1-1     By:  Madla                                             S.B. No. 730
 1-2           (In the Senate - Filed February 26, 1999; March 1, 1999, read
 1-3     first time and referred to Committee on Health Services;
 1-4     March 17, 1999, reported favorably by the following vote:  Yeas 5,
 1-5     Nays 0; March 17, 1999, sent to printer.)
 1-6                            A BILL TO BE ENTITLED
 1-7                                   AN ACT
 1-8     relating to the licensing and regulation of pharmacists and
 1-9     pharmacies.
1-10           BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-11           SECTION 1.  Subdivision (7), Section 5, Texas Pharmacy Act
1-12     (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
1-13     read as follows:
1-14                 (7)  "Class C pharmacy license" or "institutional
1-15     pharmacy license" means a license issued to a pharmacy located in:
1-16                       (A)  a hospital or other in-patient facility that
1-17     is licensed under Chapter 241 or 577, Health and Safety Code;
1-18                       (B)  [, or Chapter 6,  Texas Mental Health Code
1-19     (Article 5547-1 et seq., Vernon's Texas Civil Statutes), to] a
1-20     hospice in-patient facility that is licensed under Chapter 142,
1-21     Health and Safety Code;
1-22                       (C)  an ambulatory surgical center licensed under
1-23     Chapter 243, Health and Safety Code; or
1-24                       (D)  [, or to a pharmacy located in] a hospital
1-25     maintained or operated by the state.
1-26           SECTION 2.  Subsections (a) and (b), Section 17, Texas
1-27     Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
1-28     amended to read as follows:
1-29           (a)  The board is responsible for the regulation of the
1-30     practice of pharmacy in this state, including the following:
1-31                 (1)  the licensing by examination or by reciprocity of
1-32     applicants who are qualified to engage in the practice of pharmacy
1-33     and the licensing of pharmacies under this Act;
1-34                 (2)  the renewal of licenses to engage in the practice
1-35     of pharmacy and licenses to operate pharmacies;
1-36                 (3)  the determination and issuance of standards for
1-37     recognition and approval of degree requirements of colleges of
1-38     pharmacy whose graduates shall be eligible for licensing in this
1-39     state and the specification and enforcement of requirements for
1-40     practical training, including internship;
1-41                 (4)  the determination and issuance of standards for
1-42     recognition and approval of pharmacist certification programs,
1-43     including a requirement that a pharmacist may not use the
1-44     designation "board certified" unless the pharmacist has attended a
1-45     certification program that meets board standards;
1-46                 (5)  the enforcement of those provisions of this Act
1-47     relating to the conduct or competence of pharmacists practicing in
1-48     this state and the conduct of pharmacies operating in this state
1-49     and the suspension, revocation, fining, reprimanding, cancellation,
1-50     or restriction of licenses to engage in the practice of pharmacy or
1-51     to operate a pharmacy;
1-52                 (6) [(5)] the specifications of conditions under which
1-53     a pharmacist may administer medications, including immunizations
1-54     and vaccinations,  which at a minimum shall include the following:
1-55                       (A)  a licensed health care provider authorized
1-56     to administer the medication is not reasonably available to
1-57     administer the medication;
1-58                       (B)  failure to administer the medication, other
1-59     than an immunization or vaccination, might result in a significant
1-60     delay or interruption of a critical phase of drug therapy;
1-61                       (C)  the pharmacist possesses the necessary
1-62     skill, education, and certification to administer the medication as
1-63     specified by the board;
1-64                       (D)  the pharmacist notifies the appropriate
 2-1     licensed health care provider responsible for the patient's care
 2-2     within a reasonable time that the medication was administered;
 2-3                       (E)  a pharmacist may not administer medications
 2-4     to a patient where the patient resides, except in a licensed
 2-5     nursing home or hospital;
 2-6                       (F)  the pharmacist administers immunizations or
 2-7     vaccinations under a physician's written protocol and meets the
 2-8     standards established by the board;
 2-9                       (G)  the authority of the pharmacist to
2-10     administer medications may not be delegated;
2-11                       (H)  nothing in this subdivision shall be
2-12     construed to prohibit a pharmacist from preparing or manipulating
2-13     biotechnological agents or devices; and
2-14                       (I)  nothing in this subdivision shall be
2-15     construed as prohibiting a pharmacist from performing an act
2-16     delegated by a physician in accordance with the provisions of
2-17     Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
2-18     Vernon's Texas Civil Statutes), and the pharmacist performing such
2-19     a delegated medical act shall be considered to be performing a
2-20     medical act and not as engaged in the practice of pharmacy;
2-21                 (7) [(6)]  the regulation of the training,
2-22     qualifications, and employment of pharmacist-interns; and
2-23                 (8) [(7)]  the enforcement of this Act and any rules
2-24     adopted under this Act.
2-25           (b)  The board has the following responsibilities relating to
2-26     the practice of pharmacy and to prescription drugs and devices used
2-27     in this state in the diagnosis, mitigation, and treatment or
2-28     prevention of injury, illness, and disease:
2-29                 (1)  regulation of the delivery or distribution of
2-30     prescription drugs and devices, including the right to seize, after
2-31     notice and hearing, any prescription drugs or devices posing a
2-32     hazard to the public health and welfare, but the board may not
2-33     regulate:
2-34                       (A)  manufacturers' representatives or employees
2-35     acting in the normal course of business;
2-36                       (B)  persons engaged in the wholesale drug
2-37     business and registered with the commissioner of health as provided
2-38     by Chapter 431, Health and Safety Code; or
2-39                       (C)  employees of persons engaged in the
2-40     wholesale drug business and registered with the commissioner of
2-41     health as provided by Chapter 431, Health and Safety Code, if the
2-42     employees are acting in the normal course of business;
2-43                 (2)  specification of minimum standards for
2-44     professional environment, technical equipment, and security in the
2-45     prescription dispensing area;
2-46                 (3)  specification of minimum standards for drug
2-47     storage, maintenance of prescription drug records, and procedures
2-48     for the delivery, dispensing in a suitable container appropriately
2-49     labeled, providing of prescription drugs or devices, monitoring of
2-50     drug therapy, and counseling of patients on proper use of
2-51     prescription drugs and devices within the practice of pharmacy;
2-52                 (4)  adoption of rules regulating a prescription drug
2-53     order or medication order transmitted by electronic means; and
2-54                 (5)  [annual] registration of balances used for the
2-55     compounding of drugs in pharmacies licensed in this state and the
2-56     periodic inspection of such balances to verify accuracy.
2-57           SECTION 3.  Subsection (d), Section 24A, Texas Pharmacy Act
2-58     (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
2-59     read as follows:
2-60           (d)  An applicant who satisfies the continuing education
2-61     requirement through completion of approved programs must present
2-62     evidence satisfactory to the board of completion of not fewer than
2-63     24 [at least 12] hours of continuing education during the preceding
2-64     24 months of the applicant's license period.  [A licensee who
2-65     completes more than 12 hours during the preceding license period
2-66     may carry forward a maximum of 12 hours for the next license
2-67     period.]
2-68           SECTION 4.  Subsection (g), Section 27A, Texas Pharmacy Act
2-69     (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
 3-1     read as follows:
 3-2           (g)  The board may add a surcharge of not more than $10 for
 3-3     each 12 months in a license period to a license or license renewal
 3-4     fee authorized under this Act to fund the program to aid impaired
 3-5     pharmacists or pharmacy students.
 3-6           SECTION 5.  Subsection (b), Section 28, Texas Pharmacy Act
 3-7     (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
 3-8     read as follows:
 3-9           (b)  A person whose pharmacy license or license to practice
3-10     pharmacy in this state has been canceled, revoked, or restricted
3-11     under this Act, whether voluntarily or by action of the board, may,
3-12     after 12 months from the effective date of the cancellation,
3-13     revocation, or restriction, petition the board for reinstatement or
3-14     removal of the restriction of the license.  The petition shall be
3-15     in writing and in the form prescribed by the board.  A person
3-16     petitioning for reinstatement has the burden of proof.  On
3-17     investigation and review of the petition, the board may in its
3-18     discretion grant or deny the petition or it may modify its original
3-19     finding to reflect any circumstances that have changed sufficiently
3-20     to warrant the modification.  If such petition is denied by the
3-21     board, a subsequent petition may not be considered by the board
3-22     until 12 months from the date of denial of the previous petition.
3-23     The board in its discretion may require such person to pass an
3-24     examination or examinations for reentry into the practice of
3-25     pharmacy.
3-26           SECTION 6.  Subsections (a) and (e), Section 29, Texas
3-27     Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
3-28     amended to read as follows:
3-29           (a)  A pharmacy shall be licensed by the board.  A pharmacy
3-30     license under this Act must be renewed annually or biennially as
3-31     determined by the board.
3-32           (e)  The board shall have the discretion to determine under
3-33     which classifications a pharmacy applicant may be licensed.  With
3-34     respect to Class C pharmacies, the board may:
3-35                 (1)  establish rules for the use of pharmacy
3-36     technicians and the duties of those technicians in Class C
3-37     pharmacies licensed by the board, provided that these technicians
3-38     are responsible to and directly supervised by a pharmacist licensed
3-39     by the board; provided, however, the board may not adopt any rule
3-40     setting ratios with respect to pharmacists and pharmacy technicians
3-41     or limiting the number of pharmacy technicians that may be
3-42     utilized; and
3-43                 (2)  issue a license to a pharmacy on certification by
3-44     the appropriate agency that the facility in which the pharmacy is
3-45     located has substantially completed the requirements for licensing.
3-46           SECTION 7.  Subsections (d) and (f), Section 31, Texas
3-47     Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
3-48     amended to read as follows:            
3-49           (d)  The board shall remove the name from the register of
3-50     licensed pharmacies and suspend the license of a pharmacy that does
3-51     not file a completed application and pay the renewal fee before the
3-52     license expiration date [June 1 of each year].
3-53           (f)  The board may adopt a system in which licenses to
3-54     operate a pharmacy expire on various dates during the year or every
3-55     other year, as appropriate.
3-56           SECTION 8.  (a)  This Act takes effect September 1, 1999.
3-57           (b)  The change in law made by this Act to Subsection (d),
3-58     Section 24A, Subsection (g), Section 27A, and Subsection (d),
3-59     Section 31, Texas Pharmacy Act (Article 4542a-1, Vernon's Texas
3-60     Civil Statutes), applies only to an application for issuance of a
3-61     license or for renewal of a license that is filed on or after the
3-62     effective date of this Act.  An application for issuance or renewal
3-63     of a license filed before the effective date of this Act is
3-64     governed by the law in effect on the date the application was
3-65     filed, and the former law is continued in effect for that purpose.
3-66           (c)  The change in law made by this Act to Subsection (b),
3-67     Section 28, Texas Pharmacy Act (Article 4542a-1, Vernon's Texas
3-68     Civil Statutes), applies only to a petition for reinstatement of a
3-69     license filed on or after the effective date of this Act.  A
 4-1     petition for reinstatement filed before the effective date of this
 4-2     Act is governed by the law in effect on the date the petition was
 4-3     filed, and the former law is continued in effect for that purpose.
 4-4           SECTION 9.  The importance of this legislation and the
 4-5     crowded condition of the calendars in both houses create an
 4-6     emergency and an imperative public necessity that the
 4-7     constitutional rule requiring bills to be read on three several
 4-8     days in each house be suspended, and this rule is hereby suspended.
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