By: Lucio S.B. No. 1774
Line and page numbers may not match official copy.
Bill not drafted by TLC or Senate E&E.
A BILL TO BE ENTITLED
AN ACT
1-1 relating to the creation of a long-term care pharmacy and a
1-2 long-term care satellite pharmacy license.
1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-4 SECTION 1. Section 242.161 of the Health and Safety Code is
1-5 amended as follows:
1-6 (A) A pharmacy is entitled to maintain a supply of
1-7 controlled substances and dangerous drugs for a resident's
1-8 immediate therapeutic needs, provided the supply of drugs is
1-9 maintained in compliance with the Texas Pharmacy Act (Texas Civil
1-10 Statutes, Article 4542a-1).
1-11 (B) The administration of the controlled substances and
1-12 dangerous drugs authorized in this section shall comply with all
1-13 applicable laws.
1-14 SECTION 2. Section 5 of the Texas Pharmacy Act (Texas Civil
1-15 Statutes, Article 4542a-1) is amended as follows:
1-16 In this Act, unless the context of its use clearly indicated
1-17 otherwise:
1-18 (1) "A.C.P.E." means the American Council on
1-19 Pharmaceutical Education.
1-20 (2) "Administer" means the direct application of a
1-21 prescription drug by injection, inhalation, ingestion, or any other
2-1 means to the body of a patient by:
2-2 (A) a practitioner, an authorized agent under
2-3 his supervision, or other preauthorized by law; or
2-4 (B) the patient at the direction of a
2-5 practitioner.
2-6 (3) "Administrative Procedure Act" means the
2-7 Administrative Procedure and Texas Register Act, as amended
2-8 (Article 6252-13a, Vernon's Texas Civil Statutes).
2-9 (4) "Board" means the Texas State Board of Pharmacy.
2-10 (5) "Class A pharmacy license" or "community pharmacy
2-11 license" means a license issued to a pharmacy dispensing drugs or
2-12 devices to the general public pursuant to a prescription drug
2-13 order.
2-14 (6) "Class B pharmacy license" or "nuclear pharmacy
2-15 license" means a license issued to a pharmacy dispensing or
2-16 providing radioactive drugs or devices for administration to an
2-17 ultimate user.
2-18 (7) "Class C pharmacy license" or "institutional
2-19 pharmacy license" means a license issued to a pharmacy located in a
2-20 hospital or other in-patient facility that is licensed under
2-21 Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental
2-22 Health Code (Article 5547-1 et seq., Vernon's Texas Civil
2-23 Statutes), to a hospice in-patient facility that is licensed under
2-24 Chapter 142, Health and Safety Code, or to a pharmacy located in a
2-25 hospital maintained or operated by the state.
3-1 (8) "Class D pharmacy license" or "clinic pharmacy
3-2 license" means a license issued to a pharmacy dispensing a limited
3-3 type of drugs or devices pursuant to a prescription drug order.
3-4 (9) "Class E pharmacy license" or "nonresident
3-5 pharmacy license" means a license issued under this Act to a
3-6 pharmacy located in a state of the United States other than this
3-7 state whose primary business is to dispense a prescription drug or
3-8 device under a prescription drug order and to deliver the drug or
3-9 device to a patient, including a patient in this state, by the
3-10 United States mail, a common carrier, or a delivery service.
3-11 (10) "Class L pharmacy license" or "long-term care
3-12 pharmacy license" means a license issued to a pharmacy that
3-13 dispenses prescription drugs or devices under a prescription drug
3-14 order to patients who are residents of a long-term care faculty
3-15 licensed under Chapter 242.
3-16 (11) "Class S pharmacy license" or "long-term care
3-17 satellite pharmacy license" Means a license issued to a holder of a
3-18 Class A, Class C, or Class L pharmacy license under this Act to
3-19 maintain a supply of dangerous drugs and controlled substances at a
3-20 long-term care facility licensed under Chapter 242, Health and
3-21 Safety Code. The controlled substances and dangerous drugs
3-22 maintained at the long-term care facility shall only be those
3-23 required to meet the immediate therapeutic needs of the patients of
3-24 the faculty.
3-25 (12) "College of pharmacy" means a school, university,
4-1 or college of pharmacy that satisfies the accreditation standards
4-2 of A.C.P.E. as adopted by the board; or that has degree
4-3 requirements which meet the standards of accreditation set by the
4-4 board.
4-5 (13) "Compounding" means the preparation, mixing,
4-6 assembling, packaging, or labeling of a drug or device:
4-7 (A) as the result of a practitioner's
4-8 prescription drug order or initiative based on the
4-9 practitioner-patient-pharmacist relationship in the course of
4-10 professional practice;
4-11 (B) in anticipation of prescription drug orders
4-12 based on routine, regularly observed prescribing patterns; or
4-13 (C) for the purpose of or as an incident to
4-14 research, teaching, or chemical analysis and not for sale or
4-15 dispensing.
4-16 (14) "Confidential record" means any health-related
4-17 record maintained by a pharmacy or pharmacist such as a patient
4-18 medication record, prescription drug order, or medication order.
4-19 (15) "Controlled substance" means a drug, immediate
4-20 precursor, or other substance listed in Schedules I-V or Penalty
4-21 Groups 1-4 of Chapter 481, Health and Safety Code, or a drug,
4-22 immediate precursor, or other substance included in Schedule I, II,
4-23 III, IV, or V of the Federal Comprehensive Drug Abuse Prevention
4-24 and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
4-25 (16) "Controlled Substances Act" means Chapter 481,
5-1 Health and Safety Code, or the Federal Comprehensive Drug Abuse
5-2 Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
5-3 (17) "Dangerous drug" means any drug or device that is
5-4 not included in Penalty Groups 1-4 of the Controlled Substances Act
5-5 and that is unsafe for self-medication or any drug or device that
5-6 bears or is required to bear the legend:
5-7 (A) "Caution: federal law prohibits dispensing
5-8 without prescription"; or
5-9 (B) "Caution: federal law restricts this drug
5-10 to use by or on the order of a licensed veterinarian."
5-11 (18) "Dangerous Drug Act" means Chapter 483, Health
5-12 and Safety Code.
5-13 (19) "Deliver" or "delivery" means the actual,
5-14 constructive, or attempted transfer of a prescription drug or
5-15 device or controlled substance from one person to another, whether
5-16 or not for a consideration.
5-17 (20) "Designated agent" means:
5-18 (A) a licensed nurse, physician assistant,
5-19 pharmacist, or other individual designated by a practitioner, and
5-20 for whom the practitioner assumes legal responsibility, who
5-21 communicates prescription drug orders to a pharmacist;
5-22 (B) a licensed nurse, physician assistant, or
5-23 pharmacist employed in a health care facility to whom the
5-24 practitioner communicates a prescription drug order; or
5-25 (C) a registered nurse or physician assistant
6-1 authorized by a practitioner to carry out a prescription drug order
6-2 for dangerous drugs under Subdivision (5) or (6), Subsection (d),
6-3 Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas
6-4 Civil Statutes).
6-5 (21) "Device" means an instrument, apparatus,
6-6 implement, machine, contrivance, implant, in vitro reagent, or
6-7 other similar or related article, including any component part or
6-8 accessory, that is required under federal or state law to be
6-9 ordered or prescribed by a practitioner.
6-10 (22) "Dispense" means preparing, packaging,
6-11 compounding, or labeling for delivery a prescription drug or device
6-12 in the course of professional practice to an ultimate user or his
6-13 agent by or pursuant to the lawful order of a practitioner.
6-14 (23) "Distribute" means the delivery of a prescription
6-15 drug or device other than by administering or dispensing.
6-16 (24) "Drug" means:
6-17 (A) a substance recognized as drugs in the
6-18 current official United States Pharmacopoeia, official National
6-19 Formulary, official Homeopathic Pharmacopoeia, or other drug
6-20 compendium or any supplement to any of them;
6-21 (B) a substance intended for use in the
6-22 diagnosis, cure, mitigation, treatment, or prevention of disease in
6-23 man or other animals;
6-24 (C) a substance, other than food, intended to
6-25 affect the structure or any function of the body of man or other
7-1 animals;
7-2 (D) a substance intended for use as a component
7-3 of any articles specified in Paragraph (A), (B), or (C) of this
7-4 subdivision;
7-5 (E) a dangerous drug; or
7-6 (F) a controlled substance.
7-7 (25) "Drug regimen review" includes the following
7-8 activities:
7-9 (A) evaluation of prescription drug or
7-10 medication orders and patient medication records for:
7-11 (i) known allergies;
7-12 (ii) rational therapy-contraindications;
7-13 (iii) reasonable dose and route of
7-14 administration; and
7-15 (iv) reasonable directions for use;
7-16 (B) evaluation of prescription drug or
7-17 medication orders and patient medication records for duplication of
7-18 therapy;
7-19 (C) evaluation of prescription drug or
7-20 medication orders and patient medication records for:
7-21 (i) drug-drug interactions;
7-22 (ii) drug-food interactions;
7-23 (iii) drug-disease interactions;
7-24 (iv) adverse drug reactions; and
7-25 (D) evaluation of prescription drug and
8-1 medication orders and patient medication records for proper
8-2 utilization, including overutilization or underutilization.
8-3 (26) "Internship" means a practical experience program
8-4 that is approved by the board.
8-5 (27) "Label" means written, printed, or graphic matter
8-6 on the immediate container of a drug or device.
8-7 (28) "Labeling" means the process of affixing a label
8-8 including all information required by federal and state law or
8-9 regulation to any drug or device container. The term does not
8-10 include the labeling by a manufacturer, packer, or distributor of a
8-11 nonprescription drug or commercially packaged prescription drug or
8-12 device, or unit dose packaging.
8-13 (29) "Manufacturing" means the production,
8-14 preparation, propagation, conversion, or processing of a drug or
8-15 device, either directly or indirectly, by extraction from
8-16 substances of natural origin or independently by means of chemical
8-17 or biological synthesis and includes any packaging or repackaging
8-18 of the substances or labeling or relabeling of the container and
8-19 the promotion and marketing of such drugs or devices.
8-20 Manufacturing also includes the preparation and promotion of
8-21 commercially available products from bulk compounds for resale by
8-22 pharmacies, practitioners, or other persons but does not include
8-23 compounding.
8-24 (30) "Medication order" means an order from a
8-25 practitioner or a practitioner's designated agent for
9-1 administration of a drug or device.
9-2 (31) "Nonprescription drug" means a nonnarcotic drug
9-3 or device that may be sold without a prescription and that is
9-4 labeled and packaged in compliance with applicable state or federal
9-5 law.
9-6 (32) "Patient counseling" means the communication by
9-7 the pharmacist of information, as specified in the rules of the
9-8 board, to the patient or caregiver, in order to improve therapy by
9-9 ensuring proper use of drugs and devices.
9-10 (33) "Person" means an individual, corporation,
9-11 government or governmental subdivision or agency, business trust,
9-12 estate, trust, partnership, association, or any other legal entity.
9-13 (34) "Pharmaceutical care" is the provision of drug
9-14 therapy and other pharmaceutical services defined in the rules of
9-15 the board and intended to assist in the cure or prevention of a
9-16 disease, elimination or reduction of a patient's symptoms, or
9-17 arresting or slowing of a disease process.
9-18 (35) "Pharmacist" means a person licensed by the board
9-19 to practice pharmacy.
9-20 (36) "Pharmacist-in-charge" means the pharmacist
9-21 designated on a pharmacy license as the pharmacist who has the
9-22 authority or responsibility for a pharmacy's compliance with laws
9-23 and rules pertaining to the practice of pharmacy.
9-24 (37) "Pharmacist-intern" means an undergraduate
9-25 student enrolled in the professional sequence of a college of
10-1 pharmacy approved by the board and participating in a school-based,
10-2 board-approved internship program or a graduate of a college of
10-3 pharmacy who is participating in a board-approved internship.
10-4 (38) "Pharmacy" means a facility licensed by the board
10-5 pursuant to Section 29 of this Act.
10-6 (39) "Practice of pharmacy" means:
10-7 (A) provision of those acts or services
10-8 necessary to provide pharmaceutical care;
10-9 (B) interpretation and evaluation of
10-10 prescription drug orders or medication orders;
10-11 (C) participation in drug and device selection
10-12 as authorized by law, drug administration, drug regimen review, or
10-13 drug or drug-related research;
10-14 (D) provision of patient counseling;
10-15 (E) responsibility for:
10-16 (i) dispensing of prescription drug orders
10-17 or distribution of medication orders;
10-18 (ii) compounding and labeling of drugs and
10-19 devices, except labeling by a manufacturer, repackager, or
10-20 distributor of nonprescription drugs and commercially packaged
10-21 prescription drugs and devices;
10-22 (iii) proper and safe storage of drugs and
10-23 devices; or
10-24 (iv) maintenance of proper records for
10-25 drugs and devices; and
11-1 (F) performance of a specific act of drug
11-2 therapy management for a patient delegated to a pharmacist by a
11-3 written protocol from a physician licensed in this state in
11-4 compliance with the Medical Practice Act (Article 4495b, Vernon's
11-5 Texas Civil Statutes).
11-6 (40) "Practitioner" means:
11-7 (A) a physician, dentist, podiatrist,
11-8 veterinarian, or other person licensed or registered to prescribe,
11-9 distribute, administer, or dispense a prescription drug or device
11-10 in the course of professional practice in this state;
11-11 (B) a person licensed by another state in a
11-12 health field in which, under Texas law, licensees in this state may
11-13 legally prescribe dangerous drugs or a person practicing in another
11-14 state and licensed by another state as a physician, dentist,
11-15 veterinarian, or podiatrist, having a current Federal Drug
11-16 Enforcement Administration registration number, and who may legally
11-17 prescribe Schedule II, III, IV, or V controlled substances in such
11-18 other state; or
11-19 (C) a person licensed in the Dominion of Canada
11-20 or the United Mexican States in a health field in which, under the
11-21 laws of this state, a licensee may legally prescribe dangerous
11-22 drugs. "Practitioner" does not include a person licensed under
11-23 this Act.
11-24 (41) "Preceptor" means a pharmacist in good standing
11-25 licensed in this state to practice pharmacy and certified by the
12-1 board to supervise and be responsible for the activities and
12-2 functions of a pharmacist-intern in the internship program.
12-3 (42) "Prescription drug" means:
12-4 (A) a substance for which federal or state law
12-5 requires a prescription before it may be legally dispensed to the
12-6 public;
12-7 (B) a drug or device that under federal law is
12-8 required, prior to being dispensed or delivered, to be labeled with
12-9 either of the following statements:
12-10 (i) "Caution: federal law prohibits
12-11 dispensing without prescription"; or
12-12 (ii) "Caution: federal law restricts this
12-13 drug to use by or on the order of a licensed veterinarian"; or
12-14 (C) a drug or device that is required by any
12-15 applicable federal or state law or regulation to be dispensed on
12-16 prescription only or is restricted to use by a practitioner only.
12-17 (43) "Prescription drug order" means:
12-18 (A) an order from a practitioner or a
12-19 practitioner's designated agent to a pharmacist for a drug or
12-20 device to be dispensed; or
12-21 (B) an order pursuant to Subdivision (5) or (6),
12-22 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
12-23 Vernon's Texas Civil Statutes).
12-24 (44) "Prospective drug use review" means a review of
12-25 the patient's drug therapy and prescription drug order or
13-1 medication order, as defined in the rules of the board, prior to
13-2 dispensing or distributing the drug.
13-3 (45) "Provide" means to supply one or more unit doses
13-4 of a nonprescription drug or dangerous drug to a patient.
13-5 (46) "Radioactive drug" means a drug that exhibits
13-6 spontaneous disintegration of unstable nuclei with the emission of
13-7 nuclear particles or photons, including any nonradioactive reagent
13-8 kit or nuclide generator that is intended to be used in the
13-9 preparation of any such substance.
13-10 (47) "Substitution" means the dispensing of a drug or
13-11 a brand of drug other than that which is ordered or prescribed.
13-12 (48) "Supportive personnel" means those individuals
13-13 utilized in pharmacies whose responsibility it shall be to provide
13-14 technical services that do not require professional judgment
13-15 concerned with the preparation and distribution of drugs under the
13-16 direct supervision of and responsible to a pharmacist.
13-17 (49) "Ultimate user" means a person who has obtained
13-18 and possesses a prescription drug or device for the person's own
13-19 use or for the use of a member of the person's household or for
13-20 administering to an animal owned by the person or by a member of
13-21 the person's household.
13-22 (50) "Unit dose packaging" means the ordered amount of
13-23 drug in a dosage form ready for administration to a particular
13-24 patient, by the prescribed route at the prescribed time, and
13-25 properly labeled with name, strength, and expiration date of the
14-1 drug.
14-2 (51) "Written protocol" means a physician's order,
14-3 standing medical order, standing delegation order, or other order
14-4 or protocol as defined by rule of the Texas State Board of Medical
14-5 Examiners under the Medical Practice Act (Article 4495b, Vernon's
14-6 Texas Civil Statutes).
14-7 SECTION 2. Subsections (b) and (c), Section 29 of the Texas
14-8 Pharmacy Act (Article 454a-1) are amended as follows:
14-9 (b) Each pharmacy shall apply for a license in one or more
14-10 of the following classifications:
14-11 (1) Class A;
14-12 (2) Class B;
14-13 (3) Class C;
14-14 (4) Class D;
14-15 (5) Class E;
14-16 (6) Class L; or
14-17 (7) Class S.
14-18 (c) Each pharmacy shall be under the supervision of a
14-19 pharmacist as follows:
14-20 (1) a Class A pharmacy shall be under the continuous
14-21 on-site supervision of a pharmacist during the time it is open for
14-22 pharmacy services;
14-23 (2) a Class B pharmacy shall be under the continuous
14-24 on-site supervision of a pharmacist during the time it is open for
14-25 pharmacy services;
15-1 (3) a Class C pharmacy shall be under the continuous
15-2 on-site supervision of a pharmacist in institutions with more than
15-3 100 beds during the time it is open for pharmacy services; in
15-4 institutions with 100 beds or fewer, the services of a pharmacist
15-5 shall be required on a part-time or consulting basis according to
15-6 the needs of the institution;
15-7 (4) a Class D pharmacy shall be under the continuous
15-8 supervision of a pharmacist whose services shall be required
15-9 according to the needs of the pharmacy; and
15-10 (5) a Class E pharmacy shall be under the continuous
15-11 on-site supervision of a pharmacist and shall designate one
15-12 pharmacist licensed to practice pharmacy by the regulatory or
15-13 licensing agency of the state in which the Class E pharmacy is
15-14 located to serve as the pharmacist-in-charge of the Class E
15-15 pharmacy license.
15-16 (6) a Class 1 pharmacy shall be under the continuous
15-17 on-site supervision of a pharmacist during the time it is open for
15-18 pharmacy services; and
15-19 (7) a Class S pharmacy shall be under the continuous
15-20 supervision of a pharmacist whose services shall be required
15-21 according to the needs of the pharmacy.
15-22 SECTION 3. This Act takes effect September 1, 1997.
15-23 SECTION 4. The importance of this legislation and the
15-24 crowded condition of the calendars in both houses create an
15-25 emergency and an imperative public necessity that the
16-1 constitutional rule requiring bills to be read on three several
16-2 days in each house be suspended, and this rule is hereby suspended.