1-1     By:  Madla                                             S.B. No. 609

 1-2           (In the Senate - Filed February 14, 1997; February 20, 1997,

 1-3     read first time and referred to Committee on Health and Human

 1-4     Services; April 1, 1997, reported favorably, as amended, by the

 1-5     following vote:  Yeas 10, Nays 0; April 1, 1997, sent to printer.)

 1-6     COMMITTEE AMENDMENT NO. 1                                By:  Madla

 1-7     Amend S.B. No. 609 in SECTION 21 of the bill (filed version, page

 1-8     11, line 55) by striking Subsection (h) in its entirety and

 1-9     substituting the following:

1-10           (h)  No written prescription issued by a practitioner, as

1-11     such term is defined in Section 5(39)(A) of this Act, may be

1-12     dispensed unless it is ordered on a form containing two signature

1-13     lines of equal prominence, side by side, at the bottom of the form.

1-14     Under either signature line shall be printed clearly the words

1-15     "product selection permitted," and under the other signature line

1-16     shall be printed clearly the words "dispense as written."  The

1-17     practitioner shall communicate dispensing instructions to the

1-18     pharmacist by signing on the appropriate line.  If the

1-19     practitioner's signature does not clearly indicate that the

1-20     prescription must be dispensed as written, generically equivalent

1-21     drug selection is permitted.  No prescription form furnished a

1-22     practitioner shall contain a preprinted order for a drug product by

1-23     brand name, generic name, or manufacturer.

1-24                            A BILL TO BE ENTITLED

1-25                                   AN ACT

1-26     relating to the regulation of pharmacies and pharmacists; providing

1-27     a penalty.

1-28           BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

1-29           SECTION 1.  Section 5, Texas Pharmacy Act (Article 4542a-1,

1-30     Vernon's Texas Civil Statutes), is amended to read as follows:

1-31           Sec. 5.  DEFINITIONS.   In this Act, unless the context of

1-32     its use clearly indicates otherwise:

1-33                 (1)  "A.C.P.E." means the American Council on

1-34     Pharmaceutical Education.

1-35                 (2)  "Administer" means the direct application of a

1-36     prescription drug by injection, inhalation, ingestion, or any other

1-37     means to the body of a patient by:

1-38                       (A)  a practitioner, an authorized agent under

1-39     his supervision, or other person authorized by law; or

1-40                       (B)  the patient at the direction of a

1-41     practitioner.

1-42                 (3)  "Administrative Procedure Act" means Chapter 2001,

1-43     Government Code [the Administrative Procedure and Texas Register

1-44     Act, as amended (Article 6252-13a, Vernon's Texas Civil Statutes)].

1-45                 (4)  "Board" means the Texas State Board of Pharmacy.

1-46                 (5)  "Class A pharmacy license" or "community pharmacy

1-47     license" means a license issued to a pharmacy dispensing drugs or

1-48     devices to the general public pursuant to a prescription drug

1-49     order.

1-50                 (6)  "Class B pharmacy license" or "nuclear pharmacy

1-51     license" means a license issued to a pharmacy dispensing or

1-52     providing radioactive drugs or devices for administration to an

1-53     ultimate user.

1-54                 (7)  "Class C pharmacy license" or "institutional

1-55     pharmacy license" means a license issued to a pharmacy located in a

1-56     hospital or other in-patient facility that is licensed under

1-57     Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental

1-58     Health Code (Article 5547-1 et seq., Vernon's Texas Civil

1-59     Statutes), to a hospice in-patient facility that is licensed under

1-60     Chapter 142, Health and Safety Code, or to a pharmacy located in a

1-61     hospital maintained or operated by the state.

1-62                 (8)  "Class D pharmacy license" or "clinic pharmacy

1-63     license" means a license issued to a pharmacy dispensing a limited

1-64     type of drugs or devices pursuant to a prescription drug order.

 2-1                 (9)  "Class E pharmacy license" or "nonresident

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

 2-3     pharmacy located in a state of the United States other than this

 2-4     state whose primary business is to dispense a prescription drug or

 2-5     device under a prescription drug order and to deliver the drug or

 2-6     device to a patient, including a patient in this state, by the

 2-7     United States mail, a common carrier, or a delivery service.

 2-8                 (10) [(11)]  "College of pharmacy" means a school,

 2-9     university, or college of pharmacy that satisfies the accreditation

2-10     standards of A.C.P.E. as adopted by the board; or that has degree

2-11     requirements which meet the standards of accreditation set by the

2-12     board.

2-13                 (11) [(12)]  "Compounding" means the preparation,

2-14     mixing, assembling, packaging, or labeling of a drug or device:

2-15                       (A)  as the result of a practitioner's

2-16     prescription drug order or initiative based on the

2-17     practitioner-patient-pharmacist relationship in the course of

2-18     professional practice;

2-19                       (B)  in anticipation of prescription drug orders

2-20     based on routine, regularly observed prescribing patterns; or

2-21                       (C)  for the purpose of or as an incident to

2-22     research, teaching, or chemical analysis and not for sale or

2-23     dispensing.

2-24                 (12) [(13)]  "Confidential record" means any

2-25     health-related record that contains information that identifies an

2-26     individual and that is maintained by a pharmacy or pharmacist such

2-27     as a patient medication record, prescription drug order, or

2-28     medication order.

2-29                 (13) [(14)]  "Controlled substance" means a drug,

2-30     immediate precursor, or other substance listed in Schedules I-V or

2-31     Penalty Groups 1-4 of Chapter 481, Health and Safety Code, or a

2-32     drug, immediate precursor, or other substance included in Schedule

2-33     I, II, III, IV, or V of the Federal Comprehensive Drug Abuse

2-34     Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).

2-35                 (14) [(15)]  "Controlled Substances Act" means Chapter

2-36     481, Health and Safety Code, or the Federal Comprehensive Drug

2-37     Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et

2-38     seq.).

2-39                 (15) [(16)]  "Dangerous drug" means any drug or device

2-40     that is not included in Penalty Groups 1-4 of the Controlled

2-41     Substances Act and that is unsafe for self-medication or any drug

2-42     or device that bears or is required to bear the legend:

2-43                       (A)  "Caution:  federal law prohibits dispensing

2-44     without prescription"; or

2-45                       (B)  "Caution:  federal law restricts this drug

2-46     to use by or on the order of a licensed veterinarian."

2-47                 (16) [(17)]  "Dangerous Drug Act" means Chapter 483,

2-48     Health and Safety Code.

2-49                 (17) [(18)]  "Deliver" or "delivery" means the actual,

2-50     constructive, or attempted transfer of a prescription drug or

2-51     device or controlled substance from one person to another, whether

2-52     or not for a consideration.

2-53                 (18) [(19)]  "Designated agent" means:

2-54                       (A)  a licensed nurse, physician assistant,

2-55     pharmacist, or other individual designated by a practitioner, and

2-56     for whom the practitioner assumes legal responsibility, who

2-57     communicates prescription drug orders to a pharmacist;

2-58                       (B)  a licensed nurse, physician assistant, or

2-59     pharmacist employed in a health care facility to whom the

2-60     practitioner communicates a prescription drug order; or

2-61                       (C)  a registered nurse or physician assistant

2-62     authorized by a practitioner to carry out a prescription drug order

2-63     for dangerous drugs under Subdivision (5) or (6), Subsection (d),

2-64     Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas

2-65     Civil Statutes).

2-66                 (19) [(20)]  "Device" means an instrument, apparatus,

2-67     implement, machine, contrivance, implant, in vitro reagent, or

2-68     other similar or related article, including any component part or

2-69     accessory, that is required under federal or state law to be

 3-1     ordered or prescribed by a practitioner.

 3-2                 (20) [(21)]  "Dispense" means preparing, packaging,

 3-3     compounding, or labeling for delivery a prescription drug or device

 3-4     in the course of professional practice to an ultimate user or his

 3-5     agent by or pursuant to the lawful order of a practitioner.

 3-6                 (21) [(22)]  "Distribute" means the delivery of a

 3-7     prescription drug or device other than by administering or

 3-8     dispensing.

 3-9                 (22) [(23)]  "Drug" means:

3-10                       (A)  a substance recognized as drugs in the

3-11     current official United States Pharmacopoeia, official National

3-12     Formulary, official Homeopathic Pharmacopoeia, or other drug

3-13     compendium or any supplement to any of them;

3-14                       (B)  a substance intended for use in the

3-15     diagnosis, cure, mitigation, treatment, or prevention of disease in

3-16     man or other animals;

3-17                       (C)  a substance, other than food, intended to

3-18     affect the structure or any function of the body of man or other

3-19     animals;

3-20                       (D)  a substance intended for use as a component

3-21     of any articles specified in Paragraph (A), (B), or (C) of this

3-22     subdivision;

3-23                       (E)  a dangerous drug; or

3-24                       (F)  a controlled substance.

3-25                 (23) [(24)]  "Drug regimen review" includes the

3-26     following activities:

3-27                       (A)  evaluation of prescription drug or

3-28     medication orders and patient medication records for:

3-29                             (i)  known allergies;

3-30                             (ii)  rational therapy-contraindications;

3-31                             (iii)  reasonable dose and route of

3-32     administration; and

3-33                             (iv)  reasonable directions for use;

3-34                       (B)  evaluation of prescription drug or

3-35     medication orders and patient medication records for duplication of

3-36     therapy;

3-37                       (C)  evaluation of prescription drug or

3-38     medication orders and patient medication records for:

3-39                             (i)  drug-drug interactions;

3-40                             (ii)  drug-food interactions;

3-41                             (iii)  drug-disease interactions;

3-42                             (iv)  adverse drug reactions; and

3-43                       (D)  evaluation of prescription drug and

3-44     medication orders and patient medication records for proper

3-45     utilization, including overutilization or underutilization.

3-46                 (24) [(25)]  "Internship" means a practical experience

3-47     program that is approved by the board.

3-48                 (25) [(26)]  "Label" means written, printed, or graphic

3-49     matter on the immediate container of a drug or device.

3-50                 (26) [(27)]  "Labeling" means the process of affixing a

3-51     label including all information required by federal and state law

3-52     or regulation to any drug or device container.  The term does not

3-53     include the labeling by a manufacturer, packer, or distributor of a

3-54     nonprescription drug or commercially packaged prescription drug or

3-55     device, or unit dose packaging.

3-56                 (27) [(28)]  "Manufacturing" means the production,

3-57     preparation, propagation, conversion, or processing of a drug or

3-58     device, either directly or indirectly, by extraction from

3-59     substances of natural origin or independently by means of chemical

3-60     or biological synthesis and includes any packaging or repackaging

3-61     of the substances or labeling or relabeling of the container and

3-62     the promotion and marketing of such drugs or devices.

3-63     Manufacturing also includes the preparation and promotion of

3-64     commercially available products from bulk compounds for resale by

3-65     pharmacies, practitioners, or other persons but does not include

3-66     compounding.

3-67                 (28) [(29)]  "Medication order" means an order from a

3-68     practitioner or a practitioner's designated agent for

3-69     administration of a drug or device.

 4-1                 (29) [(30)]  "Nonprescription drug" means a nonnarcotic

 4-2     drug or device that may be sold without a prescription and that is

 4-3     labeled and packaged in compliance with applicable state or federal

 4-4     law.

 4-5                 (30) [(31)]  "Patient counseling" means the

 4-6     communication by the pharmacist of information, as specified in the

 4-7     rules of the board, to the patient or caregiver, in order to

 4-8     improve therapy by ensuring proper use of drugs and devices.

 4-9                 (31) [(32)]  "Person" means an individual, corporation,

4-10     government or governmental subdivision or agency, business trust,

4-11     estate, trust, partnership, association, or any other legal entity.

4-12                 (32) [(33)]  "Pharmaceutical care" is the provision of

4-13     drug therapy and other pharmaceutical services defined in the rules

4-14     of the board and intended to assist in the cure or prevention of a

4-15     disease, elimination or reduction of a patient's symptoms, or

4-16     arresting or slowing of a disease process.

4-17                 (33) [(34)]  "Pharmacist" means a person licensed by

4-18     the board to practice pharmacy.

4-19                 (34) [(35)]  "Pharmacist-in-charge" means the

4-20     pharmacist designated on a pharmacy license as the pharmacist who

4-21     has the authority or responsibility for a pharmacy's compliance

4-22     with laws and rules pertaining to the practice of pharmacy.

4-23                 (35) [(36)]  "Pharmacist-intern" means an undergraduate

4-24     student enrolled in the professional sequence of a college of

4-25     pharmacy approved by the board and participating in a school-based,

4-26     board-approved internship program or a graduate of a college of

4-27     pharmacy who is participating in a board-approved internship.

4-28                 (36) [(37)]  "Pharmacy" means a facility at which

4-29     prescription drug or medication orders are received, processed, or

4-30     dispensed under this Act, the Dangerous Drug Act, or the Controlled

4-31     Substances Act [licensed by the board pursuant to Section 29 of

4-32     this Act].

4-33                 (37)  "Pharmacy technician" means an individual

4-34     employed by a pharmacy whose responsibility is to provide technical

4-35     services that do not require professional judgment regarding the

4-36     preparation and distribution of drugs and who works under the

4-37     direct supervision of and is responsible to a pharmacist.

4-38                 (38)  "Practice of pharmacy" means:

4-39                       (A)  provision of those acts or services

4-40     necessary to provide pharmaceutical care;

4-41                       (B)  interpretation and evaluation of

4-42     prescription drug orders or medication orders;

4-43                       (C)  participation in drug and device selection

4-44     as authorized by law, drug administration, drug regimen review, or

4-45     drug or drug-related research;

4-46                       (D)  provision of patient counseling;

4-47                       (E)  responsibility for:

4-48                             (i)  dispensing of prescription drug orders

4-49     or distribution of medication orders;

4-50                             (ii)  compounding and labeling of drugs and

4-51     devices, except labeling by a manufacturer, repackager, or

4-52     distributor of nonprescription drugs and commercially packaged

4-53     prescription drugs and devices;

4-54                             (iii)  proper and safe storage of drugs and

4-55     devices; or

4-56                             (iv)  maintenance of proper records for

4-57     drugs and devices; and

4-58                       (F)  performance of a specific act of drug

4-59     therapy management for a patient delegated to a pharmacist by a

4-60     written protocol from a physician licensed in this state in

4-61     compliance with the Medical Practice Act (Article 4495b, Vernon's

4-62     Texas Civil Statutes).

4-63                 (39)  "Practitioner" means:

4-64                       (A)  a physician, dentist, podiatrist,

4-65     veterinarian, or other person licensed or registered to prescribe,

4-66     distribute, administer, or dispense a prescription drug or device

4-67     in the course of professional practice in this state;

4-68                       (B)  a person licensed by another state in a

4-69     health field in which, under Texas law, licensees in this state may

 5-1     legally prescribe dangerous drugs or a person practicing in another

 5-2     state and licensed by another state as a physician, dentist,

 5-3     veterinarian, or podiatrist, having a current Federal Drug

 5-4     Enforcement Administration registration number, and who may legally

 5-5     prescribe Schedule II, III, IV, or V controlled substances in such

 5-6     other state; or

 5-7                       (C)  a person licensed in the Dominion of Canada

 5-8     or the United Mexican States in a health field in which, under the

 5-9     laws of this state, a licensee may legally prescribe dangerous

5-10     drugs.  "Practitioner" does not include a person licensed under

5-11     this Act.

5-12                 (40)  "Preceptor" means a pharmacist [in good standing]

5-13     licensed in this state to practice pharmacy who meets the preceptor

5-14     requirements specified by rule and who is certified by the board to

5-15     supervise and be responsible for the activities and functions of a

5-16     pharmacist-intern in the internship program.

5-17                 (41)  "Prescription drug" means:

5-18                       (A)  a substance for which federal or state law

5-19     requires a prescription before it may be legally dispensed to the

5-20     public;

5-21                       (B)  a drug or device that under federal law is

5-22     required, prior to being dispensed or delivered, to be labeled with

5-23     either of the following statements:

5-24                             (i)  "Caution:  federal law prohibits

5-25     dispensing without prescription"; or

5-26                             (ii)  "Caution:  federal law restricts this

5-27     drug to use by or on the order of a licensed veterinarian"; or

5-28                       (C)  a drug or device that is required by any

5-29     applicable federal or state law or regulation to be dispensed on

5-30     prescription only or is restricted to use by a practitioner only.

5-31                 (42)  "Prescription drug order" means:

5-32                       (A)  an order from a practitioner or a

5-33     practitioner's designated agent to a pharmacist for a drug or

5-34     device to be dispensed; or

5-35                       (B)  an order pursuant to Subdivision (5) or (6),

5-36     Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,

5-37     Vernon's Texas Civil Statutes).

5-38                 (43)  "Prospective drug use review" means a review of

5-39     the patient's drug therapy and prescription drug order or

5-40     medication order, as defined in the rules of the board, prior to

5-41     dispensing or distributing the drug.

5-42                 (44)  "Provide" means to supply one or more unit doses

5-43     of a nonprescription drug or dangerous drug to a patient.

5-44                 (45)  "Radioactive drug" means a drug that exhibits

5-45     spontaneous disintegration of unstable nuclei with the emission of

5-46     nuclear particles or photons, including any nonradioactive reagent

5-47     kit or nuclide generator that is intended to be used in the

5-48     preparation of any such substance.

5-49                 (46)  "Substitution" means the dispensing of a drug or

5-50     a brand of drug other than that which is ordered or prescribed.

5-51                 (47)  "Texas trade association" means a nonprofit,

5-52     cooperative association of business or professional competitors in

5-53     this state whose purpose is to assist its members, industry, or

5-54     profession and whose members have joined voluntarily. ["Supportive

5-55     personnel" means those individuals utilized in pharmacies whose

5-56     responsibility it shall be to provide technical services that do

5-57     not require professional judgment concerned with the preparation

5-58     and distribution of drugs under the direct supervision of and

5-59     responsible to a pharmacist.]

5-60                 (48)  "Ultimate user" means a person who has obtained

5-61     and possesses a prescription drug or device for the person's own

5-62     use or for the use of a member of the person's household or for

5-63     administering to an animal owned by the person or by a member of

5-64     the person's household.

5-65                 (49)  "Unit dose packaging" means the ordered amount of

5-66     drug in a dosage form ready for administration to a particular

5-67     patient, by the prescribed route at the prescribed time, and

5-68     properly labeled with name, strength, and expiration date of the

5-69     drug.

 6-1                 (50)  "Written protocol" means a physician's order,

 6-2     standing medical order, standing delegation order, or other order

 6-3     or protocol as defined by rule of the Texas State Board of Medical

 6-4     Examiners under the Medical Practice Act (Article 4495b, Vernon's

 6-5     Texas Civil Statutes).

 6-6           SECTION 2.  Subsection (a), Section 8, Texas Pharmacy Act

 6-7     (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

 6-8     read as follows:

 6-9           (a)  A licensed pharmacist member of the board:

6-10                 (1)  may not be:

6-11                       (A)  a salaried faculty member at a college of

6-12     pharmacy; or

6-13                       (B)  an officer, employee, or paid consultant of

6-14     a Texas trade association in the field of health care or a spouse

6-15     of an officer, employee, or paid consultant; and

6-16                 (2)  must at the time of his appointment:

6-17                       (A) [(1)]  be a resident of this state;

6-18                       (B) [(2)]  be licensed for the five years

6-19     immediately preceding appointment and be in good standing to engage

6-20     in the practice of pharmacy in this state; and

6-21                       (C) [(3)]  be engaged in the practice of pharmacy

6-22     in this state.

6-23           SECTION 3.  Section 8, Texas Pharmacy Act (Article 4542a-1,

6-24     Vernon's Texas Civil Statutes), is amended by adding Subsection (f)

6-25     to read as follows:

6-26           (f)  The board shall provide to its members, as often as

6-27     necessary, information regarding their qualifications for office or

6-28     employment under this Act and their responsibilities under

6-29     applicable laws relating to standards of conduct for state officers

6-30     or employees.

6-31           SECTION 4.  Subsection (c), Section 14, Texas Pharmacy Act

6-32     (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

6-33     read as follows:

6-34           (c)  Except as otherwise provided by this subsection, all

6-35     board meetings and hearings shall be open to the public.  The board

6-36     may, in its discretion and in accordance with the open meetings

6-37     law, Chapter 551, Government Code, [Chapter 271, Acts of the 60th

6-38     Legislature, Regular Session, 1967, as amended (Article 6252-17,

6-39     Vernon's Texas Civil Statutes),] conduct any portion of its meeting

6-40     in executive session.  The board may in its discretion conduct

6-41     deliberations relative to licensee disciplinary actions in

6-42     executive session.  At the conclusion of its deliberations relative

6-43     to licensee disciplinary action, the board shall vote and announce

6-44     its decision relative to the licensee in open session.  The board

6-45     in executive session may conduct disciplinary hearings relating to

6-46     a pharmacist or pharmacy student who is impaired because of

6-47     chemical abuse or mental or physical illness.

6-48           SECTION 5.  Subsections (c), (d), and (f), Section 15, Texas

6-49     Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

6-50     amended to read as follows:

6-51           (c)  An officer, employee, or paid consultant of a Texas

6-52     trade association in the field of health care may not be an [a

6-53     member or] employee of the board who is exempt from the state's

6-54     position classification plan or is compensated at or above the

6-55     amount prescribed by the General Appropriations Act for step 1,

6-56     salary group 17, of the position classification salary schedule.

6-57           (d)  A person who is the spouse of an officer, manager, or

6-58     paid consultant of a Texas trade association in the field of health

6-59     care may not be a [board member and may not be a] board employee

6-60     who is exempt from the state's position classification plan or is

6-61     compensated at or above the amount prescribed by the General

6-62     Appropriations Act for step 1, salary group 17, of the position

6-63     classification salary schedule.

6-64           (f)  The board shall provide to its [members and] employees,

6-65     as often as necessary, information regarding their qualification

6-66     for office or employment under this Act and their responsibilities

6-67     under applicable laws relating to standards of conduct for state

6-68     officers or employees.

6-69           SECTION 6.  Subsections (o) and (q), Section 17, Texas

 7-1     Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

 7-2     amended to read as follows:

 7-3           (o)  The board:

 7-4                 (1)  shall [may] establish rules for the use of

 7-5     pharmacy technicians [supportive personnel] and the duties of those

 7-6     technicians [personnel] in pharmacies licensed by the board,

 7-7     provided that those technicians [personnel] are responsible to and

 7-8     directly supervised by a pharmacist licensed by the board; provided

 7-9     however that the board may not adopt rules or regulations

7-10     establishing ratios of pharmacists to pharmacy technicians

7-11     [supportive personnel] in Class C pharmacies; and

7-12                 (2)  may determine and issue standards for recognition

7-13     and approval of training programs for pharmacy technicians and

7-14     maintain a list of training programs that meet the standards.

7-15           (q)  Board investigative files and all information and

7-16     materials compiled by the board in connection with an investigation

7-17     are confidential and are not subject to disclosure under Chapter

7-18     552, Government Code [424, Acts of the 63rd Legislature, Regular

7-19     Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil

7-20     Statutes)], and are not subject to disclosure, discovery, subpoena,

7-21     or other means of legal compulsion for their release to anyone

7-22     other than the board or its employees or agents involved in

7-23     licensee discipline except that this information may be disclosed

7-24     to:

7-25                 (1)  persons involved with the board in a disciplinary

7-26     action against the licensee;

7-27                 (2)  pharmacist or pharmacy licensing or disciplinary

7-28     authorities of other jurisdictions;

7-29                 (3)  a pharmaceutical peer review committee as outlined

7-30     in Section 27A of this Act;

7-31                 (4)  law enforcement agencies; and

7-32                 (5)  persons engaged in bona fide research, if all

7-33     individual-identifying information has been deleted.

7-34           SECTION 7.  Subsection (a), Section 17D, Texas Pharmacy Act

7-35     (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

7-36     read as follows:

7-37           (a)  The board by rule shall adopt procedures governing:

7-38                 (1)  informal disposition of a contested case under

7-39     Chapter 2001, Government Code [Section 13(e), Administrative

7-40     Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas

7-41     Civil Statutes), and its subsequent amendments]; and

7-42                 (2)  informal proceedings held in compliance with

7-43     Chapter 2001, Government Code [Section 18(c), Administrative

7-44     Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas

7-45     Civil Statutes), and its subsequent amendments].

7-46           SECTION 8.  Subsections (a), (f), and (g), Section 19, Texas

7-47     Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

7-48     amended to read as follows:

7-49           (a)  A person may not:

7-50                 (1)  dispense or distribute prescription drugs unless

7-51     he is a licensed pharmacist or is authorized by this Act to

7-52     dispense or distribute prescription drugs; or

7-53                 (2)  operate a pharmacy unless he first obtains a

7-54     license to operate a pharmacy.

7-55           (f)  This Act does not apply to:

7-56                 (1)  a member of the faculty of a college of pharmacy

7-57     that is recognized by the board if the faculty member is a licensed

7-58     pharmacist and performs his services for the benefit of the college

7-59     only;

7-60                 (2)  [a pharmacist-intern;]

7-61                 [(3)]  a person who procures prescription drugs for

7-62     lawful research, teaching, or testing and not for resale; or

7-63                 (3) [(4)]  a home and community support services agency

7-64     that possesses a dangerous drug as authorized by Section 142.0061,

7-65     Health and Safety Code.

7-66           (g)  Any person found by the board to have unlawfully engaged

7-67     in the practice of pharmacy or unlawfully operated a pharmacy is

7-68     subject to a civil penalty under Section 37A of this Act [fine to

7-69     be imposed by the board not to exceed $1,000 for each offense].

 8-1     Each violation of this Act or the rules adopted under this Act

 8-2     pertaining to unlawfully engaging in the practice of pharmacy or

 8-3     unlawfully operating a pharmacy also constitutes a Class A

 8-4     misdemeanor.

 8-5           SECTION 9.  Section 20, Texas Pharmacy Act (Article 4542a-1,

 8-6     Vernon's Texas Civil Statutes), is amended to read as follows:

 8-7           Sec. 20.  PHARMACIST-INTERN REGISTRATION.   (a)  A person

 8-8     must register with the board before beginning the board-approved

 8-9     internship in this state.  An application for the registration of a

8-10     pharmacist-intern must be on a form prescribed by the board.

8-11     Registration shall remain in effect as long as the person meets the

8-12     qualifications for internship as specified by rules adopted by the

8-13     board [during internship training and thereafter until the earlier

8-14     of the following occurs:]

8-15                 [(1)  the failure of the pharmacist-intern to take the

8-16     next regularly scheduled examination; or]

8-17                 [(2)  the failure to pass the next regularly scheduled

8-18     examination].

8-19           (b)  The board may in its discretion refuse to issue a

8-20     registration to an applicant and may restrict, suspend, or revoke a

8-21     pharmacist-intern registration for any violation of this Act.  In

8-22     enforcing Section 26(a)(4) of this Act, the board shall, on

8-23     probable cause, request a pharmacist-intern or pharmacist-intern

8-24     applicant to submit to a mental or physical examination by

8-25     physicians or other health care professionals designated by the

8-26     board.  If the pharmacist-intern or applicant refuses to submit to

8-27     the examination, the board shall issue an order requiring the

8-28     pharmacist-intern or applicant to show cause why he will not submit

8-29     to the examination and shall schedule a hearing on the order within

8-30     30 days after notice is served on the pharmacist-intern or

8-31     applicant.  The board shall notify the pharmacist-intern or

8-32     applicant by either personal service or certified mail with return

8-33     receipt requested.  At the hearing, the pharmacist-intern or

8-34     applicant and an attorney are entitled to present any testimony and

8-35     other evidence to show why the pharmacist-intern or applicant

8-36     should not be required to submit to the examination.  After the

8-37     hearing, the board shall issue an order either requiring the

8-38     pharmacist-intern or applicant to submit to the examination or

8-39     withdrawing the request for examination.

8-40           SECTION 10.  Subsections (a) and (e), Section 21, Texas

8-41     Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

8-42     amended to read as follows:

8-43           (a)  To qualify for a license to practice pharmacy, an

8-44     applicant for licensing by examination must submit to the board a

8-45     license fee as determined by the board and a completed application

8-46     on a form prescribed by the board with satisfactory sworn evidence

8-47     that he:

8-48                 (1)  is at least 18 years old;

8-49                 (2)  is of good moral character;

8-50                 (3)  has completed a minimum of a 1,000-hour internship

8-51     or other program that has been approved by the board or has

8-52     demonstrated, to the board's satisfaction, experience in the

8-53     practice of pharmacy that meets or exceeds the minimum internship

8-54     requirements of the board;

8-55                 (4)  has graduated and received a [the first

8-56     professional undergraduate degree or the advanced] professional

8-57     practice degree, as defined by the rules adopted by the board, from

8-58     an accredited pharmacy degree program approved by the board;

8-59                 (5)  has passed the examination required by the board;

8-60     and

8-61                 (6)  has not had a pharmacist license granted by

8-62     another state suspended, revoked, canceled, surrendered, or

8-63     otherwise restricted for any reason.

8-64           (e)  The [Within 30 days after the date a licensing

8-65     examination is administered under this Act, the] board shall notify

8-66     each examinee of the results of the examination[.  However, if an

8-67     examination is graded or reviewed by a national testing service,

8-68     the board shall notify each examinee of the results of the

8-69     examination] within 30 days [two weeks] after the date the board

 9-1     receives the results from a national [the] testing service.  [If

 9-2     the notice of the examination results will be delayed for more than

 9-3     90 days after the examination date, the board shall notify the

 9-4     examinee of the reason for the delay before the 90th day.]

 9-5           SECTION 11.  Subsection (a), Section 22, Texas Pharmacy Act

 9-6     (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

 9-7     read as follows:

 9-8           (a)  To qualify for a license to practice pharmacy by

 9-9     reciprocity, an applicant for licensing must:

9-10                 (1)  submit to the board a reciprocity fee as

9-11     determined by the board and a completed application given under

9-12     oath, in the form prescribed by the board;

9-13                 (2)  have good moral character;

9-14                 (3)  have graduated and received a [the first

9-15     professional undergraduate degree or the advanced] professional

9-16     practice degree, as defined by the rules adopted by the board, from

9-17     an accredited pharmacy degree program approved by the board;

9-18                 (4)  have possessed at the time of initial licensing as

9-19     a pharmacist other qualifications necessary to have been eligible

9-20     for licensing at that time in this state;

9-21                 (5)  have presented to the board proof of initial

9-22     licensing by examination and proof that the license and other

9-23     license or licenses granted to the applicant by any other state

9-24     have not been suspended, revoked, canceled, surrendered, or

9-25     otherwise restricted for any reason; and

9-26                 (6)  pass the Texas [Drug and] Pharmacy Jurisprudence

9-27     examination.

9-28           SECTION 12.  Subsection (b), Section 26, Texas Pharmacy Act

9-29     (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

9-30     read as follows:

9-31           (b)  Grounds for Disciplining a Holder of a Pharmacy License:

9-32     The board shall refuse to issue a pharmacy license for failure to

9-33     meet the requirements of Section 29 or 30 of this Act.  The board

9-34     may in its discretion refuse to issue or renew a license or may

9-35     assess a penalty, reprimand, revoke, restrict, cancel, or suspend

9-36     any license granted by the board, and may probate any license

9-37     suspension if the board finds that the applicant or licensee has:

9-38                 (1)  been convicted of a felony or a misdemeanor

9-39     involving moral turpitude, or if the applicant or licensee is a

9-40     legal entity such as an association, joint stock company,

9-41     partnership, or corporation, that a managing officer has been

9-42     convicted of a felony or a misdemeanor involving moral turpitude

9-43     under the law of this state, another state, or the United States;

9-44                 (2)  advertised any prescription drugs or devices in a

9-45     deceitful, misleading, or fraudulent manner;

9-46                 (3)  violated any provision of this Act or any rule

9-47     adopted under this Act or that any owner or employee of a pharmacy

9-48     has violated any provision of this Act or any rule adopted under

9-49     this Act;

9-50                 (4)  sold without legal authorization prescription

9-51     drugs or devices to persons other than:

9-52                       (A)  a pharmacy licensed by the board;

9-53                       (B)  a practitioner;

9-54                       (C)  a person who procures prescription drugs or

9-55     devices for the purpose of lawful research, teaching, or testing,

9-56     and not for resale;

9-57                       (D)  a manufacturer or wholesaler registered with

9-58     the commissioner of health as required by Chapter 431, Health and

9-59     Safety Code; or

9-60                       (E)  a carrier or warehouseman;

9-61                 (5)  allowed an employee who is not a licensed

9-62     pharmacist to practice pharmacy;

9-63                 (6)  sold adulterated or misbranded prescription or

9-64     nonprescription drugs;

9-65                 (7)  failed to engage in or ceased to engage in the

9-66     business described in the application for a license;

9-67                 (8)  failed to keep and maintain records as required by

9-68     this Act, the Controlled Substances Act, Dangerous Drug Act, or

9-69     rules adopted under this Act or the Dangerous Drug Act; [or]

 10-1                (9)  failed to establish and maintain effective

 10-2    controls against diversion of prescription drugs into other than

 10-3    legitimate medical, scientific, or industrial channels as provided

 10-4    by this Act or other state or federal laws or rules; or

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

 10-6    misrepresentation as defined by the rules adopted by the board in

 10-7    operating a pharmacy or in seeking a license to operate a pharmacy.

 10-8          SECTION 13.  Subsection (c), Section 26A, Texas Pharmacy Act

 10-9    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

10-10    read as follows:

10-11          (c)  Any disciplinary action taken by the board under this

10-12    section is governed by the Administrative Procedure Act (Chapter

10-13    2001, Government Code [and Texas Register Act (Article 6252-13a,

10-14    Vernon's Texas Civil Statutes]) and the rules of practice and

10-15    procedure adopted by the board.

10-16          SECTION 14.  Section 27, Texas Pharmacy Act (Article 4542a-1,

10-17    Vernon's Texas Civil Statutes), is amended to read as follows:

10-18          Sec. 27.  PROCEDURE.   Except as provided in Section 27A of

10-19    this Act, any disciplinary action taken by the board under Section

10-20    26, 26A, or 26B of this Act is governed by the Administrative

10-21    Procedure Act (Chapter 2001, Government Code [and Texas Register

10-22    Act (Article 6252-13a, Vernon's Texas Civil Statutes]) and the

10-23    rules of practice and procedure before the board.

10-24          SECTION 15.  Subsection (d), Section 27A, Texas Pharmacy Act

10-25    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

10-26    read as follows:

10-27          (d)  The records and proceedings of the board, its authorized

10-28    agents, or any pharmaceutical organization committee as set out in

10-29    Subsections (a) and (b) of this section shall be confidential and

10-30    are not considered open records for the purposes of Chapter 552,

10-31    Government Code [424, Acts of the 63rd Legislature, Regular

10-32    Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil

10-33    Statutes)]; provided, however, the board may disclose this

10-34    confidential information only:

10-35                (1)  in a disciplinary hearing before the board or in a

10-36    subsequent trial or appeal of a board action or order;

10-37                (2)  to the pharmacist licensing or disciplinary

10-38    authorities of other jurisdictions;

10-39                (3)  pursuant to an order of a court of competent

10-40    jurisdiction; or

10-41                (4)  pursuant to Subsection (j) of this section.

10-42          SECTION 16.  Subsection (c), Section 27B, Texas Pharmacy Act

10-43    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

10-44    read as follows:

10-45          (c)  The identity of a person who reports to or assists the

10-46    board under this section and any document that could disclose the

10-47    identity of that person is confidential and does not constitute

10-48    public information for the purposes of Chapter 552, Government Code

10-49    [424, Acts of the 63rd Legislature, Regular Session, 1973 (Article

10-50    6252-17a, Vernon's Texas Civil Statutes)].

10-51          SECTION 17.  Subsection (a), Section 28, Texas Pharmacy Act

10-52    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

10-53    read as follows:

10-54          (a)  On the finding of the existence of grounds for

10-55    discipline of any person holding a license or seeking a license or

10-56    a renewal license under this Act, the board may impose one or more

10-57    of the following penalties:

10-58                (1)  suspension of the offender's license;

10-59                (2)  revocation of the offender's license;

10-60                (3)  restriction of the offender's license to prohibit

10-61    the offender from performing certain acts or from engaging in the

10-62    practice of pharmacy or operating a pharmacy in a particular manner

10-63    for a term and under conditions to be determined by the board;

10-64                (4)  imposition of an administrative penalty under

10-65    Section 28B of this Act;

10-66                (5)  refusal to issue or renew the offender's license;

10-67                (6)  placement of the offender's license on probation

10-68    and supervision by the board for a period to be determined by the

10-69    board and imposition of a requirement that the licensee:

 11-1                      (A)  report regularly to the board on matters

 11-2    that are the basis of the probation;

 11-3                      (B)  limit practice to the areas prescribed by

 11-4    the board; [or]

 11-5                      (C)  continue or review professional education

 11-6    until the licensee attains a degree of skill satisfactory to the

 11-7    board in those areas that are the basis of the probation; or

 11-8                      (D)  pay the board a probation fee to defray the

 11-9    costs of monitoring a licensee during the period of probation;

11-10                (7)  reprimand;

11-11                (8)  cancellation of the offender's license; or

11-12                (9)  retirement of the offender's license as provided

11-13    by board rule[; or]

11-14                [(10)  imposition of a civil penalty that does not

11-15    exceed $1,000 for each day of each violation and that may be

11-16    collected in a suit initiated by the board].

11-17          SECTION 18.  Subsection (e), Section 29, Texas Pharmacy Act

11-18    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

11-19    read as follows:

11-20          (e)  The board shall have the discretion to determine under

11-21    which classifications a pharmacy applicant may be licensed.  With

11-22    respect to Class C pharmacies, the board may establish rules for

11-23    the use of pharmacy technicians [supportive personnel] and the

11-24    duties of those technicians [personnel] in Class C pharmacies

11-25    licensed by the board, provided that these technicians [personnel]

11-26    are responsible to and directly supervised by a pharmacist licensed

11-27    by the board; provided, however, the board may not adopt any rule

11-28    setting ratios with respect to pharmacists and pharmacy technicians

11-29    [supportive personnel] or limiting the number of pharmacy

11-30    technicians [supportive personnel] that may be utilized.

11-31          SECTION 19.  Section 35, Texas Pharmacy Act (Article 4542a-1,

11-32    Vernon's Texas Civil Statutes), is amended to read as follows:

11-33          Sec. 35.  UNLAWFUL USE OF "PHARMACY."    (a)  A person may

11-34    not display in or on any store or place of business the word

11-35    "pharmacy," either in English or any other language, any other word

11-36    or combination of words of the same or similar meaning, or any

11-37    graphic representation that would mislead or tend to mislead the

11-38    public unless it is a pharmacy licensed under this Act.

11-39          (b)  A person may not advertise any store or place of

11-40    business as a pharmacy or provide pharmacy services unless the

11-41    facility is a pharmacy licensed under this Act.

11-42          SECTION 20.  The Texas Pharmacy Act (Article 4542a-1,

11-43    Vernon's Texas Civil Statutes) is amended by adding Section 37A to

11-44    read as follows:

11-45          Sec. 37A.  CIVIL PENALTY.  (a)  A person who violates the

11-46    license requirements of this Act is liable to the state for a civil

11-47    penalty of $1,000 for each day the violation continues.

11-48          (b)  The attorney general, district attorney, county

11-49    attorney, or city attorney may sue in a district court of Travis

11-50    County to collect the penalty.

11-51          SECTION 21.  Subsection (h), Section 40, Texas Pharmacy Act

11-52    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

11-53    read as follows:

11-54          (h)  A pharmacist may dispense a generically equivalent drug

11-55    if the practitioner does not write by hand on the face of his or

11-56    her written prescription the words "brand medically necessary" or

11-57    analogous words. [No written prescription issued by a practitioner,

11-58    as such term is defined in Section 5(39)(A) of this Act, may be

11-59    dispensed unless it is ordered on a form containing two signature

11-60    lines of equal prominence, side by side, at the bottom of the form.

11-61    Under either signature line shall be printed clearly the words

11-62    "product selection permitted," and under the other signature line

11-63    shall be printed clearly the words "dispense as written."  The

11-64    practitioner shall communicate dispensing instructions to the

11-65    pharmacist by signing on the appropriate line.  If the

11-66    practitioner's signature does not clearly indicate that the

11-67    prescription must be dispensed as written, generically equivalent

11-68    drug selection is permitted.  No prescription form furnished a

11-69    practitioner shall contain a preprinted order for a drug product by

 12-1    brand name, generic name, or manufacturer.]

 12-2          SECTION 22.  Subdivisions (10) and (11), Section 483.001,

 12-3    Health and Safety Code, are amended to read as follows:

 12-4                (10)  "Pharmacy" means a facility where prescription

 12-5    drug or medication orders are received, processed, dispensed, or

 12-6    distributed under this chapter, Chapter 481, and the Texas Pharmacy

 12-7    Act (Article 4542a-1, Vernon's Texas Civil Statutes) [licensed by

 12-8    the board pursuant to Section 29, Texas Pharmacy Act (Article

 12-9    4542a-1, Vernon's Texas Civil Statutes)].

12-10                (11)  "Practice of pharmacy" means:

12-11                      (A)  provision of those acts or services

12-12    necessary to provide pharmaceutical care;

12-13                      (B)  interpretation and evaluation of

12-14    prescription drug orders or medication orders;

12-15                      (C)  participation in drug and device selection

12-16    as authorized by law, drug administration, drug regimen review, or

12-17    drug or drug-related research;

12-18                      (D)  provision of patient counseling; [and]

12-19                      (E)  responsibility for:

12-20                            (i)  dispensing of prescription drug orders

12-21    or distribution of medication orders in the patient's best

12-22    interest;

12-23                            (ii)  compounding and labeling of drugs and

12-24    devices, except labeling by a manufacturer, repackager, or

12-25    distributor of nonprescription drugs and commercially packaged

12-26    prescription drugs and devices;

12-27                            (iii)  proper and safe storage of drugs and

12-28    devices; and

12-29                            (iv)  maintenance of proper records for

12-30    drugs and devices.  In this subdivision, "device" has the meaning

12-31    assigned by the Texas Pharmacy Act (Article 4542a-1, Vernon's Texas

12-32    Civil Statutes); and

12-33                      (F)  performance of a specific act of drug

12-34    therapy management for a patient delegated to a pharmacist by a

12-35    written protocol from a physician licensed by the state under the

12-36    Medical Practice Act (Article 4495b, Vernon's Texas Civil

12-37    Statutes).

12-38          SECTION 23.  Subsection (b), Section 483.003, Health and

12-39    Safety Code, is amended to read as follows:

12-40          (b)  On making that finding, the Texas Board of Health

12-41    [board] may limit the availability of the abused drug by permitting

12-42    its dispensing only on the prescription of a practitioner described

12-43    by Section 483.001(12)(A) or (B).

12-44          SECTION 24.  Subsection (e), Section 483.042, Health and

12-45    Safety Code, is amended to read as follows:

12-46          (e)  The labeling provisions of Subsection (a) do not apply

12-47    to a dangerous drug prescribed or dispensed for administration to a

12-48    patient who is institutionalized.  The board shall adopt rules for

12-49    the labeling of such a drug [food production animals in an

12-50    agricultural operation under a written medical directive or

12-51    treatment guideline from a veterinarian licensed under The

12-52    Veterinary Licensing Act (Article 8890, Revised Statutes) and its

12-53    subsequent amendments].

12-54          SECTION 25.  Chapter 107, Acts of the 41st Legislature,

12-55    Regular Session, 1929 (Article 4542a, Vernon's Texas Civil

12-56    Statutes), is repealed.

12-57          SECTION 26.  Subsection (b), Section 26A, Texas Pharmacy Act

12-58    (Article 4542a-1, Vernon's Texas Civil Statutes), as amended by

12-59    Section 7, Chapter 789, Acts of the 73rd Legislature, 1993, is

12-60    repealed.

12-61          SECTION 27.  This Act takes effect September 1, 1997.

12-62          SECTION 28.  (a)  This Act applies only to a license issued

12-63    by the Texas State Board of Pharmacy on or after the effective date

12-64    of this Act.  A license issued or renewed before that date is

12-65    governed by the law in effect on the date the license was issued or

12-66    renewed, and the former law is continued in effect for that

12-67    purpose.

12-68          (b)  Section 37A, Texas Pharmacy Act (Article 4542a-1,

12-69    Vernon's Texas Civil Statutes), as added by this Act, applies only

 13-1    to a violation of the licensing requirements of the Texas Pharmacy

 13-2    Act (Article 4542a-1, Vernon's Texas Civil Statutes) that occurs on

 13-3    or after the effective date of this Act.

 13-4          SECTION 29.  The importance of this legislation and the

 13-5    crowded condition of the calendars in both houses create an

 13-6    emergency and an imperative public necessity that the

 13-7    constitutional rule requiring bills to be read on three several

 13-8    days in each house be suspended, and this rule is hereby suspended.

 13-9                                 * * * * *