By:  Madla                                             S.B. No. 609

                                A BILL TO BE ENTITLED

                                       AN ACT

 1-1     relating to the regulation of pharmacies and pharmacists; providing

 1-2     a penalty.

 1-3           BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

 1-4           SECTION 1.  Section 5, Texas Pharmacy Act (Article 4542a-1,

 1-5     Vernon's Texas Civil Statutes), is amended to read as follows:

 1-6           Sec. 5.  DEFINITIONS.   In this Act, unless the context of

 1-7     its use clearly indicates otherwise:

 1-8                 (1)  "A.C.P.E." means the American Council on

 1-9     Pharmaceutical Education.

1-10                 (2)  "Administer" means the direct application of a

1-11     prescription drug by injection, inhalation, ingestion, or any other

1-12     means to the body of a patient by:

1-13                       (A)  a practitioner, an authorized agent under

1-14     his supervision, or other person authorized by law; or

1-15                       (B)  the patient at the direction of a

1-16     practitioner.

1-17                 (3)  "Administrative Procedure Act" means Chapter 2001,

1-18     Government Code [the Administrative Procedure and Texas Register

1-19     Act, as amended (Article 6252-13a, Vernon's Texas Civil Statutes)].

1-20                 (4)  "Board" means the Texas State Board of Pharmacy.

1-21                 (5)  "Class A pharmacy license" or "community pharmacy

1-22     license" means a license issued to a pharmacy dispensing drugs or

1-23     devices to the general public pursuant to a prescription drug

1-24     order.

 2-1                 (6)  "Class B pharmacy license" or "nuclear pharmacy

 2-2     license" means a license issued to a pharmacy dispensing or

 2-3     providing radioactive drugs or devices for administration to an

 2-4     ultimate user.

 2-5                 (7)  "Class C pharmacy license" or "institutional

 2-6     pharmacy license" means a license issued to a pharmacy located in a

 2-7     hospital or other in-patient facility that is licensed under

 2-8     Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental

 2-9     Health Code (Article 5547-1 et seq., Vernon's Texas Civil

2-10     Statutes), to a hospice in-patient facility that is licensed under

2-11     Chapter 142, Health and Safety Code, or to a pharmacy located in a

2-12     hospital maintained or operated by the state.

2-13                 (8)  "Class D pharmacy license" or "clinic pharmacy

2-14     license" means a license issued to a pharmacy dispensing a limited

2-15     type of drugs or devices pursuant to a prescription drug order.

2-16                 (9)  "Class E pharmacy license" or "nonresident

2-17     pharmacy license" means a license issued under this Act to a

2-18     pharmacy located in a state of the United States other than this

2-19     state whose primary business is to dispense a prescription drug or

2-20     device under a prescription drug order and to deliver the drug or

2-21     device to a patient, including a patient in this state, by the

2-22     United States mail, a common carrier, or a delivery service.

2-23                 (10) [(11)]  "College of pharmacy" means a school,

2-24     university, or college of pharmacy that satisfies the accreditation

2-25     standards of A.C.P.E. as adopted by the board; or that has degree

2-26     requirements which meet the standards of accreditation set by the

2-27     board.

 3-1                 (11) [(12)]  "Compounding" means the preparation,

 3-2     mixing, assembling, packaging, or labeling of a drug or device:

 3-3                       (A)  as the result of a practitioner's

 3-4     prescription drug order or initiative based on the

 3-5     practitioner-patient-pharmacist relationship in the course of

 3-6     professional practice;

 3-7                       (B)  in anticipation of prescription drug orders

 3-8     based on routine, regularly observed prescribing patterns; or

 3-9                       (C)  for the purpose of or as an incident to

3-10     research, teaching, or chemical analysis and not for sale or

3-11     dispensing.

3-12                 (12) [(13)]  "Confidential record" means any

3-13     health-related record that contains information that identifies an

3-14     individual and that is maintained by a pharmacy or pharmacist such

3-15     as a patient medication record, prescription drug order, or

3-16     medication order.

3-17                 (13) [(14)]  "Controlled substance" means a drug,

3-18     immediate precursor, or other substance listed in Schedules I-V or

3-19     Penalty Groups 1-4 of Chapter 481, Health and Safety Code, or a

3-20     drug, immediate precursor, or other substance included in Schedule

3-21     I, II, III, IV, or V of the Federal Comprehensive Drug Abuse

3-22     Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).

3-23                 (14) [(15)]  "Controlled Substances Act" means Chapter

3-24     481, Health and Safety Code, or the Federal Comprehensive Drug

3-25     Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et

3-26     seq.).

3-27                 (15) [(16)]  "Dangerous drug" means any drug or device

 4-1     that is not included in Penalty Groups 1-4 of the Controlled

 4-2     Substances Act and that is unsafe for self-medication or any drug

 4-3     or device that bears or is required to bear the legend:

 4-4                       (A)  "Caution:  federal law prohibits dispensing

 4-5     without prescription"; or

 4-6                       (B)  "Caution:  federal law restricts this drug

 4-7     to use by or on the order of a licensed veterinarian."

 4-8                 (16) [(17)]  "Dangerous Drug Act" means Chapter 483,

 4-9     Health and Safety Code.

4-10                 (17) [(18)]  "Deliver" or "delivery" means the actual,

4-11     constructive, or attempted transfer of a prescription drug or

4-12     device or controlled substance from one person to another, whether

4-13     or not for a consideration.

4-14                 (18) [(19)]  "Designated agent" means:

4-15                       (A)  a licensed nurse, physician assistant,

4-16     pharmacist, or other individual designated by a practitioner, and

4-17     for whom the practitioner assumes legal responsibility, who

4-18     communicates prescription drug orders to a pharmacist;

4-19                       (B)  a licensed nurse, physician assistant, or

4-20     pharmacist employed in a health care facility to whom the

4-21     practitioner communicates a prescription drug order; or

4-22                       (C)  a registered nurse or physician assistant

4-23     authorized by a practitioner to carry out a prescription drug order

4-24     for dangerous drugs under Subdivision (5) or (6), Subsection (d),

4-25     Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas

4-26     Civil Statutes).

4-27                 (19) [(20)]  "Device" means an instrument, apparatus,

 5-1     implement, machine, contrivance, implant, in vitro reagent, or

 5-2     other similar or related article, including any component part or

 5-3     accessory, that is required under federal or state law to be

 5-4     ordered or prescribed by a practitioner.

 5-5                 (20) [(21)]  "Dispense" means preparing, packaging,

 5-6     compounding, or labeling for delivery a prescription drug or device

 5-7     in the course of professional practice to an ultimate user or his

 5-8     agent by or pursuant to the lawful order of a practitioner.

 5-9                 (21) [(22)]  "Distribute" means the delivery of a

5-10     prescription drug or device other than by administering or

5-11     dispensing.

5-12                 (22) [(23)]  "Drug" means:

5-13                       (A)  a substance recognized as drugs in the

5-14     current official United States Pharmacopoeia, official National

5-15     Formulary, official Homeopathic Pharmacopoeia, or other drug

5-16     compendium or any supplement to any of them;

5-17                       (B)  a substance intended for use in the

5-18     diagnosis, cure, mitigation, treatment, or prevention of disease in

5-19     man or other animals;

5-20                       (C)  a substance, other than food, intended to

5-21     affect the structure or any function of the body of man or other

5-22     animals;

5-23                       (D)  a substance intended for use as a component

5-24     of any articles specified in Paragraph (A), (B), or (C) of this

5-25     subdivision;

5-26                       (E)  a dangerous drug; or

5-27                       (F)  a controlled substance.

 6-1                 (23) [(24)]  "Drug regimen review" includes the

 6-2     following activities:

 6-3                       (A)  evaluation of prescription drug or

 6-4     medication orders and patient medication records for:

 6-5                             (i)  known allergies;

 6-6                             (ii)  rational therapy-contraindications;

 6-7                             (iii)  reasonable dose and route of

 6-8     administration; and

 6-9                             (iv)  reasonable directions for use;

6-10                       (B)  evaluation of prescription drug or

6-11     medication orders and patient medication records for duplication of

6-12     therapy;

6-13                       (C)  evaluation of prescription drug or

6-14     medication orders and patient medication records for:

6-15                             (i)  drug-drug interactions;

6-16                             (ii)  drug-food interactions;

6-17                             (iii)  drug-disease interactions;

6-18                             (iv)  adverse drug reactions; and

6-19                       (D)  evaluation of prescription drug and

6-20     medication orders and patient medication records for proper

6-21     utilization, including overutilization or underutilization.

6-22                 (24) [(25)]  "Internship" means a practical experience

6-23     program that is approved by the board.

6-24                 (25) [(26)]  "Label" means written, printed, or graphic

6-25     matter on the immediate container of a drug or device.

6-26                 (26) [(27)]  "Labeling" means the process of affixing a

6-27     label including all information required by federal and state law

 7-1     or regulation to any drug or device container.  The term does not

 7-2     include the labeling by a manufacturer, packer, or distributor of a

 7-3     nonprescription drug or commercially packaged prescription drug or

 7-4     device, or unit dose packaging.

 7-5                 (27) [(28)]  "Manufacturing" means the production,

 7-6     preparation, propagation, conversion, or processing of a drug or

 7-7     device, either directly or indirectly, by extraction from

 7-8     substances of natural origin or independently by means of chemical

 7-9     or biological synthesis and includes any packaging or repackaging

7-10     of the substances or labeling or relabeling of the container and

7-11     the promotion and marketing of such drugs or devices.

7-12     Manufacturing also includes the preparation and promotion of

7-13     commercially available products from bulk compounds for resale by

7-14     pharmacies, practitioners, or other persons but does not include

7-15     compounding.

7-16                 (28) [(29)]  "Medication order" means an order from a

7-17     practitioner or a practitioner's designated agent for

7-18     administration of a drug or device.

7-19                 (29) [(30)]  "Nonprescription drug" means a nonnarcotic

7-20     drug or device that may be sold without a prescription and that is

7-21     labeled and packaged in compliance with applicable state or federal

7-22     law.

7-23                 (30) [(31)]  "Patient counseling" means the

7-24     communication by the pharmacist of information, as specified in the

7-25     rules of the board, to the patient or caregiver, in order to

7-26     improve therapy by ensuring proper use of drugs and devices.

7-27                 (31) [(32)]  "Person" means an individual, corporation,

 8-1     government or governmental subdivision or agency, business trust,

 8-2     estate, trust, partnership, association, or any other legal entity.

 8-3                 (32) [(33)]  "Pharmaceutical care" is the provision of

 8-4     drug therapy and other pharmaceutical services defined in the rules

 8-5     of the board and intended to assist in the cure or prevention of a

 8-6     disease, elimination or reduction of a patient's symptoms, or

 8-7     arresting or slowing of a disease process.

 8-8                 (33) [(34)]  "Pharmacist" means a person licensed by

 8-9     the board to practice pharmacy.

8-10                 (34) [(35)]  "Pharmacist-in-charge" means the

8-11     pharmacist designated on a pharmacy license as the pharmacist who

8-12     has the authority or responsibility for a pharmacy's compliance

8-13     with laws and rules pertaining to the practice of pharmacy.

8-14                 (35) [(36)]  "Pharmacist-intern" means an undergraduate

8-15     student enrolled in the professional sequence of a college of

8-16     pharmacy approved by the board and participating in a school-based,

8-17     board-approved internship program or a graduate of a college of

8-18     pharmacy who is participating in a board-approved internship.

8-19                 (36) [(37)]  "Pharmacy" means a facility at which

8-20     prescription drug or medication orders are received, processed, or

8-21     dispensed under this Act, the Dangerous Drug Act, or the Controlled

8-22     Substances Act [licensed by the board pursuant to Section 29 of

8-23     this Act].

8-24                 (37)  "Pharmacy technician" means an individual

8-25     employed by a pharmacy whose responsibility is to provide technical

8-26     services that do not require professional judgment regarding the

8-27     preparation and distribution of drugs and who works under the

 9-1     direct supervision of and is responsible to a pharmacist.

 9-2                 (38)  "Practice of pharmacy" means:

 9-3                       (A)  provision of those acts or services

 9-4     necessary to provide pharmaceutical care;

 9-5                       (B)  interpretation and evaluation of

 9-6     prescription drug orders or medication orders;

 9-7                       (C)  participation in drug and device selection

 9-8     as authorized by law, drug administration, drug regimen review, or

 9-9     drug or drug-related research;

9-10                       (D)  provision of patient counseling;

9-11                       (E)  responsibility for:

9-12                             (i)  dispensing of prescription drug orders

9-13     or distribution of medication orders;

9-14                             (ii)  compounding and labeling of drugs and

9-15     devices, except labeling by a manufacturer, repackager, or

9-16     distributor of nonprescription drugs and commercially packaged

9-17     prescription drugs and devices;

9-18                             (iii)  proper and safe storage of drugs and

9-19     devices; or

9-20                             (iv)  maintenance of proper records for

9-21     drugs and devices; and

9-22                       (F)  performance of a specific act of drug

9-23     therapy management for a patient delegated to a pharmacist by a

9-24     written protocol from a physician licensed in this state in

9-25     compliance with the Medical Practice Act (Article 4495b, Vernon's

9-26     Texas Civil Statutes).

9-27                 (39)  "Practitioner" means:

 10-1                      (A)  a physician, dentist, podiatrist,

 10-2    veterinarian, or other person licensed or registered to prescribe,

 10-3    distribute, administer, or dispense a prescription drug or device

 10-4    in the course of professional practice in this state;

 10-5                      (B)  a person licensed by another state in a

 10-6    health field in which, under Texas law, licensees in this state may

 10-7    legally prescribe dangerous drugs or a person practicing in another

 10-8    state and licensed by another state as a physician, dentist,

 10-9    veterinarian, or podiatrist, having a current Federal Drug

10-10    Enforcement Administration registration number, and who may legally

10-11    prescribe Schedule II, III, IV, or V controlled substances in such

10-12    other state; or

10-13                      (C)  a person licensed in the Dominion of Canada

10-14    or the United Mexican States in a health field in which, under the

10-15    laws of this state, a licensee may legally prescribe dangerous

10-16    drugs.  "Practitioner" does not include a person licensed under

10-17    this Act.

10-18                (40)  "Preceptor" means a pharmacist [in good standing]

10-19    licensed in this state to practice pharmacy who meets the preceptor

10-20    requirements specified by rule and who is certified by the board to

10-21    supervise and be responsible for the activities and functions of a

10-22    pharmacist-intern in the internship program.

10-23                (41)  "Prescription drug" means:

10-24                      (A)  a substance for which federal or state law

10-25    requires a prescription before it may be legally dispensed to the

10-26    public;

10-27                      (B)  a drug or device that under federal law is

 11-1    required, prior to being dispensed or delivered, to be labeled with

 11-2    either of the following statements:

 11-3                            (i)  "Caution:  federal law prohibits

 11-4    dispensing without prescription"; or

 11-5                            (ii)  "Caution:  federal law restricts this

 11-6    drug to use by or on the order of a licensed veterinarian"; or

 11-7                      (C)  a drug or device that is required by any

 11-8    applicable federal or state law or regulation to be dispensed on

 11-9    prescription only or is restricted to use by a practitioner only.

11-10                (42)  "Prescription drug order" means:

11-11                      (A)  an order from a practitioner or a

11-12    practitioner's designated agent to a pharmacist for a drug or

11-13    device to be dispensed; or

11-14                      (B)  an order pursuant to Subdivision (5) or (6),

11-15    Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,

11-16    Vernon's Texas Civil Statutes).

11-17                (43)  "Prospective drug use review" means a review of

11-18    the patient's drug therapy and prescription drug order or

11-19    medication order, as defined in the rules of the board, prior to

11-20    dispensing or distributing the drug.

11-21                (44)  "Provide" means to supply one or more unit doses

11-22    of a nonprescription drug or dangerous drug to a patient.

11-23                (45)  "Radioactive drug" means a drug that exhibits

11-24    spontaneous disintegration of unstable nuclei with the emission of

11-25    nuclear particles or photons, including any nonradioactive reagent

11-26    kit or nuclide generator that is intended to be used in the

11-27    preparation of any such substance.

 12-1                (46)  "Substitution" means the dispensing of a drug or

 12-2    a brand of drug other than that which is ordered or prescribed.

 12-3                (47)  "Texas trade association" means a nonprofit,

 12-4    cooperative association of business or professional competitors in

 12-5    this state whose purpose is to assist its members, industry, or

 12-6    profession and whose members have joined voluntarily. ["Supportive

 12-7    personnel" means those individuals utilized in pharmacies whose

 12-8    responsibility it shall be to provide technical services that do

 12-9    not require professional judgment concerned with the preparation

12-10    and distribution of drugs under the direct supervision of and

12-11    responsible to a pharmacist.]

12-12                (48)  "Ultimate user" means a person who has obtained

12-13    and possesses a prescription drug or device for the person's own

12-14    use or for the use of a member of the person's household or for

12-15    administering to an animal owned by the person or by a member of

12-16    the person's household.

12-17                (49)  "Unit dose packaging" means the ordered amount of

12-18    drug in a dosage form ready for administration to a particular

12-19    patient, by the prescribed route at the prescribed time, and

12-20    properly labeled with name, strength, and expiration date of the

12-21    drug.

12-22                (50)  "Written protocol" means a physician's order,

12-23    standing medical order, standing delegation order, or other order

12-24    or protocol as defined by rule of the Texas State Board of Medical

12-25    Examiners under the Medical Practice Act (Article 4495b, Vernon's

12-26    Texas Civil Statutes).

12-27          SECTION 2.  Subsection (a), Section 8, Texas Pharmacy Act

 13-1    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

 13-2    read as follows:

 13-3          (a)  A licensed pharmacist member of the board:

 13-4                (1)  may not be:

 13-5                      (A)  a salaried faculty member at a college of

 13-6    pharmacy; or

 13-7                      (B)  an officer, employee, or paid consultant of

 13-8    a Texas trade association in the field of health care or a spouse

 13-9    of an officer, employee, or paid consultant; and

13-10                (2)  must at the time of his appointment:

13-11                      (A) [(1)]  be a resident of this state;

13-12                      (B) [(2)]  be licensed for the five years

13-13    immediately preceding appointment and be in good standing to engage

13-14    in the practice of pharmacy in this state; and

13-15                      (C) [(3)]  be engaged in the practice of pharmacy

13-16    in this state.

13-17          SECTION 3.  Section 8, Texas Pharmacy Act (Article 4542a-1,

13-18    Vernon's Texas Civil Statutes), is amended by adding Subsection (f)

13-19    to read as follows:

13-20          (f)  The board shall provide to its members, as often as

13-21    necessary, information regarding their qualifications for office or

13-22    employment under this Act and their responsibilities under

13-23    applicable laws relating to standards of conduct for state officers

13-24    or employees.

13-25          SECTION 4.  Subsection (c), Section 14, Texas Pharmacy Act

13-26    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

13-27    read as follows:

 14-1          (c)  Except as otherwise provided by this subsection, all

 14-2    board meetings and hearings shall be open to the public.  The board

 14-3    may, in its discretion and in accordance with the open meetings

 14-4    law, Chapter 551, Government Code, [Chapter 271, Acts of the 60th

 14-5    Legislature, Regular Session, 1967, as amended (Article 6252-17,

 14-6    Vernon's Texas Civil Statutes),] conduct any portion of its meeting

 14-7    in executive session.  The board may in its discretion conduct

 14-8    deliberations relative to licensee disciplinary actions in

 14-9    executive session.  At the conclusion of its deliberations relative

14-10    to licensee disciplinary action, the board shall vote and announce

14-11    its decision relative to the licensee in open session.  The board

14-12    in executive session may conduct disciplinary hearings relating to

14-13    a pharmacist or pharmacy student who is impaired because of

14-14    chemical abuse or mental or physical illness.

14-15          SECTION 5.  Subsections (c), (d), and (f), Section 15, Texas

14-16    Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

14-17    amended to read as follows:

14-18          (c)  An officer, employee, or paid consultant of a Texas

14-19    trade association in the field of health care may not be an [a

14-20    member or] employee of the board who is exempt from the state's

14-21    position classification plan or is compensated at or above the

14-22    amount prescribed by the General Appropriations Act for step 1,

14-23    salary group 17, of the position classification salary schedule.

14-24          (d)  A person who is the spouse of an officer, manager, or

14-25    paid consultant of a Texas trade association in the field of health

14-26    care may not be a [board member and may not be a] board employee

14-27    who is exempt from the state's position classification plan or is

 15-1    compensated at or above the amount prescribed by the General

 15-2    Appropriations Act for step 1, salary group 17, of the position

 15-3    classification salary schedule.

 15-4          (f)  The board shall provide to its [members and] employees,

 15-5    as often as necessary, information regarding their qualification

 15-6    for office or employment under this Act and their responsibilities

 15-7    under applicable laws relating to standards of conduct for state

 15-8    officers or employees.

 15-9          SECTION 6.  Subsections (o) and (q), Section 17, Texas

15-10    Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

15-11    amended to read as follows:

15-12          (o)  The board:

15-13                (1)  shall [may] establish rules for the use of

15-14    pharmacy technicians [supportive personnel] and the duties of those

15-15    technicians [personnel] in pharmacies licensed by the board,

15-16    provided that those technicians [personnel] are responsible to and

15-17    directly supervised by a pharmacist licensed by the board; provided

15-18    however that the board may not adopt rules or regulations

15-19    establishing ratios of pharmacists to pharmacy technicians

15-20    [supportive personnel] in Class C pharmacies; and

15-21                (2)  may determine and issue standards for recognition

15-22    and approval of training programs for pharmacy technicians and

15-23    maintain a list of training programs that meet the standards.

15-24          (q)  Board investigative files and all information and

15-25    materials compiled by the board in connection with an investigation

15-26    are confidential and are not subject to disclosure under Chapter

15-27    552, Government Code [424, Acts of the 63rd Legislature, Regular

 16-1    Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil

 16-2    Statutes)], and are not subject to disclosure, discovery, subpoena,

 16-3    or other means of legal compulsion for their release to anyone

 16-4    other than the board or its employees or agents involved in

 16-5    licensee discipline except that this information may be disclosed

 16-6    to:

 16-7                (1)  persons involved with the board in a disciplinary

 16-8    action against the licensee;

 16-9                (2)  pharmacist or pharmacy licensing or disciplinary

16-10    authorities of other jurisdictions;

16-11                (3)  a pharmaceutical peer review committee as outlined

16-12    in Section 27A of this Act;

16-13                (4)  law enforcement agencies; and

16-14                (5)  persons engaged in bona fide research, if all

16-15    individual-identifying information has been deleted.

16-16          SECTION 7.  Subsection (a), Section 17D, Texas Pharmacy Act

16-17    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

16-18    read as follows:

16-19          (a)  The board by rule shall adopt procedures governing:

16-20                (1)  informal disposition of a contested case under

16-21    Chapter 2001, Government Code [Section 13(e), Administrative

16-22    Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas

16-23    Civil Statutes), and its subsequent amendments]; and

16-24                (2)  informal proceedings held in compliance with

16-25    Chapter 2001, Government Code [Section 18(c), Administrative

16-26    Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas

16-27    Civil Statutes), and its subsequent amendments].

 17-1          SECTION 8.  Subsections (a), (f), and (g), Section 19, Texas

 17-2    Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

 17-3    amended to read as follows:

 17-4          (a)  A person may not:

 17-5                (1)  dispense or distribute prescription drugs unless

 17-6    he is a licensed pharmacist or is authorized by this Act to

 17-7    dispense or distribute prescription drugs; or

 17-8                (2)  operate a pharmacy unless he first obtains a

 17-9    license to operate a pharmacy.

17-10          (f)  This Act does not apply to:

17-11                (1)  a member of the faculty of a college of pharmacy

17-12    that is recognized by the board if the faculty member is a licensed

17-13    pharmacist and performs his services for the benefit of the college

17-14    only;

17-15                (2)  [a pharmacist-intern;]

17-16                [(3)]  a person who procures prescription drugs for

17-17    lawful research, teaching, or testing and not for resale; or

17-18                (3) [(4)]  a home and community support services agency

17-19    that possesses a dangerous drug as authorized by Section 142.0061,

17-20    Health and Safety Code.

17-21          (g)  Any person found by the board to have unlawfully engaged

17-22    in the practice of pharmacy or unlawfully operated a pharmacy is

17-23    subject to a civil penalty under Section 37A of this Act [fine to

17-24    be imposed by the board not to exceed $1,000 for each offense].

17-25    Each violation of this Act or the rules adopted under this Act

17-26    pertaining to unlawfully engaging in the practice of pharmacy or

17-27    unlawfully operating a pharmacy also constitutes a Class A

 18-1    misdemeanor.

 18-2          SECTION 9.  Section 20, Texas Pharmacy Act (Article 4542a-1,

 18-3    Vernon's Texas Civil Statutes), is amended to read as follows:

 18-4          Sec. 20.  PHARMACIST-INTERN REGISTRATION.   (a)  A person

 18-5    must register with the board before beginning the board-approved

 18-6    internship in this state.  An application for the registration of a

 18-7    pharmacist-intern must be on a form prescribed by the board.

 18-8    Registration shall remain in effect as long as the person meets the

 18-9    qualifications for internship as specified by rules adopted by the

18-10    board [during internship training and thereafter until the earlier

18-11    of the following occurs:]

18-12                [(1)  the failure of the pharmacist-intern to take the

18-13    next regularly scheduled examination; or]

18-14                [(2)  the failure to pass the next regularly scheduled

18-15    examination].

18-16          (b)  The board may in its discretion refuse to issue a

18-17    registration to an applicant and may restrict, suspend, or revoke a

18-18    pharmacist-intern registration for any violation of this Act.  In

18-19    enforcing Section 26(a)(4) of this Act, the board shall, on

18-20    probable cause, request a pharmacist-intern or pharmacist-intern

18-21    applicant to submit to a mental or physical examination by

18-22    physicians or other health care professionals designated by the

18-23    board.  If the pharmacist-intern or applicant refuses to submit to

18-24    the examination, the board shall issue an order requiring the

18-25    pharmacist-intern or applicant to show cause why he will not submit

18-26    to the examination and shall schedule a hearing on the order within

18-27    30 days after notice is served on the pharmacist-intern or

 19-1    applicant.  The board shall notify the pharmacist-intern or

 19-2    applicant by either personal service or certified mail with return

 19-3    receipt requested.  At the hearing, the pharmacist-intern or

 19-4    applicant and an attorney are entitled to present any testimony and

 19-5    other evidence to show why the pharmacist-intern or applicant

 19-6    should not be required to submit to the examination.  After the

 19-7    hearing, the board shall issue an order either requiring the

 19-8    pharmacist-intern or applicant to submit to the examination or

 19-9    withdrawing the request for examination.

19-10          SECTION 10.  Subsections (a) and (e), Section 21, Texas

19-11    Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

19-12    amended to read as follows:

19-13          (a)  To qualify for a license to practice pharmacy, an

19-14    applicant for licensing by examination must submit to the board a

19-15    license fee as determined by the board and a completed application

19-16    on a form prescribed by the board with satisfactory sworn evidence

19-17    that he:

19-18                (1)  is at least 18 years old;

19-19                (2)  is of good moral character;

19-20                (3)  has completed a minimum of a 1,000-hour internship

19-21    or other program that has been approved by the board or has

19-22    demonstrated, to the board's satisfaction, experience in the

19-23    practice of pharmacy that meets or exceeds the minimum internship

19-24    requirements of the board;

19-25                (4)  has graduated and received a [the first

19-26    professional undergraduate degree or the advanced] professional

19-27    practice degree, as defined by the rules adopted by the board, from

 20-1    an accredited pharmacy degree program approved by the board;

 20-2                (5)  has passed the examination required by the board;

 20-3    and

 20-4                (6)  has not had a pharmacist license granted by

 20-5    another state suspended, revoked, canceled, surrendered, or

 20-6    otherwise restricted for any reason.

 20-7          (e)  The [Within 30 days after the date a licensing

 20-8    examination is administered under this Act, the] board shall notify

 20-9    each examinee of the results of the examination[.  However, if an

20-10    examination is graded or reviewed by a national testing service,

20-11    the board shall notify each examinee of the results of the

20-12    examination] within 30 days [two weeks] after the date the board

20-13    receives the results from a national [the] testing service.  [If

20-14    the notice of the examination results will be delayed for more than

20-15    90 days after the examination date, the board shall notify the

20-16    examinee of the reason for the delay before the 90th day.]

20-17          SECTION 11.  Subsection (a), Section 22, Texas Pharmacy Act

20-18    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

20-19    read as follows:

20-20          (a)  To qualify for a license to practice pharmacy by

20-21    reciprocity, an applicant for licensing must:

20-22                (1)  submit to the board a reciprocity fee as

20-23    determined by the board and a completed application given under

20-24    oath, in the form prescribed by the board;

20-25                (2)  have good moral character;

20-26                (3)  have graduated and received a [the first

20-27    professional undergraduate degree or the advanced] professional

 21-1    practice degree, as defined by the rules adopted by the board, from

 21-2    an accredited pharmacy degree program approved by the board;

 21-3                (4)  have possessed at the time of initial licensing as

 21-4    a pharmacist other qualifications necessary to have been eligible

 21-5    for licensing at that time in this state;

 21-6                (5)  have presented to the board proof of initial

 21-7    licensing by examination and proof that the license and other

 21-8    license or licenses granted to the applicant by any other state

 21-9    have not been suspended, revoked, canceled, surrendered, or

21-10    otherwise restricted for any reason; and

21-11                (6)  pass the Texas [Drug and] Pharmacy Jurisprudence

21-12    examination.

21-13          SECTION 12.  Subsection (b), Section 26, Texas Pharmacy Act

21-14    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

21-15    read as follows:

21-16          (b)  Grounds for Disciplining a Holder of a Pharmacy License:

21-17    The board shall refuse to issue a pharmacy license for failure to

21-18    meet the requirements of Section 29 or 30 of this Act.  The board

21-19    may in its discretion refuse to issue or renew a license or may

21-20    assess a penalty, reprimand, revoke, restrict, cancel, or suspend

21-21    any license granted by the board, and may probate any license

21-22    suspension if the board finds that the applicant or licensee has:

21-23                (1)  been convicted of a felony or a misdemeanor

21-24    involving moral turpitude, or if the applicant or licensee is a

21-25    legal entity such as an association, joint stock company,

21-26    partnership, or corporation, that a managing officer has been

21-27    convicted of a felony or a misdemeanor involving moral turpitude

 22-1    under the law of this state, another state, or the United States;

 22-2                (2)  advertised any prescription drugs or devices in a

 22-3    deceitful, misleading, or fraudulent manner;

 22-4                (3)  violated any provision of this Act or any rule

 22-5    adopted under this Act or that any owner or employee of a pharmacy

 22-6    has violated any provision of this Act or any rule adopted under

 22-7    this Act;

 22-8                (4)  sold without legal authorization prescription

 22-9    drugs or devices to persons other than:

22-10                      (A)  a pharmacy licensed by the board;

22-11                      (B)  a practitioner;

22-12                      (C)  a person who procures prescription drugs or

22-13    devices for the purpose of lawful research, teaching, or testing,

22-14    and not for resale;

22-15                      (D)  a manufacturer or wholesaler registered with

22-16    the commissioner of health as required by Chapter 431, Health and

22-17    Safety Code; or

22-18                      (E)  a carrier or warehouseman;

22-19                (5)  allowed an employee who is not a licensed

22-20    pharmacist to practice pharmacy;

22-21                (6)  sold adulterated or misbranded prescription or

22-22    nonprescription drugs;

22-23                (7)  failed to engage in or ceased to engage in the

22-24    business described in the application for a license;

22-25                (8)  failed to keep and maintain records as required by

22-26    this Act, the Controlled Substances Act, Dangerous Drug Act, or

22-27    rules adopted under this Act or the Dangerous Drug Act; [or]

 23-1                (9)  failed to establish and maintain effective

 23-2    controls against diversion of prescription drugs into other than

 23-3    legitimate medical, scientific, or industrial channels as provided

 23-4    by this Act or other state or federal laws or rules; or

 23-5                (10)  engaged in any fraud, deceit, or

 23-6    misrepresentation as defined by the rules adopted by the board in

 23-7    operating a pharmacy or in seeking a license to operate a pharmacy.

 23-8          SECTION 13.  Subsection (c), Section 26A, Texas Pharmacy Act

 23-9    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

23-10    read as follows:

23-11          (c)  Any disciplinary action taken by the board under this

23-12    section is governed by the Administrative Procedure Act (Chapter

23-13    2001, Government Code [and Texas Register Act (Article 6252-13a,

23-14    Vernon's Texas Civil Statutes]) and the rules of practice and

23-15    procedure adopted by the board.

23-16          SECTION 14.  Section 27, Texas Pharmacy Act (Article 4542a-1,

23-17    Vernon's Texas Civil Statutes), is amended to read as follows:

23-18          Sec. 27.  PROCEDURE.   Except as provided in Section 27A of

23-19    this Act, any disciplinary action taken by the board under Section

23-20    26, 26A, or 26B of this Act is governed by the Administrative

23-21    Procedure Act (Chapter 2001, Government Code [and Texas Register

23-22    Act (Article 6252-13a, Vernon's Texas Civil Statutes]) and the

23-23    rules of practice and procedure before the board.

23-24          SECTION 15.  Subsection (d), Section 27A, Texas Pharmacy Act

23-25    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

23-26    read as follows:

23-27          (d)  The records and proceedings of the board, its authorized

 24-1    agents, or any pharmaceutical organization committee as set out in

 24-2    Subsections (a) and (b) of this section shall be confidential and

 24-3    are not considered open records for the purposes of Chapter 552,

 24-4    Government Code [424, Acts of the 63rd Legislature, Regular

 24-5    Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil

 24-6    Statutes)]; provided, however, the board may disclose this

 24-7    confidential information only:

 24-8                (1)  in a disciplinary hearing before the board or in a

 24-9    subsequent trial or appeal of a board action or order;

24-10                (2)  to the pharmacist licensing or disciplinary

24-11    authorities of other jurisdictions;

24-12                (3)  pursuant to an order of a court of competent

24-13    jurisdiction; or

24-14                (4)  pursuant to Subsection (j) of this section.

24-15          SECTION 16.  Subsection (c), Section 27B, Texas Pharmacy Act

24-16    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

24-17    read as follows:

24-18          (c)  The identity of a person who reports to or assists the

24-19    board under this section and any document that could disclose the

24-20    identity of that person is confidential and does not constitute

24-21    public information for the purposes of Chapter 552, Government Code

24-22    [424, Acts of the 63rd Legislature, Regular Session, 1973 (Article

24-23    6252-17a, Vernon's Texas Civil Statutes)].

24-24          SECTION 17.  Subsection (a), Section 28, Texas Pharmacy Act

24-25    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

24-26    read as follows:

24-27          (a)  On the finding of the existence of grounds for

 25-1    discipline of any person holding a license or seeking a license or

 25-2    a renewal license under this Act, the board may impose one or more

 25-3    of the following penalties:

 25-4                (1)  suspension of the offender's license;

 25-5                (2)  revocation of the offender's license;

 25-6                (3)  restriction of the offender's license to prohibit

 25-7    the offender from performing certain acts or from engaging in the

 25-8    practice of pharmacy or operating a pharmacy in a particular manner

 25-9    for a term and under conditions to be determined by the board;

25-10                (4)  imposition of an administrative penalty under

25-11    Section 28B of this Act;

25-12                (5)  refusal to issue or renew the offender's license;

25-13                (6)  placement of the offender's license on probation

25-14    and supervision by the board for a period to be determined by the

25-15    board and imposition of a requirement that the licensee:

25-16                      (A)  report regularly to the board on matters

25-17    that are the basis of the probation;

25-18                      (B)  limit practice to the areas prescribed by

25-19    the board; [or]

25-20                      (C)  continue or review professional education

25-21    until the licensee attains a degree of skill satisfactory to the

25-22    board in those areas that are the basis of the probation; or

25-23                      (D)  pay the board a probation fee to defray the

25-24    costs of monitoring a licensee during the period of probation;

25-25                (7)  reprimand;

25-26                (8)  cancellation of the offender's license; or

25-27                (9)  retirement of the offender's license as provided

 26-1    by board rule[; or]

 26-2                [(10)  imposition of a civil penalty that does not

 26-3    exceed $1,000 for each day of each violation and that may be

 26-4    collected in a suit initiated by the board].

 26-5          SECTION 18.  Subsection (e), Section 29, Texas Pharmacy Act

 26-6    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

 26-7    read as follows:

 26-8          (e)  The board shall have the discretion to determine under

 26-9    which classifications a pharmacy applicant may be licensed.  With

26-10    respect to Class C pharmacies, the board may establish rules for

26-11    the use of pharmacy technicians [supportive personnel] and the

26-12    duties of those technicians [personnel] in Class C pharmacies

26-13    licensed by the board, provided that these technicians [personnel]

26-14    are responsible to and directly supervised by a pharmacist licensed

26-15    by the board; provided, however, the board may not adopt any rule

26-16    setting ratios with respect to pharmacists and pharmacy technicians

26-17    [supportive personnel] or limiting the number of pharmacy

26-18    technicians [supportive personnel] that may be utilized.

26-19          SECTION 19.  Section 35, Texas Pharmacy Act (Article 4542a-1,

26-20    Vernon's Texas Civil Statutes), is amended to read as follows:

26-21          Sec. 35.  UNLAWFUL USE OF "PHARMACY."    (a)  A person may

26-22    not display in or on any store or place of business the word

26-23    "pharmacy," either in English or any other language, any other word

26-24    or combination of words of the same or similar meaning, or any

26-25    graphic representation that would mislead or tend to mislead the

26-26    public unless it is a pharmacy licensed under this Act.

26-27          (b)  A person may not advertise any store or place of

 27-1    business as a pharmacy or provide pharmacy services unless the

 27-2    facility is a pharmacy licensed under this Act.

 27-3          SECTION 20.  The Texas Pharmacy Act (Article 4542a-1,

 27-4    Vernon's Texas Civil Statutes) is amended by adding Section 37A to

 27-5    read as follows:

 27-6          Sec. 37A.  CIVIL PENALTY.  (a)  A person who violates the

 27-7    license requirements of this Act is liable to the state for a civil

 27-8    penalty of up to $1,000 for each day the violation continues.

 27-9          (b)  At the request of the board, the attorney general shall

27-10    institute an action to collect a civil penalty from a person who

27-11    has violated this Act or rules adopted under this Act.

27-12          (c)  If the attorney general fails to take action within 30

27-13    days of referral from the board, the board shall refer the case to

27-14    the local district attorney, county attorney, or city attorney.

27-15    The district attorney, county attorney, or city attorney shall file

27-16    suit in a district court to collect and retain the penalty.

27-17          SECTION 21.  Subdivisions (10) and (11), Section 483.001,

27-18    Health and Safety Code, are amended to read as follows:

27-19                (10)  "Pharmacy" means a facility where prescription

27-20    drug or medication orders are received, processed, dispensed, or

27-21    distributed under this chapter, Chapter 481, and the Texas Pharmacy

27-22    Act (Article 4542a-1, Vernon's Texas Civil Statutes) [licensed by

27-23    the board pursuant to Section 29, Texas Pharmacy Act (Article

27-24    4542a-1, Vernon's Texas Civil Statutes)].

27-25                (11)  "Practice of pharmacy" means:

27-26                      (A)  provision of those acts or services

27-27    necessary to provide pharmaceutical care;

 28-1                      (B)  interpretation and evaluation of

 28-2    prescription drug orders or medication orders;

 28-3                      (C)  participation in drug and device selection

 28-4    as authorized by law, drug administration, drug regimen review, or

 28-5    drug or drug-related research;

 28-6                      (D)  provision of patient counseling; [and]

 28-7                      (E)  responsibility for:

 28-8                            (i)  dispensing of prescription drug orders

 28-9    or distribution of medication orders in the patient's best

28-10    interest;

28-11                            (ii)  compounding and labeling of drugs and

28-12    devices, except labeling by a manufacturer, repackager, or

28-13    distributor of nonprescription drugs and commercially packaged

28-14    prescription drugs and devices;

28-15                            (iii)  proper and safe storage of drugs and

28-16    devices; and

28-17                            (iv)  maintenance of proper records for

28-18    drugs and devices.  In this subdivision, "device" has the meaning

28-19    assigned by the Texas Pharmacy Act (Article 4542a-1, Vernon's Texas

28-20    Civil Statutes); and

28-21                      (F)  performance of a specific act of drug

28-22    therapy management for a patient delegated to a pharmacist by a

28-23    written protocol from a physician licensed by the state under the

28-24    Medical Practice Act (Article 4495b, Vernon's Texas Civil

28-25    Statutes).

28-26          SECTION 22.  Subsection (b), Section 483.003, Health and

28-27    Safety Code, is amended to read as follows:

 29-1          (b)  On making that finding, the Texas Board of Health

 29-2    [board] may limit the availability of the abused drug by permitting

 29-3    its dispensing only on the prescription of a practitioner described

 29-4    by Section 483.001(12)(A) or (B).

 29-5          SECTION 23.  Subsection (e), Section 483.042, Health and

 29-6    Safety Code, is amended to read as follows:

 29-7          (e)  The labeling provisions of Subsection (a) do not apply

 29-8    to a dangerous drug prescribed or dispensed for administration to a

 29-9    patient who is institutionalized.  The board shall adopt rules for

29-10    the labeling of such a drug [food production animals in an

29-11    agricultural operation under a written medical directive or

29-12    treatment guideline from a veterinarian licensed under The

29-13    Veterinary Licensing Act (Article 8890, Revised Statutes) and its

29-14    subsequent amendments].

29-15          SECTION 24.  Chapter 107, Acts of the 41st Legislature,

29-16    Regular Session, 1929 (Article 4542a, Vernon's Texas Civil

29-17    Statutes), is repealed.

29-18          SECTION 25.  Subsection (b), Section 26A, Texas Pharmacy Act

29-19    (Article 4542a-1, Vernon's Texas Civil Statutes), as amended by

29-20    Section 7, Chapter 789, Acts of the 73rd Legislature, 1993, is

29-21    repealed.

29-22          SECTION 26.  This Act takes effect September 1, 1997.

29-23          SECTION 27.  (a)  This Act applies only to a license issued

29-24    by the Texas State Board of Pharmacy on or after the effective date

29-25    of this Act.  A license issued or renewed before that date is

29-26    governed by the law in effect on the date the license was issued or

29-27    renewed, and the former law is continued in effect for that

 30-1    purpose.

 30-2          (b)  Section 37A, Texas Pharmacy Act (Article 4542a-1,

 30-3    Vernon's Texas Civil Statutes), as added by this Act, applies only

 30-4    to a violation of the licensing requirements of the Texas Pharmacy

 30-5    Act (Article 4542a-1, Vernon's Texas Civil Statutes) that occurs on

 30-6    or after the effective date of this Act.

 30-7          SECTION 28.  The importance of this legislation and the

 30-8    crowded condition of the calendars in both houses create an

 30-9    emergency and an imperative public necessity that the

30-10    constitutional rule requiring bills to be read on three several

30-11    days in each house be suspended, and this rule is hereby suspended.