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
2-14 successfully completed a certification program that meets board
2-15 standards;
2-16 (5) the enforcement of those provisions of this Act
2-17 relating to the conduct or competence of pharmacists practicing in
2-18 this state and the conduct of pharmacies operating in this state
2-19 and the suspension, revocation, fining, reprimanding, cancellation,
2-20 or restriction of licenses to engage in the practice of pharmacy or
2-21 to operate a pharmacy;
2-22 (6) [(5)] the specifications of conditions under which
2-23 a pharmacist may administer medications, including immunizations
2-24 and vaccinations, which at a minimum shall include the following:
2-25 (A) a licensed health care provider authorized
2-26 to administer the medication is not reasonably available to
3-1 administer the medication;
3-2 (B) failure to administer the medication, other
3-3 than an immunization or vaccination, might result in a significant
3-4 delay or interruption of a critical phase of drug therapy;
3-5 (C) the pharmacist possesses the necessary
3-6 skill, education, and certification to administer the medication as
3-7 specified by the board;
3-8 (D) the pharmacist notifies the appropriate
3-9 licensed health care provider responsible for the patient's care
3-10 within a reasonable time that the medication was administered;
3-11 (E) a pharmacist may not administer medications
3-12 to a patient where the patient resides, except in a licensed
3-13 nursing home or hospital;
3-14 (F) the pharmacist administers immunizations or
3-15 vaccinations under a physician's written protocol and meets the
3-16 standards established by the board;
3-17 (G) the authority of the pharmacist to
3-18 administer medications may not be delegated;
3-19 (H) nothing in this subdivision shall be
3-20 construed to prohibit a pharmacist from preparing or manipulating
3-21 biotechnological agents or devices; and
3-22 (I) nothing in this subdivision shall be
3-23 construed as prohibiting a pharmacist from performing an act
3-24 delegated by a physician in accordance with the provisions of
3-25 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
3-26 Vernon's Texas Civil Statutes), and the pharmacist performing such
4-1 a delegated medical act shall be considered to be performing a
4-2 medical act and not as engaged in the practice of pharmacy;
4-3 (7) [(6)] the regulation of the training,
4-4 qualifications, and employment of:
4-5 (A) pharmacist-interns; and
4-6 (B) pharmacy technicians; and
4-7 (8) [(7)] the enforcement of this Act and any rules
4-8 adopted under this Act.
4-9 (b) The board has the following responsibilities relating to
4-10 the practice of pharmacy and to prescription drugs and devices used
4-11 in this state in the diagnosis, mitigation, and treatment or
4-12 prevention of injury, illness, and disease:
4-13 (1) regulation of the delivery or distribution of
4-14 prescription drugs and devices, including the right to seize, after
4-15 notice and hearing, any prescription drugs or devices posing a
4-16 hazard to the public health and welfare, but the board may not
4-17 regulate:
4-18 (A) manufacturers' representatives or employees
4-19 acting in the normal course of business;
4-20 (B) persons engaged in the wholesale drug
4-21 business and registered with the commissioner of health as provided
4-22 by Chapter 431, Health and Safety Code; or
4-23 (C) employees of persons engaged in the
4-24 wholesale drug business and registered with the commissioner of
4-25 health as provided by Chapter 431, Health and Safety Code, if the
4-26 employees are acting in the normal course of business;
5-1 (2) specification of minimum standards for
5-2 professional environment, technical equipment, and security in the
5-3 prescription dispensing area;
5-4 (3) specification of minimum standards for drug
5-5 storage, maintenance of prescription drug records, and procedures
5-6 for the delivery, dispensing in a suitable container appropriately
5-7 labeled, providing of prescription drugs or devices, monitoring of
5-8 drug therapy, and counseling of patients on proper use of
5-9 prescription drugs and devices within the practice of pharmacy;
5-10 (4) adoption of rules regulating a prescription drug
5-11 order or medication order transmitted by electronic means; and
5-12 (5) [annual] registration of balances used for the
5-13 compounding of drugs in pharmacies licensed in this state and the
5-14 periodic inspection of such balances to verify accuracy.
5-15 SECTION 3. Subsection (o), Section 17, Texas Pharmacy Act
5-16 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
5-17 read as follows:
5-18 (o) The board:
5-19 (1) shall establish rules for the use of pharmacy
5-20 technicians and the duties of those technicians in pharmacies
5-21 licensed by the board, provided that those technicians are
5-22 responsible to and directly supervised by a pharmacist licensed by
5-23 the board;
5-24 (2) [provided however that the board] may not adopt
5-25 rules or regulations establishing ratios of pharmacists to pharmacy
5-26 technicians in Class C pharmacies; [and]
6-1 (3) shall [(2) may] determine and issue standards for
6-2 recognition and approval of training programs for pharmacy
6-3 technicians; and
6-4 (4) shall maintain a list of board-approved training
6-5 programs that meet the standards under Subdivision (3) of this
6-6 subsection.
6-7 SECTION 4. The Texas Pharmacy Act (Article 4542a-1, Vernon's
6-8 Texas Civil Statutes) is amended by adding Sections 20A and 20B to
6-9 read as follows:
6-10 Sec. 20A. QUALIFICATIONS AND SUPERVISION OF PHARMACY
6-11 TECHNICIANS; RULES. (a) In establishing rules under Section 17(o)
6-12 of this Act, the board shall require that a pharmacy technician:
6-13 (1) have a high school diploma or a high school
6-14 equivalency certificate or be working to achieve an equivalent
6-15 diploma or certificate; and
6-16 (2) have passed a board-approved pharmacy technician
6-17 certification examination.
6-18 (b) The board may allow a technician to petition the board
6-19 for a special exemption from the technician certification
6-20 requirement if the technician:
6-21 (1) is in a county with a population of less than
6-22 50,000; or
6-23 (2) on September 1, 2001, has been employed as a
6-24 pharmacy technician in this state for at least 10 years and the
6-25 technician's employer approves the petition.
6-26 (c) The board shall adopt rules that permit a pharmacy
7-1 technician to perform only nonjudgmental technical duties under the
7-2 direct supervision of a pharmacist.
7-3 Sec. 20B. PHARMACY TECHNICIAN REGISTRATION REQUIRED. (a) A
7-4 pharmacy technician must register with the board annually or
7-5 biennially, as determined by board rule, on a form prescribed by
7-6 the board.
7-7 (b) The board may refuse to issue or renew a registration or
7-8 may suspend or revoke any registration issued by the board if the
7-9 board determines that the applicant or registrant has:
7-10 (1) violated this Act or a rule adopted under this
7-11 Act;
7-12 (2) engaged in gross immorality as that term is
7-13 defined by the rules of the board;
7-14 (3) engaged in any fraud, deceit, or
7-15 misrepresentation, as those terms are defined by the rules of the
7-16 board, in seeking a registration to act as a pharmacy technician;
7-17 (4) been convicted of a misdemeanor involving moral
7-18 turpitude or a felony;
7-19 (5) a drug or alcohol dependency;
7-20 (6) violated the Texas Controlled Substances Act
7-21 (Chapter 481, Health and Safety Code) or Texas Dangerous Drug Act
7-22 (Chapter 483, Health and Safety Code) or rules relating to those
7-23 acts, Sections 485.031-485.035, Health and Safety Code, or a rule
7-24 adopted under Section 485.011, Health and Safety Code;
7-25 (7) violated the pharmacy or drug laws or rules of
7-26 this state, another state, or the United States; or
8-1 (8) had a registration as a pharmacy technician issued
8-2 by another state revoked, surrendered, or suspended for conduct
8-3 substantially equivalent to conduct described in Subdivisions (1)
8-4 through (6) of this subsection.
8-5 (c) A certified copy of the record of a state taking action
8-6 described by Subsection (b)(8) of this section is conclusive
8-7 evidence of the action taken by the state.
8-8 (d) The board may adopt a system in which the registrations
8-9 of pharmacy technicians expire on various dates during the year.
8-10 (e) The board may adopt fees as necessary for the
8-11 registration of pharmacy technicians.
8-12 SECTION 5. Subsection (d), Section 24A, Texas Pharmacy Act
8-13 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
8-14 read as follows:
8-15 (d) An applicant who satisfies the continuing education
8-16 requirement through completion of approved programs must present
8-17 evidence satisfactory to the board of completion of not fewer than
8-18 24 [at least 12] hours of continuing education during the preceding
8-19 24 months of the applicant's license period. [A licensee who
8-20 completes more than 12 hours during the preceding license period
8-21 may carry forward a maximum of 12 hours for the next license
8-22 period.]
8-23 SECTION 6. Subsection (g), Section 27A, Texas Pharmacy Act
8-24 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
8-25 read as follows:
8-26 (g) The board may add a surcharge of not more than $10 for
9-1 each 12 months in a license period to a license or license renewal
9-2 fee authorized under this Act to fund the program to aid impaired
9-3 pharmacists or pharmacy students.
9-4 SECTION 7. Subsection (b), Section 28, Texas Pharmacy Act
9-5 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
9-6 read as follows:
9-7 (b) A person whose pharmacy license, [or] license to
9-8 practice pharmacy, or pharmacy technician registration in this
9-9 state has been canceled, revoked, or restricted under this Act,
9-10 whether voluntarily or by action of the board, may, after 12 months
9-11 from the effective date of the cancellation, revocation, or
9-12 restriction, petition the board for reinstatement or removal of the
9-13 restriction of the license. The petition shall be in writing and
9-14 in the form prescribed by the board. A person petitioning for
9-15 reinstatement has the burden of proof. On investigation and review
9-16 of the petition, the board may in its discretion grant or deny the
9-17 petition or it may modify its original finding to reflect any
9-18 circumstances that have changed sufficiently to warrant the
9-19 modification. If such petition is denied by the board, a
9-20 subsequent petition may not be considered by the board until 12
9-21 months from the date of denial of the previous petition. The board
9-22 in its discretion may require such person to pass an examination or
9-23 examinations for reentry into the practice of pharmacy.
9-24 SECTION 8. Subsections (a) and (e), Section 29, Texas
9-25 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
9-26 amended to read as follows:
10-1 (a) A pharmacy shall be licensed by the board. A pharmacy
10-2 license under this Act must be renewed annually or biennially as
10-3 determined by the board.
10-4 (e) The board shall have the discretion to determine under
10-5 which classifications a pharmacy applicant may be licensed. With
10-6 respect to Class C pharmacies, the board may:
10-7 (1) establish rules for the use of pharmacy
10-8 technicians and the duties of those technicians in Class C
10-9 pharmacies licensed by the board, provided that these technicians
10-10 are responsible to and directly supervised by a pharmacist licensed
10-11 by the board; provided, however, the board may not adopt any rule
10-12 setting ratios with respect to pharmacists and pharmacy technicians
10-13 or limiting the number of pharmacy technicians that may be
10-14 utilized; and
10-15 (2) issue a license to a pharmacy on certification by
10-16 the appropriate agency that the facility in which the pharmacy is
10-17 located has substantially completed the requirements for licensing.
10-18 SECTION 9. Subsections (d) and (f), Section 31, Texas
10-19 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
10-20 amended to read as follows:
10-21 (d) The board shall remove the name from the register of
10-22 licensed pharmacies and suspend the license of a pharmacy that does
10-23 not file a completed application and pay the renewal fee before the
10-24 license expiration date [June 1 of each year].
10-25 (f) The board may adopt a system in which licenses to
10-26 operate a pharmacy expire on various dates during the year or every
11-1 other year, as appropriate.
11-2 SECTION 10. The Texas Pharmacy Act (Article 4542a-1,
11-3 Vernon's Texas Civil Statutes) is amended by adding Section 42 to
11-4 read as follows:
11-5 Sec. 42. DUTY OF PROFESSIONAL LIABILITY INSURER TO REPORT.
11-6 (a) Every insurer or other entity providing pharmacist's
11-7 professional liability insurance, pharmacy technician professional
11-8 and supplemental liability insurance, or druggist's professional
11-9 liability insurance covering a pharmacist, pharmacy technician, or
11-10 pharmacy license holder in this state shall submit to the board the
11-11 information described in Subsections (b) and (c) of this section at
11-12 the time prescribed. The information shall be provided with
11-13 respect to a notice of claim letter or complaint filed against an
11-14 insured in a court, if the notice or complaint seeks damages
11-15 relating to the insured's conduct in providing or failing to
11-16 provide appropriate service within the scope of pharmaceutical care
11-17 or services, and with respect to settlement of a claim or lawsuit
11-18 made on behalf of the insured. If a pharmacist, pharmacy
11-19 technician, or a pharmacy licensed in this state does not carry or
11-20 is not covered by pharmacist's professional liability insurance,
11-21 pharmacy technician professional and supplemental liability
11-22 insurance, or druggist's professional liability insurance and is
11-23 insured by a nonadmitted carrier or other entity providing pharmacy
11-24 professional liability insurance that does not report under this
11-25 Act, the duty to report information under Subsections (b) and (c)
11-26 of this section is the responsibility of the pharmacist, pharmacy
12-1 technician, or pharmacy license holder.
12-2 (b) The following information must be furnished to the board
12-3 not later than the 30th day after receipt by the insurer of the
12-4 notice of claim letter or complaint from the insured:
12-5 (1) the name of the insured and the insured's Texas
12-6 pharmacy technician registration number or pharmacist or pharmacy
12-7 license number;
12-8 (2) the policy number; and
12-9 (3) a copy of the notice of claim letter or complaint.
12-10 (c) The board shall, in consultation with the Texas
12-11 Department of Insurance, adopt rules for reporting additional
12-12 information as the board may require. Other claim reports required
12-13 under state and federal law shall be considered in determining the
12-14 information to be reported, the form of the report, and frequency
12-15 of reporting under the rules. Additional information that the
12-16 board may require may include:
12-17 (1) the date of any judgment, dismissal, or
12-18 settlement; and
12-19 (2) whether an appeal has been taken and by which
12-20 party.
12-21 (d) An insurer reporting under this section, its agents or
12-22 employees, or the board or its employees or representatives are not
12-23 liable for damages in a suit brought by any person or entity for
12-24 reporting as required by this section or for any other action taken
12-25 under this section.
12-26 (e) Information submitted to the board under this section
13-1 and the fact that the information has been submitted to the board
13-2 may not be:
13-3 (1) offered in evidence or used in any manner in the
13-4 trial of a suit described in this section; or
13-5 (2) used in any manner to determine the eligibility or
13-6 credentialing of a pharmacy to participate in a health insurance
13-7 plan defined by the Insurance Code.
13-8 (f) Information submitted under this section is confidential
13-9 and is not subject to disclosure under Chapter 552, Government
13-10 Code. The board shall adopt rules to ensure the confidentiality of
13-11 information submitted under this section.
13-12 (g) Except as otherwise provided in this subsection, a
13-13 report received by the board under this section is not a complaint
13-14 for which a board investigation is required. The board shall
13-15 review the information relating to a pharmacist, pharmacy
13-16 technician, or pharmacy license holder against whom at least three
13-17 professional liability claims have been reported within a five-year
13-18 period in the same manner as if a complaint against the pharmacist,
13-19 pharmacy technician, or pharmacy license holder had been made under
13-20 Section 17A of this Act.
13-21 (h) The Texas Department of Insurance may impose on any
13-22 insurer subject to this Act sanctions authorized by Section 7,
13-23 Article 1.10, Insurance Code, if the insurer fails to report
13-24 information as required by this section.
13-25 SECTION 11. (a) Except as provided by Subsection (d) of
13-26 this section, this Act takes effect September 1, 1999.
14-1 (b) The change in law made by this Act to Subsection (d),
14-2 Section 24A, Subsection (g), Section 27A, and Subsection (d),
14-3 Section 31, Texas Pharmacy Act (Article 4542a-1, Vernon's Texas
14-4 Civil Statutes), applies only to an application for issuance of a
14-5 license or for renewal of a license that is filed on or after the
14-6 effective date of this Act. An application for issuance or renewal
14-7 of a license filed before the effective date of this Act is
14-8 governed by the law in effect on the date the application was
14-9 filed, and the former law is continued in effect for that purpose.
14-10 (c) The change in law made by this Act to Subsection (b),
14-11 Section 28, Texas Pharmacy Act (Article 4542a-1, Vernon's Texas
14-12 Civil Statutes), applies only to a petition for reinstatement of a
14-13 license filed on or after the effective date of this Act. A
14-14 petition for reinstatement filed before the effective date of this
14-15 Act is governed by the law in effect on the date the petition was
14-16 filed, and the former law is continued in effect for that purpose.
14-17 (d) Section 20A, Texas Pharmacy Act (Article 4542a-1,
14-18 Vernon's Texas Civil Statutes), as added by this Act, takes effect
14-19 January 1, 2001. Section 20B, Texas Pharmacy Act (Article 4542a-1,
14-20 Vernon's Texas Civil Statutes), as added by this Act, takes effect
14-21 September 1, 2001.
14-22 SECTION 12. The importance of this legislation and the
14-23 crowded condition of the calendars in both houses create an
14-24 emergency and an imperative public necessity that the
14-25 constitutional rule requiring bills to be read on three several
14-26 days in each house be suspended, and this rule is hereby suspended.
S.B. No. 730
________________________________ ________________________________
President of the Senate Speaker of the House
I hereby certify that S.B. No. 730 passed the Senate on
March 25, 1999, by the following vote: Yeas 31, Nays 0;
May 17, 1999, Senate refused to concur in House amendments and
requested appointment of Conference Committee; May 19, 1999, House
granted request of the Senate; May 27, 1999, Senate adopted
Conference Committee Report by a viva-voce vote.
_______________________________
Secretary of the Senate
I hereby certify that S.B. No. 730 passed the House, with
amendments, on May 11, 1999, by a non-record vote; May 19, 1999,
House granted request of the Senate for appointment of Conference
Committee; May 27, 1999, House adopted Conference Committee Report
by a non-record vote.
_______________________________
Chief Clerk of the House
Approved:
________________________________
Date
________________________________
Governor