1-1 By: Madla S.B. No. 472
1-2 (In the Senate - Filed February 24, 1993; February 25, 1993,
1-3 read first time and referred to Committee on Health and Human
1-4 Services; April 6, 1993, reported adversely, with favorable
1-5 Committee Substitute by the following vote: Yeas 9, Nays 0;
1-6 April 6, 1993, sent to printer.)
1-7 COMMITTEE VOTE
1-8 Yea Nay PNV Absent
1-9 Zaffirini x
1-10 Ellis x
1-11 Madla x
1-12 Moncrief x
1-13 Nelson x
1-14 Patterson x
1-15 Shelley x
1-16 Truan x
1-17 Wentworth x
1-18 COMMITTEE SUBSTITUTE FOR S.B. No. 472 By: Madla
1-19 A BILL TO BE ENTITLED
1-20 AN ACT
1-21 relating to the practice of pharmacy, including the Texas State
1-22 Board of Pharmacy, dangerous drugs, and controlled substances.
1-23 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-24 SECTION 1. Section 5, Texas Pharmacy Act (Article 4542a-1,
1-25 Vernon's Texas Civil Statutes), is amended to read as follows:
1-26 Sec. 5. Definitions. In this Act, unless the context of its
1-27 use clearly indicates otherwise:
1-28 (1) "A.C.P.E." means the American Council on
1-29 Pharmaceutical Education.
1-30 (2) "Administer" means the direct application of a
1-31 prescription drug by injection, inhalation, ingestion, or any other
1-32 means to the body of a patient by:
1-33 (A) a practitioner, <or> an authorized agent
1-34 under his supervision, or other person authorized by law; or
1-35 (B) the patient at the direction of a
1-36 practitioner.
1-37 (3) "Administrative Procedure Act" means the
1-38 Administrative Procedure and Texas Register Act, as amended
1-39 (Article 6252-13a, Vernon's Texas Civil Statutes).
1-40 (4) "Board" means the Texas State Board of Pharmacy.
1-41 (5) "Class A pharmacy license" or "community pharmacy
1-42 license" means a license issued to a pharmacy dispensing drugs or
1-43 devices to the general public pursuant to a prescription drug
1-44 order.
1-45 (6) "Class B pharmacy license" or "nuclear pharmacy
1-46 license" means a license issued to a pharmacy dispensing or
1-47 providing radioactive drugs or devices for administration to an
1-48 ultimate user.
1-49 (7) "Class C pharmacy license" or "institutional
1-50 pharmacy license" means a license issued to a pharmacy located in a
1-51 hospital or other in-patient facility that is licensed under
1-52 Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental
1-53 Health Code (Article 5547-1 et seq., Vernon's Texas Civil
1-54 Statutes), or to a pharmacy located in a hospital maintained or
1-55 operated by the state.
1-56 (8) "Class D pharmacy license" or "clinic pharmacy
1-57 license" means a license issued to a pharmacy dispensing a limited
1-58 type of drugs or devices pursuant to a prescription drug order.
1-59 (9) "Class E pharmacy license" or "nonresident
1-60 pharmacy license" means a license issued under this Act to a
1-61 pharmacy located in a state of the United States other than this
1-62 state whose primary business is to dispense a prescription drug or
1-63 device under a prescription drug order and to deliver the drug or
1-64 device to a patient, including a patient in this state, by the
1-65 United States mail, a common carrier, or a delivery service.
1-66 (10) "College of pharmacy" means a school, university,
1-67 or college of pharmacy that satisfies the accreditation standards
1-68 of A.C.P.E. as adopted by the board; or that has degree
2-1 requirements which meet the standards of accreditation set by the
2-2 board.
2-3 (11) "Compounding" means the preparation, mixing,
2-4 assembling, packaging, or labeling of a drug or device:
2-5 (A) as the result of a practitioner's
2-6 prescription drug order or initiative based on the
2-7 practitioner-patient-pharmacist relationship in the course of
2-8 professional practice;
2-9 (B) in anticipation of prescription drug orders
2-10 based on routine, regularly observed prescribing patterns; or
2-11 (C) for the purpose of or as an incident to
2-12 research, teaching, or chemical analysis and not for sale or
2-13 dispensing.
2-14 (12) "Confidential record" means any health-related
2-15 record maintained by a pharmacy or pharmacist such as a patient
2-16 medication record, prescription drug order, or medication order.
2-17 (13) "Controlled substance" means a drug, immediate
2-18 precursor, or other substance listed in Schedules I-V or Penalty
2-19 Groups 1-4 of Chapter 481, Health and Safety Code, or a drug,
2-20 immediate precursor, or other substance included in Schedule I, II,
2-21 III, IV, or V of the Federal Comprehensive Drug Abuse Prevention
2-22 and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
2-23 (14) <(12)> "Controlled Substances Act" means Chapter
2-24 481, Health and Safety Code, or the Federal Comprehensive Drug
2-25 Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et
2-26 seq.).
2-27 (15) <(13)> "Dangerous drug" means any drug or device
2-28 that is not included in Penalty Groups 1-4 of the Controlled
2-29 Substances Act and that is unsafe for self-medication or any drug
2-30 or device that bears or is required to bear the legend:
2-31 (A) "Caution: federal law prohibits dispensing
2-32 without prescription"; or
2-33 (B) "Caution: federal law restricts this drug
2-34 to use by or on the order of a licensed veterinarian."
2-35 (16) <(14)> "Dangerous Drug Act" means Chapter 483,
2-36 Health and Safety Code.
2-37 (17) <(15)> "Deliver" or "delivery" means the actual,
2-38 constructive, or attempted transfer of a prescription drug or
2-39 device or controlled substance from one person to another, whether
2-40 or not for a consideration.
2-41 (18) <(15)> "Designated agent" means:
2-42 (A) a licensed nurse, physician assistant,
2-43 pharmacist, or other <an> individual <under the supervision of a
2-44 practitioner,> designated by a <the> practitioner, and for whom the
2-45 practitioner assumes legal responsibility, who communicates
2-46 prescription drug orders <the practitioner's instructions> to a
2-47 pharmacist;
2-48 (B) a licensed nurse, physician assistant, or
2-49 pharmacist employed in a health care facility to whom the
2-50 practitioner communicates a prescription drug order; or
2-51 (C) a registered nurse or physician assistant
2-52 authorized by a practitioner to carry out a prescription drug order
2-53 for dangerous drugs under Subdivision (5), Subsection (d), Section
2-54 3.06, Medical Practice Act (Article 4495b, Vernon's Texas Civil
2-55 Statutes).
2-56 (19) <(16)> "Device" means an instrument, apparatus,
2-57 implement, machine, contrivance, implant, in vitro reagent, or
2-58 other similar or related article, including any component part or
2-59 accessory, that is required under federal or state law to be
2-60 ordered or prescribed by a practitioner.
2-61 (20) <(17)> "Dispense" means preparing, packaging,
2-62 compounding, or labeling for delivery a prescription drug or device
2-63 in the course of professional practice to an ultimate user or his
2-64 agent by or pursuant to the lawful order of a practitioner.
2-65 (21) <(18)> "Distribute" means the delivery of a
2-66 prescription drug or device other than by administering or
2-67 dispensing.
2-68 (22) <(19)> "Drug" means:
2-69 (A) a substance recognized as drugs in the
2-70 current official United States Pharmacopoeia, official National
3-1 Formulary, official Homeopathic Pharmacopoeia, or other drug
3-2 compendium or any supplement to any of them;
3-3 (B) a substance intended for use in the
3-4 diagnosis, cure, mitigation, treatment, or prevention of disease in
3-5 man or other animals;
3-6 (C) a substance, other than food, intended to
3-7 affect the structure or any function of the body of man or other
3-8 animals;
3-9 (D) a substance intended for use as a component
3-10 of any articles specified in Paragraph (A), (B), or (C) of this
3-11 subdivision;
3-12 (E) a dangerous drug; or
3-13 (F) a controlled substance.
3-14 (23) "Drug regimen review" includes the following
3-15 activities:
3-16 (A) evaluation of the prescription drug or
3-17 medication orders and patient medication records for:
3-18 (i) known allergies;
3-19 (ii) rational therapy-contraindications;
3-20 (iii) reasonable dose and route of
3-21 administration; and
3-22 (iv) reasonable directions for use;
3-23 (B) evaluation of the prescription drug or
3-24 medication orders and patient medication records for duplication of
3-25 therapy;
3-26 (C) evaluation of the prescription drug or
3-27 medication orders and patient medication records for:
3-28 (i) drug-drug interactions;
3-29 (ii) drug-food interactions;
3-30 (iii) drug-disease interactions;
3-31 (iv) adverse drug reactions; and
3-32 (D) evaluation of prescription drug and
3-33 medication orders and patient medication records for proper
3-34 utilization, including overutilization or underutilization.
3-35 (24) <(20)> "Internship" means a practical experience
3-36 program that is approved by the board.
3-37 (25) <(21)> "Label" means written, printed, or graphic
3-38 matter on the immediate container of a drug or device.
3-39 (26) <(22)> "Labeling" means the process of affixing a
3-40 label including all information required by federal and state law
3-41 or regulation to any drug or device container. The term does not
3-42 include the labeling by a manufacturer, packer, or distributor of a
3-43 nonprescription drug or commercially packaged prescription drug or
3-44 device, or unit dose packaging.
3-45 (27) "Manufacturing" means the production,
3-46 preparation, propagation, conversion, or processing of a drug or
3-47 device, either directly or indirectly, by extraction from
3-48 substances of natural origin or independently by means of chemical
3-49 or biological synthesis and includes any packaging or repackaging
3-50 of the substances or labeling or relabeling of the container and
3-51 the promotion and marketing of such drugs or devices.
3-52 Manufacturing also includes the preparation and promotion of
3-53 commercially available products from bulk compounds for resale by
3-54 pharmacies, practitioners, or other persons but does not include
3-55 compounding.
3-56 (28) <(23)> "Medication order" means an order from a
3-57 practitioner or a practitioner's designated agent for
3-58 administration of a drug or device.
3-59 (29) <(24)> "Nonprescription drug" means a nonnarcotic
3-60 drug or device that may be sold without a prescription and that is
3-61 labeled and packaged in compliance with applicable state or federal
3-62 law.
3-63 (30) "Patient counseling" means the communication by
3-64 the pharmacist of information, as specified in the rules of the
3-65 board, to the patient or caregiver, in order to improve therapy by
3-66 ensuring proper use of drugs and devices.
3-67 (31) <(25)> "Person" means an individual, corporation,
3-68 government or governmental subdivision or agency, business trust,
3-69 estate, trust, partnership, association, or any other legal entity.
3-70 (32) "Pharmaceutical care" is the provision of drug
4-1 therapy and other pharmaceutical services defined in the rules of
4-2 the board and intended to assist in the cure or prevention of a
4-3 disease, elimination or reduction of a patient's symptoms, or
4-4 arresting or slowing of a disease process.
4-5 (33) <(26)> "Pharmacist" means a person licensed by
4-6 the board to practice pharmacy.
4-7 (34) <(27)> "Pharmacist-in-charge" means the
4-8 pharmacist designated on a pharmacy license as the pharmacist who
4-9 has the authority or responsibility for a pharmacy's compliance
4-10 with laws and rules pertaining to the practice of pharmacy.
4-11 (35) <(28)> "Pharmacist-intern" means an undergraduate
4-12 student enrolled in the professional sequence of a college of
4-13 pharmacy approved by the board and participating in a school-based,
4-14 board-approved internship program or a graduate of a college of
4-15 pharmacy who is participating in a board-approved internship.
4-16 (36) <(29)> "Pharmacy" means a facility licensed by
4-17 the board pursuant to Section 29 of this Act <where the practice of
4-18 pharmacy occurs>.
4-19 (37) <(30)> "Practice of pharmacy" means:
4-20 (A) provision of those acts or services
4-21 necessary to provide pharmaceutical care;
4-22 (B) interpretation and evaluation of
4-23 prescription drug orders or medication orders;
4-24 (C) participation in drug and device selection
4-25 as authorized by law, drug administration, drug regimen review, or
4-26 drug or drug-related research;
4-27 (D) provision of patient counseling; and
4-28 (E) responsibility for:
4-29 (i) dispensing of prescription drug orders
4-30 or distribution of medication orders;
4-31 (ii) compounding and labeling of drugs and
4-32 devices, except labeling by a manufacturer, repackager, or
4-33 distributor of nonprescription drugs and commercially packaged
4-34 prescription drugs and devices;
4-35 (iii) proper and safe storage of drugs and
4-36 devices; or
4-37 (iv) maintenance of proper records for
4-38 drugs and devices <interpreting and evaluating prescription or
4-39 medication orders, dispensing and labeling drugs or devices,
4-40 selecting drugs and reviewing drug utilization, storing
4-41 prescription drugs and devices and maintaining prescription drug
4-42 records in a pharmacy, advising or consulting when necessary or
4-43 required by law about therapeutic value, content, hazard, or use of
4-44 drugs or devices, or offering or performing the services and
4-45 transactions necessary to operate a pharmacy>.
4-46 (38) <(31)> "Practitioner" means:
4-47 (A) a physician, dentist, podiatrist,
4-48 veterinarian, or other person licensed or registered to prescribe,
4-49 distribute, administer, or dispense a prescription drug or device
4-50 in the course of professional practice in this state;
4-51 (B) a person licensed by another state in a
4-52 health field in which, under Texas law, licensees in this state may
4-53 legally prescribe dangerous drugs or a person practicing in another
4-54 state and licensed by another state as a physician, dentist,
4-55 veterinarian, or podiatrist, having a current Federal Drug
4-56 Enforcement Administration registration number, and who may legally
4-57 prescribe Schedule II, III, IV, or V controlled substances in such
4-58 other state; or
4-59 (C) a person licensed in the Dominion of Canada
4-60 or the United Mexican States in a health field in which, under the
4-61 laws of this state, a licensee may legally prescribe dangerous
4-62 drugs. "Practitioner" does not include a person licensed under
4-63 this Act.
4-64 (39) <(32)> "Preceptor" means a pharmacist in good
4-65 standing licensed in this state to practice pharmacy and certified
4-66 by the board to supervise and be responsible for the activities and
4-67 functions of a pharmacist-intern in the internship program.
4-68 (40) <(33)> "Prescription drug" means:
4-69 (A) a substance for which federal or state law
4-70 requires a prescription before it may be legally dispensed to the
5-1 public;
5-2 (B) a drug or device that under federal law is
5-3 required, prior to being dispensed or delivered, to be labeled with
5-4 either of the following statements:
5-5 (i) "Caution: federal law prohibits
5-6 dispensing without prescription"; or
5-7 (ii) "Caution: federal law restricts this
5-8 drug to use by or on the order of a licensed veterinarian"; or
5-9 (C) a drug or device that is required by any
5-10 applicable federal or state law or regulation to be dispensed on
5-11 prescription only or is restricted to use by a practitioner only.
5-12 (41) <(34)> "Prescription drug order" means:
5-13 (A) an order from a practitioner or a
5-14 practitioner's designated agent to a pharmacist for a drug or
5-15 device to be dispensed; or
5-16 (B) an order pursuant to Subdivision (5),
5-17 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
5-18 Vernon's Texas Civil Statutes).
5-19 (42) "Prospective drug use review" means a review of
5-20 the patient's drug therapy and prescription drug order or
5-21 medication order, as defined in the rules of the board, prior to
5-22 dispensing or distributing the drug.
5-23 (43) <(35)> "Provide" means to supply one or more unit
5-24 doses of a nonprescription drug or dangerous drug to a patient.
5-25 (44) <(36)> "Radioactive drug" means a drug that
5-26 exhibits spontaneous disintegration of unstable nuclei with the
5-27 emission of nuclear particles or photons, including any
5-28 nonradioactive reagent kit or nuclide generator that is intended to
5-29 be used in the preparation of any such substance.
5-30 (45) <(37)> "Substitution" means the dispensing of a
5-31 drug or a brand of drug other than that which is ordered or
5-32 prescribed.
5-33 (46) <(38)> "Supportive personnel" means those
5-34 individuals utilized in pharmacies whose responsibility it shall be
5-35 to provide <nonjudgmental> technical services that do not require
5-36 professional judgment concerned with the preparation and
5-37 distribution of drugs under the direct supervision of and
5-38 responsible to a pharmacist.
5-39 (47) <(39)> "Ultimate user" means a person who has
5-40 obtained and possesses a prescription drug or device for the
5-41 person's own use or for the use of a member of the person's
5-42 household or for administering to an animal owned by the person or
5-43 by a member of the person's household.
5-44 (48) <(40)> "Unit dose packaging" means the ordered
5-45 amount of drug in a dosage form ready for administration to a
5-46 particular patient, by the prescribed route at the prescribed time,
5-47 and properly labeled with name, strength, and expiration date of
5-48 the drug.
5-49 <(41) "Authorized agent" means an individual under the
5-50 supervision of a practitioner, designated by the practitioner, and
5-51 for whom the practitioner assumes legal responsibility, who
5-52 communicates the practitioner's instructions to the pharmacist.>
5-53 SECTION 2. Section 16, Texas Pharmacy Act (Article 4542a-1,
5-54 Vernon's Texas Civil Statutes), is amended to read as follows:
5-55 Sec. 16. Rules. (a) The board shall adopt, amend, and
5-56 repeal rules for the proper administration and enforcement of this
5-57 Act, consistent with this Act. The rules shall be adopted,
5-58 amended, or repealed in accordance with the Administrative
5-59 Procedure Act.
5-60 (b) If the board determines it necessary in order to
5-61 protect the health and welfare of the citizens of this state, it
5-62 may make a rule concerning the operation of a licensed pharmacy
5-63 located in this state also applicable to pharmacies licensed by the
5-64 board that are located in another state.
5-65 (c) The board may not adopt rules restricting
5-66 competitive bidding or advertising by a person regulated by the
5-67 board except to prohibit false, misleading, or deceptive practices
5-68 by the person.
5-69 SECTION 3. Subsections (a), (b) and (q), Section 17, Texas
5-70 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
6-1 amended to read as follows:
6-2 (a) The board is responsible for the regulation of the
6-3 practice of pharmacy in this state, including the following:
6-4 (1) the licensing by examination or by reciprocity of
6-5 applicants who are qualified to engage in the practice of pharmacy
6-6 and the licensing of pharmacies under this Act;
6-7 (2) the renewal of licenses to engage in the practice
6-8 of pharmacy and licenses to operate pharmacies;
6-9 (3) the determination and issuance of standards for
6-10 recognition and approval of degree requirements of colleges of
6-11 pharmacy whose graduates shall be eligible for licensing in this
6-12 state and the specification and enforcement of requirements for
6-13 practical training, including internship;
6-14 (4) the enforcement of those provisions of this Act
6-15 relating to the conduct or competence of pharmacists practicing in
6-16 this state and the conduct of pharmacies operating in this state
6-17 and the suspension, revocation, fining, reprimanding, cancellation,
6-18 or restriction of licenses to engage in the practice of pharmacy or
6-19 to operate a pharmacy;
6-20 (5) the determination of conditions under which a
6-21 pharmacist may administer drugs and the training or education
6-22 necessary for a pharmacist to administer drugs; the conditions
6-23 shall be adopted by rule of the board based upon the advice of a
6-24 five-member technical advisory committee to be appointed as
6-25 follows:
6-26 (A) one practicing hospital pharmacist appointed
6-27 by the board;
6-28 (B) one practicing home health pharmacist
6-29 appointed by the board;
6-30 (C) one practicing community pharmacist
6-31 appointed by the board; and
6-32 (D) two practicing registered nurses appointed
6-33 by the Board of Nurse Examiners;
6-34 (6) the regulation of the training, qualifications,
6-35 and employment of pharmacist-interns; and
6-36 (7) <(6)> the enforcement of this Act and any rules
6-37 adopted under this Act.
6-38 (b) The board has the following responsibilities relating to
6-39 the practice of pharmacy and to prescription drugs and devices used
6-40 in this state in the diagnosis, mitigation, and treatment or
6-41 prevention of injury, illness, and disease:
6-42 (1) regulation of the delivery or distribution of
6-43 prescription drugs and devices, including the right to seize, after
6-44 notice and hearing, any prescription drugs or devices posing a
6-45 hazard to the public health and welfare, but the board may not
6-46 regulate:
6-47 (A) manufacturers' representatives or employees
6-48 acting in the normal course of business;
6-49 (B) persons engaged in the wholesale drug
6-50 business and registered with the commissioner of health as provided
6-51 by Chapter 431, Health and Safety Code; or
6-52 (C) employees of persons engaged in the
6-53 wholesale drug business and registered with the commissioner of
6-54 health as provided by Chapter 431, Health and Safety Code, if the
6-55 employees are acting in the normal course of business;
6-56 (2) specification of minimum standards for
6-57 professional environment, technical equipment, and security in the
6-58 prescription dispensing area;
6-59 (3) specification of minimum standards for drug
6-60 storage, maintenance of prescription drug records, and procedures
6-61 for the delivery, dispensing in a suitable container appropriately
6-62 labeled, <or> providing of prescription drugs or devices,
6-63 monitoring of drug therapy, and counseling of patients on proper
6-64 use of prescription drugs and devices within the practice of
6-65 pharmacy; and
6-66 (4) adoption of rules regulating a prescription drug
6-67 order or medication order transmitted by electronic means <a
6-68 facsimile or FAX machine>.
6-69 (q) Board investigative files and all information and
6-70 materials compiled by the board in connection with an investigation
7-1 are confidential and are not subject to disclosure under
7-2 <considered open records for purposes of> Chapter 424, Acts of the
7-3 63rd Legislature, Regular Session, 1973, as amended (Article
7-4 6252-17a, Vernon's Texas Civil Statutes), and are not subject to
7-5 disclosure, discovery, subpoena, or other means of legal compulsion
7-6 for their release to anyone other than the board or its employees
7-7 or agents involved in licensee discipline except that this
7-8 information may be disclosed to:
7-9 (1) persons involved with the board in a disciplinary
7-10 action against the licensee;
7-11 (2) pharmacist or pharmacy licensing or disciplinary
7-12 authorities of other jurisdictions;
7-13 (3) a pharmaceutical peer review committee as outlined
7-14 in Section 27A of this Act;
7-15 (4) law enforcement agencies; and
7-16 (5) persons engaged in bona fide research, if all
7-17 individual-identifying information has been deleted.
7-18 SECTION 4. Subsection (c), Section 21, Texas Pharmacy Act
7-19 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
7-20 read as follows:
7-21 (c) The examinations for licensing required under this
7-22 section shall be given by the board at least two times during the
7-23 fiscal year of the state. The board shall determine the content
7-24 and subject matter of each examination and determine which persons
7-25 have successfully passed the examination. An applicant who fails
7-26 the examination may retake the examination two additional times.
7-27 Before an applicant who has failed the examination three times is
7-28 allowed to retake the examination, the applicant shall provide
7-29 documentation from a college of pharmacy that additional college
7-30 course work in subject areas the applicant failed in the
7-31 examination has been successfully completed. If a person who fails
7-32 the licensing examination administered under this Act so requests
7-33 in writing, the board shall furnish the person an analysis of his
7-34 performance on the examination.
7-35 SECTION 5. Subsection (a), Section 26, Texas Pharmacy Act
7-36 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
7-37 read as follows:
7-38 (a) Grounds for Disciplining a Holder of a Pharmacist
7-39 License: The board shall refuse to issue a pharmacist license for
7-40 failure to meet the requirements of Section 21 or 22 of this Act.
7-41 The board may in its discretion refuse to issue or renew a license
7-42 or may fine, reprimand, revoke, restrict, cancel, retire, or
7-43 suspend any license granted by the board<,> and may probate any
7-44 license suspension if the board finds that the applicant or
7-45 licensee has:
7-46 (1) violated any provision of this Act or any of the
7-47 rules of the board adopted under this Act;
7-48 (2) engaged in unprofessional conduct as that term is
7-49 defined by the rules of the board;
7-50 (3) engaged in gross immorality as that term is
7-51 defined by the rules of the board;
7-52 (4) developed an incapacity of a nature that prevents
7-53 a pharmacist or applicant from engaging in the practice of pharmacy
7-54 with reasonable skill, competence, and safety to the public. In
7-55 enforcing this subdivision, the board shall, on probable cause,
7-56 request a pharmacist or applicant to submit to a mental or physical
7-57 examination by physicians or other health care professionals
7-58 designated by the board. If the pharmacist or applicant refuses to
7-59 submit to the examination, the board shall issue an order requiring
7-60 the pharmacist or applicant to show cause why he will not submit to
7-61 the examination and shall schedule a hearing on the order within 30
7-62 days after notice is served on the pharmacist or applicant. The
7-63 pharmacist or applicant shall be notified by either personal
7-64 service or certified mail with return receipt requested. At the
7-65 hearing, the pharmacist or applicant and his attorney are entitled
7-66 to present any testimony and other evidence to show why the
7-67 pharmacist or applicant should not be required to submit to the
7-68 examination. After the hearing, the board shall issue an order
7-69 either requiring the pharmacist or applicant to submit to the
7-70 examination or withdrawing the request for examination;
8-1 (5) engaged in any fraud, deceit, or misrepresentation
8-2 as those words are defined by the rules of the board in the
8-3 practice of pharmacy or in seeking a license to act as a
8-4 pharmacist;
8-5 (6) been convicted of a felony or a misdemeanor
8-6 involving moral turpitude by a court of competent jurisdiction;
8-7 (7) a drug or alcohol dependency;
8-8 (8) failed to keep and maintain records required by
8-9 this Act or failed to keep and maintain complete and accurate
8-10 records of purchases and disposals of drugs listed in the
8-11 Controlled Substances Act or the Dangerous Drug Act;
8-12 (9) violated any provision of the Controlled
8-13 Substances Act or Dangerous Drug Act or a rule relating to those
8-14 acts or any provision of Sections 485.031-485.035, Health and
8-15 Safety Code, or a rule adopted under Section 485.011, Health and
8-16 Safety Code;
8-17 (10) aided or abetted an unlicensed individual to
8-18 engage in the practice of pharmacy if the pharmacist knew or
8-19 reasonably should have known that the individual was unlicensed at
8-20 the time;
8-21 (11) refused an entry into any pharmacy for any
8-22 inspection authorized by this Act if the pharmacist had received
8-23 notification from which the pharmacist knew or reasonably should
8-24 have known that the attempted inspection was authorized;
8-25 (12) violated the pharmacy or drug laws or rules of
8-26 this state or any other state or of the United States;
8-27 (13) been negligent in the practice of pharmacy;
8-28 (14) failed to submit to an examination after hearing
8-29 and being ordered to do so by the board pursuant to Subdivision (4)
8-30 of this subsection;
8-31 (15) dispensed prescription drugs while acting outside
8-32 the usual course and scope of professional practice; or
8-33 (16) had a license to practice pharmacy issued by
8-34 another state canceled, revoked, surrendered, or suspended for
8-35 conduct substantially equivalent to conduct described in
8-36 Subdivisions (1) through (15) of this subsection. A certified copy
8-37 of the record of the state taking action as set out above shall be
8-38 conclusive evidence of the action taken by such state.
8-39 SECTION 6. Subsections (a) and (b), Section 26A, Texas
8-40 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
8-41 amended to read as follows:
8-42 (a) On the entry of an initial order against an applicant
8-43 for a license to practice pharmacy or a person licensed by the
8-44 board to practice pharmacy, the board may refuse to issue a license
8-45 to the applicant or suspend the person's license. On the person's
8-46 final conviction, the board may revoke the person's license.
8-47 (b) On the entry of an initial order against an applicant
8-48 for a license for a pharmacy or a person who has been issued a
8-49 license or renewal license for a pharmacy under this Act, or
8-50 against a managing officer of the licensee or applicant if the
8-51 licensee or applicant is an association, joint-stock company,
8-52 partnership, or corporation, the board may refuse to issue the
8-53 license or suspend the license. On final conviction, the board may
8-54 revoke the license.
8-55 SECTION 7. Subsection (a), Section 26B, Texas Pharmacy Act
8-56 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
8-57 read as follows:
8-58 (a) The board may in its discretion refuse to issue or renew
8-59 a license or may fine or reprimand any licensee or revoke,
8-60 restrict, cancel, or suspend any license granted by the board, if
8-61 the board finds that an applicant or licensee has:
8-62 (1) dispensed a drug, quantity, or strength of drug
8-63 other than that which is ordered for the patient by a practitioner
8-64 or labeled a prescription with incorrect directions for use;
8-65 (2) violated any of the following provisions of this
8-66 Act:
8-67 (A) Section 29(a), (b)(5), or (c)(5);
8-68 (B) Section 30(i) or (j); or
8-69 (C) Section 32(a);
8-70 (3) failed to comply with the following requirements
9-1 unless compliance would violate the pharmacy or drug laws or rules
9-2 in the state in which the pharmacy is located:
9-3 (A) Section 481.074 or 481.075, Health and
9-4 Safety Code;
9-5 (B) Texas substitution requirements regarding:
9-6 (i) the practitioner's directions relative
9-7 to generic substitution;
9-8 (ii) the patient's right to refuse generic
9-9 substitution; or
9-10 (iii) notification to the patient of the
9-11 patient's right to refuse substitution; <or>
9-12 (C) board rules relating to the provision of
9-13 drug information to the patient or patient's agent in written form
9-14 or by telephone; or
9-15 (D) board rules adopted pursuant to Section
9-16 16(a) of this Act and determined by the board to be applicable
9-17 pursuant to Section 16(b) of this Act; or
9-18 (4) engaged in conduct which caused serious bodily
9-19 injury to a Texas resident.
9-20 SECTION 8. Section 27A, Texas Pharmacy Act (Article 4542a-1,
9-21 Vernon's Texas Civil Statutes), is amended by amending Subsection
9-22 (d) and adding Subsection (j) to read as follows:
9-23 (d) The records and proceedings of the board, its authorized
9-24 agents, or any pharmaceutical organization committee as set out in
9-25 Subsections (a) and (b) of this section shall be confidential and
9-26 are not considered open records for the purposes of Chapter 424,
9-27 Acts of the 63rd Legislature, Regular Session, 1973, as amended
9-28 (Article 6252-17a, Vernon's Texas Civil Statutes); provided,
9-29 however, the board may disclose this confidential information only:
9-30 (1) in a disciplinary hearing before the board or in a
9-31 subsequent trial or appeal of a board action or order;
9-32 (2) to the pharmacist licensing or disciplinary
9-33 authorities of other jurisdictions; <or>
9-34 (3) pursuant to an order of a court of competent
9-35 jurisdiction; or
9-36 (4) pursuant to Subsection (j) of this section.
9-37 (j) The board may disclose that the license of a pharmacist
9-38 who is the subject of an order of the board deemed confidential by
9-39 Subsection (d) of this section is suspended, revoked, canceled,
9-40 restricted, or retired or that the pharmacist is in any manner
9-41 otherwise limited in the practice of pharmacy; however, the board
9-42 may not disclose the nature of the impairment or other information
9-43 that resulted in such action.
9-44 SECTION 9. Subsection (b), Section 28, Texas Pharmacy Act
9-45 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
9-46 read as follows:
9-47 (b) A person whose pharmacy license or license to practice
9-48 pharmacy in this state has been canceled, revoked, or restricted
9-49 under this Act, whether voluntarily or by action of the board, may,
9-50 after 12 months from the effective date of the cancellation,
9-51 revocation, or restriction, petition the board for reinstatement or
9-52 removal of the restriction of the license. The petition shall be
9-53 in writing and in the form prescribed by the board. On
9-54 investigation and review of the petition <hearing>, the board may
9-55 in its discretion grant or deny the petition or it may modify its
9-56 original finding to reflect any circumstances that have changed
9-57 sufficiently to warrant the modification. If such petition is
9-58 denied by the board, a subsequent petition may not be considered by
9-59 the board until 12 months from the date of denial of the previous
9-60 petition. The board in its discretion may require such person to
9-61 pass an examination or examinations for reentry into the practice
9-62 of pharmacy.
9-63 SECTION 10. Subsection (a), Section 32, Texas Pharmacy Act
9-64 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
9-65 read as follows:
9-66 (a) A pharmacy shall report in writing to the board not
9-67 later than the 10th day after the date of the occurrence, unless
9-68 immediate notification is required by this section, any of the
9-69 following:
9-70 (1) permanent closing;
10-1 (2) change of ownership;
10-2 (3) change of location;
10-3 (4) change of pharmacist-in-charge;
10-4 (5) the theft or significant loss of any controlled
10-5 substances, immediately on discovery of the theft or loss, by
10-6 including with the notification to the board of the theft or loss a
10-7 list of all controlled substances stolen or lost;
10-8 (6) the sale or transfer of controlled substances or
10-9 dangerous drugs on the permanent closing or change of ownership of
10-10 the pharmacy;
10-11 (7) any matters and occurrences that the board may
10-12 require by rule;
10-13 (8) out-of-state purchases of controlled substances as
10-14 determined by the board; <and>
10-15 (9) a disaster, accident, or emergency that may affect
10-16 the strength, purity, or labeling of a drug, medication, device, or
10-17 other material used in the diagnosis or the treatment of injury,
10-18 illness, and disease, immediately on the occurrence of the
10-19 disaster, accident, or emergency;
10-20 (10) <. (9)> a final order against the holder of a
10-21 Class E pharmacy license by the regulatory or licensing agency of
10-22 the state in which the pharmacy is located; and
10-23 (11) <(10)> a final order against a pharmacist who is
10-24 designated as the pharmacist-in-charge of a Class E pharmacy by the
10-25 regulatory or licensing agency of the state in which the pharmacy
10-26 is located.
10-27 SECTION 11. Section 40, Texas Pharmacy Act (Article 4542a-1,
10-28 Vernon's Texas Civil Statutes), is amended by amending Subsections
10-29 (d) through (k) to read as follows:
10-30 (d) With the patient's consent and notification to the
10-31 practitioner, a pharmacist may dispense a dosage form of a drug
10-32 product different from that prescribed, such as tablet instead of
10-33 capsule or liquid instead of tablet, provided the dosage form so
10-34 dispensed:
10-35 (1) contains the identical amount of the active
10-36 ingredients as the dosage prescribed for the patient;
10-37 (2) is not an enteric coated or time release product;
10-38 and
10-39 (3) does not alter desired clinical outcomes.
10-40 (e) Unless otherwise directed by the practitioner, the label
10-41 on the dispensing container shall indicate the actual drug product
10-42 dispensed, either (1) the brand name, or if none (2) the generic
10-43 name, the strength, and the name of the manufacturer or
10-44 distributor. In instances where a drug product has been selected
10-45 other than the one prescribed, the pharmacist shall place on the
10-46 container the words "Substituted for brand prescribed" or
10-47 "Substituted for 'brand name'" where "brand name" is the actual
10-48 name of the brand name drug product prescribed.<" The brand name
10-49 of the prescribed drug shall not appear on the prescription
10-50 container label unless it is the drug product actually dispensed.>
10-51 (f) <(e)> A pharmacist may not select a generically
10-52 equivalent drug unless the generically equivalent drug selected
10-53 costs the patient less than the prescribed drug product. A
10-54 pharmacist may not charge a higher professional fee for dispensing
10-55 a generically equivalent drug product than the fee he or she
10-56 customarily charges for dispensing the brand name product
10-57 prescribed.
10-58 (g)(1) <(f)> A pharmacist who selects a generically
10-59 equivalent drug product as authorized by this section shall:
10-60 (A) <(1)> personally, or through his or her
10-61 agent or employee and prior to delivery of a generically equivalent
10-62 drug product, inform the patient or the patient's agent that a less
10-63 expensive generically equivalent drug product has been substituted
10-64 for the brand prescribed and the patient or patient's agent's right
10-65 to refuse such substitution; or
10-66 (B) <(2)> cause to be displayed, in a prominent
10-67 place that is in clear public view where prescription drugs are
10-68 dispensed, a sign in block letters not less than one inch in height
10-69 that reads, in both English and Spanish:
10-70 "TEXAS LAW ALLOWS A LESS EXPENSIVE GENERICALLY
11-1 EQUIVALENT DRUG TO BE SUBSTITUTED FOR CERTAIN BRAND
11-2 NAME DRUGS UNLESS YOUR PHYSICIAN DIRECTS OTHERWISE.
11-3 YOU HAVE A RIGHT TO REFUSE SUCH SUBSTITUTION. CONSULT
11-4 YOUR PHYSICIAN OR PHARMACIST CONCERNING THE
11-5 AVAILABILITY OF A SAFE, LESS EXPENSIVE DRUG FOR YOUR
11-6 USE."
11-7 Only one sign displayed in a pharmacy, as required above,
11-8 shall be deemed compliance with this subsection.
11-9 (2) <(3)> A pharmacist complies with the requirements
11-10 of this section if an employee or agent of the pharmacist notifies
11-11 a purchaser as required by Paragraph (A) of Subdivision (1) of this
11-12 subsection. The patient or patient's agent shall have the right to
11-13 refuse such product selection.
11-14 (h) <(g)> No written prescription issued by a practitioner,
11-15 as such term is defined in Section 5(30)(A) of this Act, may be
11-16 dispensed unless it is ordered on a form containing two signature
11-17 lines of equal prominence, side by side, at the bottom of the form.
11-18 Under either signature line shall be printed clearly the words
11-19 "product selection permitted," and under the other signature line
11-20 shall be printed clearly the words "dispense as written." The
11-21 practitioner shall communicate dispensing instructions to the
11-22 pharmacist by signing on the appropriate line. If the
11-23 practitioner's signature does not clearly indicate that the
11-24 prescription must be dispensed as written, generically equivalent
11-25 drug selection is permitted. No prescription form furnished a
11-26 practitioner shall contain a preprinted order for a drug product by
11-27 brand name, generic name, or manufacturer.
11-28 (i) <(h)> If a prescription is transmitted to a pharmacist
11-29 orally, the pharmacist shall note any dispensing instructions by
11-30 the practitioner or the practitioner's agent on the file copy of
11-31 the prescription and retain the prescription for the period of time
11-32 specified by law. Properly authorized prescription refills shall
11-33 follow the original dispensing instructions unless otherwise
11-34 indicated by the practitioner or practitioner's agent.
11-35 (j) <(i)> A pharmacist shall record on the prescription form
11-36 the name, strength, and manufacturer or distributor of any drug
11-37 product dispensed as herein authorized.
11-38 (k) <(j)> A pharmacist who selects a generically equivalent
11-39 drug to be dispensed pursuant to this section assumes the same
11-40 responsibility for selecting the generically equivalent drug that
11-41 he does in filling a prescription for a drug product prescribed by
11-42 generic name. There shall be no liability on the prescriber for an
11-43 act or omission by a pharmacist in selecting, preparing, or
11-44 dispensing a drug product pursuant to this section.
11-45 (l) <(k)> Drug product selection as authorized in this
11-46 section shall not apply to enteric-coated tablets; controlled
11-47 release products; injectable suspensions, other than antibiotics;
11-48 suppositories containing active ingredients for which systemic
11-49 absorption is necessary for therapeutic activity; and different
11-50 delivery systems for aerosol or nebulizer drugs. This subsection
11-51 shall not apply to any drug product which is determined to be
11-52 generically equivalent to the brand prescribed.
11-53 SECTION 12. The Texas Pharmacy Act (Article 4542a-1,
11-54 Vernon's Texas Civil Statutes) is amended by adding Sections 40B
11-55 and 40C to read as follows:
11-56 Sec. 40B. EMERGENCY REFILLS. A pharmacist may exercise his
11-57 professional judgment in refilling a prescription for a
11-58 prescription drug, other than a controlled substance listed in
11-59 Schedule II, without the authorization of the prescribing
11-60 practitioner, provided:
11-61 (1) failure to refill the prescription might result in
11-62 an interruption of a therapeutic regimen or create patient
11-63 suffering;
11-64 (2) either:
11-65 (A) a natural or manmade disaster has occurred
11-66 which prohibits the pharmacist from being able to contact the
11-67 practitioner; or
11-68 (B) the pharmacist is unable to contact the
11-69 practitioner after reasonable effort;
11-70 (3) the quantity of prescription drug dispensed does
12-1 not exceed a 72-hour supply;
12-2 (4) the pharmacist informs the patient or the
12-3 patient's agent at the time of dispensing that the refill is being
12-4 provided without such authorization and that authorization of the
12-5 practitioner is required for future refills; and
12-6 (5) the pharmacist informs the practitioner of the
12-7 emergency refill at the earliest reasonable time.
12-8 Sec. 40C. RELEASE OF CONFIDENTIAL RECORDS. Confidential
12-9 records are privileged and may be released only to:
12-10 (1) the patient or the patient's agent;
12-11 (2) practitioners and other pharmacists when, in the
12-12 pharmacist's professional judgment, such release is necessary to
12-13 protect the patient's health and well-being;
12-14 (3) other persons, the board, or other state or
12-15 federal agencies authorized by law to receive such confidential
12-16 records;
12-17 (4) a law enforcement agency engaged in investigation
12-18 of suspected violations of the Controlled Substances Act or the
12-19 Dangerous Drug Act;
12-20 (5) a person employed by any state agency which
12-21 licenses a practitioner as defined in this Act if such person is
12-22 engaged in the performance of the person's official duties; or
12-23 (6) an insurance carrier or other third party payor
12-24 authorized by a patient to receive such information.
12-25 SECTION 13. Subdivision (41), Section 481.002, Health and
12-26 Safety Code, is amended to read as follows:
12-27 (41) "Prescription" means an order by a practitioner
12-28 to a pharmacist for a controlled substance for a particular patient
12-29 that specifies:
12-30 (A) the date of issue;
12-31 (B) the name and address of the patient or, if
12-32 the controlled substance is prescribed for an animal, the species
12-33 of the animal and the name and address of its owner;
12-34 (C) the name and quantity of the controlled
12-35 substance prescribed with the quantity shown numerically followed
12-36 by the number written as a word if the order is written or, if the
12-37 order is communicated orally or telephonically, with the quantity
12-38 given by the practitioner and transcribed by the pharmacist
12-39 numerically; <and>
12-40 (D) directions for the use of the drug;
12-41 (E) the intended use of the controlled substance
12-42 or the diagnosis for which the controlled substance is prescribed;
12-43 and
12-44 (F) the name, address, Federal Drug Enforcement
12-45 Administration registration number, and telephone number of the
12-46 practitioner at the practitioner's usual place of business, legibly
12-47 printed or stamped.
12-48 SECTION 14. Section 481.074, Health and Safety Code, is
12-49 amended by amending Subsections (d) through (i) and adding
12-50 Subsection (l) to read as follows:
12-51 (d) Except as specified in Subsections (e) and (f) of this
12-52 section, a <A> person may not fill a prescription for a controlled
12-53 substance listed in Schedule II after the end of the seventh day
12-54 after the date on which the prescription is issued. A person may
12-55 not refill a prescription for a substance listed in Schedule II.
12-56 (e) The partial filling of a prescription for a controlled
12-57 substance listed in Schedule II is permissible, if the pharmacist
12-58 is unable to supply the full quantity called for in a written or
12-59 emergency oral prescription and the pharmacist makes a notation of
12-60 the quantity supplied on the face of the written prescription or
12-61 written record of the emergency oral prescription. The remaining
12-62 portion of the prescription may be filled within 72 hours of the
12-63 first partial filling; however, if the remaining portion is not or
12-64 cannot be filled within the 72-hour period, the pharmacist shall so
12-65 notify the prescribing individual practitioner. No further
12-66 quantity may be supplied beyond 72 hours without a new
12-67 prescription.
12-68 (f) A prescription for a Schedule II controlled substance
12-69 written for a patient in a long-term care facility (LTCF) or for a
12-70 patient with a medical diagnosis documenting a terminal illness may
13-1 be filled in partial quantities to include individual dosage units.
13-2 If there is any question about whether a patient may be classified
13-3 as having a terminal illness, the pharmacist must contact the
13-4 practitioner prior to partially filling the prescription. Both the
13-5 pharmacist and the practitioner have a corresponding responsibility
13-6 to assure that the controlled substance is for a terminally ill
13-7 patient. The pharmacist must record on the prescription whether
13-8 the patient is "terminally ill" or an "LTCF patient." A
13-9 prescription that is partially filled and does not contain the
13-10 notation "terminally ill" or "LTCF patient" shall be deemed to have
13-11 been filled in violation of this Act. For each partial filling,
13-12 the dispensing pharmacist shall record on the back of Copy 1 and
13-13 Copy 2 of the prescription the date of the partial filling, the
13-14 quantity dispensed, the remaining quantity authorized to be
13-15 dispensed, and the identification of the dispensing pharmacist.
13-16 Prior to any subsequent partial filling the pharmacist is to
13-17 determine that the additional partial filling is necessary. The
13-18 total quantity of Schedule II controlled substances dispensed in
13-19 all partial fillings must not exceed the total quantity prescribed.
13-20 Schedule II prescriptions for patients in a long-term care facility
13-21 or patients with a medical diagnosis documenting a terminal illness
13-22 shall be valid for a period not to exceed 30 days from the issue
13-23 date unless sooner terminated by discontinuance of the medication.
13-24 (g) A person may not dispense a controlled substance in
13-25 Schedule III or IV that is a prescription drug under the Federal
13-26 Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.)
13-27 without a written, oral, or telephonically communicated
13-28 prescription of a practitioner defined by Section 481.002(39)(A),
13-29 except that the practitioner may dispense the substance directly to
13-30 an ultimate user. A prescription for a controlled substance listed
13-31 in Schedule III or IV may not be filled or refilled later than six
13-32 months after the date on which the prescription is issued and may
13-33 not be refilled more than five times, unless the prescription is
13-34 renewed by the practitioner.
13-35 (h) <(f)> A pharmacist may dispense a controlled substance
13-36 listed in Schedule III, IV, or V under an original written
13-37 prescription issued by a practitioner defined by Section
13-38 481.002(38)(C) and only if the pharmacist determines that the
13-39 prescription was issued for a valid medical purpose and in the
13-40 course of professional practice. A prescription issued under this
13-41 subsection may not be filled or refilled later than six months
13-42 after the date the prescription is issued, and a prescription
13-43 authorized to be refilled on the original prescription may not be
13-44 refilled more than five times.
13-45 (i) <(g)> A person may not dispense a controlled substance
13-46 listed in Section 481.036(1) or (2) without the prescription of a
13-47 practitioner defined by Section 481.002(39)(A), except that a
13-48 practitioner may dispense the substance directly to an ultimate
13-49 user. A prescription issued under this subsection may not be
13-50 filled or refilled later than six months after the date the
13-51 prescription is issued and may not be refilled more than five
13-52 times, unless the prescription is renewed by the practitioner.
13-53 (j) <(h)> A practitioner or institutional practitioner may
13-54 not allow a patient, on the patient's release from the hospital, to
13-55 possess a controlled substance prescribed by the practitioner
13-56 unless:
13-57 (1) the substance was dispensed under a medication
13-58 order while the patient was admitted to the hospital;
13-59 (2) the substance is in a properly labeled container;
13-60 and
13-61 (3) the patient possesses not more than a seven-day
13-62 supply of the substance.
13-63 (k) <(i)> A prescription for a controlled substance must
13-64 show:
13-65 (1) the quantity of the substance prescribed:
13-66 (A) numerically, followed by the number written
13-67 as a word, if the prescription is written; or
13-68 (B) if the prescription is communicated orally
13-69 or telephonically, as transcribed by the receiving pharmacist;
13-70 (2) the date of issue;
14-1 (3) the name and address of the patient or, if the
14-2 controlled substance is prescribed for an animal, the species of
14-3 the animal and the name and address of its owner;
14-4 (4) the name and strength of the controlled substance
14-5 prescribed;
14-6 (5) the directions for use of the controlled
14-7 substance; <and>
14-8 (6) the intended use of the controlled substance or
14-9 the diagnosis for which the controlled substance is prescribed; and
14-10 (7) the name, address, <and> Federal Drug Enforcement
14-11 Administration registration number, and telephone number of the
14-12 practitioner at the practitioner's usual place of business, legibly
14-13 printed or stamped.
14-14 (l) A pharmacist may exercise his professional judgment in
14-15 refilling a prescription for a controlled substance in Schedule
14-16 III, IV, or V without the authorization of the prescribing
14-17 practitioner provided:
14-18 (1) failure to refill the prescription might result in
14-19 an interruption of a therapeutic regimen or create patient
14-20 suffering;
14-21 (2) either:
14-22 (A) a natural or manmade disaster has occurred
14-23 which prohibits the pharmacist from being able to contact the
14-24 practitioner; or
14-25 (B) the pharmacist is unable to contact the
14-26 practitioner after reasonable effort;
14-27 (3) the quantity of prescription drug dispensed does
14-28 not exceed a 72-hour supply;
14-29 (4) the pharmacist informs the patient or the
14-30 patient's agent at the time of dispensing that the refill is being
14-31 provided without such authorization and that authorization of the
14-32 practitioner is required for future refills; and
14-33 (5) the pharmacist informs the practitioner of the
14-34 emergency refill at the earliest reasonable time.
14-35 SECTION 15. Subsections (d), (e), and (f), Section 481.075,
14-36 Health and Safety Code, are amended to read as follows:
14-37 (d) Except for oral prescriptions prescribed under Section
14-38 481.074(b), the prescribing practitioner shall:
14-39 (1) legibly fill in, or direct a designated agent to
14-40 legibly fill in, on all three copies of the form in the space
14-41 provided:
14-42 (A) the date the prescription is written;
14-43 (B) the drug prescribed, the quantity (shown
14-44 numerically followed by the number written as a word), <and>
14-45 instructions for use, and the intended use of the drug or the
14-46 diagnosis for which the controlled substance is prescribed; and
14-47 (C) the name, address, and age of the patient
14-48 or, in the case of an animal, its owner, for whom the controlled
14-49 substance is prescribed;
14-50 (2) sign Copies 1 and 2 of the form and give them to
14-51 the person authorized to receive the prescription; and
14-52 (3) retain Copy 3 of the form with the practitioner's
14-53 records for at least two years after the date the prescription is
14-54 written.
14-55 (e) In the case of an oral prescription prescribed under
14-56 Section 481.074(b), the prescribing practitioner shall give the
14-57 dispensing pharmacy the information needed to complete the form.
14-58 (f) Each dispensing pharmacist shall:
14-59 (1) fill in on Copies 1 and 2 of the form in the space
14-60 provided the information not required to be filled in by the
14-61 prescribing practitioner or the Department of Public Safety;
14-62 (2) indicate the total quantity dispensed on the face
14-63 of the triplicate prescription form;
14-64 (3) retain Copy 2 with the records of the pharmacy for
14-65 at least two years; and
14-66 (4) <(3)> sign Copy 1 and send it to the Department of
14-67 Public Safety not later than the 30th day after the date the
14-68 prescription is filled or not later than the 30th day after the
14-69 completion of a prescription dispensed under Section 481.074(f).
14-70 SECTION 16. Subchapter A, Chapter 483, Health and Safety
15-1 Code, is amended by adding Section 483.0001 and amending Section
15-2 483.001 to read as follows:
15-3 Sec. 483.0001. SHORT TITLE. This Act may be cited as the
15-4 Texas Dangerous Drug Act.
15-5 Sec. 483.001. DEFINITIONS. In this chapter:
15-6 (1) <(2)> "Board" means the Texas State Board of
15-7 Pharmacy.
15-8 (2) <(3)> "Dangerous drug" means a device or a drug
15-9 that is unsafe for self-medication and that is not included in
15-10 Schedules I through V or Penalty Groups 1 through 4 of Chapter 481
15-11 (Texas Controlled Substances Act). The term includes a device or a
15-12 drug that bears or is required to bear the legend:
15-13 (A) Caution: federal law prohibits dispensing
15-14 without prescription; or
15-15 (B) Caution: federal law restricts this drug to
15-16 use by or on the order of a licensed veterinarian.
15-17 (3) <(4)> "Deliver" means to sell, dispense, give
15-18 away, or supply in any other manner.
15-19 (4) "Designated agent" means:
15-20 (A) a licensed nurse, physician assistant,
15-21 pharmacist, or other individual designated by a practitioner to
15-22 communicate prescription drug orders to a pharmacist;
15-23 (B) a licensed nurse, physician assistant, or
15-24 pharmacist employed in a health care facility to whom the
15-25 practitioner communicates a prescription drug order; or
15-26 (C) a registered nurse or physician assistant
15-27 authorized by a practitioner to carry out a prescription drug order
15-28 for dangerous drugs under Section 3.06(d)(5), Medical Practice Act
15-29 (Article 4495b, Vernon's Texas Civil Statutes).
15-30 (5) "Dispense" means to prepare, package, compound, or
15-31 label a dangerous drug in the course of professional practice for
15-32 delivery under the lawful order of a practitioner to an ultimate
15-33 user or the user's agent.
15-34 (6) "Manufacturer" means a person, other than a
15-35 pharmacist, who manufactures dangerous drugs. The term includes a
15-36 person who prepares dangerous drugs in dosage form by mixing,
15-37 compounding, encapsulating, entableting, or any other process.
15-38 (7) "Patient" means:
15-39 (A) an individual for whom a dangerous drug is
15-40 prescribed or to whom a dangerous drug is administered; or
15-41 (B) an owner or the agent of an owner of an
15-42 animal for which a dangerous drug is prescribed or to which a
15-43 dangerous drug is administered.
15-44 (8) "Person" includes an individual, corporation,
15-45 partnership, and association.
15-46 (9) "Pharmacist" means a person licensed by the Texas
15-47 State Board of Pharmacy to practice pharmacy.
15-48 (10) "Pharmacy" means a facility licensed by the board
15-49 pursuant to Section 29, Texas Pharmacy Act (Article 4542a-1,
15-50 Vernon's Texas Civil Statutes) <in which the practice of pharmacy
15-51 occurs>.
15-52 (11) "Practice of pharmacy" means:
15-53 (A) provision of those acts or services
15-54 necessary to provide pharmaceutical care;
15-55 (B) interpretation and evaluation of
15-56 prescription drug orders or medication orders;
15-57 (C) participation in drug and device selection
15-58 as authorized by law, drug administration, drug regimen review, or
15-59 drug or drug-related research;
15-60 (D) provision of patient counseling; and
15-61 (E) responsibility for:
15-62 (i) dispensing of prescription drug orders
15-63 or distribution of medication orders in the patient's best
15-64 interest;
15-65 (ii) compounding and labeling of drugs and
15-66 devices, except labeling by a manufacturer, repackager, or
15-67 distributor of nonprescription drugs and commercially packaged
15-68 prescription drugs and devices;
15-69 (iii) proper and safe storage of drugs and
15-70 devices; and
16-1 (iv) maintenance of proper records for
16-2 drugs and devices <the interpretation and evaluation of
16-3 prescription or medication orders, the dispensing and labeling of
16-4 drugs or devices, the selection of drugs and the review of drug
16-5 use, the storage of prescription drugs and devices and the
16-6 maintenance of prescription drug records in a pharmacy, the giving
16-7 of advice or consultation if necessary or required by law about the
16-8 therapeutic value, content, hazard, or use of drugs or devices, or
16-9 the offer to perform or the performance of the services and
16-10 transactions necessary to operate a pharmacy>. In this
16-11 subdivision, "device" has the meaning assigned by the Texas
16-12 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes).
16-13 (12) "Practitioner" means a person licensed:
16-14 (A) by the Texas State Board of Medical
16-15 Examiners, State Board of Dental Examiners, Texas State Board of
16-16 Podiatry Examiners, Texas Optometry Board, or State Board of
16-17 Veterinary Medical Examiners to prescribe and administer dangerous
16-18 drugs;
16-19 (B) by another state in a health field in which,
16-20 under the laws of this state, a licensee may legally prescribe
16-21 dangerous drugs; or
16-22 (C) in Canada or Mexico in a health field in
16-23 which, under the laws of this state, a licensee may legally
16-24 prescribe dangerous drugs.
16-25 (13) "Prescription" means an order from a
16-26 practitioner, or an agent of the practitioner designated in writing
16-27 as authorized to communicate prescriptions, or an order made in
16-28 accordance with Section 3.06(d)(5), Medical Practice Act (Article
16-29 4495b, Vernon's Texas Civil Statutes), to a pharmacist for a
16-30 dangerous drug to be dispensed that states:
16-31 (A) the date of the order's issue;
16-32 (B) the name and address of the patient;
16-33 (C) if the drug is prescribed for an animal, the
16-34 species of the animal;
16-35 (D) the name and quantity of the drug
16-36 prescribed; <and>
16-37 (E) the directions for the use of the drug;
16-38 (F) the intended use of the drug or the
16-39 diagnosis for which the drug is prescribed; and
16-40 (G) the name, address, and telephone number of
16-41 the practitioner at the practitioner's usual place of business,
16-42 legibly printed or stamped.
16-43 (14) "Warehouseman" means a person who stores
16-44 dangerous drugs for others and who has no control over the
16-45 disposition of the drugs except for the purpose of storage.
16-46 (15) "Wholesaler" means a person engaged in the
16-47 business of distributing dangerous drugs to a person listed in
16-48 Sections 483.041(c)(1)-(6).
16-49 SECTION 17. Section 483.022, Health and Safety Code, is
16-50 amended to read as follows:
16-51 Sec. 483.022. Practitioner's Designated Agent;
16-52 Practitioner's Responsibilities. (a) A practitioner shall provide
16-53 in writing the name of each<:>
16-54 <(1)> designated agent as defined by Section
16-55 483.001(4)(A) and (C), and the name of each healthcare facility
16-56 which employs persons defined by Section 483.001(4)(B) <authorized
16-57 by the practitioner to communicate prescriptions for the
16-58 practitioner; and>
16-59 <(2) registered nurse or physician assistant
16-60 authorized to carry out a prescription drug order under Section
16-61 3.06(d)(5), Medical Practice Act (Article 4495b, Vernon's Texas
16-62 Civil Statutes)>.
16-63 (b) The practitioner shall maintain at the practitioner's
16-64 usual place of business a list of the designated agents or
16-65 healthcare facilities as defined by Section 483.001(4) <and a list
16-66 of the designated registered nurses or physician assistants
16-67 authorized to carry out a prescription drug order>.
16-68 <(b) The practitioner shall maintain at the practitioner's
16-69 usual place of business a list of each designated agent, registered
16-70 nurse, or physician assistant who is authorized to carry out a
17-1 prescription drug order.>
17-2 (c) The practitioner shall provide a pharmacist with a copy
17-3 of the practitioner's written authorization for a designated agent
17-4 as defined by Section 483.001(4)<, registered nurse, or physician
17-5 assistant> on the pharmacist's request.
17-6 (d) This section does not relieve a practitioner or the
17-7 practitioner's designated agent from the requirements of Section
17-8 40, Texas Pharmacy Act (Article 4542a-1, Vernon's Texas Civil
17-9 Statutes).
17-10 (e) A practitioner remains personally responsible for the
17-11 actions of a designated agent who communicates a prescription to a
17-12 pharmacist.
17-13 SECTION 18. Subsection (d), Section 483.041, Health and
17-14 Safety Code, is amended to read as follows:
17-15 (d) An offense under this section is a felony of the third
17-16 degree <Class B misdemeanor unless it is shown on the trial of the
17-17 defendant that the defendant has previously been convicted of an
17-18 offense under this section, in which event the offense is a Class A
17-19 misdemeanor>.
17-20 SECTION 19. Section 483.042, Health and Safety Code, is
17-21 amended by amending Subsections (c) and (d) to read as follows:
17-22 (c) The labeling provisions of Subsection (a) do not apply
17-23 when the dangerous drug is prescribed for administration to an
17-24 ultimate user who is institutionalized. The board shall adopt
17-25 rules for the labeling of such drugs.
17-26 (d) Proof of an offer to sell a dangerous drug must be
17-27 corroborated by a person other than the offeree or by evidence
17-28 other than a statement by the offeree.
17-29 (e) <(d)> An offense under this section is a felony of the
17-30 third degree.
17-31 SECTION 20. Section 483.047, Health and Safety Code, is
17-32 amended to read as follows:
17-33 Sec. 483.047. Refilling Prescription Without Authorization.
17-34 (a) Except as authorized by Subsection (b), a <A> pharmacist
17-35 commits an offense if the pharmacist refills a prescription unless:
17-36 (1) the prescription contains an authorization by the
17-37 practitioner for the refilling of the prescription, and the
17-38 pharmacist refills the prescription in the manner provided by the
17-39 authorization; or
17-40 (2) at the time of refilling the prescription, the
17-41 pharmacist is authorized to do so by the practitioner who issued
17-42 the prescription.
17-43 (b) A pharmacist may exercise his professional judgment in
17-44 refilling a prescription for a dangerous drug without the
17-45 authorization of the prescribing practitioner provided:
17-46 (1) failure to refill the prescription might result in
17-47 an interruption of a therapeutic regimen or create patient
17-48 suffering;
17-49 (2) either:
17-50 (A) a natural or manmade disaster has occurred
17-51 which prohibits the pharmacist from being able to contact the
17-52 practitioner; or
17-53 (B) the pharmacist is unable to contact the
17-54 practitioner after reasonable effort;
17-55 (3) the quantity of drug dispensed does not exceed a
17-56 72-hour supply;
17-57 (4) the pharmacist informs the patient or the
17-58 patient's agent at the time of dispensing that the refill is being
17-59 provided without such authorization and that authorization of the
17-60 practitioner is required for future refills; and
17-61 (5) the pharmacist informs the practitioner of the
17-62 emergency refill at the earliest reasonable time.
17-63 (c) An offense under this section is a Class B misdemeanor
17-64 unless it is shown on the trial of the defendant that the defendant
17-65 has previously been convicted under this chapter, in which event
17-66 the offense is a Class A misdemeanor.
17-67 SECTION 21. This Act takes effect September 1, 1993.
17-68 SECTION 22. (a) A change in law made by this Act which
17-69 applies to a criminal offense applies only to an offense committed
17-70 on or after the effective date of this Act. For purposes of this
18-1 section, an offense is committed before the effective date of this
18-2 Act if any element of the offense occurs before that date.
18-3 (b) A criminal offense committed before the effective date
18-4 of this Act is covered by the law in effect when the offense was
18-5 committed, and the former law is continued in effect for this
18-6 purpose.
18-7 SECTION 23. The importance of this legislation and the
18-8 crowded condition of the calendars in both houses create an
18-9 emergency and an imperative public necessity that the
18-10 constitutional rule requiring bills to be read on three several
18-11 days in each house be suspended, and this rule is hereby suspended.
18-12 * * * * *
18-13 Austin,
18-14 Texas
18-15 April 6, 1993
18-16 Hon. Bob Bullock
18-17 President of the Senate
18-18 Sir:
18-19 We, your Committee on Health and Human Services to which was
18-20 referred S.B. No. 472, have had the same under consideration, and I
18-21 am instructed to report it back to the Senate with the
18-22 recommendation that it do not pass, but that the Committee
18-23 Substitute adopted in lieu thereof do pass and be printed.
18-24 Zaffirini,
18-25 Chair
18-26 * * * * *
18-27 WITNESSES
18-28 FOR AGAINST ON
18-29 ___________________________________________________________________
18-30 Name: Michael Galt x
18-31 Representing: Tx Society of Hosp Pharm
18-32 City: Houston
18-33 -------------------------------------------------------------------
18-34 Name: Sarah Moody x
18-35 Representing: Tx Nurses Assn
18-36 City: Austin
18-37 -------------------------------------------------------------------
18-38 FOR AGAINST ON
18-39 ___________________________________________________________________
18-40 Name: James Willmonn x
18-41 Representing: Tx Nurses Assn
18-42 City: Austin
18-43 -------------------------------------------------------------------
18-44 Name: Donna B. Rogers x
18-45 Representing: Tx Society of Hosp Pharmacist
18-46 City: San Antonio
18-47 -------------------------------------------------------------------
18-48 Name: Pamela E. Ford x
18-49 Representing: Intravenous Nurses Society
18-50 City: Cedar Hill
18-51 -------------------------------------------------------------------