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