By Van de Putte 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 3, Texas Pharmacy Act (Article 4542a-1,
1-6 Vernon's Texas Civil Statutes), is amended to read as follows:
1-7 Sec. 3. Sunset provision. The Texas State Board of Pharmacy
1-8 is subject to Chapter 325, Government Code (Texas Sunset Act).
1-9 Unless continued in existence as provided by that chapter, the
1-10 board is abolished and this Act expires September 1, 2005<1993>.
1-11 SECTION 2. Section 5, Texas Pharmacy Act (Article 4542a-1,
1-12 Vernon's Texas Civil Statutes), is amended to read as follows:
1-13 Sec. 5. Definitions. In this Act, unless the context of its
1-14 use clearly indicates otherwise:
1-15 (1) "A.C.P.E." means the American Council on
1-16 Pharmaceutical Education.
1-17 (2) "Administer" means the direct application of a
1-18 prescription drug by injection, inhalation, ingestion, or any other
1-19 means to the body of a patient by:
1-20 (A) a practitioner or an authorized agent under
1-21 his supervision; or
1-22 (B) the patient at the direction of a
1-23 practitioner.
2-1 (3) "Administrative Procedure Act" means the
2-2 Administrative Procedure and Texas Register Act, as amended
2-3 (Article 6252-13a, Vernon's Texas Civil Statutes).
2-4 (4) "Board" means the Texas State Board of Pharmacy.
2-5 (5) "Class A pharmacy license" or "community pharmacy
2-6 license" means a license issued to a pharmacy dispensing drugs or
2-7 devices to the general public pursuant to a prescription drug
2-8 order.
2-9 (6) "Class B pharmacy license" or "nuclear pharmacy
2-10 license" means a license issued to a pharmacy dispensing or
2-11 providing radioactive drugs or devices for administration to an
2-12 ultimate user.
2-13 (7) "Class C pharmacy license" or "institutional
2-14 pharmacy license" means a license issued to a pharmacy located in a
2-15 hospital or other in-patient facility that is licensed under
2-16 Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental
2-17 Health Code (Article 5547-1 et seq., Vernon's Texas Civil
2-18 Statutes), or to a pharmacy located in a hospital maintained or
2-19 operated by the state.
2-20 (8) "Class D pharmacy license" or "clinic pharmacy
2-21 license" means a license issued to a pharmacy dispensing a limited
2-22 type of drugs or devices pursuant to a prescription drug order.
2-23 (9) "Class E pharmacy license" or "nonresident
2-24 pharmacy license" means a license issued under this Act to a
2-25 pharmacy located in a state of the United States other than this
3-1 state whose primary business is to dispense a prescription drug or
3-2 device under a prescription drug order and to deliver the drug or
3-3 device to a patient, including a patient in this state, by the
3-4 United States mail, a common carrier, or a delivery service.
3-5 (10) "College of pharmacy" means a school, university,
3-6 or college of pharmacy that satisfies the accreditation standards
3-7 of A.C.P.E. as adopted by the board; or that has degree
3-8 requirements which meet the standards of accreditation set by the
3-9 board.
3-10 (11) "Compounding" means the preparation, mixing,
3-11 assembling, packaging, or labeling of a drug or device:
3-12 (A) as the result of a practitioner's
3-13 prescription drug order or initiative based on the
3-14 practitioner-patient-pharmacist relationship in the course of
3-15 professional practice;
3-16 (B) in anticipation of prescription drug orders
3-17 based on routine, regularly observed prescribing patterns; or
3-18 (C) for the purpose of or as an incident to
3-19 research, teaching, or chemical analysis and not for sale or
3-20 dispensing.
3-21 (12) "Confidential record" means any health-related
3-22 record maintained by a pharmacy or pharmacist such as a patient
3-23 medication record, prescription drug order, or medication order.
3-24 (13) "Controlled substance" means a drug, immediate
3-25 precursor, or other substance listed in Schedules I-V or Penalty
4-1 Groups 1-4 of Chapter 481, Health and Safety Code, or a drug,
4-2 immediate precursor, or other substance included in Schedule I, II,
4-3 III, IV, or V of the Federal Comprehensive Drug Abuse Prevention
4-4 and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
4-5 (14) <(12)> "Controlled Substances Act" means Chapter
4-6 481, Health and Safety Code, or the Federal Comprehensive Drug
4-7 Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et
4-8 seq.).
4-9 (15) <(13)> "Dangerous drug" means any drug or device
4-10 that is not included in Penalty Groups 1-4 of the Controlled
4-11 Substances Act and that is unsafe for self-medication or any drug
4-12 or device that bears or is required to bear the legend:
4-13 (A) "Caution: federal law prohibits dispensing
4-14 without prescription"; or
4-15 (B) "Caution: federal law restricts this drug
4-16 to use by or on the order of a licensed veterinarian."
4-17 (16) <(14)> "Dangerous Drug Act" means Chapter 483,
4-18 Health and Safety Code.
4-19 (17) <(15)> "Deliver" or "delivery" means the actual,
4-20 constructive, or attempted transfer of a prescription drug or
4-21 device or controlled substance from one person to another, whether
4-22 or not for a consideration.
4-23 (18) <(15)> "Designated agent" means:
4-24 (A) a licensed nurse, physician assistant,
4-25 pharmacist, or other <an> individual <under the supervision of a
5-1 practitioner,> designated by a <the> practitioner, and for whom the
5-2 practitioner assumes legal responsibility, who communicates
5-3 prescription drug orders <the practitioner's instructions> to a
5-4 pharmacist;
5-5 (B) a licensed nurse, physician assistant, or
5-6 pharmacist employed in a health care facility to whom the
5-7 practitioner communicates a prescription drug order; or
5-8 (C) a registered nurse or physician assistant
5-9 authorized by a practitioner to carry out a prescription drug order
5-10 for dangerous drugs under Subdivision (5), Subsection (d), Section
5-11 3.06, Medical Practice Act (Article 4495b, Vernon's Texas Civil
5-12 Statutes).
5-13 (19) <(16)> "Device" means an instrument, apparatus,
5-14 implement, machine, contrivance, implant, in vitro reagent, or
5-15 other similar or related article, including any component part or
5-16 accessory, that is required under federal or state law to be
5-17 ordered or prescribed by a practitioner.
5-18 (20) <(17)> "Dispense" means preparing, packaging,
5-19 compounding, or labeling for delivery a prescription drug or device
5-20 in the course of professional practice to an ultimate user or his
5-21 agent by or pursuant to the lawful order of a practitioner.
5-22 (21) <(18)> "Distribute" means the delivery of a
5-23 prescription drug or device other than by administering or
5-24 dispensing.
5-25 (22) <(19)> "Drug" means:
6-1 (A) a substance recognized as drugs in the
6-2 current official United States Pharmacopoeia, official National
6-3 Formulary, official Homeopathic Pharmacopoeia, or other drug
6-4 compendium or any supplement to any of them;
6-5 (B) a substance intended for use in the
6-6 diagnosis, cure, mitigation, treatment, or prevention of disease in
6-7 man or other animals;
6-8 (C) a substance, other than food, intended to
6-9 affect the structure or any function of the body of man or other
6-10 animals;
6-11 (D) a substance intended for use as a component
6-12 of any articles specified in Paragraph (A), (B), or (C) of this
6-13 subdivision;
6-14 (E) a dangerous drug; or
6-15 (F) a controlled substance.
6-16 (23) "Drug regimen review" includes the following
6-17 activities:
6-18 (A) evaluation of the prescription drug orders
6-19 and patient records for:
6-20 (i) known allergies;
6-21 (ii) rational therapy-contraindications;
6-22 (iii) reasonable dose and route of
6-23 administration; and
6-24 (iv) reasonable directions for use;
6-25 (B) evaluation of the prescription drug orders
7-1 and patient records for duplication of therapy;
7-2 (C) evaluation of the prescription drug orders
7-3 and patient records for:
7-4 (i) drug-drug interactions;
7-5 (ii) drug-food interactions;
7-6 (iii) drug-disease interactions;
7-7 (iv) adverse drug reactions; and
7-8 (D) evaluation of the prescription drug orders
7-9 and patient records for proper utilization, including
7-10 overutilization or underutilization, and optimal therapeutic
7-11 outcomes.
7-12 (24) <(20)> "Internship" means a practical experience
7-13 program that is approved by the board.
7-14 (25) <(21)> "Label" means written, printed, or graphic
7-15 matter on the immediate container of a drug or device.
7-16 (26) <(22)> "Labeling" means the process of affixing a
7-17 label including all information required by federal and state law
7-18 or regulation to any drug or device container. The term does not
7-19 include the labeling by a manufacturer, packer, or distributor of a
7-20 nonprescription drug or commercially packaged prescription drug or
7-21 device, or unit dose packaging.
7-22 (27) "Manufacturing" means the production,
7-23 preparation, propagation, conversion, or processing of a drug or
7-24 device, either directly or indirectly, by extraction from
7-25 substances of natural origin or independently by means of chemical
8-1 or biological synthesis and includes any packaging or repackaging
8-2 of the substances or labeling or relabeling of the container and
8-3 the promotion and marketing of such drugs or devices.
8-4 Manufacturing also includes the preparation and promotion of
8-5 commercially available products from bulk compounds for resale by
8-6 pharmacies, practitioners, or other persons but does not include
8-7 compounding.
8-8 (28) <(23)> "Medication order" means an order from a
8-9 practitioner or a practitioner's designated agent for
8-10 administration of a drug or device.
8-11 (29) <(24)> "Nonprescription drug" means a nonnarcotic
8-12 drug or device that may be sold without a prescription and that is
8-13 labeled and packaged in compliance with applicable state or federal
8-14 law.
8-15 (30) "Patient counseling" means the communication by
8-16 the pharmacist of information, as specified in the rules of the
8-17 board, to the patient or caregiver, in order to improve therapy by
8-18 ensuring proper use of drugs and devices.
8-19 (31) <(25)> "Person" means an individual, corporation,
8-20 government or governmental subdivision or agency, business trust,
8-21 estate, trust, partnership, association, or any other legal entity.
8-22 (32) "Pharmaceutical care" is the provision of drug
8-23 therapy and other services defined in the rules of the board and
8-24 intended to assist in the cure or prevention of a disease,
8-25 elimination or reduction of a patient's symptoms, or arresting or
9-1 slowing of a disease process.
9-2 (33) <(26)> "Pharmacist" means a person licensed by
9-3 the board to practice pharmacy.
9-4 (34) <(27)> "Pharmacist-in-charge" means the
9-5 pharmacist designated on a pharmacy license as the pharmacist who
9-6 has the authority or responsibility for a pharmacy's compliance
9-7 with laws and rules pertaining to the practice of pharmacy.
9-8 (35) <(28)> "Pharmacist-intern" means an undergraduate
9-9 student enrolled in the professional sequence of a college of
9-10 pharmacy approved by the board and participating in a school-based,
9-11 board-approved internship program or a graduate of a college of
9-12 pharmacy who is participating in a board-approved internship.
9-13 (36) <(29)> "Pharmacy" means a facility licensed by
9-14 the board pursuant to Section 29 of this Act <where the practice of
9-15 pharmacy occurs>.
9-16 (37) <(30)> "Practice of pharmacy" means:
9-17 (A) provision of those acts or services
9-18 necessary to provide pharmaceutical care;
9-19 (B) interpretation and evaluation of
9-20 prescription drug orders or medication orders;
9-21 (C) participation in drug and device selection,
9-22 drug administration, drug regimen review, or drug or drug-related
9-23 research;
9-24 (D) provision of patient counseling; and
9-25 (E) responsibility for:
10-1 (i) dispensing of prescription drug orders
10-2 or distribution of medication orders in the patient's best
10-3 interest;
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; and
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 (38) <(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 (39) <(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 (40) <(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 (41) <(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 (42) "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 (43) <(35)> "Provide" means to supply one or more unit
12-17 doses of a nonprescription drug or dangerous drug to a patient.
12-18 (44) <(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 (45) <(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 (46) <(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 (47) <(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 (48) <(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 3. 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 4. Subsections (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 (b) The board has the following responsibilities relating to
14-16 the practice of pharmacy and to prescription drugs and devices used
14-17 in this state in the diagnosis, mitigation, and treatment or
14-18 prevention of injury, illness, and disease:
14-19 (1) regulation of the delivery or distribution of
14-20 prescription drugs and devices, including the right to seize, after
14-21 notice and hearing, any prescription drugs or devices posing a
14-22 hazard to the public health and welfare, but the board may not
14-23 regulate:
14-24 (A) manufacturers' representatives or employees
14-25 acting in the normal course of business;
15-1 (B) persons engaged in the wholesale drug
15-2 business and registered with the commissioner of health as provided
15-3 by Chapter 431, Health and Safety Code; or
15-4 (C) employees of persons engaged in the
15-5 wholesale drug business and registered with the commissioner of
15-6 health as provided by Chapter 431, Health and Safety Code, if the
15-7 employees are acting in the normal course of business;
15-8 (2) specification of minimum standards for
15-9 professional environment, technical equipment, and security in the
15-10 prescription dispensing area;
15-11 (3) specification of minimum standards for drug
15-12 storage, maintenance of prescription drug records, and procedures
15-13 for the delivery, dispensing in a suitable container appropriately
15-14 labeled, <or> providing of prescription drugs or devices,
15-15 monitoring of drug therapy, and counseling of patients on proper
15-16 use of prescription drugs and devices within the practice of
15-17 pharmacy; and
15-18 (4) adoption of rules regulating a prescription drug
15-19 order or medication order transmitted by electronic means <a
15-20 facsimile or FAX machine>.
15-21 (q) Board investigative files and all information and
15-22 materials compiled by the board in connection with an investigation
15-23 are confidential and are not subject to disclosure under
15-24 <considered open records for purposes of> Chapter 424, Acts of the
15-25 63rd Legislature, Regular Session, 1973, as amended (Article
16-1 6252-17a, Vernon's Texas Civil Statutes), and not subject to
16-2 disclosure, discovery, subpoena, or other means of legal compulsion
16-3 for their release to anyone other than the board or its employees
16-4 or agents involved in licensee discipline except that this
16-5 information may be disclosed to:
16-6 (1) persons involved with the board in a disciplinary
16-7 action against the licensee;
16-8 (2) pharmacist or pharmacy licensing or disciplinary
16-9 authorities of other jurisdictions;
16-10 (3) a pharmaceutical peer review committee as outlined
16-11 in Section 27A of this Act;
16-12 (4) law enforcement agencies; and
16-13 (5) persons engaged in bona fide research, if all
16-14 individual-identifying information has been deleted.
16-15 SECTION 5. Subsection (c), Section 21, Texas Pharmacy Act
16-16 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
16-17 read as follows:
16-18 (c) The examinations for licensing required under this
16-19 section shall be given by the board at least two times during the
16-20 fiscal year of the state. The board shall determine the content
16-21 and subject matter of each examination and determine which persons
16-22 have successfully passed the examination. An applicant who fails
16-23 the examination may retake the examination two additional times.
16-24 Before an applicant who has failed the examination three times is
16-25 allowed to retake the examination, the applicant shall provide
17-1 documentation from a college of pharmacy that additional college
17-2 course work in subject areas the applicant failed in the
17-3 examination has been successfully completed. If a person who fails
17-4 the licensing examination administered under this Act so requests
17-5 in writing, the board shall furnish the person an analysis of his
17-6 performance on the examination.
17-7 SECTION 6. Subsection (a), Section 26, Texas Pharmacy Act
17-8 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
17-9 read as follows:
17-10 (a) Grounds for Disciplining a Holder of a Pharmacist
17-11 License: The board shall refuse to issue a pharmacist license for
17-12 failure to meet the requirements of Section 21 or 22 of this Act.
17-13 The board may in its discretion refuse to issue or renew a license
17-14 or may fine, reprimand, revoke, restrict, cancel, retire, or
17-15 suspend any license granted by the board<,> and may probate any
17-16 license suspension if the board finds that the applicant or
17-17 licensee has:
17-18 (1) violated any provision of this Act or any of the
17-19 rules of the board adopted under this Act;
17-20 (2) engaged in unprofessional conduct as that term is
17-21 defined by the rules of the board;
17-22 (3) engaged in gross immorality as that term is
17-23 defined by the rules of the board;
17-24 (4) developed an incapacity of a nature that prevents
17-25 a pharmacist or applicant from engaging in the practice of pharmacy
18-1 with reasonable skill, competence, and safety to the public. In
18-2 enforcing this subdivision, the board shall, on probable cause,
18-3 request a pharmacist or applicant to submit to a mental or physical
18-4 examination by physicians or other health care professionals
18-5 designated by the board. If the pharmacist or applicant refuses to
18-6 submit to the examination, the board shall issue an order requiring
18-7 the pharmacist or applicant to show cause why he will not submit to
18-8 the examination and shall schedule a hearing on the order within 30
18-9 days after notice is served on the pharmacist or applicant. The
18-10 pharmacist or applicant shall be notified by either personal
18-11 service or certified mail with return receipt requested. At the
18-12 hearing, the pharmacist or applicant and his attorney are entitled
18-13 to present any testimony and other evidence to show why the
18-14 pharmacist or applicant should not be required to submit to the
18-15 examination. After the hearing, the board shall issue an order
18-16 either requiring the pharmacist or applicant to submit to the
18-17 examination or withdrawing the request for examination;
18-18 (5) engaged in any fraud, deceit, or misrepresentation
18-19 as those words are defined by the rules of the board in the
18-20 practice of pharmacy or in seeking a license to act as a
18-21 pharmacist;
18-22 (6) been convicted of a felony or a misdemeanor
18-23 involving moral turpitude by a court of competent jurisdiction;
18-24 (7) a drug or alcohol dependency;
18-25 (8) failed to keep and maintain records required by
19-1 this Act or failed to keep and maintain complete and accurate
19-2 records of purchases and disposals of drugs listed in the
19-3 Controlled Substances Act or the Dangerous Drug Act;
19-4 (9) violated any provision of the Controlled
19-5 Substances Act or Dangerous Drug Act or a rule relating to those
19-6 acts or any provision of Sections 485.031-485.035, Health and
19-7 Safety Code, or a rule adopted under Section 485.011, Health and
19-8 Safety Code;
19-9 (10) aided or abetted an unlicensed individual to
19-10 engage in the practice of pharmacy if the pharmacist knew or
19-11 reasonably should have known that the individual was unlicensed at
19-12 the time;
19-13 (11) refused an entry into any pharmacy for any
19-14 inspection authorized by this Act if the pharmacist had received
19-15 notification from which the pharmacist knew or reasonably should
19-16 have known that the attempted inspection was authorized;
19-17 (12) violated the pharmacy or drug laws or rules of
19-18 this state or any other state or of the United States;
19-19 (13) been negligent in the practice of pharmacy;
19-20 (14) failed to submit to an examination after hearing
19-21 and being ordered to do so by the board pursuant to Subdivision (4)
19-22 of this subsection;
19-23 (15) dispensed prescription drugs while acting outside
19-24 the usual course and scope of professional practice; or
19-25 (16) had a license to practice pharmacy issued by
20-1 another state canceled, revoked, surrendered, or suspended for
20-2 conduct substantially equivalent to conduct described in
20-3 Subdivisions (1) through (15) of this subsection. A certified copy
20-4 of the record of the state taking action as set out above shall be
20-5 conclusive evidence of the action taken by such state.
20-6 SECTION 7. Subsections (a) and (b), Section 26A, Texas
20-7 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
20-8 amended to read as follows:
20-9 (a) On the entry of an initial order against an applicant
20-10 for a license to practice pharmacy or a person licensed by the
20-11 board to practice pharmacy, the board may refuse to issue a license
20-12 to the applicant or suspend the person's license. On the person's
20-13 final conviction, the board may revoke the person's license.
20-14 (b) On the entry of an initial order against an applicant
20-15 for a license for a pharmacy or a person who has been issued a
20-16 license or renewal license for a pharmacy under this Act, or
20-17 against a managing officer of the licensee or applicant if the
20-18 licensee or applicant is an association, joint-stock company,
20-19 partnership, or corporation, the board may refuse to issue the
20-20 license or suspend the license. On final conviction, the board may
20-21 revoke the license.
20-22 SECTION 8. Subsection (a), Section 26B, Texas Pharmacy Act
20-23 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
20-24 read as follows:
20-25 (a) The board may in its discretion refuse to issue or renew
21-1 a license or may fine or reprimand any licensee or revoke,
21-2 restrict, cancel, or suspend any license granted by the board, if
21-3 the board finds that an applicant or licensee has:
21-4 (1) dispensed a drug, quantity, or strength of drug
21-5 other than that which is ordered for the patient by a practitioner
21-6 or labeled a prescription with incorrect directions for use;
21-7 (2) violated any of the following provisions of this
21-8 Act:
21-9 (A) Section 29(a), (b)(5), or (c)(5);
21-10 (B) Section 30(i) or (j); or
21-11 (C) Section 32(a);
21-12 (3) failed to comply with the following requirements
21-13 unless compliance would violate the pharmacy or drug laws or rules
21-14 in the state in which the pharmacy is located:
21-15 (A) Section 481.074 or 481.075, Health and
21-16 Safety Code;
21-17 (B) Texas substitution requirements regarding:
21-18 (i) the practitioner's directions relative
21-19 to generic substitution;
21-20 (ii) the patient's right to refuse generic
21-21 substitution; or
21-22 (iii) notification to the patient of the
21-23 patient's right to refuse substitution; <or>
21-24 (C) board rules relating to the provision of
21-25 drug information to the patient or patient's agent in written form
22-1 or by telephone; <or>
22-2 (D) board rules adopted pursuant to Section
22-3 16(a) of this Act and determined by the board to be applicable
22-4 pursuant to Section 16(b) of this Act; or
22-5 (4) engaged in conduct which caused serious bodily
22-6 injury to a Texas resident.
22-7 SECTION 9. Section 27A, Texas Pharmacy Act (Article 4542a-1,
22-8 Vernon's Texas Civil Statutes), is amended by amending Subsection
22-9 (d) and adding Subsection (j) to read as follows:
22-10 (d) The records and proceedings of the board, its authorized
22-11 agents, or any pharmaceutical organization committee as set out in
22-12 Subsections (a) and (b) of this section shall be confidential and
22-13 are not considered open records for the purposes of Chapter 424,
22-14 Acts of the 63rd Legislature, Regular Session, 1973, as amended
22-15 (Article 6252-17a, Vernon's Texas Civil Statutes); provided,
22-16 however, the board may disclose this confidential information only:
22-17 (1) in a disciplinary hearing before the board or in a
22-18 subsequent trial or appeal of a board action or order;
22-19 (2) to the pharmacist licensing or disciplinary
22-20 authorities of other jurisdictions; <or>
22-21 (3) pursuant to an order of a court of competent
22-22 jurisdiction; or
22-23 (4) pursuant to Subsection (j) of this section.
22-24 (j) The board may disclose that the license of a pharmacist
22-25 who is the subject of an order of the board deemed confidential by
23-1 Subsection (d) of this section is suspended, revoked, canceled,
23-2 restricted, or retired or that the pharmacist is in any manner
23-3 otherwise limited in the practice of pharmacy; however, the board
23-4 may not disclose the nature of the impairment or other information
23-5 that resulted in such action.
23-6 SECTION 10. Subsection (b), Section 28, Texas Pharmacy Act
23-7 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
23-8 read as follows:
23-9 (b) A person whose pharmacy license or license to practice
23-10 pharmacy in this state has been canceled, revoked, or restricted
23-11 under this Act, whether voluntarily or by action of the board, may,
23-12 after 12 months from the effective date of the cancellation,
23-13 revocation, or restriction, petition the board for reinstatement or
23-14 removal of the restriction of the license. The petition shall be
23-15 in writing and in the form prescribed by the board. On
23-16 investigation and review of the petition <hearing>, the board may
23-17 in its discretion grant or deny the petition or it may modify its
23-18 original finding to reflect any circumstances that have changed
23-19 sufficiently to warrant the modification. If such petition is
23-20 denied by the board, a subsequent petition may not be considered by
23-21 the board until 12 months from the date of denial of the previous
23-22 petition. The board in its discretion may require such person to
23-23 pass an examination or examinations for reentry into the practice
23-24 of pharmacy.
23-25 SECTION 11. Subsection (a), Section 32, Texas Pharmacy Act
24-1 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
24-2 read as follows:
24-3 (a) A pharmacy shall report in writing to the board not
24-4 later than the 10th day after the date of the occurrence, unless
24-5 immediate notification is required by this section, any of the
24-6 following:
24-7 (1) permanent closing;
24-8 (2) change of ownership;
24-9 (3) change of location;
24-10 (4) change of pharmacist-in-charge;
24-11 (5) the theft or significant loss of any controlled
24-12 substances, immediately on discovery of the theft or loss, by
24-13 including with the notification to the board of the theft or loss a
24-14 list of all controlled substances stolen or lost;
24-15 (6) the sale or transfer of controlled substances or
24-16 dangerous drugs on the permanent closing or change of ownership of
24-17 the pharmacy;
24-18 (7) any matters and occurrences that the board may
24-19 require by rule;
24-20 (8) out-of-state purchases of controlled substances as
24-21 determined by the board; <and>
24-22 (9) a disaster, accident, or emergency that may affect
24-23 the strength, purity, or labeling of a drug, medication, device, or
24-24 other material used in the diagnosis or the treatment of injury,
24-25 illness, and disease, immediately on the occurrence of the
25-1 disaster, accident, or emergency;
25-2 (10) <. (9)> a final order against the holder of a
25-3 Class E pharmacy license by the regulatory or licensing agency of
25-4 the state in which the pharmacy is located; and
25-5 (11) <(10)> a final order against a pharmacist who is
25-6 designated as the pharmacist-in-charge of a Class E pharmacy by the
25-7 regulatory or licensing agency of the state in which the pharmacy
25-8 is located.
25-9 SECTION 12. Section 40, Texas Pharmacy Act (Article 4542a-1,
25-10 Vernon's Texas Civil Statutes), is amended by amending Subsections
25-11 (d) and (e) and relettering Subsections (f) through (k) to read as
25-12 follows:
25-13 (d) With the patient's consent, a pharmacist may dispense a
25-14 dosage form of a drug product different from that prescribed, such
25-15 as tablet instead of capsule or liquid instead of tablet, provided
25-16 the dosage form so dispensed contains the identical amount of the
25-17 active ingredients as the dosage prescribed for the patient.
25-18 (e) Unless otherwise directed by the practitioner, the label
25-19 on the dispensing container shall indicate the actual drug product
25-20 dispensed, either (1) the brand name, or if none (2) the generic
25-21 name, the strength, and the name of the manufacturer or
25-22 distributor. In instances where a drug product has been selected
25-23 other than the one prescribed, the pharmacist shall place on the
25-24 container the words "Substituted for brand prescribed" or
25-25 "Substituted for 'brand name'" where "brand name" is the actual
26-1 name of the brand name drug product prescribed.<" The brand name
26-2 of the prescribed drug shall not appear on the prescription
26-3 container label unless it is the drug product actually dispensed.>
26-4 (f) <(e)> A pharmacist may not select a generically
26-5 equivalent drug unless the generically equivalent drug selected
26-6 costs the patient less than the prescribed drug product. <A
26-7 pharmacist may not charge a higher professional fee for dispensing
26-8 a generically equivalent drug product than the fee he or she
26-9 customarily charges for dispensing the brand name product
26-10 prescribed.>
26-11 (g)(1) <(f)> A pharmacist who selects a generically
26-12 equivalent drug product as authorized by this section shall:
26-13 (A) <(1)> personally, or through his or her
26-14 agent or employee and prior to delivery of a generically equivalent
26-15 drug product, inform the patient or the patient's agent that a less
26-16 expensive generically equivalent drug product has been substituted
26-17 for the brand prescribed and the patient or patient's agent's right
26-18 to refuse such substitution; or
26-19 (B) <(2)> cause to be displayed, in a prominent
26-20 place that is in clear public view where prescription drugs are
26-21 dispensed, a sign in block letters not less than one inch in height
26-22 that reads, in both English and Spanish:
26-23 "TEXAS LAW ALLOWS A LESS EXPENSIVE GENERICALLY
26-24 EQUIVALENT DRUG TO BE SUBSTITUTED FOR CERTAIN BRAND
26-25 NAME DRUGS UNLESS YOUR PHYSICIAN DIRECTS OTHERWISE.
27-1 YOU HAVE A RIGHT TO REFUSE SUCH SUBSTITUTION. CONSULT
27-2 YOUR PHYSICIAN OR PHARMACIST CONCERNING THE
27-3 AVAILABILITY OF A SAFE, LESS EXPENSIVE DRUG FOR YOUR
27-4 USE."
27-5 Only one sign displayed in a pharmacy, as required above,
27-6 shall be deemed compliance with this subsection.
27-7 (2) <(3)> A pharmacist complies with the requirements
27-8 of this section if an employee or agent of the pharmacist notifies
27-9 a purchaser as required by Paragraph (A) of Subdivision (1) of this
27-10 subsection. The patient or patient's agent shall have the right to
27-11 refuse such product selection.
27-12 (h) <(g)> No written prescription issued by a practitioner,
27-13 as such term is defined in Section 5(30)(A) of this Act, may be
27-14 dispensed unless it is ordered on a form containing two signature
27-15 lines of equal prominence, side by side, at the bottom of the form.
27-16 Under either signature line shall be printed clearly the words
27-17 "product selection permitted," and under the other signature line
27-18 shall be printed clearly the words "dispense as written." The
27-19 practitioner shall communicate dispensing instructions to the
27-20 pharmacist by signing on the appropriate line. If the
27-21 practitioner's signature does not clearly indicate that the
27-22 prescription must be dispensed as written, generically equivalent
27-23 drug selection is permitted. No prescription form furnished a
27-24 practitioner shall contain a preprinted order for a drug product by
27-25 brand name, generic name, or manufacturer.
28-1 (i) <(h)> If a prescription is transmitted to a pharmacist
28-2 orally, the pharmacist shall note any dispensing instructions by
28-3 the practitioner or the practitioner's agent on the file copy of
28-4 the prescription and retain the prescription for the period of time
28-5 specified by law. Properly authorized prescription refills shall
28-6 follow the original dispensing instructions unless otherwise
28-7 indicated by the practitioner or practitioner's agent.
28-8 (j) <(i)> A pharmacist shall record on the prescription form
28-9 the name, strength, and manufacturer or distributor of any drug
28-10 product dispensed as herein authorized.
28-11 (k) <(j)> A pharmacist who selects a generically equivalent
28-12 drug to be dispensed pursuant to this section assumes the same
28-13 responsibility for selecting the generically equivalent drug that
28-14 he does in filling a prescription for a drug product prescribed by
28-15 generic name. There shall be no liability on the prescriber for an
28-16 act or omission by a pharmacist in selecting, preparing, or
28-17 dispensing a drug product pursuant to this section.
28-18 (l) <(k)> Drug product selection as authorized in this
28-19 section shall not apply to enteric-coated tablets; controlled
28-20 release products; injectable suspensions, other than antibiotics;
28-21 suppositories containing active ingredients for which systemic
28-22 absorption is necessary for therapeutic activity; and different
28-23 delivery systems for aerosol or nebulizer drugs. This subsection
28-24 shall not apply to any drug product which is determined to be
28-25 generically equivalent to the brand prescribed.
29-1 SECTION 13. The Texas Pharmacy Act (Article 4542a-1,
29-2 Vernon's Texas Civil Statutes) is amended by adding Sections 40B
29-3 and 40C to read as follows:
29-4 Sec. 40B. EMERGENCY REFILLS. A pharmacist may exercise his
29-5 professional judgment in refilling a prescription for a
29-6 prescription drug, other than a controlled substance listed in
29-7 Schedule II, without the authorization of the prescribing
29-8 practitioner, provided:
29-9 (1) failure to refill the prescription might result in
29-10 an interruption of a therapeutic regimen or create patient
29-11 suffering;
29-12 (2) either:
29-13 (A) a natural or manmade disaster has occurred
29-14 which prohibits the pharmacist from being able to contact the
29-15 practitioner; or
29-16 (B) the pharmacist is unable to contact the
29-17 practitioner after reasonable effort;
29-18 (3) the quantity of prescription drug dispensed does
29-19 not exceed a 72-hour supply;
29-20 (4) the pharmacist informs the patient or the
29-21 patient's agent at the time of dispensing that the refill is being
29-22 provided without such authorization and that authorization of the
29-23 practitioner is required for future refills; and
29-24 (5) the pharmacist informs the practitioner of the
29-25 emergency refill at the earliest reasonable time.
30-1 Sec. 40C. RELEASE OF CONFIDENTIAL RECORDS. Confidential
30-2 records are privileged and may be released only to:
30-3 (1) the patient or the patient's agent;
30-4 (2) practitioners and other pharmacists when, in the
30-5 pharmacist's professional judgment, such release is necessary to
30-6 protect the patient's health and well-being;
30-7 (3) other persons, the board, or other state or
30-8 federal agencies authorized by law to receive such confidential
30-9 records;
30-10 (4) a law enforcement agency engaged in investigation
30-11 of suspected violations of the Controlled Substances Act or
30-12 Dangerous Drug Act;
30-13 (5) a person employed by any state agency which
30-14 licenses a practitioner as defined in this Act if such person is
30-15 engaged in the performance of the person's official duties; or
30-16 (6) an insurance carrier or other third party payor
30-17 authorized by a patient to receive such information.
30-18 SECTION 14. Subdivision (41), Section 481.002, Health and
30-19 Safety Code, is amended to read as follows:
30-20 (41) "Prescription" means an order by a practitioner
30-21 to a pharmacist for a controlled substance for a particular patient
30-22 that specifies:
30-23 (A) the date of issue;
30-24 (B) the name and address of the patient or, if
30-25 the controlled substance is prescribed for an animal, the species
31-1 of the animal and the name and address of its owner;
31-2 (C) the name and quantity of the controlled
31-3 substance prescribed with the quantity shown numerically followed
31-4 by the number written as a word if the order is written or, if the
31-5 order is communicated orally or telephonically, with the quantity
31-6 given by the practitioner and transcribed by the pharmacist
31-7 numerically; <and>
31-8 (D) directions for the use of the drug;
31-9 (E) the intended use of the controlled substance
31-10 or the diagnosis for which the controlled substance is prescribed;
31-11 and
31-12 (F) the name, address, Federal Drug Enforcement
31-13 Administration registration number, and telephone number of the
31-14 practitioner at the practitioner's usual place of business, legibly
31-15 printed or stamped.
31-16 SECTION 15. Section 481.074, Health and Safety Code, is
31-17 amended by amending Subsections (d) through (i) and adding
31-18 Subsection (k) to read as follows:
31-19 (d) Except as specified in Subsections (e) and (f) of this
31-20 section, a <A> person may not fill a prescription for a controlled
31-21 substance listed in Schedule II after the end of the seventh day
31-22 after the date on which the prescription is issued. A person may
31-23 not refill a prescription for a substance listed in Schedule II.
31-24 (e) The partial filling of a prescription for a controlled
31-25 substance listed in Schedule II is permissible, if the pharmacist
32-1 is unable to supply the full quantity called for in a written or
32-2 emergency oral prescription and the pharmacist makes a notation of
32-3 the quantity supplied on the face of the written prescription or
32-4 written record of the emergency oral prescription. The remaining
32-5 portion of the prescription may be filled within 72 hours of the
32-6 first partial filling; however, if the remaining portion is not or
32-7 cannot be filled within the 72-hour period, the pharmacist shall so
32-8 notify the prescribing individual practitioner. No further
32-9 quantity may be supplied beyond 72 hours without a new
32-10 prescription.
32-11 (f) A prescription for a Schedule II controlled substance
32-12 written for a patient in a long-term care facility (LTCF) or for a
32-13 patient with a medical diagnosis documenting a terminal illness may
32-14 be filled in partial quantities to include individual dosage units.
32-15 If there is any question about whether a patient may be classified
32-16 as having a terminal illness, the pharmacist must contact the
32-17 practitioner prior to partially filling the prescription. Both the
32-18 pharmacist and the practitioner have a corresponding responsibility
32-19 to assure that the controlled substance is for a terminally ill
32-20 patient. The pharmacist must record on the prescription whether
32-21 the patient is "terminally ill" or an "LTCF patient." A
32-22 prescription that is partially filled and does not contain the
32-23 notation "terminally ill" or "LTCF patient" shall be deemed to have
32-24 been filled in violation of this Act. For each partial filling,
32-25 the dispensing pharmacist shall record on the back of Copy 1 and
33-1 Copy 2 of the prescription the date of the partial filling, the
33-2 quantity dispensed, the remaining quantity authorized to be
33-3 dispensed, and the identification of the dispensing pharmacist.
33-4 Prior to any subsequent partial filling the pharmacist is to
33-5 determine that the additional partial filling is necessary. The
33-6 total quantity of Schedule II controlled substances dispensed in
33-7 all partial fillings must not exceed the total quantity prescribed.
33-8 Schedule II prescriptions for patients in a long-term care facility
33-9 or patients with a medical diagnosis documenting a terminal illness
33-10 shall be valid for a period not to exceed 30 days from the issue
33-11 date unless sooner terminated by discontinuance of the medication.
33-12 (g) A person may not dispense a controlled substance in
33-13 Schedule III or IV that is a prescription drug under the Federal
33-14 Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.)
33-15 without a written, oral, or telephonically communicated
33-16 prescription of a practitioner defined by Section 481.002(39)(A),
33-17 except that the practitioner may dispense the substance directly to
33-18 an ultimate user. A prescription for a controlled substance listed
33-19 in Schedule III or IV may not be filled or refilled later than six
33-20 months after the date on which the prescription is issued and may
33-21 not be refilled more than five times, unless the prescription is
33-22 renewed by the practitioner.
33-23 (h) <(f)> A pharmacist may dispense a controlled substance
33-24 listed in Schedule III, IV, or V under an original written
33-25 prescription issued by a practitioner defined by Section
34-1 481.002(38)(C) and only if the pharmacist determines that the
34-2 prescription was issued for a valid medical purpose and in the
34-3 course of professional practice. A prescription issued under this
34-4 subsection may not be filled or refilled later than six months
34-5 after the date the prescription is issued, and a prescription
34-6 authorized to be refilled on the original prescription may not be
34-7 refilled more than five times.
34-8 (i) <(g)> A person may not dispense a controlled substance
34-9 listed in Section 481.036(1) or (2) without the prescription of a
34-10 practitioner defined by Section 481.002(39)(A), except that a
34-11 practitioner may dispense the substance directly to an ultimate
34-12 user. A prescription issued under this subsection may not be
34-13 filled or refilled later than six months after the date the
34-14 prescription is issued and may not be refilled more than five
34-15 times, unless the prescription is renewed by the practitioner.
34-16 (j) <(h)> A practitioner or institutional practitioner may
34-17 not allow a patient, on the patient's release from the hospital, to
34-18 possess a controlled substance prescribed by the practitioner
34-19 unless:
34-20 (1) the substance was dispensed under a medication
34-21 order while the patient was admitted to the hospital;
34-22 (2) the substance is in a properly labeled container;
34-23 and
34-24 (3) the patient possesses not more than a seven-day
34-25 supply of the substance.
35-1 (k) <(i)> A prescription for a controlled substance must
35-2 show:
35-3 (1) the quantity of the substance prescribed:
35-4 (A) numerically followed by the number written
35-5 as a word if the prescription is written; or
35-6 (B) if the prescription is communicated orally
35-7 or telephonically, as transcribed by the receiving pharmacist;
35-8 (2) the date of issue;
35-9 (3) the name and address of the patient or, if the
35-10 controlled substance is prescribed for an animal, the species of
35-11 the animal and the name and address of its owner;
35-12 (4) the name and strength of the controlled substance
35-13 prescribed;
35-14 (5) the directions for use of the controlled
35-15 substance; <and>
35-16 (6) the intended use of the controlled substance or
35-17 the diagnosis for which the controlled substance is prescribed; and
35-18 (7) the name, address, <and> Federal Drug Enforcement
35-19 Administration registration number, and telephone number of the
35-20 practitioner at the practitioner's usual place of business, legibly
35-21 printed or stamped.
35-22 (l) A pharmacist may exercise his professional judgment in
35-23 refilling a prescription for a controlled substance in Schedule
35-24 III, IV, or V without the authorization of the prescribing
35-25 practitioner provided:
36-1 (1) failure to refill the prescription might result in
36-2 an interruption of a therapeutic regimen or create patient
36-3 suffering;
36-4 (2) either:
36-5 (A) a natural or manmade disaster has occurred
36-6 which prohibits the pharmacist from being able to contact the
36-7 practitioner; or
36-8 (B) the pharmacist is unable to contact the
36-9 practitioner after reasonable effort;
36-10 (3) the quantity of prescription drug dispensed does
36-11 not exceed a 72-hour supply;
36-12 (4) the pharmacist informs the patient or the
36-13 patient's agent at the time of dispensing that the refill is being
36-14 provided without such authorization and that authorization of the
36-15 practitioner is required for future refills; and
36-16 (5) the pharmacist informs the practitioner of the
36-17 emergency refill at the earliest reasonable time.
36-18 SECTION 16. Subsections (d), (e), and (f), Section 481.075,
36-19 Health and Safety Code, are amended to read as follows:
36-20 (d) Except for oral prescriptions prescribed under Section
36-21 481.074(b), the prescribing practitioner shall:
36-22 (1) legibly fill in, or direct a designated agent to
36-23 legibly fill in, on all three copies of the form in the space
36-24 provided:
36-25 (A) the date the prescription is written;
37-1 (B) the drug prescribed, the quantity (shown
37-2 numerically followed by the number written as a word), <and>
37-3 instructions for use, and the intended use of the drug or the
37-4 diagnosis for which the controlled substance is prescribed; and
37-5 (C) the name, address, and age of the patient
37-6 or, in the case of an animal, its owner, for whom the controlled
37-7 substance is prescribed;
37-8 (2) sign Copies 1 and 2 of the form and give them to
37-9 the person authorized to receive the prescription; and
37-10 (3) retain Copy 3 of the form with the practitioner's
37-11 records for at least two years after the date the prescription is
37-12 written.
37-13 (e) In the case of an oral prescription prescribed under
37-14 Section 481.074(b), the prescribing practitioner shall give the
37-15 dispensing pharmacy the information needed to complete the form.
37-16 (f) Each dispensing pharmacist shall:
37-17 (1) fill in on Copies 1 and 2 of the form in the space
37-18 provided the information not required to be filled in by the
37-19 prescribing practitioner or the Department of Public Safety;
37-20 (2) indicate the total quantity dispensed on the face
37-21 of the triplicate prescription form;
37-22 (3) retain Copy 2 with the records of the pharmacy for
37-23 at least two years; <and>
37-24 (4) <(3)> sign Copy 1 and send it to the Department of
37-25 Public Safety not later than the 30th day after the date the
38-1 prescription is filled or not later than the 30th day after the
38-2 completion of a prescription dispensed under Section 481.074(f).
38-3 SECTION 17. Subchapter A, Chapter 483, Health and Safety
38-4 Code, is amended by adding Section 483.0001 and amending Section
38-5 483.001 to read as follows:
38-6 Sec. 483.0001. SHORT TITLE. This Act may be cited as the
38-7 Texas Dangerous Drug Act.
38-8 Sec. 483.001. DEFINITIONS. In this chapter:
38-9 (1) <(2)> "Board" means the Texas State Board of
38-10 Pharmacy.
38-11 (2) <(3)> "Dangerous drug" means a device or a drug
38-12 that is unsafe for self-medication and that is not included in
38-13 Schedules I through V or Penalty Groups 1 through 4 of Chapter 481
38-14 (Texas Controlled Substances Act). The term includes a device or a
38-15 drug that bears or is required to bear the legend:
38-16 (A) Caution: federal law prohibits dispensing
38-17 without prescription; or
38-18 (B) Caution: federal law restricts this drug to
38-19 use by or on the order of a licensed veterinarian.
38-20 (3) <(4)> "Deliver" means to sell, dispense, give
38-21 away, or supply in any other manner.
38-22 (4) "Designated agent" means:
38-23 (A) a licensed nurse, physician assistant,
38-24 pharmacist, or other individual designated by a practitioner to
38-25 communicate prescription drug orders to a pharmacist;
39-1 (B) a licensed nurse, physician assistant, or
39-2 pharmacist employed in a health care facility to whom the
39-3 practitioner communicates a prescription drug order; or
39-4 (C) a registered nurse or physician assistant
39-5 authorized by a practitioner to carry out a prescription drug order
39-6 for dangerous drugs under Section 3.06(d)(5), Medical Practice Act
39-7 (Article 4495b, Vernon's Texas Civil Statutes).
39-8 (5) "Dispense" means to prepare, package, compound, or
39-9 label a dangerous drug in the course of professional practice for
39-10 delivery under the lawful order of a practitioner to an ultimate
39-11 user or the user's agent.
39-12 (6) "Manufacturer" means a person, other than a
39-13 pharmacist, who manufactures dangerous drugs. The term includes a
39-14 person who prepares dangerous drugs in dosage form by mixing,
39-15 compounding, encapsulating, entableting, or any other process.
39-16 (7) "Patient" means:
39-17 (A) an individual for whom a dangerous drug is
39-18 prescribed or to whom a dangerous drug is administered; or
39-19 (B) an owner or the agent of an owner of an
39-20 animal for which a dangerous drug is prescribed or to which a
39-21 dangerous drug is administered.
39-22 (8) "Person" includes an individual, corporation,
39-23 partnership, and association.
39-24 (9) "Pharmacist" means a person licensed by the Texas
39-25 State Board of Pharmacy to practice pharmacy.
40-1 (10) "Pharmacy" means a facility licensed by the board
40-2 pursuant to Section 29, Texas Pharmacy Act (Article 4542a-1,
40-3 Vernon's Texas Civil Statutes) <in which the practice of pharmacy
40-4 occurs>.
40-5 (11) "Practice of pharmacy" means:
40-6 (A) provision of those acts or services
40-7 necessary to provide pharmaceutical care;
40-8 (B) interpretation and evaluation of
40-9 prescription drug orders or medication orders;
40-10 (C) participation in drug and device selection,
40-11 drug administration, drug regimen review, or drug or drug-related
40-12 research;
40-13 (D) provision of patient counseling; and
40-14 (E) responsibility for:
40-15 (i) dispensing of prescription drug orders
40-16 or distribution of medication orders in the patient's best
40-17 interest;
40-18 (ii) compounding and labeling of drugs and
40-19 devices, except labeling by a manufacturer, repackager, or
40-20 distributor of nonprescription drugs and commercially packaged
40-21 prescription drugs and devices;
40-22 (iii) proper and safe storage of drugs and
40-23 devices; and
40-24 (iv) maintenance of proper records for
40-25 drugs and devices <the interpretation and evaluation of
41-1 prescription or medication orders, the dispensing and labeling of
41-2 drugs or devices, the selection of drugs and the review of drug
41-3 use, the storage of prescription drugs and devices and the
41-4 maintenance of prescription drug records in a pharmacy, the giving
41-5 of advice or consultation if necessary or required by law about the
41-6 therapeutic value, content, hazard, or use of drugs or devices, or
41-7 the offer to perform or the performance of the services and
41-8 transactions necessary to operate a pharmacy>. In this
41-9 subdivision, "device" has the meaning assigned by the Texas
41-10 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes).
41-11 (12) "Practitioner" means a person licensed:
41-12 (A) by the Texas State Board of Medical
41-13 Examiners, State Board of Dental Examiners, Texas State Board of
41-14 Podiatry Examiners, Texas Optometry Board, or State Board of
41-15 Veterinary Medical Examiners to prescribe and administer dangerous
41-16 drugs;
41-17 (B) by another state in a health field in which,
41-18 under the laws of this state, a licensee may legally prescribe
41-19 dangerous drugs; or
41-20 (C) in Canada or Mexico in a health field in
41-21 which, under the laws of this state, a licensee may legally
41-22 prescribe dangerous drugs.
41-23 (13) "Prescription" means an order from a
41-24 practitioner, or an agent of the practitioner designated in writing
41-25 as authorized to communicate prescriptions, or an order made in
42-1 accordance with Section 3.06(d)(5), Medical Practice Act (Article
42-2 4495b, Vernon's Texas Civil Statutes), to a pharmacist for a
42-3 dangerous drug to be dispensed that states:
42-4 (A) the date of the order's issue;
42-5 (B) the name and address of the patient;
42-6 (C) if the drug is prescribed for an animal, the
42-7 species of the animal;
42-8 (D) the name and quantity of the drug
42-9 prescribed; <and>
42-10 (E) the directions for the use of the drug;
42-11 (F) the intended use of the drug or the
42-12 diagnosis for which the drug is prescribed; and
42-13 (G) the name, address, and telephone number of
42-14 the practitioner at the practitioner's usual place of business,
42-15 legibly printed or stamped.
42-16 (14) "Warehouseman" means a person who stores
42-17 dangerous drugs for others and who has no control over the
42-18 disposition of the drugs except for the purpose of storage.
42-19 (15) "Wholesaler" means a person engaged in the
42-20 business of distributing dangerous drugs to a person listed in
42-21 Sections 483.041(c)(1)-(6).
42-22 SECTION 18. Section 483.022, Health and Safety Code, is
42-23 amended to read as follows:
42-24 Sec. 483.022. Practitioner's Designated Agent;
42-25 Practitioner's Responsibilities. (a) A practitioner shall provide
43-1 in writing the name of each<:>
43-2 <(1)> designated agent as defined by Section
43-3 483.001(4) <authorized by the practitioner to communicate
43-4 prescriptions for the practitioner; and>
43-5 <(2) registered nurse or physician assistant
43-6 authorized to carry out a prescription drug order under Section
43-7 3.06(d)(5), Medical Practice Act (Article 4495b, Vernon's Texas
43-8 Civil Statutes)>.
43-9 (b) The practitioner shall maintain at the practitioner's
43-10 usual place of business a list of the designated agents as defined
43-11 by Section 483.001(4) <and a list of the designated registered
43-12 nurses or physician assistants authorized to carry out a
43-13 prescription drug order>.
43-14 <(b) The practitioner shall maintain at the practitioner's
43-15 usual place of business a list of each designated agent, registered
43-16 nurse, or physician assistant who is authorized to carry out a
43-17 prescription drug order.>
43-18 (c) The practitioner shall provide a pharmacist with a copy
43-19 of the practitioner's written authorization for a designated agent
43-20 as defined by Section 483.001(4)<, registered nurse, or physician
43-21 assistant> on the pharmacist's request.
43-22 (d) This section does not relieve a practitioner or the
43-23 practitioner's designated agent from the requirements of Section
43-24 40, Texas Pharmacy Act (Article 4542a-1, Vernon's Texas Civil
43-25 Statutes).
44-1 (e) A practitioner remains personally responsible for the
44-2 actions of a designated agent who communicates a prescription to a
44-3 pharmacist.
44-4 SECTION 19. Subsection (d), Section 483.041, Health and
44-5 Safety Code, is amended to read as follows:
44-6 (d) An offense under this section is a felony of the third
44-7 degree <Class B misdemeanor unless it is shown on the trial of the
44-8 defendant that the defendant has previously been convicted of an
44-9 offense under this section, in which event the offense is a Class A
44-10 misdemeanor>.
44-11 SECTION 20. Section 483.042, Health and Safety Code, is
44-12 amended by amending Subsections (c) and (d) to read as follows:
44-13 (c) The labeling provisions of Subsection (a) do not apply
44-14 when the dangerous drug is prescribed for administration to an
44-15 ultimate user who is institutionalized. The board shall adopt
44-16 rules for the labeling of such drugs.
44-17 (d) Proof of an offer to sell a dangerous drug must be
44-18 corroborated by a person other than the offeree or by evidence
44-19 other than a statement by the offeree.
44-20 (e) <(d)> An offense under this section is a felony of the
44-21 third degree.
44-22 SECTION 21. Section 483.047, Health and Safety Code, is
44-23 amended to read as follows:
44-24 Sec. 483.047. Refilling Prescription Without Authorization.
44-25 (a) Except as authorized by Subsection (b), a <A> pharmacist
45-1 commits an offense if the pharmacist refills a prescription unless:
45-2 (1) the prescription contains an authorization by the
45-3 practitioner for the refilling of the prescription, and the
45-4 pharmacist refills the prescription in the manner provided by the
45-5 authorization; or
45-6 (2) at the time of refilling the prescription, the
45-7 pharmacist is authorized to do so by the practitioner who issued
45-8 the prescription.
45-9 (b) A pharmacist may exercise his professional judgment in
45-10 refilling a prescription for a dangerous drug without the
45-11 authorization of the prescribing practitioner provided:
45-12 (1) failure to refill the prescription might result in
45-13 an interruption of a therapeutic regimen or create patient
45-14 suffering;
45-15 (2) either:
45-16 (A) a natural or manmade disaster has occurred
45-17 which prohibits the pharmacist from being able to contact the
45-18 practitioner; or
45-19 (B) the pharmacist is unable to contact the
45-20 practitioner after reasonable effort;
45-21 (3) the quantity of drug dispensed does not exceed a
45-22 72-hour supply;
45-23 (4) the pharmacist informs the patient or the
45-24 patient's agent at the time of dispensing that the refill is being
45-25 provided without such authorization and that authorization of the
46-1 practitioner is required for future refills; and
46-2 (5) the pharmacist informs the practitioner of the
46-3 emergency refill at the earliest reasonable time.
46-4 (c) An offense under this section is a Class B misdemeanor
46-5 unless it is shown on the trial of the defendant that the defendant
46-6 has previously been convicted under this chapter, in which event
46-7 the offense is a Class A misdemeanor.
46-8 SECTION 22. This Act takes effect September 1, 1993.
46-9 SECTION 23. (a) A change in law made by this Act which
46-10 applies to a criminal offense applies only to an offense committed
46-11 on or after the effective date of this Act. For purposes of this
46-12 section, an offense is committed before the effective date of this
46-13 Act if any element of the offense occurs before that date.
46-14 (b) A criminal offense committed before the effective date
46-15 of this Act is covered by the law in effect when the offense was
46-16 committed, and the former law is continued in effect for this
46-17 purpose.
46-18 SECTION 24. The importance of this legislation and the
46-19 crowded condition of the calendars in both houses create an
46-20 emergency and an imperative public necessity that the
46-21 constitutional rule requiring bills to be read on three several
46-22 days in each house be suspended, and this rule is hereby suspended.