By: Lucio S.B. No. 1774
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, Health and Safety Code, is
1-5 amended to read as follows:
1-6 Sec. 242.161. EMERGENCY MEDICATION KIT. (a) A pharmacy [An
1-7 institution licensed under this chapter] is entitled to maintain a
1-8 supply of controlled substances and dangerous drugs for a
1-9 resident's immediate therapeutic needs, provided the supply of
1-10 drugs is maintained in compliance with the Texas Pharmacy Act
1-11 (Article 4542a-1, Vernon's Texas Civil Statutes) [in an emergency
1-12 medication kit for a resident's emergency medication needs].
1-13 (b) [The controlled substances shall be labeled in
1-14 accordance with all applicable state and federal food and drug
1-15 laws, including Chapter 481 (Texas Controlled Substances Act).]
1-16 [(c) The board shall adopt rules governing the amount, type,
1-17 and procedure for use of the controlled substances in the emergency
1-18 medication kit. The storage of the controlled substances in the
1-19 kit is under the supervision of the consultant pharmacist.]
1-20 [(d)] The administration of the controlled substances and
1-21 dangerous drugs authorized in this section [in the emergency
1-22 medication kit] shall comply with all applicable laws.
1-23 SECTION 2. Section 5, Texas Pharmacy Act, (Article 4542a-1,
2-1 Vernon's Texas Civil Statutes), is amended to read as follows:
2-2 Sec. 5. DEFINITIONS. In this Act, unless the context of its
2-3 use clearly indicates otherwise:
2-4 (1) "A.C.P.E." means the American Council on
2-5 Pharmaceutical Education.
2-6 (2) "Administer" means the direct application of a
2-7 prescription drug by injection, inhalation, ingestion, or any other
2-8 means to the body of a patient by:
2-9 (A) a practitioner, an authorized agent under
2-10 his supervision, or other person authorized by law; or
2-11 (B) the patient at the direction of a
2-12 practitioner.
2-13 (3) "Administrative Procedure Act" means Chapter 2001,
2-14 Government Code [the Administrative Procedure and Texas Register
2-15 Act, as amended (Article 6252-13a, Vernon's Texas Civil Statutes)].
2-16 (4) "Board" means the Texas State Board of Pharmacy.
2-17 (5) "Class A pharmacy license" or "community pharmacy
2-18 license" means a license issued to a pharmacy dispensing drugs or
2-19 devices to the general public pursuant to a prescription drug
2-20 order.
2-21 (6) "Class B pharmacy license" or "nuclear pharmacy
2-22 license" means a license issued to a pharmacy dispensing or
2-23 providing radioactive drugs or devices for administration to an
2-24 ultimate user.
2-25 (7) "Class C pharmacy license" or "institutional
3-1 pharmacy license" means a license issued to a pharmacy located in a
3-2 hospital or other in-patient facility that is licensed under
3-3 Chapter 241 or 577, Health and Safety Code, [or Chapter 6, Texas
3-4 Mental Health Code (Article 5547-1 et seq., Vernon's Texas Civil
3-5 Statutes),] to a hospice in-patient facility that is licensed under
3-6 Chapter 142, Health and Safety Code, or to a pharmacy located in a
3-7 hospital maintained or operated by the state.
3-8 (8) "Class D pharmacy license" or "clinic pharmacy
3-9 license" means a license issued to a pharmacy dispensing a limited
3-10 type of drugs or devices pursuant to a prescription drug order.
3-11 (9) "Class E pharmacy license" or "nonresident
3-12 pharmacy license" means a license issued under this Act to a
3-13 pharmacy located in a state of the United States other than this
3-14 state whose primary business is to dispense a prescription drug or
3-15 device under a prescription drug order and to deliver the drug or
3-16 device to a patient, including a patient in this state, by the
3-17 United States mail, a common carrier, or a delivery service.
3-18 (10) "Class L pharmacy license" or "long-term care
3-19 pharmacy license" means a license issued to a pharmacy that
3-20 dispenses prescription drugs or devices under a prescription drug
3-21 order to patients who are residents of a long-term care facility
3-22 licensed under Chapter 242, Health and Safety Code.
3-23 (11) "Class S pharmacy license" or "long-term care
3-24 satellite pharmacy license" means a license issued to a holder of a
3-25 Class A, Class C, or Class L pharmacy license under this Act to
4-1 maintain a supply of controlled substances and dangerous drugs at a
4-2 long-term care facility licensed under Chapter 242, Health and
4-3 Safety Code. The controlled substances and dangerous drugs
4-4 maintained at the long-term care facility shall only be those
4-5 required to meet the immediate therapeutic needs of the patients of
4-6 the facility.
4-7 (12) "College of pharmacy" means a school, university,
4-8 or college of pharmacy that satisfies the accreditation standards
4-9 of A.C.P.E. as adopted by the board; or that has degree
4-10 requirements which meet the standards of accreditation set by the
4-11 board.
4-12 (13) [(12)] "Compounding" means the preparation,
4-13 mixing, assembling, packaging, or labeling of a drug or device:
4-14 (A) as the result of a practitioner's
4-15 prescription drug order or initiative based on the
4-16 practitioner-patient-pharmacist relationship in the course of
4-17 professional practice;
4-18 (B) in anticipation of prescription drug orders
4-19 based on routine, regularly observed prescribing patterns; or
4-20 (C) for the purpose of or as an incident to
4-21 research, teaching, or chemical analysis and not for sale or
4-22 dispensing.
4-23 (14) [(13)] "Confidential record" means any
4-24 health-related record maintained by a pharmacy or pharmacist such
4-25 as a patient medication record, prescription drug order, or
5-1 medication order.
5-2 (15) [(14)] "Controlled substance" means a drug,
5-3 immediate precursor, or other substance listed in Schedules I-V or
5-4 Penalty Groups 1-4 of Chapter 481, Health and Safety Code, or a
5-5 drug, immediate precursor, or other substance included in Schedule
5-6 I, II, III, IV, or V of the Federal Comprehensive Drug Abuse
5-7 Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
5-8 (16) [(15)] "Controlled Substances Act" means Chapter
5-9 481, Health and Safety Code, or the Federal Comprehensive Drug
5-10 Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et
5-11 seq.).
5-12 (17) [(16)] "Dangerous drug" means any drug or device
5-13 that is not included in Penalty Groups 1-4 of the Controlled
5-14 Substances Act and that is unsafe for self-medication or any drug
5-15 or device that bears or is required to bear the legend:
5-16 (A) "Caution: federal law prohibits dispensing
5-17 without prescription"; or
5-18 (B) "Caution: federal law restricts this drug
5-19 to use by or on the order of a licensed veterinarian."
5-20 (18) [(17)] "Dangerous Drug Act" means Chapter 483,
5-21 Health and Safety Code.
5-22 (19) [(18)] "Deliver" or "delivery" means the actual,
5-23 constructive, or attempted transfer of a prescription drug or
5-24 device or controlled substance from one person to another, whether
5-25 or not for a consideration.
6-1 (20) [(19)] "Designated agent" means:
6-2 (A) a licensed nurse, physician assistant,
6-3 pharmacist, or other individual designated by a practitioner, and
6-4 for whom the practitioner assumes legal responsibility, who
6-5 communicates prescription drug orders to a pharmacist;
6-6 (B) a licensed nurse, physician assistant, or
6-7 pharmacist employed in a health care facility to whom the
6-8 practitioner communicates a prescription drug order; or
6-9 (C) a registered nurse or physician assistant
6-10 authorized by a practitioner to carry out a prescription drug order
6-11 for dangerous drugs under Subdivision (5) or (6), Subsection (d),
6-12 Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas
6-13 Civil Statutes).
6-14 (21) [(20)] "Device" means an instrument, apparatus,
6-15 implement, machine, contrivance, implant, in vitro reagent, or
6-16 other similar or related article, including any component part or
6-17 accessory, that is required under federal or state law to be
6-18 ordered or prescribed by a practitioner.
6-19 (22) [(21)] "Dispense" means preparing, packaging,
6-20 compounding, or labeling for delivery a prescription drug or device
6-21 in the course of professional practice to an ultimate user or his
6-22 agent by or pursuant to the lawful order of a practitioner.
6-23 (23) [(22)] "Distribute" means the delivery of a
6-24 prescription drug or device other than by administering or
6-25 dispensing.
7-1 (24) [(23)] "Drug" means:
7-2 (A) a substance recognized as drugs in the
7-3 current official United States Pharmacopoeia, official National
7-4 Formulary, official Homeopathic Pharmacopoeia, or other drug
7-5 compendium or any supplement to any of them;
7-6 (B) a substance intended for use in the
7-7 diagnosis, cure, mitigation, treatment, or prevention of disease in
7-8 man or other animals;
7-9 (C) a substance, other than food, intended to
7-10 affect the structure or any function of the body of man or other
7-11 animals;
7-12 (D) a substance intended for use as a component
7-13 of any articles specified in Paragraph (A), (B), or (C) of this
7-14 subdivision;
7-15 (E) a dangerous drug; or
7-16 (F) a controlled substance.
7-17 (25) [(24)] "Drug regimen review" includes the
7-18 following activities:
7-19 (A) evaluation of prescription drug or
7-20 medication orders and patient medication records for:
7-21 (i) known allergies;
7-22 (ii) rational therapy-contraindications;
7-23 (iii) reasonable dose and route of
7-24 administration; and
7-25 (iv) reasonable directions for use;
8-1 (B) evaluation of prescription drug or
8-2 medication orders and patient medication records for duplication of
8-3 therapy;
8-4 (C) evaluation of prescription drug or
8-5 medication orders and patient medication records for:
8-6 (i) drug-drug interactions;
8-7 (ii) drug-food interactions;
8-8 (iii) drug-disease interactions;
8-9 (iv) adverse drug reactions; and
8-10 (D) evaluation of prescription drug and
8-11 medication orders and patient medication records for proper
8-12 utilization, including overutilization or underutilization.
8-13 (26) [(25)] "Internship" means a practical experience
8-14 program that is approved by the board.
8-15 (27) [(26)] "Label" means written, printed, or graphic
8-16 matter on the immediate container of a drug or device.
8-17 (28) [(27)] "Labeling" means the process of affixing a
8-18 label including all information required by federal and state law
8-19 or regulation to any drug or device container. The term does not
8-20 include the labeling by a manufacturer, packer, or distributor of a
8-21 nonprescription drug or commercially packaged prescription drug or
8-22 device, or unit dose packaging.
8-23 (29) [(28)] "Manufacturing" means the production,
8-24 preparation, propagation, conversion, or processing of a drug or
8-25 device, either directly or indirectly, by extraction from
9-1 substances of natural origin or independently by means of chemical
9-2 or biological synthesis and includes any packaging or repackaging
9-3 of the substances or labeling or relabeling of the container and
9-4 the promotion and marketing of such drugs or devices.
9-5 Manufacturing also includes the preparation and promotion of
9-6 commercially available products from bulk compounds for resale by
9-7 pharmacies, practitioners, or other persons but does not include
9-8 compounding.
9-9 (30) [(29)] "Medication order" means an order from a
9-10 practitioner or a practitioner's designated agent for
9-11 administration of a drug or device.
9-12 (31) [(30)] "Nonprescription drug" means a nonnarcotic
9-13 drug or device that may be sold without a prescription and that is
9-14 labeled and packaged in compliance with applicable state or federal
9-15 law.
9-16 (32) [(31)] "Patient counseling" means the
9-17 communication by the pharmacist of information, as specified in the
9-18 rules of the board, to the patient or caregiver, in order to
9-19 improve therapy by ensuring proper use of drugs and devices.
9-20 (33) [(32)] "Person" means an individual, corporation,
9-21 government or governmental subdivision or agency, business trust,
9-22 estate, trust, partnership, association, or any other legal entity.
9-23 (34) [(33)] "Pharmaceutical care" is the provision of
9-24 drug therapy and other pharmaceutical services defined in the rules
9-25 of the board and intended to assist in the cure or prevention of a
10-1 disease, elimination or reduction of a patient's symptoms, or
10-2 arresting or slowing of a disease process.
10-3 (35) [(34)] "Pharmacist" means a person licensed by
10-4 the board to practice pharmacy.
10-5 (36) [(35)] "Pharmacist-in-charge" means the
10-6 pharmacist designated on a pharmacy license as the pharmacist who
10-7 has the authority or responsibility for a pharmacy's compliance
10-8 with laws and rules pertaining to the practice of pharmacy.
10-9 (37) [(36)] "Pharmacist-intern" means an undergraduate
10-10 student enrolled in the professional sequence of a college of
10-11 pharmacy approved by the board and participating in a school-based,
10-12 board-approved internship program or a graduate of a college of
10-13 pharmacy who is participating in a board-approved internship.
10-14 (38) [(37)] "Pharmacy" means a facility licensed by
10-15 the board pursuant to Section 29 of this Act.
10-16 (39) [(38)] "Practice of pharmacy" means:
10-17 (A) provision of those acts or services
10-18 necessary to provide pharmaceutical care;
10-19 (B) interpretation and evaluation of
10-20 prescription drug orders or medication orders;
10-21 (C) participation in drug and device selection
10-22 as authorized by law, drug administration, drug regimen review, or
10-23 drug or drug-related research;
10-24 (D) provision of patient counseling;
10-25 (E) responsibility for:
11-1 (i) dispensing of prescription drug orders
11-2 or distribution of medication orders;
11-3 (ii) compounding and labeling of drugs and
11-4 devices, except labeling by a manufacturer, repackager, or
11-5 distributor of nonprescription drugs and commercially packaged
11-6 prescription drugs and devices;
11-7 (iii) proper and safe storage of drugs and
11-8 devices; or
11-9 (iv) maintenance of proper records for
11-10 drugs and devices; and
11-11 (F) performance of a specific act of drug
11-12 therapy management for a patient delegated to a pharmacist by a
11-13 written protocol from a physician licensed in this state in
11-14 compliance with the Medical Practice Act (Article 4495b, Vernon's
11-15 Texas Civil Statutes).
11-16 (40) [(39)] "Practitioner" means:
11-17 (A) a physician, dentist, podiatrist,
11-18 veterinarian, or other person licensed or registered to prescribe,
11-19 distribute, administer, or dispense a prescription drug or device
11-20 in the course of professional practice in this state;
11-21 (B) a person licensed by another state in a
11-22 health field in which, under Texas law, licensees in this state may
11-23 legally prescribe dangerous drugs or a person practicing in another
11-24 state and licensed by another state as a physician, dentist,
11-25 veterinarian, or podiatrist, having a current Federal Drug
12-1 Enforcement Administration registration number, and who may legally
12-2 prescribe Schedule II, III, IV, or V controlled substances in such
12-3 other state; or
12-4 (C) a person licensed in the Dominion of Canada
12-5 or the United Mexican States in a health field in which, under the
12-6 laws of this state, a licensee may legally prescribe dangerous
12-7 drugs. "Practitioner" does not include a person licensed under
12-8 this Act.
12-9 (41) [(40)] "Preceptor" means a pharmacist in good
12-10 standing licensed in this state to practice pharmacy and certified
12-11 by the board to supervise and be responsible for the activities and
12-12 functions of a pharmacist-intern in the internship program.
12-13 (42) [(41)] "Prescription drug" means:
12-14 (A) a substance for which federal or state law
12-15 requires a prescription before it may be legally dispensed to the
12-16 public;
12-17 (B) a drug or device that under federal law is
12-18 required, prior to being dispensed or delivered, to be labeled with
12-19 either of the following statements:
12-20 (i) "Caution: federal law prohibits
12-21 dispensing without prescription"; or
12-22 (ii) "Caution: federal law restricts this
12-23 drug to use by or on the order of a licensed veterinarian"; or
12-24 (C) a drug or device that is required by any
12-25 applicable federal or state law or regulation to be dispensed on
13-1 prescription only or is restricted to use by a practitioner only.
13-2 (43) [(42)] "Prescription drug order" means:
13-3 (A) an order from a practitioner or a
13-4 practitioner's designated agent to a pharmacist for a drug or
13-5 device to be dispensed; or
13-6 (B) an order pursuant to Subdivision (5) or (6),
13-7 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
13-8 Vernon's Texas Civil Statutes).
13-9 (44) [(43)] "Prospective drug use review" means a
13-10 review of the patient's drug therapy and prescription drug order or
13-11 medication order, as defined in the rules of the board, prior to
13-12 dispensing or distributing the drug.
13-13 (45) [(44)] "Provide" means to supply one or more unit
13-14 doses of a nonprescription drug or dangerous drug to a patient.
13-15 (46) [(45)] "Radioactive drug" means a drug that
13-16 exhibits spontaneous disintegration of unstable nuclei with the
13-17 emission of nuclear particles or photons, including any
13-18 nonradioactive reagent kit or nuclide generator that is intended to
13-19 be used in the preparation of any such substance.
13-20 (47) [(46)] "Substitution" means the dispensing of a
13-21 drug or a brand of drug other than that which is ordered or
13-22 prescribed.
13-23 (48) [(47)] "Supportive personnel" means those
13-24 individuals utilized in pharmacies whose responsibility it shall be
13-25 to provide technical services that do not require professional
14-1 judgment concerned with the preparation and distribution of drugs
14-2 under the direct supervision of and responsible to a pharmacist.
14-3 (49) [(48)] "Ultimate user" means a person who has
14-4 obtained and possesses a prescription drug or device for the
14-5 person's own use or for the use of a member of the person's
14-6 household or for administering to an animal owned by the person or
14-7 by a member of the person's household.
14-8 (50) [(49)] "Unit dose packaging" means the ordered
14-9 amount of drug in a dosage form ready for administration to a
14-10 particular patient, by the prescribed route at the prescribed time,
14-11 and properly labeled with name, strength, and expiration date of
14-12 the drug.
14-13 (51) [(50)] "Written protocol" means a physician's
14-14 order, standing medical order, standing delegation order, or other
14-15 order or protocol as defined by rule of the Texas State Board of
14-16 Medical Examiners under the Medical Practice Act (Article 4495b,
14-17 Vernon's Texas Civil Statutes).
14-18 SECTION 3. Subsections (b) and (c), Section 29, Texas
14-19 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes) are
14-20 amended to read as follows:
14-21 (b) Each pharmacy shall apply for a license in one or more
14-22 of the following classifications:
14-23 (1) Class A;
14-24 (2) Class B;
14-25 (3) Class C;
15-1 (4) Class D; [or]
15-2 (5) Class E;
15-3 (6) Class L; or
15-4 (7) Class S.
15-5 (c) Each pharmacy shall be under the supervision of a
15-6 pharmacist as follows:
15-7 (1) a Class A pharmacy shall be under the continuous
15-8 on-site supervision of a pharmacist during the time it is open for
15-9 pharmacy services;
15-10 (2) a Class B pharmacy shall be under the continuous
15-11 on-site supervision of a pharmacist during the time it is open for
15-12 pharmacy services;
15-13 (3) a Class C pharmacy shall be under the continuous
15-14 on-site supervision of a pharmacist in institutions with more than
15-15 100 beds during the time it is open for pharmacy services; in
15-16 institutions with 100 beds or fewer, the services of a pharmacist
15-17 shall be required on a part-time or consulting basis according to
15-18 the needs of the institution;
15-19 (4) a Class D 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; [and]
15-22 (5) a Class E pharmacy shall be under the continuous
15-23 on-site supervision of a pharmacist and shall designate one
15-24 pharmacist licensed to practice pharmacy by the regulatory or
15-25 licensing agency of the state in which the Class E pharmacy is
16-1 located to serve as the pharmacist-in-charge of the Class E
16-2 pharmacy license;
16-3 (6) a Class L pharmacy shall be under the continuous
16-4 on-site supervision of a pharmacist during the time it is open for
16-5 pharmacy services; and
16-6 (7) a Class S pharmacy shall be under the continuous
16-7 supervision of a pharmacist whose services shall be required
16-8 according to the needs of the pharmacy.
16-9 SECTION 4. This Act takes effect September 1, 1997.
16-10 SECTION 5. The importance of this legislation and the
16-11 crowded condition of the calendars in both houses create an
16-12 emergency and an imperative public necessity that the
16-13 constitutional rule requiring bills to be read on three several
16-14 days in each house be suspended, and this rule is hereby suspended.
16-15 COMMITTEE AMENDMENT NO. 1
16-16 Amend SB 1774 as follows:
16-17 On page 4, line 1 delete the words "a supply of" and replace
16-18 them with the words "an emergency medication kit".
16-19 On page 4, line 6, following the words "the facility" add the
16-20 following language:
16-21 . . . the board shall adopt rules to specify the quantities and
16-22 types of controlled substances and dangerous drugs included in
16-23 these emergency medication kits.
16-24 Berlanga