 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
7-48 amended to read as follows:
7-49 (a) A person may not:
7-50 (1) dispense or distribute prescription drugs unless
7-51 he is a licensed pharmacist or is authorized by this Act to
7-52 dispense or distribute prescription drugs; or
7-53 (2) operate a pharmacy unless he first obtains a
7-54 license to operate a pharmacy.
7-55 (f) This Act does not apply to:
7-56 (1) a member of the faculty of a college of pharmacy
7-57 that is recognized by the board if the faculty member is a licensed
7-58 pharmacist and performs his services for the benefit of the college
7-59 only;
7-60 (2) [a pharmacist-intern;]
7-61 [(3)] a person who procures prescription drugs for
7-62 lawful research, teaching, or testing and not for resale; or
7-63 (3) [(4)] a home and community support services agency
7-64 that possesses a dangerous drug as authorized by Section 142.0061,
7-65 Health and Safety Code.
7-66 (g) Any person found by the board to have unlawfully engaged
7-67 in the practice of pharmacy or unlawfully operated a pharmacy is
7-68 subject to a civil penalty under Section 37A of this Act [fine to
7-69 be imposed by the board not to exceed $1,000 for each offense].
8-1 Each violation of this Act or the rules adopted under this Act
8-2 pertaining to unlawfully engaging in the practice of pharmacy or
8-3 unlawfully operating a pharmacy also constitutes a Class A
8-4 misdemeanor.
8-5 SECTION 9. Section 20, Texas Pharmacy Act (Article 4542a-1,
8-6 Vernon's Texas Civil Statutes), is amended to read as follows:
8-7 Sec. 20. PHARMACIST-INTERN REGISTRATION. (a) A person
8-8 must register with the board before beginning the board-approved
8-9 internship in this state. An application for the registration of a
8-10 pharmacist-intern must be on a form prescribed by the board.
8-11 Registration shall remain in effect as long as the person meets the
8-12 qualifications for internship as specified by rules adopted by the
8-13 board [during internship training and thereafter until the earlier
8-14 of the following occurs:]
8-15 [(1) the failure of the pharmacist-intern to take the
8-16 next regularly scheduled examination; or]
8-17 [(2) the failure to pass the next regularly scheduled
8-18 examination].
8-19 (b) The board may in its discretion refuse to issue a
8-20 registration to an applicant and may restrict, suspend, or revoke a
8-21 pharmacist-intern registration for any violation of this Act. In
8-22 enforcing Section 26(a)(4) of this Act, the board shall, on
8-23 probable cause, request a pharmacist-intern or pharmacist-intern
8-24 applicant to submit to a mental or physical examination by
8-25 physicians or other health care professionals designated by the
8-26 board. If the pharmacist-intern or applicant refuses to submit to
8-27 the examination, the board shall issue an order requiring the
8-28 pharmacist-intern or applicant to show cause why he will not submit
8-29 to the examination and shall schedule a hearing on the order within
8-30 30 days after notice is served on the pharmacist-intern or
8-31 applicant. The board shall notify the pharmacist-intern or
8-32 applicant by either personal service or certified mail with return
8-33 receipt requested. At the hearing, the pharmacist-intern or
8-34 applicant and an attorney are entitled to present any testimony and
8-35 other evidence to show why the pharmacist-intern or applicant
8-36 should not be required to submit to the examination. After the
8-37 hearing, the board shall issue an order either requiring the
8-38 pharmacist-intern or applicant to submit to the examination or
8-39 withdrawing the request for examination.
8-40 SECTION 10. Subsections (a) and (e), Section 21, Texas
8-41 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
8-42 amended to read as follows:
8-43 (a) To qualify for a license to practice pharmacy, an
8-44 applicant for licensing by examination must submit to the board a
8-45 license fee as determined by the board and a completed application
8-46 on a form prescribed by the board with satisfactory sworn evidence
8-47 that he:
8-48 (1) is at least 18 years old;
8-49 (2) is of good moral character;
8-50 (3) has completed a minimum of a 1,000-hour internship
8-51 or other program that has been approved by the board or has
8-52 demonstrated, to the board's satisfaction, experience in the
8-53 practice of pharmacy that meets or exceeds the minimum internship
8-54 requirements of the board;
8-55 (4) has graduated and received a [the first
8-56 professional undergraduate degree or the advanced] professional
8-57 practice degree, as defined by the rules adopted by the board, from
8-58 an accredited pharmacy degree program approved by the board;
8-59 (5) has passed the examination required by the board;
8-60 and
8-61 (6) has not had a pharmacist license granted by
8-62 another state suspended, revoked, canceled, surrendered, or
8-63 otherwise restricted for any reason.
8-64 (e) The [Within 30 days after the date a licensing
8-65 examination is administered under this Act, the] board shall notify
8-66 each examinee of the results of the examination[. However, if an
8-67 examination is graded or reviewed by a national testing service,
8-68 the board shall notify each examinee of the results of the
8-69 examination] within 30 days [two weeks] after the date the board
9-1 receives the results from a national [the] testing service. [If
9-2 the notice of the examination results will be delayed for more than
9-3 90 days after the examination date, the board shall notify the
9-4 examinee of the reason for the delay before the 90th day.]
9-5 SECTION 11. Subsection (a), Section 22, Texas Pharmacy Act
9-6 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
9-7 read as follows:
9-8 (a) To qualify for a license to practice pharmacy by
9-9 reciprocity, an applicant for licensing must:
9-10 (1) submit to the board a reciprocity fee as
9-11 determined by the board and a completed application given under
9-12 oath, in the form prescribed by the board;
9-13 (2) have good moral character;
9-14 (3) have graduated and received a [the first
9-15 professional undergraduate degree or the advanced] professional
9-16 practice degree, as defined by the rules adopted by the board, from
9-17 an accredited pharmacy degree program approved by the board;
9-18 (4) have possessed at the time of initial licensing as
9-19 a pharmacist other qualifications necessary to have been eligible
9-20 for licensing at that time in this state;
9-21 (5) have presented to the board proof of initial
9-22 licensing by examination and proof that the license and other
9-23 license or licenses granted to the applicant by any other state
9-24 have not been suspended, revoked, canceled, surrendered, or
9-25 otherwise restricted for any reason; and
9-26 (6) pass the Texas [Drug and] Pharmacy Jurisprudence
9-27 examination.
9-28 SECTION 12. Subsection (b), Section 26, Texas Pharmacy Act
9-29 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
9-30 read as follows:
9-31 (b) Grounds for Disciplining a Holder of a Pharmacy License:
9-32 The board shall refuse to issue a pharmacy license for failure to
9-33 meet the requirements of Section 29 or 30 of this Act. The board
9-34 may in its discretion refuse to issue or renew a license or may
9-35 assess a penalty, reprimand, revoke, restrict, cancel, or suspend
9-36 any license granted by the board, and may probate any license
9-37 suspension if the board finds that the applicant or licensee has:
9-38 (1) been convicted of a felony or a misdemeanor
9-39 involving moral turpitude, or if the applicant or licensee is a
9-40 legal entity such as an association, joint stock company,
9-41 partnership, or corporation, that a managing officer has been
9-42 convicted of a felony or a misdemeanor involving moral turpitude
9-43 under the law of this state, another state, or the United States;
9-44 (2) advertised any prescription drugs or devices in a
9-45 deceitful, misleading, or fraudulent manner;
9-46 (3) violated any provision of this Act or any rule
9-47 adopted under this Act or that any owner or employee of a pharmacy
9-48 has violated any provision of this Act or any rule adopted under
9-49 this Act;
9-50 (4) sold without legal authorization prescription
9-51 drugs or devices to persons other than:
9-52 (A) a pharmacy licensed by the board;
9-53 (B) a practitioner;
9-54 (C) a person who procures prescription drugs or
9-55 devices for the purpose of lawful research, teaching, or testing,
9-56 and not for resale;
9-57 (D) a manufacturer or wholesaler registered with
9-58 the commissioner of health as required by Chapter 431, Health and
9-59 Safety Code; or
9-60 (E) a carrier or warehouseman;
9-61 (5) allowed an employee who is not a licensed
9-62 pharmacist to practice pharmacy;
9-63 (6) sold adulterated or misbranded prescription or
9-64 nonprescription drugs;
9-65 (7) failed to engage in or ceased to engage in the
9-66 business described in the application for a license;
9-67 (8) failed to keep and maintain records as required by
9-68 this Act, the Controlled Substances Act, Dangerous Drug Act, or
9-69 rules adopted under this Act or the Dangerous Drug Act; [or]
10-1 (9) failed to establish and maintain effective
10-2 controls against diversion of prescription drugs into other than
10-3 legitimate medical, scientific, or industrial channels as provided
10-4 by this Act or other state or federal laws or rules; or
10-5 (10) engaged in any fraud, deceit, or
10-6 misrepresentation as defined by the rules adopted by the board in
10-7 operating a pharmacy or in seeking a license to operate a pharmacy.
10-8 SECTION 13. Subsection (c), Section 26A, Texas Pharmacy Act
10-9 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
10-10 read as follows:
10-11 (c) Any disciplinary action taken by the board under this
10-12 section is governed by the Administrative Procedure Act (Chapter
10-13 2001, Government Code [and Texas Register Act (Article 6252-13a,
10-14 Vernon's Texas Civil Statutes]) and the rules of practice and
10-15 procedure adopted by the board.
10-16 SECTION 14. Section 27, Texas Pharmacy Act (Article 4542a-1,
10-17 Vernon's Texas Civil Statutes), is amended to read as follows:
10-18 Sec. 27. PROCEDURE. Except as provided in Section 27A of
10-19 this Act, any disciplinary action taken by the board under Section
10-20 26, 26A, or 26B of this Act is governed by the Administrative
10-21 Procedure Act (Chapter 2001, Government Code [and Texas Register
10-22 Act (Article 6252-13a, Vernon's Texas Civil Statutes]) and the
10-23 rules of practice and procedure before the board.
10-24 SECTION 15. Subsection (d), Section 27A, Texas Pharmacy Act
10-25 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
10-26 read as follows:
10-27 (d) The records and proceedings of the board, its authorized
10-28 agents, or any pharmaceutical organization committee as set out in
10-29 Subsections (a) and (b) of this section shall be confidential and
10-30 are not considered open records for the purposes of Chapter 552,
10-31 Government Code [424, Acts of the 63rd Legislature, Regular
10-32 Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil
10-33 Statutes)]; provided, however, the board may disclose this
10-34 confidential information only:
10-35 (1) in a disciplinary hearing before the board or in a
10-36 subsequent trial or appeal of a board action or order;
10-37 (2) to the pharmacist licensing or disciplinary
10-38 authorities of other jurisdictions;
10-39 (3) pursuant to an order of a court of competent
10-40 jurisdiction; or
10-41 (4) pursuant to Subsection (j) of this section.
10-42 SECTION 16. Subsection (c), Section 27B, Texas Pharmacy Act
10-43 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
10-44 read as follows:
10-45 (c) The identity of a person who reports to or assists the
10-46 board under this section and any document that could disclose the
10-47 identity of that person is confidential and does not constitute
10-48 public information for the purposes of Chapter 552, Government Code
10-49 [424, Acts of the 63rd Legislature, Regular Session, 1973 (Article
10-50 6252-17a, Vernon's Texas Civil Statutes)].
10-51 SECTION 17. Subsection (a), Section 28, Texas Pharmacy Act
10-52 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
10-53 read as follows:
10-54 (a) On the finding of the existence of grounds for
10-55 discipline of any person holding a license or seeking a license or
10-56 a renewal license under this Act, the board may impose one or more
10-57 of the following penalties:
10-58 (1) suspension of the offender's license;
10-59 (2) revocation of the offender's license;
10-60 (3) restriction of the offender's license to prohibit
10-61 the offender from performing certain acts or from engaging in the
10-62 practice of pharmacy or operating a pharmacy in a particular manner
10-63 for a term and under conditions to be determined by the board;
10-64 (4) imposition of an administrative penalty under
10-65 Section 28B of this Act;
10-66 (5) refusal to issue or renew the offender's license;
10-67 (6) placement of the offender's license on probation
10-68 and supervision by the board for a period to be determined by the
10-69 board and imposition of a requirement that the licensee:
11-1 (A) report regularly to the board on matters
11-2 that are the basis of the probation;
11-3 (B) limit practice to the areas prescribed by
11-4 the board; [or]
11-5 (C) continue or review professional education
11-6 until the licensee attains a degree of skill satisfactory to the
11-7 board in those areas that are the basis of the probation; or
11-8 (D) pay the board a probation fee to defray the
11-9 costs of monitoring a licensee during the period of probation;
11-10 (7) reprimand;
11-11 (8) cancellation of the offender's license; or
11-12 (9) retirement of the offender's license as provided
11-13 by board rule[; or]
11-14 [(10) imposition of a civil penalty that does not
11-15 exceed $1,000 for each day of each violation and that may be
11-16 collected in a suit initiated by the board].
11-17 SECTION 18. Subsection (e), Section 29, Texas Pharmacy Act
11-18 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
11-19 read as follows:
11-20 (e) The board shall have the discretion to determine under
11-21 which classifications a pharmacy applicant may be licensed. With
11-22 respect to Class C pharmacies, the board may establish rules for
11-23 the use of pharmacy technicians [supportive personnel] and the
11-24 duties of those technicians [personnel] in Class C pharmacies
11-25 licensed by the board, provided that these technicians [personnel]
11-26 are responsible to and directly supervised by a pharmacist licensed
11-27 by the board; provided, however, the board may not adopt any rule
11-28 setting ratios with respect to pharmacists and pharmacy technicians
11-29 [supportive personnel] or limiting the number of pharmacy
11-30 technicians [supportive personnel] that may be utilized.
11-31 SECTION 19. Section 35, Texas Pharmacy Act (Article 4542a-1,
11-32 Vernon's Texas Civil Statutes), is amended to read as follows:
11-33 Sec. 35. UNLAWFUL USE OF "PHARMACY." (a) A person may
11-34 not display in or on any store or place of business the word
11-35 "pharmacy," either in English or any other language, any other word
11-36 or combination of words of the same or similar meaning, or any
11-37 graphic representation that would mislead or tend to mislead the
11-38 public unless it is a pharmacy licensed under this Act.
11-39 (b) A person may not advertise any store or place of
11-40 business as a pharmacy or provide pharmacy services unless the
11-41 facility is a pharmacy licensed under this Act.
11-42 SECTION 20. The Texas Pharmacy Act (Article 4542a-1,
11-43 Vernon's Texas Civil Statutes) is amended by adding Section 37A to
11-44 read as follows:
11-45 Sec. 37A. CIVIL PENALTY. (a) A person who violates the
11-46 license requirements of this Act is liable to the state for a civil
11-47 penalty of $1,000 for each day the violation continues.
11-48 (b) The attorney general, district attorney, county
11-49 attorney, or city attorney may sue in a district court of Travis
11-50 County to collect the penalty.
11-51 SECTION 21. Subsection (h), Section 40, Texas Pharmacy Act
11-52 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
11-53 read as follows:
11-54 (h) A pharmacist may dispense a generically equivalent drug
11-55 if the practitioner does not write by hand on the face of his or
11-56 her written prescription the words "brand medically necessary" or
11-57 analogous words. [No written prescription issued by a practitioner,
11-58 as such term is defined in Section 5(39)(A) of this Act, may be
11-59 dispensed unless it is ordered on a form containing two signature
11-60 lines of equal prominence, side by side, at the bottom of the form.
11-61 Under either signature line shall be printed clearly the words
11-62 "product selection permitted," and under the other signature line
11-63 shall be printed clearly the words "dispense as written." The
11-64 practitioner shall communicate dispensing instructions to the
11-65 pharmacist by signing on the appropriate line. If the
11-66 practitioner's signature does not clearly indicate that the
11-67 prescription must be dispensed as written, generically equivalent
11-68 drug selection is permitted. No prescription form furnished a
11-69 practitioner shall contain a preprinted order for a drug product by
12-1 brand name, generic name, or manufacturer.]
12-2 SECTION 22. Subdivisions (10) and (11), Section 483.001,
12-3 Health and Safety Code, are amended to read as follows:
12-4 (10) "Pharmacy" means a facility where prescription
12-5 drug or medication orders are received, processed, dispensed, or
12-6 distributed under this chapter, Chapter 481, and the Texas Pharmacy
12-7 Act (Article 4542a-1, Vernon's Texas Civil Statutes) [licensed by
12-8 the board pursuant to Section 29, Texas Pharmacy Act (Article
12-9 4542a-1, Vernon's Texas Civil Statutes)].
12-10 (11) "Practice of pharmacy" means:
12-11 (A) provision of those acts or services
12-12 necessary to provide pharmaceutical care;
12-13 (B) interpretation and evaluation of
12-14 prescription drug orders or medication orders;
12-15 (C) participation in drug and device selection
12-16 as authorized by law, drug administration, drug regimen review, or
12-17 drug or drug-related research;
12-18 (D) provision of patient counseling; [and]
12-19 (E) responsibility for:
12-20 (i) dispensing of prescription drug orders
12-21 or distribution of medication orders in the patient's best
12-22 interest;
12-23 (ii) compounding and labeling of drugs and
12-24 devices, except labeling by a manufacturer, repackager, or
12-25 distributor of nonprescription drugs and commercially packaged
12-26 prescription drugs and devices;
12-27 (iii) proper and safe storage of drugs and
12-28 devices; and
12-29 (iv) maintenance of proper records for
12-30 drugs and devices. In this subdivision, "device" has the meaning
12-31 assigned by the Texas Pharmacy Act (Article 4542a-1, Vernon's Texas
12-32 Civil Statutes); and
12-33 (F) performance of a specific act of drug
12-34 therapy management for a patient delegated to a pharmacist by a
12-35 written protocol from a physician licensed by the state under the
12-36 Medical Practice Act (Article 4495b, Vernon's Texas Civil
12-37 Statutes).
12-38 SECTION 23. Subsection (b), Section 483.003, Health and
12-39 Safety Code, is amended to read as follows:
12-40 (b) On making that finding, the Texas Board of Health
12-41 [board] may limit the availability of the abused drug by permitting
12-42 its dispensing only on the prescription of a practitioner described
12-43 by Section 483.001(12)(A) or (B).
12-44 SECTION 24. Subsection (e), Section 483.042, Health and
12-45 Safety Code, is amended to read as follows:
12-46 (e) The labeling provisions of Subsection (a) do not apply
12-47 to a dangerous drug prescribed or dispensed for administration to a
12-48 patient who is institutionalized. The board shall adopt rules for
12-49 the labeling of such a drug [food production animals in an
12-50 agricultural operation under a written medical directive or
12-51 treatment guideline from a veterinarian licensed under The
12-52 Veterinary Licensing Act (Article 8890, Revised Statutes) and its
12-53 subsequent amendments].
12-54 SECTION 25. Chapter 107, Acts of the 41st Legislature,
12-55 Regular Session, 1929 (Article 4542a, Vernon's Texas Civil
12-56 Statutes), is repealed.
12-57 SECTION 26. Subsection (b), Section 26A, Texas Pharmacy Act
12-58 (Article 4542a-1, Vernon's Texas Civil Statutes), as amended by
12-59 Section 7, Chapter 789, Acts of the 73rd Legislature, 1993, is
12-60 repealed.
12-61 SECTION 27. This Act takes effect September 1, 1997.
12-62 SECTION 28. (a) This Act applies only to a license issued
12-63 by the Texas State Board of Pharmacy on or after the effective date
12-64 of this Act. A license issued or renewed before that date is
12-65 governed by the law in effect on the date the license was issued or
12-66 renewed, and the former law is continued in effect for that
12-67 purpose.
12-68 (b) Section 37A, Texas Pharmacy Act (Article 4542a-1,
12-69 Vernon's Texas Civil Statutes), as added by this Act, applies only
13-1 to a violation of the licensing requirements of the Texas Pharmacy
13-2 Act (Article 4542a-1, Vernon's Texas Civil Statutes) that occurs on
13-3 or after the effective date of this Act.
13-4 SECTION 29. The importance of this legislation and the
13-5 crowded condition of the calendars in both houses create an
13-6 emergency and an imperative public necessity that the
13-7 constitutional rule requiring bills to be read on three several
13-8 days in each house be suspended, and this rule is hereby suspended.
13-9 * * * * *