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.
4-9 * * * * *