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