1-1 By: Lucio S.B. No. 1774
1-2 (In the Senate - Filed March 14, 1997; March 24, 1997, read
1-3 first time and referred to Committee on Health and Human Services;
1-4 May 5, 1997, reported adversely, with favorable Committee
1-5 Substitute by the following vote: Yeas 9, Nays 1; May 5, 1997,
1-6 sent to printer.)
1-7 COMMITTEE SUBSTITUTE FOR S.B. No. 1774 By: Moncrief
1-8 A BILL TO BE ENTITLED
1-9 AN ACT
1-10 relating to the creation of a long-term care pharmacy and a
1-11 long-term care satellite pharmacy license.
1-12 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-13 SECTION 1. Section 242.161, Health and Safety Code, is
1-14 amended to read as follows:
1-15 Sec. 242.161. EMERGENCY MEDICATION KIT. (a) A pharmacy [An
1-16 institution licensed under this chapter] is entitled to maintain a
1-17 supply of controlled substances and dangerous drugs for a
1-18 resident's immediate therapeutic needs, provided the supply of
1-19 drugs is maintained in compliance with the Texas Pharmacy Act
1-20 (Article 4542a-1, Vernon's Texas Civil Statutes) [in an emergency
1-21 medication kit for a resident's emergency medication needs].
1-22 (b) [The controlled substances shall be labeled in
1-23 accordance with all applicable state and federal food and drug
1-24 laws, including Chapter 481 (Texas Controlled Substances Act).]
1-25 [(c) The board shall adopt rules governing the amount, type,
1-26 and procedure for use of the controlled substances in the emergency
1-27 medication kit. The storage of the controlled substances in the
1-28 kit is under the supervision of the consultant pharmacist.]
1-29 [(d)] The administration of the controlled substances and
1-30 dangerous drugs authorized in this section [in the emergency
1-31 medication kit] shall comply with all applicable laws.
1-32 SECTION 2. Section 5, Texas Pharmacy Act, (Article 4542a-1,
1-33 Vernon's Texas Civil Statutes), is amended to read as follows:
1-34 Sec. 5. DEFINITIONS. In this Act, unless the context of its
1-35 use clearly indicates otherwise:
1-36 (1) "A.C.P.E." means the American Council on
1-37 Pharmaceutical Education.
1-38 (2) "Administer" means the direct application of a
1-39 prescription drug by injection, inhalation, ingestion, or any other
1-40 means to the body of a patient by:
1-41 (A) a practitioner, an authorized agent under
1-42 his supervision, or other person authorized by law; or
1-43 (B) the patient at the direction of a
1-44 practitioner.
1-45 (3) "Administrative Procedure Act" means Chapter 2001,
1-46 Government Code [the Administrative Procedure and Texas Register
1-47 Act, as amended (Article 6252-13a, Vernon's Texas Civil Statutes)].
1-48 (4) "Board" means the Texas State Board of Pharmacy.
1-49 (5) "Class A pharmacy license" or "community pharmacy
1-50 license" means a license issued to a pharmacy dispensing drugs or
1-51 devices to the general public pursuant to a prescription drug
1-52 order.
1-53 (6) "Class B pharmacy license" or "nuclear pharmacy
1-54 license" means a license issued to a pharmacy dispensing or
1-55 providing radioactive drugs or devices for administration to an
1-56 ultimate user.
1-57 (7) "Class C pharmacy license" or "institutional
1-58 pharmacy license" means a license issued to a pharmacy located in a
1-59 hospital or other in-patient facility that is licensed under
1-60 Chapter 241 or 577, Health and Safety Code, [or Chapter 6, Texas
1-61 Mental Health Code (Article 5547-1 et seq., Vernon's Texas Civil
1-62 Statutes),] to a hospice in-patient facility that is licensed under
1-63 Chapter 142, Health and Safety Code, or to a pharmacy located in a
1-64 hospital maintained or operated by the state.
2-1 (8) "Class D pharmacy license" or "clinic pharmacy
2-2 license" means a license issued to a pharmacy dispensing a limited
2-3 type of drugs or devices pursuant to a prescription drug order.
2-4 (9) "Class E pharmacy license" or "nonresident
2-5 pharmacy license" means a license issued under this Act to a
2-6 pharmacy located in a state of the United States other than this
2-7 state whose primary business is to dispense a prescription drug or
2-8 device under a prescription drug order and to deliver the drug or
2-9 device to a patient, including a patient in this state, by the
2-10 United States mail, a common carrier, or a delivery service.
2-11 (10) "Class L pharmacy license" or "long-term care
2-12 pharmacy license" means a license issued to a pharmacy that
2-13 dispenses prescription drugs or devices under a prescription drug
2-14 order to patients who are residents of a long-term care facility
2-15 licensed under Chapter 242, Health and Safety Code.
2-16 (11) "Class S pharmacy license" or "long-term care
2-17 satellite pharmacy license" means a license issued to a holder of a
2-18 Class A, Class C, or Class L pharmacy license under this Act to
2-19 maintain a supply of controlled substances and dangerous drugs at a
2-20 long-term care facility licensed under Chapter 242, Health and
2-21 Safety Code. The controlled substances and dangerous drugs
2-22 maintained at the long-term care facility shall only be those
2-23 required to meet the immediate therapeutic needs of the patients of
2-24 the facility.
2-25 (12) "College of pharmacy" means a school, university,
2-26 or college of pharmacy that satisfies the accreditation standards
2-27 of A.C.P.E. as adopted by the board; or that has degree
2-28 requirements which meet the standards of accreditation set by the
2-29 board.
2-30 (13) [(12)] "Compounding" means the preparation,
2-31 mixing, assembling, packaging, or labeling of a drug or device:
2-32 (A) as the result of a practitioner's
2-33 prescription drug order or initiative based on the
2-34 practitioner-patient-pharmacist relationship in the course of
2-35 professional practice;
2-36 (B) in anticipation of prescription drug orders
2-37 based on routine, regularly observed prescribing patterns; or
2-38 (C) for the purpose of or as an incident to
2-39 research, teaching, or chemical analysis and not for sale or
2-40 dispensing.
2-41 (14) [(13)] "Confidential record" means any
2-42 health-related record maintained by a pharmacy or pharmacist such
2-43 as a patient medication record, prescription drug order, or
2-44 medication order.
2-45 (15) [(14)] "Controlled substance" means a drug,
2-46 immediate precursor, or other substance listed in Schedules I-V or
2-47 Penalty Groups 1-4 of Chapter 481, Health and Safety Code, or a
2-48 drug, immediate precursor, or other substance included in Schedule
2-49 I, II, III, IV, or V of the Federal Comprehensive Drug Abuse
2-50 Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
2-51 (16) [(15)] "Controlled Substances Act" means Chapter
2-52 481, Health and Safety Code, or the Federal Comprehensive Drug
2-53 Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et
2-54 seq.).
2-55 (17) [(16)] "Dangerous drug" means any drug or device
2-56 that is not included in Penalty Groups 1-4 of the Controlled
2-57 Substances Act and that is unsafe for self-medication or any drug
2-58 or device that bears or is required to bear the legend:
2-59 (A) "Caution: federal law prohibits dispensing
2-60 without prescription"; or
2-61 (B) "Caution: federal law restricts this drug
2-62 to use by or on the order of a licensed veterinarian."
2-63 (18) [(17)] "Dangerous Drug Act" means Chapter 483,
2-64 Health and Safety Code.
2-65 (19) [(18)] "Deliver" or "delivery" means the actual,
2-66 constructive, or attempted transfer of a prescription drug or
2-67 device or controlled substance from one person to another, whether
2-68 or not for a consideration.
2-69 (20) [(19)] "Designated agent" means:
3-1 (A) a licensed nurse, physician assistant,
3-2 pharmacist, or other individual designated by a practitioner, and
3-3 for whom the practitioner assumes legal responsibility, who
3-4 communicates prescription drug orders to a pharmacist;
3-5 (B) a licensed nurse, physician assistant, or
3-6 pharmacist employed in a health care facility to whom the
3-7 practitioner communicates a prescription drug order; or
3-8 (C) a registered nurse or physician assistant
3-9 authorized by a practitioner to carry out a prescription drug order
3-10 for dangerous drugs under Subdivision (5) or (6), Subsection (d),
3-11 Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas
3-12 Civil Statutes).
3-13 (21) [(20)] "Device" means an instrument, apparatus,
3-14 implement, machine, contrivance, implant, in vitro reagent, or
3-15 other similar or related article, including any component part or
3-16 accessory, that is required under federal or state law to be
3-17 ordered or prescribed by a practitioner.
3-18 (22) [(21)] "Dispense" means preparing, packaging,
3-19 compounding, or labeling for delivery a prescription drug or device
3-20 in the course of professional practice to an ultimate user or his
3-21 agent by or pursuant to the lawful order of a practitioner.
3-22 (23) [(22)] "Distribute" means the delivery of a
3-23 prescription drug or device other than by administering or
3-24 dispensing.
3-25 (24) [(23)] "Drug" means:
3-26 (A) a substance recognized as drugs in the
3-27 current official United States Pharmacopoeia, official National
3-28 Formulary, official Homeopathic Pharmacopoeia, or other drug
3-29 compendium or any supplement to any of them;
3-30 (B) a substance intended for use in the
3-31 diagnosis, cure, mitigation, treatment, or prevention of disease in
3-32 man or other animals;
3-33 (C) a substance, other than food, intended to
3-34 affect the structure or any function of the body of man or other
3-35 animals;
3-36 (D) a substance intended for use as a component
3-37 of any articles specified in Paragraph (A), (B), or (C) of this
3-38 subdivision;
3-39 (E) a dangerous drug; or
3-40 (F) a controlled substance.
3-41 (25) [(24)] "Drug regimen review" includes the
3-42 following activities:
3-43 (A) evaluation of prescription drug or
3-44 medication orders and patient medication records for:
3-45 (i) known allergies;
3-46 (ii) rational therapy-contraindications;
3-47 (iii) reasonable dose and route of
3-48 administration; and
3-49 (iv) reasonable directions for use;
3-50 (B) evaluation of prescription drug or
3-51 medication orders and patient medication records for duplication of
3-52 therapy;
3-53 (C) evaluation of prescription drug or
3-54 medication orders and patient medication records for:
3-55 (i) drug-drug interactions;
3-56 (ii) drug-food interactions;
3-57 (iii) drug-disease interactions;
3-58 (iv) adverse drug reactions; and
3-59 (D) evaluation of prescription drug and
3-60 medication orders and patient medication records for proper
3-61 utilization, including overutilization or underutilization.
3-62 (26) [(25)] "Internship" means a practical experience
3-63 program that is approved by the board.
3-64 (27) [(26)] "Label" means written, printed, or graphic
3-65 matter on the immediate container of a drug or device.
3-66 (28) [(27)] "Labeling" means the process of affixing a
3-67 label including all information required by federal and state law
3-68 or regulation to any drug or device container. The term does not
3-69 include the labeling by a manufacturer, packer, or distributor of a
4-1 nonprescription drug or commercially packaged prescription drug or
4-2 device, or unit dose packaging.
4-3 (29) [(28)] "Manufacturing" means the production,
4-4 preparation, propagation, conversion, or processing of a drug or
4-5 device, either directly or indirectly, by extraction from
4-6 substances of natural origin or independently by means of chemical
4-7 or biological synthesis and includes any packaging or repackaging
4-8 of the substances or labeling or relabeling of the container and
4-9 the promotion and marketing of such drugs or devices.
4-10 Manufacturing also includes the preparation and promotion of
4-11 commercially available products from bulk compounds for resale by
4-12 pharmacies, practitioners, or other persons but does not include
4-13 compounding.
4-14 (30) [(29)] "Medication order" means an order from a
4-15 practitioner or a practitioner's designated agent for
4-16 administration of a drug or device.
4-17 (31) [(30)] "Nonprescription drug" means a nonnarcotic
4-18 drug or device that may be sold without a prescription and that is
4-19 labeled and packaged in compliance with applicable state or federal
4-20 law.
4-21 (32) [(31)] "Patient counseling" means the
4-22 communication by the pharmacist of information, as specified in the
4-23 rules of the board, to the patient or caregiver, in order to
4-24 improve therapy by ensuring proper use of drugs and devices.
4-25 (33) [(32)] "Person" means an individual, corporation,
4-26 government or governmental subdivision or agency, business trust,
4-27 estate, trust, partnership, association, or any other legal entity.
4-28 (34) [(33)] "Pharmaceutical care" is the provision of
4-29 drug therapy and other pharmaceutical services defined in the rules
4-30 of the board and intended to assist in the cure or prevention of a
4-31 disease, elimination or reduction of a patient's symptoms, or
4-32 arresting or slowing of a disease process.
4-33 (35) [(34)] "Pharmacist" means a person licensed by
4-34 the board to practice pharmacy.
4-35 (36) [(35)] "Pharmacist-in-charge" means the
4-36 pharmacist designated on a pharmacy license as the pharmacist who
4-37 has the authority or responsibility for a pharmacy's compliance
4-38 with laws and rules pertaining to the practice of pharmacy.
4-39 (37) [(36)] "Pharmacist-intern" means an undergraduate
4-40 student enrolled in the professional sequence of a college of
4-41 pharmacy approved by the board and participating in a school-based,
4-42 board-approved internship program or a graduate of a college of
4-43 pharmacy who is participating in a board-approved internship.
4-44 (38) [(37)] "Pharmacy" means a facility licensed by
4-45 the board pursuant to Section 29 of this Act.
4-46 (39) [(38)] "Practice of pharmacy" means:
4-47 (A) provision of those acts or services
4-48 necessary to provide pharmaceutical care;
4-49 (B) interpretation and evaluation of
4-50 prescription drug orders or medication orders;
4-51 (C) participation in drug and device selection
4-52 as authorized by law, drug administration, drug regimen review, or
4-53 drug or drug-related research;
4-54 (D) provision of patient counseling;
4-55 (E) responsibility for:
4-56 (i) dispensing of prescription drug orders
4-57 or distribution of medication orders;
4-58 (ii) compounding and labeling of drugs and
4-59 devices, except labeling by a manufacturer, repackager, or
4-60 distributor of nonprescription drugs and commercially packaged
4-61 prescription drugs and devices;
4-62 (iii) proper and safe storage of drugs and
4-63 devices; or
4-64 (iv) maintenance of proper records for
4-65 drugs and devices; and
4-66 (F) performance of a specific act of drug
4-67 therapy management for a patient delegated to a pharmacist by a
4-68 written protocol from a physician licensed in this state in
4-69 compliance with the Medical Practice Act (Article 4495b, Vernon's
5-1 Texas Civil Statutes).
5-2 (40) [(39)] "Practitioner" means:
5-3 (A) a physician, dentist, podiatrist,
5-4 veterinarian, or other person licensed or registered to prescribe,
5-5 distribute, administer, or dispense a prescription drug or device
5-6 in the course of professional practice in this state;
5-7 (B) a person licensed by another state in a
5-8 health field in which, under Texas law, licensees in this state may
5-9 legally prescribe dangerous drugs or a person practicing in another
5-10 state and licensed by another state as a physician, dentist,
5-11 veterinarian, or podiatrist, having a current Federal Drug
5-12 Enforcement Administration registration number, and who may legally
5-13 prescribe Schedule II, III, IV, or V controlled substances in such
5-14 other state; or
5-15 (C) a person licensed in the Dominion of Canada
5-16 or the United Mexican States in a health field in which, under the
5-17 laws of this state, a licensee may legally prescribe dangerous
5-18 drugs. "Practitioner" does not include a person licensed under
5-19 this Act.
5-20 (41) [(40)] "Preceptor" means a pharmacist in good
5-21 standing licensed in this state to practice pharmacy and certified
5-22 by the board to supervise and be responsible for the activities and
5-23 functions of a pharmacist-intern in the internship program.
5-24 (42) [(41)] "Prescription drug" means:
5-25 (A) a substance for which federal or state law
5-26 requires a prescription before it may be legally dispensed to the
5-27 public;
5-28 (B) a drug or device that under federal law is
5-29 required, prior to being dispensed or delivered, to be labeled with
5-30 either of the following statements:
5-31 (i) "Caution: federal law prohibits
5-32 dispensing without prescription"; or
5-33 (ii) "Caution: federal law restricts this
5-34 drug to use by or on the order of a licensed veterinarian"; or
5-35 (C) a drug or device that is required by any
5-36 applicable federal or state law or regulation to be dispensed on
5-37 prescription only or is restricted to use by a practitioner only.
5-38 (43) [(42)] "Prescription drug order" means:
5-39 (A) an order from a practitioner or a
5-40 practitioner's designated agent to a pharmacist for a drug or
5-41 device to be dispensed; or
5-42 (B) an order pursuant to Subdivision (5) or (6),
5-43 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
5-44 Vernon's Texas Civil Statutes).
5-45 (44) [(43)] "Prospective drug use review" means a
5-46 review of the patient's drug therapy and prescription drug order or
5-47 medication order, as defined in the rules of the board, prior to
5-48 dispensing or distributing the drug.
5-49 (45) [(44)] "Provide" means to supply one or more unit
5-50 doses of a nonprescription drug or dangerous drug to a patient.
5-51 (46) [(45)] "Radioactive drug" means a drug that
5-52 exhibits spontaneous disintegration of unstable nuclei with the
5-53 emission of nuclear particles or photons, including any
5-54 nonradioactive reagent kit or nuclide generator that is intended to
5-55 be used in the preparation of any such substance.
5-56 (47) [(46)] "Substitution" means the dispensing of a
5-57 drug or a brand of drug other than that which is ordered or
5-58 prescribed.
5-59 (48) [(47)] "Supportive personnel" means those
5-60 individuals utilized in pharmacies whose responsibility it shall be
5-61 to provide technical services that do not require professional
5-62 judgment concerned with the preparation and distribution of drugs
5-63 under the direct supervision of and responsible to a pharmacist.
5-64 (49) [(48)] "Ultimate user" means a person who has
5-65 obtained and possesses a prescription drug or device for the
5-66 person's own use or for the use of a member of the person's
5-67 household or for administering to an animal owned by the person or
5-68 by a member of the person's household.
5-69 (50) [(49)] "Unit dose packaging" means the ordered
6-1 amount of drug in a dosage form ready for administration to a
6-2 particular patient, by the prescribed route at the prescribed time,
6-3 and properly labeled with name, strength, and expiration date of
6-4 the drug.
6-5 (51) [(50)] "Written protocol" means a physician's
6-6 order, standing medical order, standing delegation order, or other
6-7 order or protocol as defined by rule of the Texas State Board of
6-8 Medical Examiners under the Medical Practice Act (Article 4495b,
6-9 Vernon's Texas Civil Statutes).
6-10 SECTION 3. Subsections (b) and (c), Section 29, Texas
6-11 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes) are
6-12 amended to read as follows:
6-13 (b) Each pharmacy shall apply for a license in one or more
6-14 of the following classifications:
6-15 (1) Class A;
6-16 (2) Class B;
6-17 (3) Class C;
6-18 (4) Class D; [or]
6-19 (5) Class E;
6-20 (6) Class L; or
6-21 (7) Class S.
6-22 (c) Each pharmacy shall be under the supervision of a
6-23 pharmacist as follows:
6-24 (1) a Class A pharmacy shall be under the continuous
6-25 on-site supervision of a pharmacist during the time it is open for
6-26 pharmacy services;
6-27 (2) a Class B pharmacy shall be under the continuous
6-28 on-site supervision of a pharmacist during the time it is open for
6-29 pharmacy services;
6-30 (3) a Class C pharmacy shall be under the continuous
6-31 on-site supervision of a pharmacist in institutions with more than
6-32 100 beds during the time it is open for pharmacy services; in
6-33 institutions with 100 beds or fewer, the services of a pharmacist
6-34 shall be required on a part-time or consulting basis according to
6-35 the needs of the institution;
6-36 (4) a Class D pharmacy shall be under the continuous
6-37 supervision of a pharmacist whose services shall be required
6-38 according to the needs of the pharmacy; [and]
6-39 (5) a Class E pharmacy shall be under the continuous
6-40 on-site supervision of a pharmacist and shall designate one
6-41 pharmacist licensed to practice pharmacy by the regulatory or
6-42 licensing agency of the state in which the Class E pharmacy is
6-43 located to serve as the pharmacist-in-charge of the Class E
6-44 pharmacy license;
6-45 (6) a Class L pharmacy shall be under the continuous
6-46 on-site supervision of a pharmacist during the time it is open for
6-47 pharmacy services; and
6-48 (7) a Class S pharmacy shall be under the continuous
6-49 supervision of a pharmacist whose services shall be required
6-50 according to the needs of the pharmacy.
6-51 SECTION 4. This Act takes effect September 1, 1997.
6-52 SECTION 5. The importance of this legislation and the
6-53 crowded condition of the calendars in both houses create an
6-54 emergency and an imperative public necessity that the
6-55 constitutional rule requiring bills to be read on three several
6-56 days in each house be suspended, and this rule is hereby suspended.
6-57 * * * * *