S.B. No. 472
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 providing penalties.
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) "Class F pharmacy license" means a license issued
2-25 to a pharmacy located in a facility licensed under Chapter 142,
3-1 Health and Safety Code, for the purpose of dispensing,
3-2 distributing, or administering to their patients under physicians'
3-3 orders the following dangerous drugs: sterile water for injection
3-4 and irrigation, sterile saline for injection and irrigation, and
3-5 heparin flush kits for intravenous flushes.
3-6 (11) "College of pharmacy" means a school, university,
3-7 or college of pharmacy that satisfies the accreditation standards
3-8 of A.C.P.E. as adopted by the board; or that has degree
3-9 requirements which meet the standards of accreditation set by the
3-10 board.
3-11 (12) "Compounding" means the preparation, mixing,
3-12 assembling, packaging, or labeling of a drug or device:
3-13 (A) as the result of a practitioner's
3-14 prescription drug order or initiative based on the
3-15 practitioner-patient-pharmacist relationship in the course of
3-16 professional practice;
3-17 (B) in anticipation of prescription drug orders
3-18 based on routine, regularly observed prescribing patterns; or
3-19 (C) for the purpose of or as an incident to
3-20 research, teaching, or chemical analysis and not for sale or
3-21 dispensing.
3-22 (13) "Confidential record" means any health-related
3-23 record maintained by a pharmacy or pharmacist such as a patient
3-24 medication record, prescription drug order, or medication order.
3-25 (14) <(11)> "Controlled substance" means a drug,
4-1 immediate precursor, or other substance listed in Schedules I-V or
4-2 Penalty Groups 1-4 of Chapter 481, Health and Safety Code, or a
4-3 drug, immediate precursor, or other substance included in Schedule
4-4 I, II, III, IV, or V of the Federal Comprehensive Drug Abuse
4-5 Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
4-6 (15) <(12)> "Controlled Substances Act" means Chapter
4-7 481, Health and Safety Code, or the Federal Comprehensive Drug
4-8 Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et
4-9 seq.).
4-10 (16) <(13)> "Dangerous drug" means any drug or device
4-11 that is not included in Penalty Groups 1-4 of the Controlled
4-12 Substances Act and that is unsafe for self-medication or any drug
4-13 or device that bears or is required to bear the legend:
4-14 (A) "Caution: federal law prohibits dispensing
4-15 without prescription"; or
4-16 (B) "Caution: federal law restricts this drug
4-17 to use by or on the order of a licensed veterinarian."
4-18 (17) <(14)> "Dangerous Drug Act" means Chapter 483,
4-19 Health and Safety Code.
4-20 (18) <(15)> "Deliver" or "delivery" means the actual,
4-21 constructive, or attempted transfer of a prescription drug or
4-22 device or controlled substance from one person to another, whether
4-23 or not for a consideration.
4-24 (19) <(15)> "Designated agent" means:
4-25 (A) a licensed nurse, physician assistant,
5-1 pharmacist, or other <an> individual <under the supervision of a
5-2 practitioner,> designated by a <the> practitioner, and for whom the
5-3 practitioner assumes legal responsibility, who communicates
5-4 prescription drug orders <the practitioner's instructions> to a
5-5 pharmacist;
5-6 (B) a licensed nurse, physician assistant, or
5-7 pharmacist employed in a health care facility to whom the
5-8 practitioner communicates a prescription drug order; or
5-9 (C) a registered nurse or physician assistant
5-10 authorized by a practitioner to carry out a prescription drug order
5-11 for dangerous drugs under Subdivision (5), Subsection (d), Section
5-12 3.06, Medical Practice Act (Article 4495b, Vernon's Texas Civil
5-13 Statutes).
5-14 (20) <(16)> "Device" means an instrument, apparatus,
5-15 implement, machine, contrivance, implant, in vitro reagent, or
5-16 other similar or related article, including any component part or
5-17 accessory, that is required under federal or state law to be
5-18 ordered or prescribed by a practitioner.
5-19 (21) <(17)> "Dispense" means preparing, packaging,
5-20 compounding, or labeling for delivery a prescription drug or device
5-21 in the course of professional practice to an ultimate user or his
5-22 agent by or pursuant to the lawful order of a practitioner.
5-23 (22) <(18)> "Distribute" means the delivery of a
5-24 prescription drug or device other than by administering or
5-25 dispensing.
6-1 (23) <(19)> "Drug" means:
6-2 (A) a substance recognized as drugs in the
6-3 current official United States Pharmacopoeia, official National
6-4 Formulary, official Homeopathic Pharmacopoeia, or other drug
6-5 compendium or any supplement to any of them;
6-6 (B) a substance intended for use in the
6-7 diagnosis, cure, mitigation, treatment, or prevention of disease in
6-8 man or other animals;
6-9 (C) a substance, other than food, intended to
6-10 affect the structure or any function of the body of man or other
6-11 animals;
6-12 (D) a substance intended for use as a component
6-13 of any articles specified in Paragraph (A), (B), or (C) of this
6-14 subdivision;
6-15 (E) a dangerous drug; or
6-16 (F) a controlled substance.
6-17 (24) "Drug regimen review" includes the following
6-18 activities:
6-19 (A) evaluation of prescription drug or
6-20 medication orders and patient medication records for:
6-21 (i) known allergies;
6-22 (ii) rational therapy-contraindications;
6-23 (iii) reasonable dose and route of
6-24 administration; and
6-25 (iv) reasonable directions for use;
7-1 (B) evaluation of prescription drug or
7-2 medication orders and patient medication records for duplication of
7-3 therapy;
7-4 (C) evaluation of prescription drug or
7-5 medication orders and patient medication records for:
7-6 (i) drug-drug interactions;
7-7 (ii) drug-food interactions;
7-8 (iii) drug-disease interactions;
7-9 (iv) adverse drug reactions; and
7-10 (D) evaluation of prescription drug and
7-11 medication orders and patient medication records for proper
7-12 utilization, including overutilization or underutilization.
7-13 (25) <(20)> "Internship" means a practical experience
7-14 program that is approved by the board.
7-15 (26) <(21)> "Label" means written, printed, or graphic
7-16 matter on the immediate container of a drug or device.
7-17 (27) <(22)> "Labeling" means the process of affixing a
7-18 label including all information required by federal and state law
7-19 or regulation to any drug or device container. The term does not
7-20 include the labeling by a manufacturer, packer, or distributor of a
7-21 nonprescription drug or commercially packaged prescription drug or
7-22 device, or unit dose packaging.
7-23 (28) "Manufacturing" means the production,
7-24 preparation, propagation, conversion, or processing of a drug or
7-25 device, either directly or indirectly, by extraction from
8-1 substances of natural origin or independently by means of chemical
8-2 or biological synthesis and includes any packaging or repackaging
8-3 of the substances or labeling or relabeling of the container and
8-4 the promotion and marketing of such drugs or devices.
8-5 Manufacturing also includes the preparation and promotion of
8-6 commercially available products from bulk compounds for resale by
8-7 pharmacies, practitioners, or other persons but does not include
8-8 compounding.
8-9 (29) <(23)> "Medication order" means an order from a
8-10 practitioner or a practitioner's designated agent for
8-11 administration of a drug or device.
8-12 (30) <(24)> "Nonprescription drug" means a nonnarcotic
8-13 drug or device that may be sold without a prescription and that is
8-14 labeled and packaged in compliance with applicable state or federal
8-15 law.
8-16 (31) "Patient counseling" means the communication by
8-17 the pharmacist of information, as specified in the rules of the
8-18 board, to the patient or caregiver, in order to improve therapy by
8-19 ensuring proper use of drugs and devices.
8-20 (32) <(25)> "Person" means an individual, corporation,
8-21 government or governmental subdivision or agency, business trust,
8-22 estate, trust, partnership, association, or any other legal entity.
8-23 (33) "Pharmaceutical care" is the provision of drug
8-24 therapy and other pharmaceutical services defined in the rules of
8-25 the board and intended to assist in the cure or prevention of a
9-1 disease, elimination or reduction of a patient's symptoms, or
9-2 arresting or slowing of a disease process.
9-3 (34) <(26)> "Pharmacist" means a person licensed by
9-4 the board to practice pharmacy.
9-5 (35) <(27)> "Pharmacist-in-charge" means the
9-6 pharmacist designated on a pharmacy license as the pharmacist who
9-7 has the authority or responsibility for a pharmacy's compliance
9-8 with laws and rules pertaining to the practice of pharmacy.
9-9 (36) <(28)> "Pharmacist-intern" means an undergraduate
9-10 student enrolled in the professional sequence of a college of
9-11 pharmacy approved by the board and participating in a school-based,
9-12 board-approved internship program or a graduate of a college of
9-13 pharmacy who is participating in a board-approved internship.
9-14 (37) <(29)> "Pharmacy" means a facility licensed by
9-15 the board pursuant to Section 29 of this Act <where the practice of
9-16 pharmacy occurs>.
9-17 (38) <(30)> "Practice of pharmacy" means:
9-18 (A) provision of those acts or services
9-19 necessary to provide pharmaceutical care;
9-20 (B) interpretation and evaluation of
9-21 prescription drug orders or medication orders;
9-22 (C) participation in drug and device selection
9-23 as authorized by law, drug administration, drug regimen review, or
9-24 drug or drug-related research;
9-25 (D) provision of patient counseling; and
10-1 (E) responsibility for:
10-2 (i) dispensing of prescription drug orders
10-3 or distribution of medication orders;
10-4 (ii) compounding and labeling of drugs and
10-5 devices, except labeling by a manufacturer, repackager, or
10-6 distributor of nonprescription drugs and commercially packaged
10-7 prescription drugs and devices;
10-8 (iii) proper and safe storage of drugs and
10-9 devices; or
10-10 (iv) maintenance of proper records for
10-11 drugs and devices <interpreting and evaluating prescription or
10-12 medication orders, dispensing and labeling drugs or devices,
10-13 selecting drugs and reviewing drug utilization, storing
10-14 prescription drugs and devices and maintaining prescription drug
10-15 records in a pharmacy, advising or consulting when necessary or
10-16 required by law about therapeutic value, content, hazard, or use of
10-17 drugs or devices, or offering or performing the services and
10-18 transactions necessary to operate a pharmacy>.
10-19 (39) <(31)> "Practitioner" means:
10-20 (A) a physician, dentist, podiatrist,
10-21 veterinarian, or other person licensed or registered to prescribe,
10-22 distribute, administer, or dispense a prescription drug or device
10-23 in the course of professional practice in this state;
10-24 (B) a person licensed by another state in a
10-25 health field in which, under Texas law, licensees in this state may
11-1 legally prescribe dangerous drugs or a person practicing in another
11-2 state and licensed by another state as a physician, dentist,
11-3 veterinarian, or podiatrist, having a current Federal Drug
11-4 Enforcement Administration registration number, and who may legally
11-5 prescribe Schedule II, III, IV, or V controlled substances in such
11-6 other state; or
11-7 (C) a person licensed in the Dominion of Canada
11-8 or the United Mexican States in a health field in which, under the
11-9 laws of this state, a licensee may legally prescribe dangerous
11-10 drugs. "Practitioner" does not include a person licensed under
11-11 this Act.
11-12 (40) <(32)> "Preceptor" means a pharmacist in good
11-13 standing licensed in this state to practice pharmacy and certified
11-14 by the board to supervise and be responsible for the activities and
11-15 functions of a pharmacist-intern in the internship program.
11-16 (41) <(33)> "Prescription drug" means:
11-17 (A) a substance for which federal or state law
11-18 requires a prescription before it may be legally dispensed to the
11-19 public;
11-20 (B) a drug or device that under federal law is
11-21 required, prior to being dispensed or delivered, to be labeled with
11-22 either of the following statements:
11-23 (i) "Caution: federal law prohibits
11-24 dispensing without prescription"; or
11-25 (ii) "Caution: federal law restricts this
12-1 drug to use by or on the order of a licensed veterinarian"; or
12-2 (C) a drug or device that is required by any
12-3 applicable federal or state law or regulation to be dispensed on
12-4 prescription only or is restricted to use by a practitioner only.
12-5 (42) <(34)> "Prescription drug order" means:
12-6 (A) an order from a practitioner or a
12-7 practitioner's designated agent to a pharmacist for a drug or
12-8 device to be dispensed; or
12-9 (B) an order pursuant to Subdivision (5),
12-10 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
12-11 Vernon's Texas Civil Statutes).
12-12 (43) "Prospective drug use review" means a review of
12-13 the patient's drug therapy and prescription drug order or
12-14 medication order, as defined in the rules of the board, prior to
12-15 dispensing or distributing the drug.
12-16 (44) <(35)> "Provide" means to supply one or more unit
12-17 doses of a nonprescription drug or dangerous drug to a patient.
12-18 (45) <(36)> "Radioactive drug" means a drug that
12-19 exhibits spontaneous disintegration of unstable nuclei with the
12-20 emission of nuclear particles or photons, including any
12-21 nonradioactive reagent kit or nuclide generator that is intended to
12-22 be used in the preparation of any such substance.
12-23 (46) <(37)> "Substitution" means the dispensing of a
12-24 drug or a brand of drug other than that which is ordered or
12-25 prescribed.
13-1 (47) <(38)> "Supportive personnel" means those
13-2 individuals utilized in pharmacies whose responsibility it shall be
13-3 to provide <nonjudgmental> technical services that do not require
13-4 professional judgment concerned with the preparation and
13-5 distribution of drugs under the direct supervision of and
13-6 responsible to a pharmacist.
13-7 (48) <(39)> "Ultimate user" means a person who has
13-8 obtained and possesses a prescription drug or device for the
13-9 person's own use or for the use of a member of the person's
13-10 household or for administering to an animal owned by the person or
13-11 by a member of the person's household.
13-12 (49) <(40)> "Unit dose packaging" means the ordered
13-13 amount of drug in a dosage form ready for administration to a
13-14 particular patient, by the prescribed route at the prescribed time,
13-15 and properly labeled with name, strength, and expiration date of
13-16 the drug.
13-17 <(41) "Authorized agent" means an individual under the
13-18 supervision of a practitioner, designated by the practitioner, and
13-19 for whom the practitioner assumes legal responsibility, who
13-20 communicates the practitioner's instructions to the pharmacist.>
13-21 SECTION 2. Section 16, Texas Pharmacy Act (Article 4542a-1,
13-22 Vernon's Texas Civil Statutes), is amended to read as follows:
13-23 Sec. 16. Rules. (a) The board shall adopt, amend, and
13-24 repeal rules for the proper administration and enforcement of this
13-25 Act, consistent with this Act. The rules shall be adopted,
14-1 amended, or repealed in accordance with the Administrative
14-2 Procedure Act.
14-3 (b) If the board determines it necessary in order to
14-4 protect the health and welfare of the citizens of this state, it
14-5 may make a rule concerning the operation of a licensed pharmacy
14-6 located in this state also applicable to pharmacies licensed by the
14-7 board that are located in another state.
14-8 (c) The board may not adopt rules restricting
14-9 competitive bidding or advertising by a person regulated by the
14-10 board except to prohibit false, misleading, or deceptive practices
14-11 by the person.
14-12 SECTION 3. Subsections (a), (b), and (q), Section 17, Texas
14-13 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
14-14 amended to read as follows:
14-15 (a) The board is responsible for the regulation of the
14-16 practice of pharmacy in this state, including the following:
14-17 (1) the licensing by examination or by reciprocity of
14-18 applicants who are qualified to engage in the practice of pharmacy
14-19 and the licensing of pharmacies under this Act;
14-20 (2) the renewal of licenses to engage in the practice
14-21 of pharmacy and licenses to operate pharmacies;
14-22 (3) the determination and issuance of standards for
14-23 recognition and approval of degree requirements of colleges of
14-24 pharmacy whose graduates shall be eligible for licensing in this
14-25 state and the specification and enforcement of requirements for
15-1 practical training, including internship;
15-2 (4) the enforcement of those provisions of this Act
15-3 relating to the conduct or competence of pharmacists practicing in
15-4 this state and the conduct of pharmacies operating in this state
15-5 and the suspension, revocation, fining, reprimanding, cancellation,
15-6 or restriction of licenses to engage in the practice of pharmacy or
15-7 to operate a pharmacy;
15-8 (5) the specifications of conditions under which a
15-9 pharmacist may administer medications which at a minimum shall
15-10 include the following:
15-11 (A) a licensed health care provider authorized
15-12 to administer the medication is not reasonably available to
15-13 administer the medication;
15-14 (B) failure to administer the medication might
15-15 result in a significant delay or interruption of a critical phase
15-16 of drug therapy;
15-17 (C) the pharmacist possesses the necessary skill
15-18 and education to administer the medication;
15-19 (D) the pharmacist notifies the appropriate
15-20 licensed health care provider responsible for the patient's care
15-21 within a reasonable time that the medication was administered;
15-22 (E) a pharmacist may not administer medications
15-23 to a patient where the patient resides, except in a licensed
15-24 nursing home or hospital;
15-25 (F) the authority of the pharmacist to
16-1 administer medications may not be delegated;
16-2 (G) nothing in this subdivision shall be
16-3 construed to prohibit a pharmacist from preparing or manipulating
16-4 biotechnological agents or devices; and
16-5 (H) nothing in this subdivision shall be
16-6 construed as prohibiting a pharmacist from performing an act
16-7 delegated by a physician in accordance with the provisions of
16-8 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
16-9 Vernon's Texas Civil Statutes), and the pharmacist performing such
16-10 a delegated medical act shall be considered to be performing a
16-11 medical act and not as engaged in the practice of pharmacy;
16-12 (6) the regulation of the training, qualifications,
16-13 and employment of pharmacist-interns; and
16-14 (7) <(6)> the enforcement of this Act and any rules
16-15 adopted under this Act.
16-16 (b) The board has the following responsibilities relating to
16-17 the practice of pharmacy and to prescription drugs and devices used
16-18 in this state in the diagnosis, mitigation, and treatment or
16-19 prevention of injury, illness, and disease:
16-20 (1) regulation of the delivery or distribution of
16-21 prescription drugs and devices, including the right to seize, after
16-22 notice and hearing, any prescription drugs or devices posing a
16-23 hazard to the public health and welfare, but the board may not
16-24 regulate:
16-25 (A) manufacturers' representatives or employees
17-1 acting in the normal course of business;
17-2 (B) persons engaged in the wholesale drug
17-3 business and registered with the commissioner of health as provided
17-4 by Chapter 431, Health and Safety Code; or
17-5 (C) employees of persons engaged in the
17-6 wholesale drug business and registered with the commissioner of
17-7 health as provided by Chapter 431, Health and Safety Code, if the
17-8 employees are acting in the normal course of business;
17-9 (2) specification of minimum standards for
17-10 professional environment, technical equipment, and security in the
17-11 prescription dispensing area;
17-12 (3) specification of minimum standards for drug
17-13 storage, maintenance of prescription drug records, and procedures
17-14 for the delivery, dispensing in a suitable container appropriately
17-15 labeled, <or> providing of prescription drugs or devices,
17-16 monitoring of drug therapy, and counseling of patients on proper
17-17 use of prescription drugs and devices within the practice of
17-18 pharmacy; and
17-19 (4) adoption of rules regulating a prescription drug
17-20 order or medication order transmitted by electronic means <a
17-21 facsimile or FAX machine>.
17-22 (q) Board investigative files and all information and
17-23 materials compiled by the board in connection with an investigation
17-24 are confidential and are not subject to disclosure under
17-25 <considered open records for purposes of> Chapter 424, Acts of the
18-1 63rd Legislature, Regular Session, 1973, as amended (Article
18-2 6252-17a, Vernon's Texas Civil Statutes), and are not subject to
18-3 disclosure, discovery, subpoena, or other means of legal compulsion
18-4 for their release to anyone other than the board or its employees
18-5 or agents involved in licensee discipline except that this
18-6 information may be disclosed to:
18-7 (1) persons involved with the board in a disciplinary
18-8 action against the licensee;
18-9 (2) pharmacist or pharmacy licensing or disciplinary
18-10 authorities of other jurisdictions;
18-11 (3) a pharmaceutical peer review committee as outlined
18-12 in Section 27A of this Act;
18-13 (4) law enforcement agencies; and
18-14 (5) persons engaged in bona fide research, if all
18-15 individual-identifying information has been deleted.
18-16 SECTION 4. Subsection (f), Section 19, Texas Pharmacy Act
18-17 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
18-18 read as follows:
18-19 (f) This Act does not apply to:
18-20 (1) a member of the faculty of a college of pharmacy
18-21 that is recognized by the board if the faculty member is a licensed
18-22 pharmacist and performs his services for the benefit of the college
18-23 only;
18-24 (2) a pharmacist-intern; or
18-25 (3) a person who procures prescription drugs for
19-1 lawful research, teaching, or testing and not for resale<; or>
19-2 <(4) a home health agency possessing dangerous drugs
19-3 as authorized by Section 142.0061, Health and Safety Code>.
19-4 SECTION 5. Subsection (c), Section 21, Texas Pharmacy Act
19-5 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
19-6 read as follows:
19-7 (c) The examinations for licensing required under this
19-8 section shall be given by the board at least two times during the
19-9 fiscal year of the state. The board shall determine the content
19-10 and subject matter of each examination and determine which persons
19-11 have successfully passed the examination. An applicant who fails
19-12 the examination may retake the examination two additional times.
19-13 Before an applicant who has failed the examination three times is
19-14 allowed to retake the examination, the applicant shall provide
19-15 documentation from a college of pharmacy that additional college
19-16 course work in subject areas the applicant failed in the
19-17 examination has been successfully completed. If a person who fails
19-18 the licensing examination administered under this Act so requests
19-19 in writing, the board shall furnish the person an analysis of his
19-20 performance on the examination.
19-21 SECTION 6. Subsection (a), Section 26, Texas Pharmacy Act
19-22 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
19-23 read as follows:
19-24 (a) Grounds for Disciplining a Holder of a Pharmacist
19-25 License: The board shall refuse to issue a pharmacist license for
20-1 failure to meet the requirements of Section 21 or 22 of this Act.
20-2 The board may in its discretion refuse to issue or renew a license
20-3 or may fine, reprimand, revoke, restrict, cancel, retire, or
20-4 suspend any license granted by the board<,> and may probate any
20-5 license suspension if the board finds that the applicant or
20-6 licensee has:
20-7 (1) violated any provision of this Act or any of the
20-8 rules of the board adopted under this Act;
20-9 (2) engaged in unprofessional conduct as that term is
20-10 defined by the rules of the board;
20-11 (3) engaged in gross immorality as that term is
20-12 defined by the rules of the board;
20-13 (4) developed an incapacity of a nature that prevents
20-14 a pharmacist or applicant from engaging in the practice of pharmacy
20-15 with reasonable skill, competence, and safety to the public. In
20-16 enforcing this subdivision, the board shall, on probable cause,
20-17 request a pharmacist or applicant to submit to a mental or physical
20-18 examination by physicians or other health care professionals
20-19 designated by the board. If the pharmacist or applicant refuses to
20-20 submit to the examination, the board shall issue an order requiring
20-21 the pharmacist or applicant to show cause why he will not submit to
20-22 the examination and shall schedule a hearing on the order within 30
20-23 days after notice is served on the pharmacist or applicant. The
20-24 pharmacist or applicant shall be notified by either personal
20-25 service or certified mail with return receipt requested. At the
21-1 hearing, the pharmacist or applicant and his attorney are entitled
21-2 to present any testimony and other evidence to show why the
21-3 pharmacist or applicant should not be required to submit to the
21-4 examination. After the hearing, the board shall issue an order
21-5 either requiring the pharmacist or applicant to submit to the
21-6 examination or withdrawing the request for examination;
21-7 (5) engaged in any fraud, deceit, or misrepresentation
21-8 as those words are defined by the rules of the board in the
21-9 practice of pharmacy or in seeking a license to act as a
21-10 pharmacist;
21-11 (6) been convicted of a felony or a misdemeanor
21-12 involving moral turpitude by a court of competent jurisdiction;
21-13 (7) a drug or alcohol dependency;
21-14 (8) failed to keep and maintain records required by
21-15 this Act or failed to keep and maintain complete and accurate
21-16 records of purchases and disposals of drugs listed in the
21-17 Controlled Substances Act or the Dangerous Drug Act;
21-18 (9) violated any provision of the Controlled
21-19 Substances Act or Dangerous Drug Act or a rule relating to those
21-20 acts or any provision of Sections 485.031-485.035, Health and
21-21 Safety Code, or a rule adopted under Section 485.011, Health and
21-22 Safety Code;
21-23 (10) aided or abetted an unlicensed individual to
21-24 engage in the practice of pharmacy if the pharmacist knew or
21-25 reasonably should have known that the individual was unlicensed at
22-1 the time;
22-2 (11) refused an entry into any pharmacy for any
22-3 inspection authorized by this Act if the pharmacist had received
22-4 notification from which the pharmacist knew or reasonably should
22-5 have known that the attempted inspection was authorized;
22-6 (12) violated the pharmacy or drug laws or rules of
22-7 this state or any other state or of the United States;
22-8 (13) been negligent in the practice of pharmacy;
22-9 (14) failed to submit to an examination after hearing
22-10 and being ordered to do so by the board pursuant to Subdivision (4)
22-11 of this subsection;
22-12 (15) dispensed prescription drugs while acting outside
22-13 the usual course and scope of professional practice; or
22-14 (16) had a license to practice pharmacy issued by
22-15 another state canceled, revoked, surrendered, or suspended for
22-16 conduct substantially equivalent to conduct described in
22-17 Subdivisions (1) through (15) of this subsection. A certified copy
22-18 of the record of the state taking action as set out above shall be
22-19 conclusive evidence of the action taken by such state.
22-20 SECTION 7. Subsections (a) and (b), Section 26A, Texas
22-21 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
22-22 amended to read as follows:
22-23 (a) On the entry of an initial order against an applicant
22-24 for a license to practice pharmacy or a person licensed by the
22-25 board to practice pharmacy, the board may refuse to issue a license
23-1 to the applicant or suspend the person's license. On the person's
23-2 final conviction, the board may revoke the person's license.
23-3 (b) On the entry of an initial order against an applicant
23-4 for a license for a pharmacy or a person who has been issued a
23-5 license or renewal license for a pharmacy under this Act, or
23-6 against a managing officer of the licensee or applicant if the
23-7 licensee or applicant is an association, joint-stock company,
23-8 partnership, or corporation, the board may refuse to issue the
23-9 license or suspend the license. On final conviction, the board may
23-10 revoke the license.
23-11 SECTION 8. Subsection (a), Section 26B, Texas Pharmacy Act
23-12 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
23-13 read as follows:
23-14 (a) The board may in its discretion refuse to issue or renew
23-15 a license or may fine or reprimand any licensee or revoke,
23-16 restrict, cancel, or suspend any license granted by the board, if
23-17 the board finds that an applicant or licensee has:
23-18 (1) dispensed a drug, quantity, or strength of drug
23-19 other than that which is ordered for the patient by a practitioner
23-20 or labeled a prescription with incorrect directions for use;
23-21 (2) violated any of the following provisions of this
23-22 Act:
23-23 (A) Section 29(a), (b)(5), or (c)(5);
23-24 (B) Section 30(i) or (j); or
23-25 (C) Section 32(a);
24-1 (3) failed to comply with the following requirements
24-2 unless compliance would violate the pharmacy or drug laws or rules
24-3 in the state in which the pharmacy is located:
24-4 (A) Section 481.074 or 481.075, Health and
24-5 Safety Code;
24-6 (B) Texas substitution requirements regarding:
24-7 (i) the practitioner's directions relative
24-8 to generic substitution;
24-9 (ii) the patient's right to refuse generic
24-10 substitution; or
24-11 (iii) notification to the patient of the
24-12 patient's right to refuse substitution; <or>
24-13 (C) board rules relating to the provision of
24-14 drug information to the patient or patient's agent in written form
24-15 or by telephone; or
24-16 (D) board rules adopted pursuant to Section
24-17 16(a) of this Act and determined by the board to be applicable
24-18 pursuant to Section 16(b) of this Act; or
24-19 (4) engaged in conduct which caused serious bodily
24-20 injury to a Texas resident.
24-21 SECTION 9. Section 27A, Texas Pharmacy Act (Article 4542a-1,
24-22 Vernon's Texas Civil Statutes), is amended by amending Subsection
24-23 (d) and adding Subsection (j) to read as follows:
24-24 (d) The records and proceedings of the board, its authorized
24-25 agents, or any pharmaceutical organization committee as set out in
25-1 Subsections (a) and (b) of this section shall be confidential and
25-2 are not considered open records for the purposes of Chapter 424,
25-3 Acts of the 63rd Legislature, Regular Session, 1973, as amended
25-4 (Article 6252-17a, Vernon's Texas Civil Statutes); provided,
25-5 however, the board may disclose this confidential information only:
25-6 (1) in a disciplinary hearing before the board or in a
25-7 subsequent trial or appeal of a board action or order;
25-8 (2) to the pharmacist licensing or disciplinary
25-9 authorities of other jurisdictions; <or>
25-10 (3) pursuant to an order of a court of competent
25-11 jurisdiction; or
25-12 (4) pursuant to Subsection (j) of this section.
25-13 (j) The board may disclose that the license of a pharmacist
25-14 who is the subject of an order of the board deemed confidential by
25-15 Subsection (d) of this section is suspended, revoked, canceled,
25-16 restricted, or retired or that the pharmacist is in any manner
25-17 otherwise limited in the practice of pharmacy; however, the board
25-18 may not disclose the nature of the impairment or other information
25-19 that resulted in such action.
25-20 SECTION 10. Subsection (b), Section 28, Texas Pharmacy Act
25-21 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
25-22 read as follows:
25-23 (b) A person whose pharmacy license or license to practice
25-24 pharmacy in this state has been canceled, revoked, or restricted
25-25 under this Act, whether voluntarily or by action of the board, may,
26-1 after 12 months from the effective date of the cancellation,
26-2 revocation, or restriction, petition the board for reinstatement or
26-3 removal of the restriction of the license. The petition shall be
26-4 in writing and in the form prescribed by the board. On
26-5 investigation and review of the petition <hearing>, the board may
26-6 in its discretion grant or deny the petition or it may modify its
26-7 original finding to reflect any circumstances that have changed
26-8 sufficiently to warrant the modification. If such petition is
26-9 denied by the board, a subsequent petition may not be considered by
26-10 the board until 12 months from the date of denial of the previous
26-11 petition. The board in its discretion may require such person to
26-12 pass an examination or examinations for reentry into the practice
26-13 of pharmacy.
26-14 SECTION 11. Subsections (b) and (c), Section 29, Texas
26-15 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
26-16 amended to read as follows:
26-17 (b) Each pharmacy shall apply for a license in one or more
26-18 of the following classifications:
26-19 (1) Class A;
26-20 (2) Class B;
26-21 (3) Class C;
26-22 (4) Class D; <or>
26-23 (5) Class E; or
26-24 (6) Class F.
26-25 (c) Each pharmacy shall be under the supervision of a
27-1 pharmacist as follows:
27-2 (1) a Class A pharmacy shall be under the continuous
27-3 on-site supervision of a pharmacist during the time it is open for
27-4 pharmacy services;
27-5 (2) a Class B pharmacy shall be under the continuous
27-6 on-site supervision of a pharmacist during the time it is open for
27-7 pharmacy services;
27-8 (3) a Class C pharmacy shall be under the continuous
27-9 on-site supervision of a pharmacist in institutions with more than
27-10 100 beds during the time it is open for pharmacy services; in
27-11 institutions with 100 beds or fewer, the services of a pharmacist
27-12 shall be required on a part-time or consulting basis according to
27-13 the needs of the institution;
27-14 (4) a Class D pharmacy shall be under the continuous
27-15 supervision of a pharmacist whose services shall be required
27-16 according to the needs of the pharmacy; <and>
27-17 (5) a Class E pharmacy shall be under the continuous
27-18 on-site supervision of a pharmacist and shall designate one
27-19 pharmacist licensed to practice pharmacy by the regulatory or
27-20 licensing agency of the state in which the Class E pharmacy is
27-21 located to serve as the pharmacist-in-charge of the Class E
27-22 pharmacy license; and
27-23 (6) a Class F pharmacy shall be under the continuous
27-24 supervision of a pharmacist whose services shall be required
27-25 according to the needs of the pharmacy.
28-1 SECTION 12. Subsection (a), Section 32, Texas Pharmacy Act
28-2 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
28-3 read as follows:
28-4 (a) A pharmacy shall report in writing to the board not
28-5 later than the 10th day after the date of the occurrence, unless
28-6 immediate notification is required by this section, any of the
28-7 following:
28-8 (1) permanent closing;
28-9 (2) change of ownership;
28-10 (3) change of location;
28-11 (4) change of pharmacist-in-charge;
28-12 (5) the theft or significant loss of any controlled
28-13 substances, immediately on discovery of the theft or loss, by
28-14 including with the notification to the board of the theft or loss a
28-15 list of all controlled substances stolen or lost;
28-16 (6) the sale or transfer of controlled substances or
28-17 dangerous drugs on the permanent closing or change of ownership of
28-18 the pharmacy;
28-19 (7) any matters and occurrences that the board may
28-20 require by rule;
28-21 (8) out-of-state purchases of controlled substances as
28-22 determined by the board; <and>
28-23 (9) a disaster, accident, or emergency that may affect
28-24 the strength, purity, or labeling of a drug, medication, device, or
28-25 other material used in the diagnosis or the treatment of injury,
29-1 illness, and disease, immediately on the occurrence of the
29-2 disaster, accident, or emergency;
29-3 (10) <. (9)> a final order against the holder of a
29-4 Class E pharmacy license by the regulatory or licensing agency of
29-5 the state in which the pharmacy is located; and
29-6 (11) <(10)> a final order against a pharmacist who is
29-7 designated as the pharmacist-in-charge of a Class E pharmacy by the
29-8 regulatory or licensing agency of the state in which the pharmacy
29-9 is located.
29-10 SECTION 13. Section 40, Texas Pharmacy Act (Article 4542a-1,
29-11 Vernon's Texas Civil Statutes), is amended by amending Subsections
29-12 (d) through (k) to read as follows:
29-13 (d) With the patient's consent and notification to the
29-14 practitioner, a pharmacist may dispense a dosage form of a drug
29-15 product different from that prescribed, such as tablet instead of
29-16 capsule or liquid instead of tablet, provided the dosage form so
29-17 dispensed:
29-18 (1) contains the identical amount of the active
29-19 ingredients as the dosage prescribed for the patient;
29-20 (2) is not an enteric-coated or time release product;
29-21 and
29-22 (3) does not alter desired clinical outcomes.
29-23 (e) Unless otherwise directed by the practitioner, the label
29-24 on the dispensing container shall indicate the actual drug product
29-25 dispensed, either (1) the brand name, or if none (2) the generic
30-1 name, the strength, and the name of the manufacturer or
30-2 distributor. In instances where a drug product has been selected
30-3 other than the one prescribed, the pharmacist shall place on the
30-4 container the words "Substituted for brand prescribed" or
30-5 "Substituted for 'brand name'" where "brand name" is the actual
30-6 name of the brand name drug product prescribed.<" The brand name
30-7 of the prescribed drug shall not appear on the prescription
30-8 container label unless it is the drug product actually dispensed.>
30-9 (f) <(e)> A pharmacist may not select a generically
30-10 equivalent drug unless the generically equivalent drug selected
30-11 costs the patient less than the prescribed drug product. A
30-12 pharmacist may not charge a higher professional fee for dispensing
30-13 a generically equivalent drug product than the fee he or she
30-14 customarily charges for dispensing the brand name product
30-15 prescribed.
30-16 (g)(1) <(f)> A pharmacist who selects a generically
30-17 equivalent drug product as authorized by this section shall:
30-18 (A) <(1)> personally, or through his or her
30-19 agent or employee and prior to delivery of a generically equivalent
30-20 drug product, inform the patient or the patient's agent that a less
30-21 expensive generically equivalent drug product has been substituted
30-22 for the brand prescribed and the patient or patient's agent's right
30-23 to refuse such substitution; or
30-24 (B) <(2)> cause to be displayed, in a prominent
30-25 place that is in clear public view where prescription drugs are
31-1 dispensed, a sign in block letters not less than one inch in height
31-2 that reads, in both English and Spanish:
31-3 "TEXAS LAW ALLOWS A LESS EXPENSIVE GENERICALLY
31-4 EQUIVALENT DRUG TO BE SUBSTITUTED FOR CERTAIN BRAND
31-5 NAME DRUGS UNLESS YOUR PHYSICIAN DIRECTS OTHERWISE.
31-6 YOU HAVE A RIGHT TO REFUSE SUCH SUBSTITUTION. CONSULT
31-7 YOUR PHYSICIAN OR PHARMACIST CONCERNING THE
31-8 AVAILABILITY OF A SAFE, LESS EXPENSIVE DRUG FOR YOUR
31-9 USE."
31-10 Only one sign displayed in a pharmacy, as required above,
31-11 shall be deemed compliance with this subsection.
31-12 (2) <(3)> A pharmacist complies with the requirements
31-13 of this section if an employee or agent of the pharmacist notifies
31-14 a purchaser as required by Paragraph (A) of Subdivision (1) of this
31-15 subsection. The patient or patient's agent shall have the right to
31-16 refuse such product selection.
31-17 (h) <(g)> No written prescription issued by a practitioner,
31-18 as such term is defined in Section 5(39)(A) <5(30)(A)> of this Act,
31-19 may be dispensed unless it is ordered on a form containing two
31-20 signature lines of equal prominence, side by side, at the bottom of
31-21 the form. Under either signature line shall be printed clearly the
31-22 words "product selection permitted," and under the other signature
31-23 line shall be printed clearly the words "dispense as written." The
31-24 practitioner shall communicate dispensing instructions to the
31-25 pharmacist by signing on the appropriate line. If the
32-1 practitioner's signature does not clearly indicate that the
32-2 prescription must be dispensed as written, generically equivalent
32-3 drug selection is permitted. No prescription form furnished a
32-4 practitioner shall contain a preprinted order for a drug product by
32-5 brand name, generic name, or manufacturer.
32-6 (i) <(h)> If a prescription is transmitted to a pharmacist
32-7 orally, the pharmacist shall note any dispensing instructions by
32-8 the practitioner or the practitioner's agent on the file copy of
32-9 the prescription and retain the prescription for the period of time
32-10 specified by law. Properly authorized prescription refills shall
32-11 follow the original dispensing instructions unless otherwise
32-12 indicated by the practitioner or practitioner's agent.
32-13 (j) <(i)> A pharmacist shall record on the prescription form
32-14 the name, strength, and manufacturer or distributor of any drug
32-15 product dispensed as herein authorized.
32-16 (k) <(j)> A pharmacist who selects a generically equivalent
32-17 drug to be dispensed pursuant to this section assumes the same
32-18 responsibility for selecting the generically equivalent drug that
32-19 he does in filling a prescription for a drug product prescribed by
32-20 generic name. There shall be no liability on the prescriber for an
32-21 act or omission by a pharmacist in selecting, preparing, or
32-22 dispensing a drug product pursuant to this section.
32-23 (l) <(k)> Drug product selection as authorized in this
32-24 section shall not apply to enteric-coated tablets; controlled
32-25 release products; injectable suspensions, other than antibiotics;
33-1 suppositories containing active ingredients for which systemic
33-2 absorption is necessary for therapeutic activity; and different
33-3 delivery systems for aerosol or nebulizer drugs. This subsection
33-4 shall not apply to any drug product which is determined to be
33-5 generically equivalent to the brand prescribed.
33-6 SECTION 14. The Texas Pharmacy Act (Article 4542a-1,
33-7 Vernon's Texas Civil Statutes) is amended by adding Sections 40B
33-8 and 40C to read as follows:
33-9 Sec. 40B. EMERGENCY REFILLS. A pharmacist may exercise his
33-10 professional judgment in refilling a prescription for a
33-11 prescription drug, other than a controlled substance listed in
33-12 Schedule II, without the authorization of the prescribing
33-13 practitioner, provided:
33-14 (1) failure to refill the prescription might result in
33-15 an interruption of a therapeutic regimen or create patient
33-16 suffering;
33-17 (2) either:
33-18 (A) a natural or manmade disaster has occurred
33-19 which prohibits the pharmacist from being able to contact the
33-20 practitioner; or
33-21 (B) the pharmacist is unable to contact the
33-22 practitioner after reasonable effort;
33-23 (3) the quantity of prescription drug dispensed does
33-24 not exceed a 72-hour supply;
33-25 (4) the pharmacist informs the patient or the
34-1 patient's agent at the time of dispensing that the refill is being
34-2 provided without such authorization and that authorization of the
34-3 practitioner is required for future refills; and
34-4 (5) the pharmacist informs the practitioner of the
34-5 emergency refill at the earliest reasonable time.
34-6 Sec. 40C. RELEASE OF CONFIDENTIAL RECORDS. Confidential
34-7 records are privileged and may be released only to:
34-8 (1) the patient or the patient's agent;
34-9 (2) practitioners and other pharmacists when, in the
34-10 pharmacist's professional judgment, such release is necessary to
34-11 protect the patient's health and well-being;
34-12 (3) other persons, the board, or other state or
34-13 federal agencies authorized by law to receive such confidential
34-14 records;
34-15 (4) a law enforcement agency engaged in investigation
34-16 of suspected violations of the Controlled Substances Act or the
34-17 Dangerous Drug Act;
34-18 (5) a person employed by any state agency which
34-19 licenses a practitioner as defined in this Act if such person is
34-20 engaged in the performance of the person's official duties; or
34-21 (6) an insurance carrier or other third party payor
34-22 authorized by a patient to receive such information.
34-23 SECTION 15. Subdivision (41), Section 481.002, Health and
34-24 Safety Code, is amended to read as follows:
34-25 (41) "Prescription" means an order by a practitioner
35-1 to a pharmacist for a controlled substance for a particular patient
35-2 that specifies:
35-3 (A) the date of issue;
35-4 (B) the name and address of the patient or, if
35-5 the controlled substance is prescribed for an animal, the species
35-6 of the animal and the name and address of its owner;
35-7 (C) the name and quantity of the controlled
35-8 substance prescribed with the quantity shown numerically followed
35-9 by the number written as a word if the order is written or, if the
35-10 order is communicated orally or telephonically, with the quantity
35-11 given by the practitioner and transcribed by the pharmacist
35-12 numerically; <and>
35-13 (D) directions for the use of the drug;
35-14 (E) the intended use of the drug unless the
35-15 practitioner determines the furnishing of this information is not
35-16 in the best interest of the patient; and
35-17 (F) the name, address, Federal Drug Enforcement
35-18 Administration registration number, and telephone number of the
35-19 practitioner at the practitioner's usual place of business, legibly
35-20 printed or stamped.
35-21 SECTION 16. Section 481.074, Health and Safety Code, is
35-22 amended by amending Subsections (d) through (i) and adding
35-23 Subsection (l) to read as follows:
35-24 (d) Except as specified in Subsections (e) and (f) of this
35-25 section, a <A> person may not fill a prescription for a controlled
36-1 substance listed in Schedule II after the end of the seventh day
36-2 after the date on which the prescription is issued. A person may
36-3 not refill a prescription for a substance listed in Schedule II.
36-4 (e) The partial filling of a prescription for a controlled
36-5 substance listed in Schedule II is permissible, if the pharmacist
36-6 is unable to supply the full quantity called for in a written or
36-7 emergency oral prescription and the pharmacist makes a notation of
36-8 the quantity supplied on the face of the written prescription or
36-9 written record of the emergency oral prescription. The remaining
36-10 portion of the prescription may be filled within 72 hours of the
36-11 first partial filling; however, if the remaining portion is not or
36-12 cannot be filled within the 72-hour period, the pharmacist shall so
36-13 notify the prescribing individual practitioner. No further
36-14 quantity may be supplied beyond 72 hours without a new
36-15 prescription.
36-16 (f) A prescription for a Schedule II controlled substance
36-17 written for a patient in a long-term care facility (LTCF) or for a
36-18 patient with a medical diagnosis documenting a terminal illness may
36-19 be filled in partial quantities to include individual dosage units.
36-20 If there is any question about whether a patient may be classified
36-21 as having a terminal illness, the pharmacist must contact the
36-22 practitioner prior to partially filling the prescription. Both the
36-23 pharmacist and the practitioner have a corresponding responsibility
36-24 to assure that the controlled substance is for a terminally ill
36-25 patient. The pharmacist must record on the prescription whether
37-1 the patient is "terminally ill" or an "LTCF patient." A
37-2 prescription that is partially filled and does not contain the
37-3 notation "terminally ill" or "LTCF patient" shall be deemed to have
37-4 been filled in violation of this Act. For each partial filling,
37-5 the dispensing pharmacist shall record on the back of Copy 1 and
37-6 Copy 2 of the prescription the date of the partial filling, the
37-7 quantity dispensed, the remaining quantity authorized to be
37-8 dispensed, and the identification of the dispensing pharmacist.
37-9 Prior to any subsequent partial filling the pharmacist is to
37-10 determine that the additional partial filling is necessary. The
37-11 total quantity of Schedule II controlled substances dispensed in
37-12 all partial fillings must not exceed the total quantity prescribed.
37-13 Schedule II prescriptions for patients in a long-term care facility
37-14 or patients with a medical diagnosis documenting a terminal illness
37-15 shall be valid for a period not to exceed 30 days from the issue
37-16 date unless sooner terminated by discontinuance of the medication.
37-17 (g) A person may not dispense a controlled substance in
37-18 Schedule III or IV that is a prescription drug under the Federal
37-19 Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.)
37-20 without a written, oral, or telephonically communicated
37-21 prescription of a practitioner defined by Section 481.002(39)(A),
37-22 except that the practitioner may dispense the substance directly to
37-23 an ultimate user. A prescription for a controlled substance listed
37-24 in Schedule III or IV may not be filled or refilled later than six
37-25 months after the date on which the prescription is issued and may
38-1 not be refilled more than five times, unless the prescription is
38-2 renewed by the practitioner.
38-3 (h) <(f)> A pharmacist may dispense a controlled substance
38-4 listed in Schedule III, IV, or V under an original written
38-5 prescription issued by a practitioner defined by Section
38-6 481.002(38)(C) and only if the pharmacist determines that the
38-7 prescription was issued for a valid medical purpose and in the
38-8 course of professional practice. A prescription issued under this
38-9 subsection may not be filled or refilled later than six months
38-10 after the date the prescription is issued, and a prescription
38-11 authorized to be refilled on the original prescription may not be
38-12 refilled more than five times.
38-13 (i) <(g)> A person may not dispense a controlled substance
38-14 listed in Section 481.036(1) or (2) without the prescription of a
38-15 practitioner defined by Section 481.002(39)(A), except that a
38-16 practitioner may dispense the substance directly to an ultimate
38-17 user. A prescription issued under this subsection may not be
38-18 filled or refilled later than six months after the date the
38-19 prescription is issued and may not be refilled more than five
38-20 times, unless the prescription is renewed by the practitioner.
38-21 (j) <(h)> A practitioner or institutional practitioner may
38-22 not allow a patient, on the patient's release from the hospital, to
38-23 possess a controlled substance prescribed by the practitioner
38-24 unless:
38-25 (1) the substance was dispensed under a medication
39-1 order while the patient was admitted to the hospital;
39-2 (2) the substance is in a properly labeled container;
39-3 and
39-4 (3) the patient possesses not more than a seven-day
39-5 supply of the substance.
39-6 (k) <(i)> A prescription for a controlled substance must
39-7 show:
39-8 (1) the quantity of the substance prescribed:
39-9 (A) numerically, followed by the number written
39-10 as a word, if the prescription is written; or
39-11 (B) if the prescription is communicated orally
39-12 or telephonically, as transcribed by the receiving pharmacist;
39-13 (2) the date of issue;
39-14 (3) the name and address of the patient or, if the
39-15 controlled substance is prescribed for an animal, the species of
39-16 the animal and the name and address of its owner;
39-17 (4) the name and strength of the controlled substance
39-18 prescribed;
39-19 (5) the directions for use of the controlled
39-20 substance; <and>
39-21 (6) the intended use of the drug unless the
39-22 practitioner determines the furnishing of this information is not
39-23 in the best interest of the patient; and
39-24 (7) the name, address, <and> Federal Drug Enforcement
39-25 Administration registration number, and telephone number of the
40-1 practitioner at the practitioner's usual place of business, legibly
40-2 printed or stamped.
40-3 (l) A pharmacist may exercise his professional judgment in
40-4 refilling a prescription for a controlled substance in Schedule
40-5 III, IV, or V without the authorization of the prescribing
40-6 practitioner provided:
40-7 (1) failure to refill the prescription might result in
40-8 an interruption of a therapeutic regimen or create patient
40-9 suffering;
40-10 (2) either:
40-11 (A) a natural or manmade disaster has occurred
40-12 which prohibits the pharmacist from being able to contact the
40-13 practitioner; or
40-14 (B) the pharmacist is unable to contact the
40-15 practitioner after reasonable effort;
40-16 (3) the quantity of prescription drug dispensed does
40-17 not exceed a 72-hour supply;
40-18 (4) the pharmacist informs the patient or the
40-19 patient's agent at the time of dispensing that the refill is being
40-20 provided without such authorization and that authorization of the
40-21 practitioner is required for future refills; and
40-22 (5) the pharmacist informs the practitioner of the
40-23 emergency refill at the earliest reasonable time.
40-24 SECTION 17. Subsections (d), (e), and (f), Section 481.075,
40-25 Health and Safety Code, are amended to read as follows:
41-1 (d) Except for oral prescriptions prescribed under Section
41-2 481.074(b), the prescribing practitioner shall:
41-3 (1) legibly fill in, or direct a designated agent to
41-4 legibly fill in, on all three copies of the form in the space
41-5 provided:
41-6 (A) the date the prescription is written;
41-7 (B) the drug prescribed, the quantity (shown
41-8 numerically followed by the number written as a word), <and>
41-9 instructions for use, and the intended use of the drug or the
41-10 diagnosis for which the controlled substance is prescribed; and
41-11 (C) the name, address, and age of the patient
41-12 or, in the case of an animal, its owner, for whom the controlled
41-13 substance is prescribed;
41-14 (2) sign Copies 1 and 2 of the form and give them to
41-15 the person authorized to receive the prescription; and
41-16 (3) retain Copy 3 of the form with the practitioner's
41-17 records for at least two years after the date the prescription is
41-18 written.
41-19 (e) In the case of an oral prescription prescribed under
41-20 Section 481.074(b), the prescribing practitioner shall give the
41-21 dispensing pharmacy the information needed to complete the form.
41-22 (f) Each dispensing pharmacist shall:
41-23 (1) fill in on Copies 1 and 2 of the form in the space
41-24 provided the information not required to be filled in by the
41-25 prescribing practitioner or the Department of Public Safety;
42-1 (2) indicate the total quantity dispensed on the face
42-2 of the triplicate prescription form;
42-3 (3) retain Copy 2 with the records of the pharmacy for
42-4 at least two years; and
42-5 (4) <(3)> sign Copy 1 and send it to the Department of
42-6 Public Safety not later than the 30th day after the date the
42-7 prescription is filled or not later than the 30th day after the
42-8 completion of a prescription dispensed under Section 481.074(f).
42-9 SECTION 18. Subchapter A, Chapter 483, Health and Safety
42-10 Code, is amended by adding Section 483.0001 and amending Section
42-11 483.001 to read as follows:
42-12 Sec. 483.0001. SHORT TITLE. This Act may be cited as the
42-13 Texas Dangerous Drug Act.
42-14 Sec. 483.001. DEFINITIONS. In this chapter:
42-15 (1) <(2)> "Board" means the Texas State Board of
42-16 Pharmacy.
42-17 (2) <(3)> "Dangerous drug" means a device or a drug
42-18 that is unsafe for self-medication and that is not included in
42-19 Schedules I through V or Penalty Groups 1 through 4 of Chapter 481
42-20 (Texas Controlled Substances Act). The term includes a device or a
42-21 drug that bears or is required to bear the legend:
42-22 (A) Caution: federal law prohibits dispensing
42-23 without prescription; or
42-24 (B) Caution: federal law restricts this drug to
42-25 use by or on the order of a licensed veterinarian.
43-1 (3) <(4)> "Deliver" means to sell, dispense, give
43-2 away, or supply in any other manner.
43-3 (4) "Designated agent" means:
43-4 (A) a licensed nurse, physician assistant,
43-5 pharmacist, or other individual designated by a practitioner to
43-6 communicate prescription drug orders to a pharmacist;
43-7 (B) a licensed nurse, physician assistant, or
43-8 pharmacist employed in a health care facility to whom the
43-9 practitioner communicates a prescription drug order; or
43-10 (C) a registered nurse or physician assistant
43-11 authorized by a practitioner to carry out a prescription drug order
43-12 for dangerous drugs under Section 3.06(d)(5), Medical Practice Act
43-13 (Article 4495b, Vernon's Texas Civil Statutes).
43-14 (5) "Dispense" means to prepare, package, compound, or
43-15 label a dangerous drug in the course of professional practice for
43-16 delivery under the lawful order of a practitioner to an ultimate
43-17 user or the user's agent.
43-18 (6) "Manufacturer" means a person, other than a
43-19 pharmacist, who manufactures dangerous drugs. The term includes a
43-20 person who prepares dangerous drugs in dosage form by mixing,
43-21 compounding, encapsulating, entableting, or any other process.
43-22 (7) "Patient" means:
43-23 (A) an individual for whom a dangerous drug is
43-24 prescribed or to whom a dangerous drug is administered; or
43-25 (B) an owner or the agent of an owner of an
44-1 animal for which a dangerous drug is prescribed or to which a
44-2 dangerous drug is administered.
44-3 (8) "Person" includes an individual, corporation,
44-4 partnership, and association.
44-5 (9) "Pharmacist" means a person licensed by the Texas
44-6 State Board of Pharmacy to practice pharmacy.
44-7 (10) "Pharmacy" means a facility licensed by the board
44-8 pursuant to Section 29, Texas Pharmacy Act (Article 4542a-1,
44-9 Vernon's Texas Civil Statutes) <in which the practice of pharmacy
44-10 occurs>.
44-11 (11) "Practice of pharmacy" means:
44-12 (A) provision of those acts or services
44-13 necessary to provide pharmaceutical care;
44-14 (B) interpretation and evaluation of
44-15 prescription drug orders or medication orders;
44-16 (C) participation in drug and device selection
44-17 as authorized by law, drug administration, drug regimen review, or
44-18 drug or drug-related research;
44-19 (D) provision of patient counseling; and
44-20 (E) responsibility for:
44-21 (i) dispensing of prescription drug orders
44-22 or distribution of medication orders in the patient's best
44-23 interest;
44-24 (ii) compounding and labeling of drugs and
44-25 devices, except labeling by a manufacturer, repackager, or
45-1 distributor of nonprescription drugs and commercially packaged
45-2 prescription drugs and devices;
45-3 (iii) proper and safe storage of drugs and
45-4 devices; and
45-5 (iv) maintenance of proper records for
45-6 drugs and devices <the interpretation and evaluation of
45-7 prescription or medication orders, the dispensing and labeling of
45-8 drugs or devices, the selection of drugs and the review of drug
45-9 use, the storage of prescription drugs and devices and the
45-10 maintenance of prescription drug records in a pharmacy, the giving
45-11 of advice or consultation if necessary or required by law about the
45-12 therapeutic value, content, hazard, or use of drugs or devices, or
45-13 the offer to perform or the performance of the services and
45-14 transactions necessary to operate a pharmacy>. In this
45-15 subdivision, "device" has the meaning assigned by the Texas
45-16 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes).
45-17 (12) "Practitioner" means a person licensed:
45-18 (A) by the Texas State Board of Medical
45-19 Examiners, State Board of Dental Examiners, Texas State Board of
45-20 Podiatry Examiners, Texas Optometry Board, or State Board of
45-21 Veterinary Medical Examiners to prescribe and administer dangerous
45-22 drugs;
45-23 (B) by another state in a health field in which,
45-24 under the laws of this state, a licensee may legally prescribe
45-25 dangerous drugs; or
46-1 (C) in Canada or Mexico in a health field in
46-2 which, under the laws of this state, a licensee may legally
46-3 prescribe dangerous drugs.
46-4 (13) "Prescription" means an order from a
46-5 practitioner, or an agent of the practitioner designated in writing
46-6 as authorized to communicate prescriptions, or an order made in
46-7 accordance with Section 3.06(d)(5), Medical Practice Act (Article
46-8 4495b, Vernon's Texas Civil Statutes), to a pharmacist for a
46-9 dangerous drug to be dispensed that states:
46-10 (A) the date of the order's issue;
46-11 (B) the name and address of the patient;
46-12 (C) if the drug is prescribed for an animal, the
46-13 species of the animal;
46-14 (D) the name and quantity of the drug
46-15 prescribed; <and>
46-16 (E) the directions for the use of the drug;
46-17 (F) the intended use of the drug unless the
46-18 practitioner determines the furnishing of this information is not
46-19 in the best interest of the patient; and
46-20 (G) the name, address, and telephone number of
46-21 the practitioner at the practitioner's usual place of business,
46-22 legibly printed or stamped.
46-23 (14) "Warehouseman" means a person who stores
46-24 dangerous drugs for others and who has no control over the
46-25 disposition of the drugs except for the purpose of storage.
47-1 (15) "Wholesaler" means a person engaged in the
47-2 business of distributing dangerous drugs to a person listed in
47-3 Sections 483.041(c)(1)-(6).
47-4 SECTION 19. Section 483.022, Health and Safety Code, is
47-5 amended to read as follows:
47-6 Sec. 483.022. Practitioner's Designated Agent;
47-7 Practitioner's Responsibilities. (a) A practitioner shall provide
47-8 in writing the name of each<:>
47-9 <(1)> designated agent as defined by Section
47-10 483.001(4)(A) and (C), and the name of each healthcare facility
47-11 which employs persons defined by Section 483.001(4)(B) <authorized
47-12 by the practitioner to communicate prescriptions for the
47-13 practitioner; and>
47-14 <(2) registered nurse or physician assistant
47-15 authorized to carry out a prescription drug order under Section
47-16 3.06(d)(5), Medical Practice Act (Article 4495b, Vernon's Texas
47-17 Civil Statutes)>.
47-18 (b) The practitioner shall maintain at the practitioner's
47-19 usual place of business a list of the designated agents or
47-20 healthcare facilities as defined by Section 483.001(4) <and a list
47-21 of the designated registered nurses or physician assistants
47-22 authorized to carry out a prescription drug order>.
47-23 <(b) The practitioner shall maintain at the practitioner's
47-24 usual place of business a list of each designated agent, registered
47-25 nurse, or physician assistant who is authorized to carry out a
48-1 prescription drug order.>
48-2 (c) The practitioner shall provide a pharmacist with a copy
48-3 of the practitioner's written authorization for a designated agent
48-4 as defined by Section 483.001(4)<, registered nurse, or physician
48-5 assistant> on the pharmacist's request.
48-6 (d) This section does not relieve a practitioner or the
48-7 practitioner's designated agent from the requirements of Section
48-8 40, Texas Pharmacy Act (Article 4542a-1, Vernon's Texas Civil
48-9 Statutes).
48-10 (e) A practitioner remains personally responsible for the
48-11 actions of a designated agent who communicates a prescription to a
48-12 pharmacist.
48-13 SECTION 20. Subsection (d), Section 483.041, Health and
48-14 Safety Code, is amended to read as follows:
48-15 (d) An offense under this section is a felony of the third
48-16 degree <Class B misdemeanor unless it is shown on the trial of the
48-17 defendant that the defendant has previously been convicted of an
48-18 offense under this section, in which event the offense is a Class A
48-19 misdemeanor>.
48-20 SECTION 21. Section 483.042, Health and Safety Code, is
48-21 amended by amending Subsections (c) and (d) to read as follows:
48-22 (c) The labeling provisions of Subsection (a) do not apply
48-23 when the dangerous drug is prescribed for administration to an
48-24 ultimate user who is institutionalized. The board shall adopt
48-25 rules for the labeling of such drugs.
49-1 (d) Proof of an offer to sell a dangerous drug must be
49-2 corroborated by a person other than the offeree or by evidence
49-3 other than a statement by the offeree.
49-4 (e) <(d)> An offense under this section is a felony of the
49-5 third degree.
49-6 SECTION 22. Section 483.047, Health and Safety Code, is
49-7 amended to read as follows:
49-8 Sec. 483.047. Refilling Prescription Without Authorization.
49-9 (a) Except as authorized by Subsection (b), a <A> pharmacist
49-10 commits an offense if the pharmacist refills a prescription unless:
49-11 (1) the prescription contains an authorization by the
49-12 practitioner for the refilling of the prescription, and the
49-13 pharmacist refills the prescription in the manner provided by the
49-14 authorization; or
49-15 (2) at the time of refilling the prescription, the
49-16 pharmacist is authorized to do so by the practitioner who issued
49-17 the prescription.
49-18 (b) A pharmacist may exercise his professional judgment in
49-19 refilling a prescription for a dangerous drug without the
49-20 authorization of the prescribing practitioner provided:
49-21 (1) failure to refill the prescription might result in
49-22 an interruption of a therapeutic regimen or create patient
49-23 suffering;
49-24 (2) either:
49-25 (A) a natural or manmade disaster has occurred
50-1 which prohibits the pharmacist from being able to contact the
50-2 practitioner; or
50-3 (B) the pharmacist is unable to contact the
50-4 practitioner after reasonable effort;
50-5 (3) the quantity of drug dispensed does not exceed a
50-6 72-hour supply;
50-7 (4) the pharmacist informs the patient or the
50-8 patient's agent at the time of dispensing that the refill is being
50-9 provided without such authorization and that authorization of the
50-10 practitioner is required for future refills; and
50-11 (5) the pharmacist informs the practitioner of the
50-12 emergency refill at the earliest reasonable time.
50-13 (c) An offense under this section is a Class B misdemeanor
50-14 unless it is shown on the trial of the defendant that the defendant
50-15 has previously been convicted under this chapter, in which event
50-16 the offense is a Class A misdemeanor.
50-17 SECTION 23. Section 142.0061, Health and Safety Code, is
50-18 amended to read as follows:
50-19 Sec. 142.0061. POSSESSION OF DANGEROUS DRUGS. A home health
50-20 agency that is licensed as a Class F Pharmacy under the Texas
50-21 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes) or
50-22 its employees who are registered nurses or licensed vocational
50-23 nurses may purchase, store, or transport for the purpose of
50-24 administering to their home health patients under physician's
50-25 orders the following dangerous drugs: sterile water for injection
51-1 and irrigation, sterile saline for injection and irrigation, and
51-2 heparin flush kits for intravenous flushes.
51-3 SECTION 24. This Act takes effect September 1, 1993.
51-4 SECTION 25. (a) A change in law made by this Act which
51-5 applies to a criminal offense applies only to an offense committed
51-6 on or after the effective date of this Act. For purposes of this
51-7 section, an offense is committed before the effective date of this
51-8 Act if any element of the offense occurs before that date.
51-9 (b) A criminal offense committed before the effective date
51-10 of this Act is covered by the law in effect when the offense was
51-11 committed, and the former law is continued in effect for this
51-12 purpose.
51-13 SECTION 26. The importance of this legislation and the
51-14 crowded condition of the calendars in both houses create an
51-15 emergency and an imperative public necessity that the
51-16 constitutional rule requiring bills to be read on three several
51-17 days in each house be suspended, and this rule is hereby suspended.