By Van de Putte H.B. No. 1189
Substitute the following for H.B. No. 1189:
By McCall C.S.H.B. No. 1189
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to the practice of pharmacy, including the Texas State
1-3 Board of Pharmacy, dangerous drugs, and controlled substances.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Section 5, Texas Pharmacy Act (Article 4542a-1,
1-6 Vernon's Texas Civil Statutes), is amended to read as follows:
1-7 Sec. 5. Definitions. In this Act, unless the context of its
1-8 use clearly indicates otherwise:
1-9 (1) "A.C.P.E." means the American Council on
1-10 Pharmaceutical Education.
1-11 (2) "Administer" means the direct application of a
1-12 prescription drug by injection, inhalation, ingestion, or any other
1-13 means to the body of a patient by:
1-14 (A) a practitioner, <or> an authorized agent
1-15 under his supervision, or other person authorized by law; or
1-16 (B) the patient at the direction of a
1-17 practitioner.
1-18 (3) "Administrative Procedure Act" means the
1-19 Administrative Procedure and Texas Register Act, as amended
1-20 (Article 6252-13a, Vernon's Texas Civil Statutes).
1-21 (4) "Board" means the Texas State Board of Pharmacy.
1-22 (5) "Class A pharmacy license" or "community pharmacy
1-23 license" means a license issued to a pharmacy dispensing drugs or
2-1 devices to the general public pursuant to a prescription drug
2-2 order.
2-3 (6) "Class B pharmacy license" or "nuclear pharmacy
2-4 license" means a license issued to a pharmacy dispensing or
2-5 providing radioactive drugs or devices for administration to an
2-6 ultimate user.
2-7 (7) "Class C pharmacy license" or "institutional
2-8 pharmacy license" means a license issued to a pharmacy located in a
2-9 hospital or other in-patient facility that is licensed under
2-10 Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental
2-11 Health Code (Article 5547-1 et seq., Vernon's Texas Civil
2-12 Statutes), or to a pharmacy located in a hospital maintained or
2-13 operated by the state.
2-14 (8) "Class D pharmacy license" or "clinic pharmacy
2-15 license" means a license issued to a pharmacy dispensing a limited
2-16 type of drugs or devices pursuant to a prescription drug order.
2-17 (9) "Class E pharmacy license" or "nonresident
2-18 pharmacy license" means a license issued under this Act to a
2-19 pharmacy located in a state of the United States other than this
2-20 state whose primary business is to dispense a prescription drug or
2-21 device under a prescription drug order and to deliver the drug or
2-22 device to a patient, including a patient in this state, by the
2-23 United States mail, a common carrier, or a delivery service.
2-24 (10) "College of pharmacy" means a school, university,
2-25 or college of pharmacy that satisfies the accreditation standards
3-1 of A.C.P.E. as adopted by the board; or that has degree
3-2 requirements which meet the standards of accreditation set by the
3-3 board.
3-4 (11) "Compounding" means the preparation, mixing,
3-5 assembling, packaging, or labeling of a drug or device:
3-6 (A) as the result of a practitioner's
3-7 prescription drug order or initiative based on the
3-8 practitioner-patient-pharmacist relationship in the course of
3-9 professional practice;
3-10 (B) in anticipation of prescription drug orders
3-11 based on routine, regularly observed prescribing patterns; or
3-12 (C) for the purpose of or as an incident to
3-13 research, teaching, or chemical analysis and not for sale or
3-14 dispensing.
3-15 (12) "Confidential record" means any health-related
3-16 record maintained by a pharmacy or pharmacist such as a patient
3-17 medication record, prescription drug order, or medication order.
3-18 (13) "Controlled substance" means a drug, immediate
3-19 precursor, or other substance listed in Schedules I-V or Penalty
3-20 Groups 1-4 of Chapter 481, Health and Safety Code, or a drug,
3-21 immediate precursor, or other substance included in Schedule I, II,
3-22 III, IV, or V of the Federal Comprehensive Drug Abuse Prevention
3-23 and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
3-24 (14) <(12)> "Controlled Substances Act" means Chapter
3-25 481, Health and Safety Code, or the Federal Comprehensive Drug
4-1 Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et
4-2 seq.).
4-3 (15) <(13)> "Dangerous drug" means any drug or device
4-4 that is not included in Penalty Groups 1-4 of the Controlled
4-5 Substances Act and that is unsafe for self-medication or any drug
4-6 or device that bears or is required to bear the legend:
4-7 (A) "Caution: federal law prohibits dispensing
4-8 without prescription"; or
4-9 (B) "Caution: federal law restricts this drug
4-10 to use by or on the order of a licensed veterinarian."
4-11 (16) <(14)> "Dangerous Drug Act" means Chapter 483,
4-12 Health and Safety Code.
4-13 (17) <(15)> "Deliver" or "delivery" means the actual,
4-14 constructive, or attempted transfer of a prescription drug or
4-15 device or controlled substance from one person to another, whether
4-16 or not for a consideration.
4-17 (18) <(15)> "Designated agent" means:
4-18 (A) a licensed nurse, physician assistant,
4-19 pharmacist, or other <an> individual <under the supervision of a
4-20 practitioner,> designated by a <the> practitioner, and for whom the
4-21 practitioner assumes legal responsibility, who communicates
4-22 prescription drug orders <the practitioner's instructions> to a
4-23 pharmacist;
4-24 (B) a licensed nurse, physician assistant, or
4-25 pharmacist employed in a health care facility to whom the
5-1 practitioner communicates a prescription drug order; or
5-2 (C) a registered nurse or physician assistant
5-3 authorized by a practitioner to carry out a prescription drug order
5-4 for dangerous drugs under Subdivision (5), Subsection (d), Section
5-5 3.06, Medical Practice Act (Article 4495b, Vernon's Texas Civil
5-6 Statutes).
5-7 (19) <(16)> "Device" means an instrument, apparatus,
5-8 implement, machine, contrivance, implant, in vitro reagent, or
5-9 other similar or related article, including any component part or
5-10 accessory, that is required under federal or state law to be
5-11 ordered or prescribed by a practitioner.
5-12 (20) <(17)> "Dispense" means preparing, packaging,
5-13 compounding, or labeling for delivery a prescription drug or device
5-14 in the course of professional practice to an ultimate user or his
5-15 agent by or pursuant to the lawful order of a practitioner.
5-16 (21) <(18)> "Distribute" means the delivery of a
5-17 prescription drug or device other than by administering or
5-18 dispensing.
5-19 (22) <(19)> "Drug" means:
5-20 (A) a substance recognized as drugs in the
5-21 current official United States Pharmacopoeia, official National
5-22 Formulary, official Homeopathic Pharmacopoeia, or other drug
5-23 compendium or any supplement to any of them;
5-24 (B) a substance intended for use in the
5-25 diagnosis, cure, mitigation, treatment, or prevention of disease in
6-1 man or other animals;
6-2 (C) a substance, other than food, intended to
6-3 affect the structure or any function of the body of man or other
6-4 animals;
6-5 (D) a substance intended for use as a component
6-6 of any articles specified in Paragraph (A), (B), or (C) of this
6-7 subdivision;
6-8 (E) a dangerous drug; or
6-9 (F) a controlled substance.
6-10 (23) "Drug regimen review" includes the following
6-11 activities:
6-12 (A) evaluation of prescription drug or
6-13 medication orders and patient medication records for:
6-14 (i) known allergies;
6-15 (ii) rational therapy-contraindications;
6-16 (iii) reasonable dose and route of
6-17 administration; and
6-18 (iv) reasonable directions for use;
6-19 (B) evaluation of the prescription drug or
6-20 medication orders and patient medication records for duplication of
6-21 therapy;
6-22 (C) evaluation of prescription drug or
6-23 medication orders and patient medication records for:
6-24 (i) drug-drug interactions;
6-25 (ii) drug-food interactions;
7-1 (iii) drug-disease interactions;
7-2 (iv) adverse drug reactions; and
7-3 (D) evaluation of prescription drug and
7-4 medication orders and patient medication records for proper
7-5 utilization, including overutilization or underutilization.
7-6 (24) <(20)> "Internship" means a practical experience
7-7 program that is approved by the board.
7-8 (25) <(21)> "Label" means written, printed, or graphic
7-9 matter on the immediate container of a drug or device.
7-10 (26) <(22)> "Labeling" means the process of affixing a
7-11 label including all information required by federal and state law
7-12 or regulation to any drug or device container. The term does not
7-13 include the labeling by a manufacturer, packer, or distributor of a
7-14 nonprescription drug or commercially packaged prescription drug or
7-15 device, or unit dose packaging.
7-16 (27) "Manufacturing" means the production,
7-17 preparation, propagation, conversion, or processing of a drug or
7-18 device, either directly or indirectly, by extraction from
7-19 substances of natural origin or independently by means of chemical
7-20 or biological synthesis and includes any packaging or repackaging
7-21 of the substances or labeling or relabeling of the container and
7-22 the promotion and marketing of such drugs or devices.
7-23 Manufacturing also includes the preparation and promotion of
7-24 commercially available products from bulk compounds for resale by
7-25 pharmacies, practitioners, or other persons but does not include
8-1 compounding.
8-2 (28) <(23)> "Medication order" means an order from a
8-3 practitioner or a practitioner's designated agent for
8-4 administration of a drug or device.
8-5 (29) <(24)> "Nonprescription drug" means a nonnarcotic
8-6 drug or device that may be sold without a prescription and that is
8-7 labeled and packaged in compliance with applicable state or federal
8-8 law.
8-9 (30) "Patient counseling" means the communication by
8-10 the pharmacist of information, as specified in the rules of the
8-11 board, to the patient or caregiver, in order to improve therapy by
8-12 ensuring proper use of drugs and devices.
8-13 (31) <(25)> "Person" means an individual, corporation,
8-14 government or governmental subdivision or agency, business trust,
8-15 estate, trust, partnership, association, or any other legal entity.
8-16 (32) "Pharmaceutical care" is the provision of drug
8-17 therapy and other pharmaceutical services defined in the rules of
8-18 the board and intended to assist in the cure or prevention of a
8-19 disease, elimination or reduction of a patient's symptoms, or
8-20 arresting or slowing of a disease process.
8-21 (33) <(26)> "Pharmacist" means a person licensed by
8-22 the board to practice pharmacy.
8-23 (34) <(27)> "Pharmacist-in-charge" means the
8-24 pharmacist designated on a pharmacy license as the pharmacist who
8-25 has the authority or responsibility for a pharmacy's compliance
9-1 with laws and rules pertaining to the practice of pharmacy.
9-2 (35) <(28)> "Pharmacist-intern" means an undergraduate
9-3 student enrolled in the professional sequence of a college of
9-4 pharmacy approved by the board and participating in a school-based,
9-5 board-approved internship program or a graduate of a college of
9-6 pharmacy who is participating in a board-approved internship.
9-7 (36) <(29)> "Pharmacy" means a facility licensed by
9-8 the board pursuant to Section 29 of this Act <where the practice of
9-9 pharmacy occurs>.
9-10 (37) <(30)> "Practice of pharmacy" means:
9-11 (A) provision of those acts or services
9-12 necessary to provide pharmaceutical care;
9-13 (B) interpretation and evaluation of
9-14 prescription drug orders or medication orders;
9-15 (C) participation in drug and device selection
9-16 as authorized by law, drug administration in accordance with
9-17 subsection 17(a)(5) of this Act, drug regimen review, or drug or
9-18 drug-related research;
9-19 (D) provision of patient counseling; and
9-20 (E) responsibility for:
9-21 (i) dispensing of prescription drug orders
9-22 or distribution of medication orders;
9-23 (ii) compounding and labeling of drugs and
9-24 devices, except labeling by a manufacturer, repackager, or
9-25 distributor of nonprescription drugs and commercially packaged
10-1 prescription drugs and devices;
10-2 (iii) proper and safe storage of drugs and
10-3 devices; or
10-4 (iv) maintenance of proper records for
10-5 drugs and devices <interpreting and evaluating prescription or
10-6 medication orders, dispensing and labeling drugs or devices,
10-7 selecting drugs and reviewing drug utilization, storing
10-8 prescription drugs and devices and maintaining prescription drug
10-9 records in a pharmacy, advising or consulting when necessary or
10-10 required by law about therapeutic value, content, hazard, or use of
10-11 drugs or devices, or offering or performing the services and
10-12 transactions necessary to operate a pharmacy>.
10-13 (38) <(31)> "Practitioner" means:
10-14 (A) a physician, dentist, podiatrist,
10-15 veterinarian, or other person licensed or registered to prescribe,
10-16 distribute, administer, or dispense a prescription drug or device
10-17 in the course of professional practice in this state;
10-18 (B) a person licensed by another state in a
10-19 health field in which, under Texas law, licensees in this state may
10-20 legally prescribe dangerous drugs or a person practicing in another
10-21 state and licensed by another state as a physician, dentist,
10-22 veterinarian, or podiatrist, having a current Federal Drug
10-23 Enforcement Administration registration number, and who may legally
10-24 prescribe Schedule II, III, IV, or V controlled substances in such
10-25 other state; or
11-1 (C) a person licensed in the Dominion of Canada
11-2 or the United Mexican States in a health field in which, under the
11-3 laws of this state, a licensee may legally prescribe dangerous
11-4 drugs. "Practitioner" does not include a person licensed under
11-5 this Act.
11-6 (39) <(32)> "Preceptor" means a pharmacist in good
11-7 standing licensed in this state to practice pharmacy and certified
11-8 by the board to supervise and be responsible for the activities and
11-9 functions of a pharmacist-intern in the internship program.
11-10 (40) <(33)> "Prescription drug" means:
11-11 (A) a substance for which federal or state law
11-12 requires a prescription before it may be legally dispensed to the
11-13 public;
11-14 (B) a drug or device that under federal law is
11-15 required, prior to being dispensed or delivered, to be labeled with
11-16 either of the following statements:
11-17 (i) "Caution: federal law prohibits
11-18 dispensing without prescription"; or
11-19 (ii) "Caution: federal law restricts this
11-20 drug to use by or on the order of a licensed veterinarian"; or
11-21 (C) a drug or device that is required by any
11-22 applicable federal or state law or regulation to be dispensed on
11-23 prescription only or is restricted to use by a practitioner only.
11-24 (41) <(34)> "Prescription drug order" means:
11-25 (A) an order from a practitioner or a
12-1 practitioner's designated agent to a pharmacist for a drug or
12-2 device to be dispensed; or
12-3 (B) an order pursuant to Subdivision (5),
12-4 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
12-5 Vernon's Texas Civil Statutes).
12-6 (42) "Prospective drug use review" means a review of
12-7 the patient's drug therapy and prescription drug order or
12-8 medication order, as defined in the rules of the board, prior to
12-9 dispensing or distributing the drug.
12-10 (43) <(35)> "Provide" means to supply one or more unit
12-11 doses of a nonprescription drug or dangerous drug to a patient.
12-12 (44) <(36)> "Radioactive drug" means a drug that
12-13 exhibits spontaneous disintegration of unstable nuclei with the
12-14 emission of nuclear particles or photons, including any
12-15 nonradioactive reagent kit or nuclide generator that is intended to
12-16 be used in the preparation of any such substance.
12-17 (45) <(37)> "Substitution" means the dispensing of a
12-18 drug or a brand of drug other than that which is ordered or
12-19 prescribed.
12-20 (46) <(38)> "Supportive personnel" means those
12-21 individuals utilized in pharmacies whose responsibility it shall be
12-22 to provide <nonjudgmental> technical services that do not require
12-23 professional judgment concerned with the preparation and
12-24 distribution of drugs under the direct supervision of and
12-25 responsible to a pharmacist.
13-1 (47) <(39)> "Ultimate user" means a person who has
13-2 obtained and possesses a prescription drug or device for the
13-3 person's own use or for the use of a member of the person's
13-4 household or for administering to an animal owned by the person or
13-5 by a member of the person's household.
13-6 (48) <(40)> "Unit dose packaging" means the ordered
13-7 amount of drug in a dosage form ready for administration to a
13-8 particular patient, by the prescribed route at the prescribed time,
13-9 and properly labeled with name, strength, and expiration date of
13-10 the drug.
13-11 <(41) "Authorized agent" means an individual under the
13-12 supervision of a practitioner, designated by the practitioner, and
13-13 for whom the practitioner assumes legal responsibility, who
13-14 communicates the practitioner's instructions to the pharmacist.>
13-15 SECTION 2. Section 16, Texas Pharmacy Act (Article 4542a-1,
13-16 Vernon's Texas Civil Statutes), is amended to read as follows:
13-17 Sec. 16. Rules. (a) The board shall adopt, amend, and
13-18 repeal rules for the proper administration and enforcement of this
13-19 Act, consistent with this Act. The rules shall be adopted,
13-20 amended, or repealed in accordance with the Administrative
13-21 Procedure Act.
13-22 (b) If the board determines it necessary in order to
13-23 protect the health and welfare of the citizens of this state, it
13-24 may make a rule concerning the operation of a licensed pharmacy
13-25 located in this state also applicable to pharmacies licensed by the
14-1 board that are located in another state.
14-2 (c) The board may not adopt rules restricting
14-3 competitive bidding or advertising by a person regulated by the
14-4 board except to prohibit false, misleading, or deceptive practices
14-5 by the person.
14-6 SECTION 3. Subsections (a), (b), and (q), Section 17, Texas
14-7 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
14-8 amended to read as follows:
14-9 (a) The board is responsible for the regulation of the
14-10 practice of pharmacy in this state, including the following:
14-11 (1) the licensing by examination or by reciprocity of
14-12 applicant who are qualified to engage in the practice of pharmacy
14-13 and the licensing of pharmacies under this Act;
14-14 (2) the renewal of licenses to engage in the practice
14-15 of pharmacy and licenses to operate pharmacies;
14-16 (3) the determination and issuance of standards for
14-17 recognition and approval of degree requirements of colleges of
14-18 pharmacy whose graduates shall be eligible for licensing in this
14-19 state and the specification and enforcement of requirements for
14-20 practical training, including internship;
14-21 (4) the enforcement of those provisions of this Act
14-22 relating to the conduct or competence of pharmacists practicing in
14-23 this state and the conduct of pharmacies operating in this state
14-24 and the suspension, revocation, fining, reprimanding, cancellation,
14-25 or restriction of licenses to engage in the practice of pharmacy or
15-1 to operate a pharmacy;
15-2 (5) the specifications of conditions under which a
15-3 pharmacist may administer medications which at a minimum shall
15-4 include the following:
15-5 (A) a licensed health care provider authorized
15-6 to administer the medication is not reasonably available to
15-7 administer the medication;
15-8 (B) failure to administer the medication might
15-9 result in a significant delay or interruption of a critical phase
15-10 of drug therapy;
15-11 (C) the pharmacist possesses the necessary skill
15-12 and education to administer the medication;
15-13 (D) the pharmacist notifies the appropriate
15-14 licensed health care provider responsible for the patient's care
15-15 within a reasonable time that the medication was administered;
15-16 (E) the authority of the pharmacist to
15-17 administer medications may not be delegated;
15-18 (F) nothing in this paragraph shall be construed
15-19 to prohibit a pharmacist from preparing or manipulating
15-20 biotechnological agents or devices; and
15-21 (G) nothing in this paragraph shall be construed
15-22 as prohibiting a pharmacist from performing an act delegated by a
15-23 physician in accordance with the provisions of Subsection (d),
15-24 Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas
15-25 Civil Statutes) and the pharmacist performing such delegated
16-1 medical act shall be considered to be performing a medical act and
16-2 not as engaged in the practice of pharmacy.
16-3 (6) the regulation of the training, qualifications,
16-4 and employment of pharmacist-interns; and
16-5 (7) <(6)> the enforcement of this Act and any rules
16-6 adopted under this Act.
16-7 (b) The board has the following responsibilities relating to
16-8 the practice of pharmacy and to prescription drugs and devices used
16-9 in this state in the diagnosis, mitigation, and treatment or
16-10 prevention of injury, illness, and disease:
16-11 (1) regulation of the delivery or distribution of
16-12 prescription drugs and devices, including the right to seize, after
16-13 notice and hearing, any prescription drugs or devices posing a
16-14 hazard to the public health and welfare, but the board may not
16-15 regulate:
16-16 (A) manufacturers' representatives or employees
16-17 acting in the normal course of business;
16-18 (B) persons engaged in the wholesale drug
16-19 business and registered with the commissioner of health as provided
16-20 by Chapter 431, Health and Safety Code; or
16-21 (C) employees of persons engaged in the
16-22 wholesale drug business and registered with the commissioner of
16-23 health as provided by Chapter 431, Health and Safety Code, if the
16-24 employees are acting in the normal course of business;
16-25 (2) specification of minimum standards for
17-1 professional environment, technical equipment, and security in the
17-2 prescription dispensing area;
17-3 (3) specification of minimum standards for drug
17-4 storage, maintenance of prescription drug records, and procedures
17-5 for the delivery, dispensing in a suitable container appropriately
17-6 labeled, <or> providing of prescription drugs or devices,
17-7 monitoring of drug therapy, and counseling of patients on proper
17-8 use of prescription drugs and devices within the practice of
17-9 pharmacy; and
17-10 (4) adoption of rules regulating a prescription drug
17-11 order or medication order transmitted by electronic means <a
17-12 facsimile or FAX machine>.
17-13 (q) Board investigative files and all information and
17-14 materials compiled by the board in connection with an investigation
17-15 are confidential and are not subject to disclosure under
17-16 <considered open records for purposes of> Chapter 424, Acts of the
17-17 63rd Legislature, Regular Session, 1973, as amended (Article
17-18 6252-17a, Vernon's Texas Civil Statutes), and not subject to
17-19 disclosure, discovery, subpoena, or other means of legal compulsion
17-20 for their release to anyone other than the board or its employees
17-21 or agents involved in licensee discipline except that this
17-22 information may be disclosed to:
17-23 (1) persons involved with the board in a disciplinary
17-24 action against the licensee;
17-25 (2) pharmacist or pharmacy licensing or disciplinary
18-1 authorities of other jurisdictions;
18-2 (3) a pharmaceutical peer review committee as outlined
18-3 in Section 27A of this Act;
18-4 (4) law enforcement agencies; and
18-5 (5) persons engaged in bona fide research, if all
18-6 individual-identifying information has been deleted.
18-7 SECTION 4. Subsection (c), Section 21, Texas Pharmacy Act
18-8 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
18-9 read as follows:
18-10 (c) The examinations for licensing required under this
18-11 section shall be given by the board at least two times during the
18-12 fiscal year of the state. The board shall determine the content
18-13 and subject matter of each examination and determine which persons
18-14 have successfully passed the examination. An applicant who fails
18-15 the examination may retake the examination two additional times.
18-16 Before an applicant who has failed the examination three times is
18-17 allowed to retake the examination, the applicant shall provide
18-18 documentation from a college of pharmacy that additional college
18-19 course work in subject areas the applicant failed in the
18-20 examination has been successfully completed. If a person who fails
18-21 the licensing examination administered under this Act so requests
18-22 in writing, the board shall furnish the person an analysis of his
18-23 performance on the examination.
18-24 SECTION 5. Subsection (a), Section 26, Texas Pharmacy Act
18-25 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
19-1 read as follows:
19-2 (a) Grounds for Disciplining a Holder of a Pharmacist
19-3 License: The board shall refuse to issue a pharmacist license for
19-4 failure to meet the requirements of Section 21 or 22 of this Act.
19-5 The board may in its discretion refuse to issue or renew a license
19-6 or may fine, reprimand, revoke, restrict, cancel, retire, or
19-7 suspend any license granted by the board<,> and may probate any
19-8 license suspension if the board finds that the applicant or
19-9 licensee has:
19-10 (1) violated any provision of this Act or any of the
19-11 rules of the board adopted under this Act;
19-12 (2) engaged in unprofessional conduct as that term is
19-13 defined by the rules of the board;
19-14 (3) engaged in gross immorality as that term is
19-15 defined by the rules of the board;
19-16 (4) developed an incapacity of a nature that prevents
19-17 a pharmacist or applicant from engaging in the practice of pharmacy
19-18 with reasonable skill, competence, and safety to the public. In
19-19 enforcing this subdivision, the board shall, on probable cause,
19-20 request a pharmacist or applicant to submit to a mental or physical
19-21 examination by physicians or other health care professionals
19-22 designated by the board. If the pharmacist or applicant refuses to
19-23 submit to the examination, the board shall issue an order requiring
19-24 the pharmacist or applicant to show cause why he will not submit to
19-25 the examination and shall schedule a hearing on the order within 30
20-1 days after notice is served on the pharmacist or applicant. The
20-2 pharmacist or applicant shall be notified by either personal
20-3 service or certified mail with return receipt requested. At the
20-4 hearing, the pharmacist or applicant and his attorney are entitled
20-5 to present any testimony and other evidence to show why the
20-6 pharmacist or applicant should not be required to submit to the
20-7 examination. After the hearing, the board shall issue an order
20-8 either requiring the pharmacist or applicant to submit to the
20-9 examination or withdrawing the request for examination;
20-10 (5) engaged in any fraud, deceit, or misrepresentation
20-11 as those words are defined by the rules of the board in the
20-12 practice of pharmacy or in seeking a license to act as a
20-13 pharmacist;
20-14 (6) been convicted of a felony or a misdemeanor
20-15 involving moral turpitude by a court of competent jurisdiction;
20-16 (7) a drug or alcohol dependency;
20-17 (8) failed to keep and maintain records required by
20-18 this Act or failed to keep and maintain complete and accurate
20-19 records of purchases and disposals of drugs listed in the
20-20 Controlled Substances Act or the Dangerous Drug Act;
20-21 (9) violated any provision of the Controlled
20-22 Substances Act or Dangerous Drug Act or a rule relating to those
20-23 acts or any provision of Sections 485.031-485.035, Health and
20-24 Safety Code, or a rule adopted under Section 485.011, Health and
20-25 Safety Code;
21-1 (10) aided or abetted an unlicensed individual to
21-2 engage in the practice of pharmacy if the pharmacist knew or
21-3 reasonably should have known that the individual was unlicensed at
21-4 the time;
21-5 (11) refused an entry into any pharmacy for any
21-6 inspection authorized by this Act if the pharmacist had received
21-7 notification from which the pharmacist knew or reasonably should
21-8 have known that the attempted inspection was authorized;
21-9 (12) violated the pharmacy or drug laws or rules of
21-10 this state or any other state or of the United States;
21-11 (13) been negligent in the practice of pharmacy;
21-12 (14) failed to submit to an examination after hearing
21-13 and being ordered to do so by the board pursuant to Subdivision (4)
21-14 of this subsection;
21-15 (15) dispensed prescription drugs while acting outside
21-16 the usual course and scope of professional practice; or
21-17 (16) had a license to practice pharmacy issued by
21-18 another state canceled, revoked, surrendered, or suspended for
21-19 conduct substantially equivalent to conduct described in
21-20 Subdivisions (1) through (15) of this subsection. A certified copy
21-21 of the record of the state taking action as set out above shall be
21-22 conclusive evidence of the action taken by such state.
21-23 SECTION 6. Subsections (a) and (b), Section 26A, Texas
21-24 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
21-25 amended to read as follows:
22-1 (a) On the entry of an initial order against an applicant
22-2 for a license to practice pharmacy or a person licensed by the
22-3 board to practice pharmacy, the board may refuse to issue a license
22-4 to the applicant or suspend the person's license. On the person's
22-5 final conviction, the board may revoke the person's license.
22-6 (b) On the entry of an initial order against an applicant
22-7 for a license for a pharmacy or a person who has been issued a
22-8 license or renewal license for a pharmacy under this Act, or
22-9 against a managing officer of the licensee or applicant if the
22-10 licensee or applicant is an association, joint-stock company,
22-11 partnership, or corporation, the board may refuse to issue the
22-12 license or suspend the license. On final conviction, the board may
22-13 revoke the license.
22-14 SECTION 7. Subsection (a), Section 26B, Texas Pharmacy Act
22-15 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
22-16 read as follows:
22-17 (a) The board may in its discretion refuse to issue or renew
22-18 a license or may fine or reprimand any licensee or revoke,
22-19 restrict, cancel, or suspend any license granted by the board, if
22-20 the board finds that an applicant or licensee has:
22-21 (1) dispensed a drug, quantity, or strength of drug
22-22 other than that which is ordered for the patient by a practitioner
22-23 or labeled a prescription with incorrect directions for use;
22-24 (2) violated any of the following provisions of this
22-25 Act:
23-1 (A) Section 29(a), (b)(5), or (c)(5);
23-2 (B) Section 30(i) or (j); or
23-3 (C) Section 32(a);
23-4 (3) failed to comply with the following requirements
23-5 unless compliance would violate the pharmacy or drug laws or rules
23-6 in the state in which the pharmacy is located:
23-7 (A) Section 481.074 or 481.075, Health and
23-8 Safety Code;
23-9 (B) Texas substitution requirements regarding:
23-10 (i) the practitioner's directions relative
23-11 to generic substitution;
23-12 (ii) the patient's right to refuse generic
23-13 substitution; or
23-14 (iii) notification to the patient of the
23-15 patient's right to refuse substitution; <or>
23-16 (C) board rules relating to the provision of
23-17 drug information to the patient or patient's agent in written form
23-18 or by telephone; <or>
23-19 (D) board rules adopted pursuant to Section
23-20 16(a) of this Act and determined by the board to be applicable
23-21 pursuant to Section 16(b) of this Act; or
23-22 (4) engaged in conduct which caused serious bodily
23-23 injury to a Texas resident.
23-24 SECTION 8. Section 27A, Texas Pharmacy Act (Article 4542a-1,
23-25 Vernon's Texas Civil Statutes), is amended by amending Subsection
24-1 (d) and adding Subsection (j) to read as follows:
24-2 (d) The records and proceedings of the board, its authorized
24-3 agents, or any pharmaceutical organization committee as set out in
24-4 Subsections (a) and (b) of this section shall be confidential and
24-5 are not considered open records for the purposes of Chapter 424,
24-6 Acts of the 63rd Legislature, Regular Session, 1973, as amended
24-7 (Article 6252-17a, Vernon's Texas Civil Statutes); provided,
24-8 however, the board may disclose this confidential information only:
24-9 (1) in a disciplinary hearing before the board or in a
24-10 subsequent trial or appeal of a board action or order;
24-11 (2) to the pharmacist licensing or disciplinary
24-12 authorities of other jurisdictions; <or>
24-13 (3) pursuant to an order of a court of competent
24-14 jurisdiction; or
24-15 (4) pursuant to Subsection (j) of this section.
24-16 (j) The board may disclose that the license of a pharmacist
24-17 who is the subject of an order of the board deemed confidential by
24-18 Subsection (d) of this section is suspended, revoked, canceled,
24-19 restricted, or retired or that the pharmacist is in any manner
24-20 otherwise limited in the practice of pharmacy; however, the board
24-21 may not disclose the nature of the impairment or other information
24-22 that resulted in such action.
24-23 SECTION 9. Subsection (b), Section 28, Texas Pharmacy Act
24-24 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
24-25 read as follows:
25-1 (b) A person whose pharmacy license or license to practice
25-2 pharmacy in this state has been canceled, revoked, or restricted
25-3 under this Act, whether voluntarily or by action of the board, may,
25-4 after 12 months from the effective date of the cancellation,
25-5 revocation, or restriction, petition the board for reinstatement or
25-6 removal of the restriction of the license. The petition shall be
25-7 in writing and in the form prescribed by the board. On
25-8 investigation and review of the petition <hearing>, the board may
25-9 in its discretion grant or deny the petition or it may modify its
25-10 original finding to reflect any circumstances that have changed
25-11 sufficiently to warrant the modification. If such petition is
25-12 denied by the board, a subsequent petition may not be considered by
25-13 the board until 12 months from the date of denial of the previous
25-14 petition. The board in its discretion may require such person to
25-15 pass an examination or examinations for reentry into the practice
25-16 of pharmacy.
25-17 SECTION 10. Subsection (a), Section 32, Texas Pharmacy Act
25-18 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
25-19 read as follows:
25-20 (a) A pharmacy shall report in writing to the board not
25-21 later than the 10th day after the date of the occurrence, unless
25-22 immediate notification is required by this section, any of the
25-23 following:
25-24 (1) permanent closing;
25-25 (2) change of ownership;
26-1 (3) change of location;
26-2 (4) change of pharmacist-in-charge;
26-3 (5) the theft or significant loss of any controlled
26-4 substances, immediately on discovery of the theft or loss, by
26-5 including with the notification to the board of the theft or loss a
26-6 list of all controlled substances stolen or lost;
26-7 (6) the sale or transfer of controlled substances or
26-8 dangerous drugs on the permanent closing or change of ownership of
26-9 the pharmacy;
26-10 (7) any matters and occurrences that the board may
26-11 require by rule;
26-12 (8) out-of-state purchases of controlled substances as
26-13 determined by the board; <and>
26-14 (9) a disaster, accident, or emergency that may affect
26-15 the strength, purity, or labeling of a drug, medication, device, or
26-16 other material used in the diagnosis or the treatment of injury,
26-17 illness, and disease, immediately on the occurrence of the
26-18 disaster, accident, or emergency;
26-19 (10) <. (9)> a final order against the holder of a
26-20 Class E pharmacy license by the regulatory or licensing agency of
26-21 the state in which the pharmacy is located; and
26-22 (11) <(10)> a final order against a pharmacist who is
26-23 designated as the pharmacist-in-charge of a Class E pharmacy by the
26-24 regulatory or licensing agency of the state in which the pharmacy
26-25 is located.
27-1 SECTION 11. Section 40, Texas Pharmacy Act (Article 4542a-1,
27-2 Vernon's Texas Civil Statutes), is amended by amending Subsections
27-3 (d), (e), and (f) and relettering Subsections (g) through (k) to
27-4 read as follows:
27-5 (d) With the patient's consent and notification to the
27-6 practitioner, a pharmacist may dispense a dosage form of a drug
27-7 product different from that prescribed, such as tablet instead of
27-8 capsule or liquid instead of tablet, provided the dosage form so
27-9 dispensed:
27-10 (1) contains the identical amount of the active
27-11 ingredients as the dosage prescribed for the patient;
27-12 (2) is not an enteric coated or time release product;
27-13 and
27-14 (3) does not alter desired clinical outcomes.
27-15 (e) Unless otherwise directed by the practitioner, the label
27-16 on the dispensing container shall indicate the actual drug product
27-17 dispensed, either (1) the brand name, or if none (2) the generic
27-18 name, the strength, and the name of the manufacturer or
27-19 distributor. In instances where a drug product has been selected
27-20 other than the one prescribed, the pharmacist shall place on the
27-21 container the words "Substituted for brand prescribed" or
27-22 "Substituted for 'brand name'" where "brand name" is the actual
27-23 name of the brand name drug product prescribed.<" The brand name
27-24 of the prescribed drug shall not appear on the prescription
27-25 container label unless it is the drug product actually dispensed.>
28-1 (f) <(e)> A pharmacist may not select a generically
28-2 equivalent drug unless the generically equivalent drug selected
28-3 costs the patient less than the prescribed drug product. A
28-4 pharmacist may not charge a higher professional fee for dispensing
28-5 a generically equivalent drug product than the fee he or she
28-6 customarily charges for dispensing the brand name product
28-7 prescribed.
28-8 (g)(1) <(f)> A pharmacist who selects a generically
28-9 equivalent drug product as authorized by this section shall:
28-10 (A) <(1)> personally, or through his or her
28-11 agent or employee and prior to delivery of a generically equivalent
28-12 drug product, inform the patient or the patient's agent that a less
28-13 expensive generically equivalent drug product has been substituted
28-14 for the brand prescribed and the patient or patient's agent's right
28-15 to refuse such substitution; or
28-16 (B) <(2)> cause to be displayed, in a prominent
28-17 place that is in clear public view where prescription drugs are
28-18 dispensed, a sign in block letters not less than one inch in height
28-19 that reads, in both English and Spanish:
28-20 "TEXAS LAW ALLOWS A LESS EXPENSIVE GENERICALLY
28-21 EQUIVALENT DRUG TO BE SUBSTITUTED FOR CERTAIN BRAND
28-22 NAME DRUGS UNLESS YOUR PHYSICIAN DIRECTS OTHERWISE.
28-23 YOU HAVE A RIGHT TO REFUSE SUCH SUBSTITUTION. CONSULT
28-24 YOUR PHYSICIAN OR PHARMACIST CONCERNING THE
28-25 AVAILABILITY OF A SAFE, LESS EXPENSIVE DRUG FOR YOUR
29-1 USE."
29-2 Only one sign displayed in a pharmacy, as required above,
29-3 shall be deemed compliance with this subsection.
29-4 (2) <(3)> A pharmacist complies with the requirements
29-5 of this section if an employee or agent of the pharmacist notifies
29-6 a purchaser as required by Paragraph (A) of Subdivision (1) of this
29-7 subsection. The patient or patient's agent shall have the right to
29-8 refuse such product selection.
29-9 (h) <(g)> No written prescription issued by a practitioner,
29-10 as such term is defined in Section 5(30)(A) of this Act, may be
29-11 dispensed unless it is ordered on a form containing two signature
29-12 lines of equal prominence, side by side, at the bottom of the form.
29-13 Under either signature line shall be printed clearly the words
29-14 "product selection permitted," and under the other signature line
29-15 shall be printed clearly the words "dispense as written." The
29-16 practitioner shall communicate dispensing instructions to the
29-17 pharmacist by signing on the appropriate line. If the
29-18 practitioner's signature does not clearly indicate that the
29-19 prescription must be dispensed as written, generically equivalent
29-20 drug selection is permitted. No prescription form furnished a
29-21 practitioner shall contain a preprinted order for a drug product by
29-22 brand name, generic name, or manufacturer.
29-23 (i) <(h)> If a prescription is transmitted to a pharmacist
29-24 orally, the pharmacist shall note any dispensing instructions by
29-25 the practitioner or the practitioner's agent on the file copy of
30-1 the prescription and retain the prescription for the period of time
30-2 specified by law. Properly authorized prescription refills shall
30-3 follow the original dispensing instructions unless otherwise
30-4 indicated by the practitioner or practitioner's agent.
30-5 (j) <(i)> A pharmacist shall record on the prescription form
30-6 the name, strength, and manufacturer or distributor of any drug
30-7 product dispensed as herein authorized.
30-8 (k) <(j)> A pharmacist who selects a generically equivalent
30-9 drug to be dispensed pursuant to this section assumes the same
30-10 responsibility for selecting the generically equivalent drug that
30-11 he does in filling a prescription for a drug product prescribed by
30-12 generic name. There shall be no liability on the prescriber for an
30-13 act or omission by a pharmacist in selecting, preparing, or
30-14 dispensing a drug product pursuant to this section.
30-15 (l) <(k)> Drug product selection as authorized in this
30-16 section shall not apply to enteric-coated tablets; controlled
30-17 release products; injectable suspensions, other than antibiotics;
30-18 suppositories containing active ingredients for which systemic
30-19 absorption is necessary for therapeutic activity; and different
30-20 delivery systems for aerosol or nebulizer drugs. This subsection
30-21 shall not apply to any drug product which is determined to be
30-22 generically equivalent to the brand prescribed.
30-23 SECTION 12. The Texas Pharmacy Act (Article 4542a-1,
30-24 Vernon's Texas Civil Statutes) is amended by adding Sections 40B
30-25 and 40C to read as follows:
31-1 Sec. 40B. EMERGENCY REFILLS. A pharmacist may exercise his
31-2 professional judgment in refilling a prescription for a
31-3 prescription drug, other than a controlled substance listed in
31-4 Schedule II, without the authorization of the prescribing
31-5 practitioner, provided:
31-6 (1) failure to refill the prescription might result in
31-7 an interruption of a therapeutic regimen or create patient
31-8 suffering;
31-9 (2) either:
31-10 (A) a natural or manmade disaster has occurred
31-11 which prohibits the pharmacist from being able to contact the
31-12 practitioner; or
31-13 (B) the pharmacist is unable to contact the
31-14 practitioner after reasonable effort;
31-15 (3) the quantity of prescription drug dispensed does
31-16 not exceed a 72-hour supply;
31-17 (4) the pharmacist informs the patient or the
31-18 patient's agent at the time of dispensing that the refill is being
31-19 provided without such authorization and that authorization of the
31-20 practitioner is required for future refills; and
31-21 (5) the pharmacist informs the practitioner of the
31-22 emergency refill at the earliest reasonable time.
31-23 Sec. 40C. RELEASE OF CONFIDENTIAL RECORDS. Confidential
31-24 records are privileged and may be released only to:
31-25 (1) the patient or the patient's agent;
32-1 (2) practitioners and other pharmacists when, in the
32-2 pharmacist's professional judgment, such release is necessary to
32-3 protect the patient's health and well-being;
32-4 (3) other persons, the board, or other state or
32-5 federal agencies authorized by law to receive such confidential
32-6 records;
32-7 (4) a law enforcement agency engaged in investigation
32-8 of suspected violations of the Controlled Substances Act or
32-9 Dangerous Drug Act;
32-10 (5) a person employed by any state agency which
32-11 licenses a practitioner as defined in this Act if such person is
32-12 engaged in the performance of the person's official duties; or
32-13 (6) an insurance carrier or other third party payor
32-14 authorized by a patient to receive such information.
32-15 SECTION 13. Subdivision (41), Section 481.002, Health and
32-16 Safety Code, is amended to read as follows:
32-17 (41) "Prescription" means an order by a practitioner
32-18 to a pharmacist for a controlled substance for a particular patient
32-19 that specifies:
32-20 (A) the date of issue;
32-21 (B) the name and address of the patient or, if
32-22 the controlled substance is prescribed for an animal, the species
32-23 of the animal and the name and address of its owner;
32-24 (C) the name and quantity of the controlled
32-25 substance prescribed with the quantity shown numerically followed
33-1 by the number written as a word if the order is written or, if the
33-2 order is communicated orally or telephonically, with the quantity
33-3 given by the practitioner and transcribed by the pharmacist
33-4 numerically; <and>
33-5 (D) directions for the use of the drug;
33-6 (E) the intended use of the controlled substance
33-7 or the diagnosis for which the controlled substance is prescribed;
33-8 and
33-9 (F) the name, address, Federal Drug Enforcement
33-10 Administration registration number, and telephone number of the
33-11 practitioner at the practitioner's usual place of business, legibly
33-12 printed or stamped.
33-13 SECTION 14. Section 481.074, Health and Safety Code, is
33-14 amended by amending Subsections (d) through (i) and adding
33-15 Subsection (k) to read as follows:
33-16 (d) Except as specified in Subsections (e) and (f) of this
33-17 section, a <A> person may not fill a prescription for a controlled
33-18 substance listed in Schedule II after the end of the seventh day
33-19 after the date on which the prescription is issued. A person may
33-20 not refill a prescription for a substance listed in Schedule II.
33-21 (e) The partial filling of a prescription for a controlled
33-22 substance listed in Schedule II is permissible, if the pharmacist
33-23 is unable to supply the full quantity called for in a written or
33-24 emergency oral prescription and the pharmacist makes a notation of
33-25 the quantity supplied on the face of the written prescription or
34-1 written record of the emergency oral prescription. The remaining
34-2 portion of the prescription may be filled within 72 hours of the
34-3 first partial filling; however, if the remaining portion is not or
34-4 cannot be filled within the 72-hour period, the pharmacist shall so
34-5 notify the prescribing individual practitioner. No further
34-6 quantity may be supplied beyond 72 hours without a new
34-7 prescription.
34-8 (f) A prescription for a Schedule II controlled substance
34-9 written for a patient in a long-term care facility (LTCF) or for a
34-10 patient with a medical diagnosis documenting a terminal illness may
34-11 be filled in partial quantities to include individual dosage units.
34-12 If there is any question about whether a patient may be classified
34-13 as having a terminal illness, the pharmacist must contact the
34-14 practitioner prior to partially filling the prescription. Both the
34-15 pharmacist and the practitioner have a corresponding responsibility
34-16 to assure that the controlled substance is for a terminally ill
34-17 patient. The pharmacist must record on the prescription whether
34-18 the patient is "terminally ill" or an "LTCF patient." A
34-19 prescription that is partially filled and does not contain the
34-20 notation "terminally ill" or "LTCF patient" shall be deemed to have
34-21 been filled in violation of this Act. For each partial filling,
34-22 the dispensing pharmacist shall record on the back of Copy 1 and
34-23 Copy 2 of the prescription the date of the partial filling, the
34-24 quantity dispensed, the remaining quantity authorized to be
34-25 dispensed, and the identification of the dispensing pharmacist.
35-1 Prior to any subsequent partial filling the pharmacist is to
35-2 determine that the additional partial filling is necessary. The
35-3 total quantity of Schedule II controlled substances dispensed in
35-4 all partial fillings must not exceed the total quantity prescribed.
35-5 Schedule II prescriptions for patients in a long-term care facility
35-6 or patients with a medical diagnosis documenting a terminal illness
35-7 shall be valid for a period not to exceed 30 days from the issue
35-8 date unless sooner terminated by discontinuance of the medication.
35-9 (g) A person may not dispense a controlled substance in
35-10 Schedule III or IV that is a prescription drug under the Federal
35-11 Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.)
35-12 without a written, oral, or telephonically communicated
35-13 prescription of a practitioner defined by Section 481.002(39)(A),
35-14 except that the practitioner may dispense the substance directly to
35-15 an ultimate user. A prescription for a controlled substance listed
35-16 in Schedule III or IV may not be filled or refilled later than six
35-17 months after the date on which the prescription is issued and may
35-18 not be refilled more than five times, unless the prescription is
35-19 renewed by the practitioner.
35-20 (h) <(f)> A pharmacist may dispense a controlled substance
35-21 listed in Schedule III, IV, or V under an original written
35-22 prescription issued by a practitioner defined by Section
35-23 481.002(38)(C) and only if the pharmacist determines that the
35-24 prescription was issued for a valid medical purpose and in the
35-25 course of professional practice. A prescription issued under this
36-1 subsection may not be filled or refilled later than six months
36-2 after the date the prescription is issued, and a prescription
36-3 authorized to be refilled on the original prescription may not be
36-4 refilled more than five times.
36-5 (i) <(g)> A person may not dispense a controlled substance
36-6 listed in Section 481.036(1) or (2) without the prescription of a
36-7 practitioner defined by Section 481.002(39)(A), except that a
36-8 practitioner may dispense the substance directly to an ultimate
36-9 user. A prescription issued under this subsection may not be
36-10 filled or refilled later than six months after the date the
36-11 prescription is issued and may not be refilled more than five
36-12 times, unless the prescription is renewed by the practitioner.
36-13 (j) <(h)> A practitioner or institutional practitioner may
36-14 not allow a patient, on the patient's release from the hospital, to
36-15 possess a controlled substance prescribed by the practitioner
36-16 unless:
36-17 (1) the substance was dispensed under a medication
36-18 order while the patient was admitted to the hospital;
36-19 (2) the substance is in a properly labeled container;
36-20 and
36-21 (3) the patient possesses not more than a seven-day
36-22 supply of the substance.
36-23 (k) <(i)> A prescription for a controlled substance must
36-24 show:
36-25 (1) the quantity of the substance prescribed:
37-1 (A) numerically followed by the number written
37-2 as a word if the prescription is written; or
37-3 (B) if the prescription is communicated orally
37-4 or telephonically, as transcribed by the receiving pharmacist;
37-5 (2) the date of issue;
37-6 (3) the name and address of the patient or, if the
37-7 controlled substance is prescribed for an animal, the species of
37-8 the animal and the name and address of its owner;
37-9 (4) the name and strength of the controlled substance
37-10 prescribed;
37-11 (5) the directions for use of the controlled
37-12 substance; <and>
37-13 (6) the intended use of the controlled substance or
37-14 the diagnosis for which the controlled substance is prescribed; and
37-15 (7) the name, address, <and> Federal Drug Enforcement
37-16 Administration registration number, and telephone number of the
37-17 practitioner at the practitioner's usual place of business, legibly
37-18 printed or stamped.
37-19 (l) A pharmacist may exercise his professional judgment in
37-20 refilling a prescription for a controlled substance in Schedule
37-21 III, IV, or V without the authorization of the prescribing
37-22 practitioner provided:
37-23 (1) failure to refill the prescription might result in
37-24 an interruption of a therapeutic regimen or create patient
37-25 suffering;
38-1 (2) either:
38-2 (A) a natural or manmade disaster has occurred
38-3 which prohibits the pharmacist from being able to contact the
38-4 practitioner; or
38-5 (B) the pharmacist is unable to contact the
38-6 practitioner after reasonable effort;
38-7 (3) the quantity of prescription drug dispensed does
38-8 not exceed a 72-hour supply;
38-9 (4) the pharmacist informs the patient or the
38-10 patient's agent at the time of dispensing that the refill is being
38-11 provided without such authorization and that authorization of the
38-12 practitioner is required for future refills; and
38-13 (5) the pharmacist informs the practitioner of the
38-14 emergency refill at the earliest reasonable time.
38-15 SECTION 15. Subsections (d), (e), and (f), Section 481.075,
38-16 Health and Safety Code, are amended to read as follows:
38-17 (d) Except for oral prescriptions prescribed under Section
38-18 481.074(b), the prescribing practitioner shall:
38-19 (1) legibly fill in, or direct a designated agent to
38-20 legibly fill in, on all three copies of the form in the space
38-21 provided:
38-22 (A) the date the prescription is written;
38-23 (B) the drug prescribed, the quantity (shown
38-24 numerically followed by the number written as a word), <and>
38-25 instructions for use, and the intended use of the drug or the
39-1 diagnosis for which the controlled substance is prescribed; and
39-2 (C) the name, address, and age of the patient
39-3 or, in the case of an animal, its owner, for whom the controlled
39-4 substance is prescribed;
39-5 (2) sign Copies 1 and 2 of the form and give them to
39-6 the person authorized to receive the prescription; and
39-7 (3) retain Copy 3 of the form with the practitioner's
39-8 records for at least two years after the date the prescription is
39-9 written.
39-10 (e) In the case of an oral prescription prescribed under
39-11 Section 481.074(b), the prescribing practitioner shall give the
39-12 dispensing pharmacy the information needed to complete the form.
39-13 (f) Each dispensing pharmacist shall:
39-14 (1) fill in on Copies 1 and 2 of the form in the space
39-15 provided the information not required to be filled in by the
39-16 prescribing practitioner or the Department of Public Safety;
39-17 (2) indicate the total quantity dispensed on the face
39-18 of the triplicate prescription form;
39-19 (3) retain Copy 2 with the records of the pharmacy for
39-20 at least two years; <and>
39-21 (4) <(3)> sign Copy 1 and send it to the Department of
39-22 Public Safety not later than the 30th day after the date the
39-23 prescription is filled or not later than the 30th day after the
39-24 completion of a prescription dispensed under Section 481.074(f).
39-25 SECTION 16. Subchapter A, Chapter 483, Health and Safety
40-1 Code, is amended by adding Section 483.0001 and amending Section
40-2 483.001 to read as follows:
40-3 Sec. 483.0001. SHORT TITLE. This Act may be cited as the
40-4 Texas Dangerous Drug Act.
40-5 Sec. 483.001. DEFINITIONS. In this chapter:
40-6 (1) <(2)> "Board" means the Texas State Board of
40-7 Pharmacy.
40-8 (2) <(3)> "Dangerous drug" means a device or a drug
40-9 that is unsafe for self-medication and that is not included in
40-10 Schedules I through V or Penalty Groups 1 through 4 of Chapter 481
40-11 (Texas Controlled Substances Act). The term includes a device or a
40-12 drug that bears or is required to bear the legend:
40-13 (A) Caution: federal law prohibits dispensing
40-14 without prescription; or
40-15 (B) Caution: federal law restricts this drug to
40-16 use by or on the order of a licensed veterinarian.
40-17 (3) <(4)> "Deliver" means to sell, dispense, give
40-18 away, or supply in any other manner.
40-19 (4) "Designated agent" means:
40-20 (A) a licensed nurse, physician assistant,
40-21 pharmacist, or other individual designated by a practitioner to
40-22 communicate prescription drug orders to a pharmacist;
40-23 (B) a licensed nurse, physician assistant, or
40-24 pharmacist employed by a health care facility or agency to whom the
40-25 practitioner communicates a prescription drug order; or
41-1 (C) a registered nurse or physician assistant
41-2 authorized by a practitioner to carry out a prescription drug order
41-3 for dangerous drugs under Section 3.06(d)(5), Medical Practice Act
41-4 (Article 4495b, Vernon's Texas Civil Statutes).
41-5 (5) "Dispense" means to prepare, package, compound, or
41-6 label a dangerous drug in the course of professional practice for
41-7 delivery under the lawful order of a practitioner to an ultimate
41-8 user or the user's agent.
41-9 (6) "Manufacturer" means a person, other than a
41-10 pharmacist, who manufactures dangerous drugs. The term includes a
41-11 person who prepares dangerous drugs in dosage form by mixing,
41-12 compounding, encapsulating, entableting, or any other process.
41-13 (7) "Patient" means:
41-14 (A) an individual for whom a dangerous drug is
41-15 prescribed or to whom a dangerous drug is administered; or
41-16 (B) an owner or the agent of an owner of an
41-17 animal for which a dangerous drug is prescribed or to which a
41-18 dangerous drug is administered.
41-19 (8) "Person" includes an individual, corporation,
41-20 partnership, and association.
41-21 (9) "Pharmacist" means a person licensed by the Texas
41-22 State Board of Pharmacy to practice pharmacy.
41-23 (10) "Pharmacy" means a facility licensed by the board
41-24 pursuant to Section 29, Texas Pharmacy Act (Article 4542a-1,
41-25 Vernon's Texas Civil Statutes) <in which the practice of pharmacy
42-1 occurs>.
42-2 (11) "Practice of pharmacy" means:
42-3 (A) provision of those acts or services
42-4 necessary to provide pharmaceutical care;
42-5 (B) interpretation and evaluation of
42-6 prescription drug orders or medication orders;
42-7 (C) participation in drug and device selection
42-8 as authorized by law, drug administration, drug regimen review, or
42-9 drug or drug-related research;
42-10 (D) provision of patient counseling; and
42-11 (E) responsibility for:
42-12 (i) dispensing of prescription drug orders
42-13 or distribution of medication orders in the patient's best
42-14 interest;
42-15 (ii) compounding and labeling of drugs and
42-16 devices, except labeling by a manufacturer, repackager, or
42-17 distributor of nonprescription drugs and commercially packaged
42-18 prescription drugs and devices;
42-19 (iii) proper and safe storage of drugs and
42-20 devices; and
42-21 (iv) maintenance of proper records for
42-22 drugs and devices <the interpretation and evaluation of
42-23 prescription or medication orders, the dispensing and labeling of
42-24 drugs or devices, the selection of drugs and the review of drug
42-25 use, the storage of prescription drugs and devices and the
43-1 maintenance of prescription drug records in a pharmacy, the giving
43-2 of advice or consultation if necessary or required by law about the
43-3 therapeutic value, content, hazard, or use of drugs or devices, or
43-4 the offer to perform or the performance of the services and
43-5 transactions necessary to operate a pharmacy>. In this
43-6 subdivision, "device" has the meaning assigned by the Texas
43-7 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes).
43-8 (12) "Practitioner" means a person licensed:
43-9 (A) by the Texas State Board of Medical
43-10 Examiners, State Board of Dental Examiners, Texas State Board of
43-11 Podiatry Examiners, Texas Optometry Board, or State Board of
43-12 Veterinary Medical Examiners to prescribe and administer dangerous
43-13 drugs;
43-14 (B) by another state in a health field in which,
43-15 under the laws of this state, a licensee may legally prescribe
43-16 dangerous drugs; or
43-17 (C) in Canada or Mexico in a health field in
43-18 which, under the laws of this state, a licensee may legally
43-19 prescribe dangerous drugs.
43-20 (13) "Prescription" means an order from a
43-21 practitioner, or an agent of the practitioner designated in writing
43-22 as authorized to communicate prescriptions, or an order made in
43-23 accordance with Section 3.06(d)(5), Medical Practice Act (Article
43-24 4495b, Vernon's Texas Civil Statutes), to a pharmacist for a
43-25 dangerous drug to be dispensed that states:
44-1 (A) the date of the order's issue;
44-2 (B) the name and address of the patient;
44-3 (C) if the drug is prescribed for an animal, the
44-4 species of the animal;
44-5 (D) the name and quantity of the drug
44-6 prescribed; <and>
44-7 (E) the directions for the use of the drug;
44-8 (F) the intended use of the drug or the
44-9 diagnosis for which the drug is prescribed; and
44-10 (G) the name, address, and telephone number of
44-11 the practitioner at the practitioner's usual place of business,
44-12 legibly printed or stamped.
44-13 (14) "Warehouseman" means a person who stores
44-14 dangerous drugs for others and who has no control over the
44-15 disposition of the drugs except for the purpose of storage.
44-16 (15) "Wholesaler" means a person engaged in the
44-17 business of distributing dangerous drugs to a person listed in
44-18 Sections 483.041(c)(1)-(6).
44-19 SECTION 17. Section 483.022, Health and Safety Code, is
44-20 amended to read as follows:
44-21 Sec. 483.022. Practitioner's Designated Agent;
44-22 Practitioner's Responsibilities. (a) A practitioner shall provide
44-23 in writing the name of each<:>
44-24 <(1)> designated agent as defined by Section
44-25 483.001(4)(A) and (C), and the name of each healthcare facility or
45-1 agency which employs persons defined by Section 483.001(4)(B)
45-2 <authorized by the practitioner to communicate prescriptions for
45-3 the practitioner; and>
45-4 <(2) registered nurse or physician assistant
45-5 authorized to carry out a prescription drug order under Section
45-6 3.06(d)(5), Medical Practice Act (Article 4495b, Vernon's Texas
45-7 Civil Statutes)>.
45-8 (b) The practitioner shall maintain at the practitioner's
45-9 usual place of business a list of the designated agents or
45-10 healthcare facilities or agencies as defined by Section 483.001(4)
45-11 <and a list of the designated registered nurses or physician
45-12 assistants authorized to carry out a prescription drug order>.
45-13 <(b) The practitioner shall maintain at the practitioner's
45-14 usual place of business a list of each designated agent, registered
45-15 nurse, or physician assistant who is authorized to carry out a
45-16 prescription drug order.>
45-17 (c) The practitioner shall provide a pharmacist with a copy
45-18 of the practitioner's written authorization for a designated agent
45-19 as defined by Section 483.001(4)<, registered nurse, or physician
45-20 assistant> on the pharmacist's request.
45-21 (d) This section does not relieve a practitioner or the
45-22 practitioner's designated agent from the requirements of Section
45-23 40, Texas Pharmacy Act (Article 4542a-1, Vernon's Texas Civil
45-24 Statutes).
45-25 (e) A practitioner remains personally responsible for the
46-1 actions of a designated agent who communicates a prescription to a
46-2 pharmacist.
46-3 SECTION 18. Subsection (d), Section 483.041, Health and
46-4 Safety Code, is amended to read as follows:
46-5 (d) An offense under this section is a felony of the third
46-6 degree <Class B misdemeanor unless it is shown on the trial of the
46-7 defendant that the defendant has previously been convicted of an
46-8 offense under this section, in which event the offense is a Class A
46-9 misdemeanor>.
46-10 SECTION 19. Section 483.042, Health and Safety Code, is
46-11 amended by amending Subsections (c) and (d) to read as follows:
46-12 (c) The labeling provisions of Subsection (a) do not apply
46-13 when the dangerous drug is prescribed for administration to an
46-14 ultimate user who is institutionalized. The board shall adopt
46-15 rules for the labeling of such drugs.
46-16 (d) Proof of an offer to sell a dangerous drug must be
46-17 corroborated by a person other than the offeree or by evidence
46-18 other than a statement by the offeree.
46-19 (e) <(d)> An offense under this section is a felony of the
46-20 third degree.
46-21 SECTION 20. Section 483.047, Health and Safety Code, is
46-22 amended to read as follows:
46-23 Sec. 483.047. Refilling Prescription Without Authorization.
46-24 (a) Except as authorized by Subsection (b), a <A> pharmacist
46-25 commits an offense if the pharmacist refills a prescription unless:
47-1 (1) the prescription contains an authorization by the
47-2 practitioner for the refilling of the prescription, and the
47-3 pharmacist refills the prescription in the manner provided by the
47-4 authorization; or
47-5 (2) at the time of refilling the prescription, the
47-6 pharmacist is authorized to do so by the practitioner who issued
47-7 the prescription.
47-8 (b) A pharmacist may exercise his professional judgment in
47-9 refilling a prescription for a dangerous drug without the
47-10 authorization of the prescribing practitioner provided:
47-11 (1) failure to refill the prescription might result in
47-12 an interruption of a therapeutic regimen or create patient
47-13 suffering;
47-14 (2) either:
47-15 (A) a natural or manmade disaster has occurred
47-16 which prohibits the pharmacist from being able to contact the
47-17 practitioner; or
47-18 (B) the pharmacist is unable to contact the
47-19 practitioner after reasonable effort;
47-20 (3) the quantity of drug dispensed does not exceed a
47-21 72-hour supply;
47-22 (4) the pharmacist informs the patient or the
47-23 patient's agent at the time of dispensing that the refill is being
47-24 provided without such authorization and that authorization of the
47-25 practitioner is required for future refills; and
48-1 (5) the pharmacist informs the practitioner of the
48-2 emergency refill at the earliest reasonable time.
48-3 (c) An offense under this section is a Class B misdemeanor
48-4 unless it is shown on the trial of the defendant that the defendant
48-5 has previously been convicted under this chapter, in which event
48-6 the offense is a Class A misdemeanor.
48-7 SECTION 21. This Act takes effect September 1, 1993.
48-8 SECTION 22. (a) A change in law made by this Act which
48-9 applies to a criminal offense applies only to an offense committed
48-10 on or after the effective date of this Act. For purposes of this
48-11 section, an offense is committed before the effective date of this
48-12 Act if any element of the offense occurs before that date.
48-13 (b) A criminal offense committed before the effective date
48-14 of this Act is covered by the law in effect when the offense was
48-15 committed, and the former law is continued in effect for this
48-16 purpose.
48-17 SECTION 23. The importance of this legislation and the
48-18 crowded condition of the calendars in both houses create an
48-19 emergency and an imperative public necessity that the
48-20 constitutional rule requiring bills to be read on three several
48-21 days in each house be suspended, and this rule is hereby
48-22 suspended."