2013 -- S 0616

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LC01583

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STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2013

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A N A C T

RELATING TO BUSINESSES AND PROFESSIONS - PHARMACIES

     Introduced By: Senators Doyle, Nesselbush, and P Fogarty

     Date Introduced: March 06, 2013

     Referred To: Senate Health & Human Services

It is enacted by the General Assembly as follows:

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     SECTION 1. Section 5-19.1-2 of the General Laws in Chapter 5-19.1 entitled

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"Pharmacies" is hereby amended to read as follows:

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     5-19.1-2. Definitions. -- (a) "Board" means the Rhode Island board of pharmacy.

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      (b) "Change of ownership" means:

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      (1) In the case of a pharmacy, manufacturer, or wholesaler, which is a partnership, any

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change which results in a new partner acquiring a controlling interest in the partnership;

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      (2) In the case of a pharmacy, manufacturer or wholesaler which is a sole proprietorship,

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the transfer of the title and property to another person;

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      (3) In the case of a pharmacy, manufacturer, or wholesaler which is a corporation:

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      (i) A sale, lease exchange, or other disposition of all or substantially all of the property

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and assets of the corporation; or

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      (ii) A merger of the corporation into another corporation; or

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      (iii) The consolidation of two (2) or more corporations, resulting in the creation of a new

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corporation; or

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      (iv) In the case of a pharmacy, manufacturer, or wholesaler which is a business

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corporation, any transfer of corporate stock which results in a new person acquiring a controlling

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interest in the corporation; or

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      (v) In the case of a pharmacy, manufacturer, or wholesaler which is a non-business

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corporation, any change in membership, which results in a new person acquiring a controlling

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vote in the corporation.

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      (c) "Compounding" means the act of combining two (2) or more ingredients as a result

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of a practitioner's prescription or medication order occurring in the course of professional practice

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based upon the individual needs of a patient and a relationship between the practitioner, patient,

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and pharmacist. Compounding does not mean the routine preparation, mixing or assembling of

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drug products that are essentially copies of a commercially available product. Compounding shall

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only occur in the pharmacy where the drug or device is dispensed to the patient or caregiver and

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includes the preparation of drugs or devices in anticipation of prescription orders based upon

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routine, regularly observed prescribing patterns.

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      (d) "Controlled substance" means a drug or substance, or an immediate precursor of such

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drug or substance, so designated under or pursuant to the provisions of chapter 28 of title 21.

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      (e) "Deliver" or "delivery" means the actual, constructive, or attempted transfer from one

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person to another of a drug or device, whether or not there is an agency relationship.

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      (f) "Device" means instruments, apparatus, and contrivances, including their

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components, parts, and accessories, intended:

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      (1) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man

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or other animals; or

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      (2) To affect the structure or any function of the body of man or other animals.

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      (g) "Director" means the director of the Rhode Island state department of health.

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      (h) "Dispense" means the interpretation of a prescription or order for a drug, biological,

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or device and, pursuant to that prescription or order, the proper selection, measuring,

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compounding, labeling, or packaging necessary to prepare that prescription or order for delivery

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or administration.

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      (i) "Distribute" means the delivery of a drug or device other than by administering or

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dispensing.

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      (j) "Drug" means:

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      (1) Articles recognized in the official United States Pharmacopoeia or the Official

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Homeopathic Pharmacopoeia of the U.S.;

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      (2) Substances intended for use in the diagnosis, cure, mitigation, treatment, or

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prevention of disease in man, woman or other animals;

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      (3) Substances (other than food) intended to affect the structure or any function of the

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body of man, woman or other animals; or

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      (4) Substances intended for use as a component of any substances specified in

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subdivision (1), (2), or (3) of this subsection and section 5-19-1(16), but not including devices or

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their component parts or accessories.

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      (k) "Equivalent and interchangeable" means having the same generic name, dosage form,

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and labeled potency, meeting standards of the United States Pharmacopoeia or National

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Formulary, or their successors, if applicable, and not found in violation of the requirements of the

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United States Food and Drug Administration, or its successor agency, or the Rhode Island

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department of health.

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      (l) "Intern" means:

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      (1) A graduate of an American Council on Pharmaceutical Education (ACPE) accredited

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program of pharmacy;

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      (2) A student who is enrolled in at least the first year of a professional ACPE accredited

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program of pharmacy; or

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      (3) A graduate of a foreign college of pharmacy who has obtained full certification from

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the FPGEC (Foreign Pharmacy Graduate Equivalency Commission) administered by the National

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Association of Boards of Pharmacy.

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      (m) "Limited function test" means those tests listed in the federal register under the

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clinical laboratory improvement amendments of 1988 (CLIA) as waived tests.

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     (m)(n) "Legend drugs" means any drugs, which are required by any applicable federal or

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state law or regulation to be dispensed on prescription only or are restricted to use by practitioners

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only.

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      (n)(o) "Manufacture" means the production, preparation, propagation, compounding, or

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processing of a drug or other substance or device or the packaging or repackaging.

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      (o)(p) "Non-legend" or "nonprescription drugs" means any drugs, which may be lawfully

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sold without a prescription.

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      (p)(q) "Person" means an individual, corporation, government, subdivision or agency,

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business trust, estate, trust, partnership or association, or any other legal entity.

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      (q)(r) "Pharmaceutical care" is the provision of drugs and other pharmaceutical services

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intended to achieve outcomes related to cure or prevention of a disease, elimination or reduction

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of a patient's symptoms, or arresting or slowing of a disease process. "Pharmaceutical care"

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includes the judgment of a pharmacist in dispensing an equivalent and interchangeable drug or

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device in response to a prescription, after appropriate communication with the prescriber and the

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patient.

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      (r)(s) "Pharmacist-in-charge" means a pharmacist licensed in this state as designated by

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the owner as the person responsible for the operation of a pharmacy in conformance with all laws

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and regulations pertinent to the practice of pharmacy and who is personally in full and actual

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charge of such pharmacy and personnel.

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      (s)(t) "Pharmacy" means that portion or part of a premise where prescriptions are

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compounded and dispensed, including that portion utilized for the storage of prescription or

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legend drugs.

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      (t)(u) "Pharmacy technician" means an individual who meets minimum qualifications

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established by the board, which are less than those established by this chapter as necessary for

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licensing as a pharmacist, and works under the direction and supervision of a licensed pharmacist.

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      (u)(v) "Practice of pharmacy" means the interpretation, evaluation, and implementation

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of medical orders; the dispensing of prescription drug orders; participation in drug and device

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selection; the compounding of prescription drugs; drug regimen reviews and drug or drug related

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research; the administration of adult immunizations pursuant to a valid prescription or physician

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approved protocol and in accordance with regulations, to include training requirements as

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promulgated by the department of health; the administration of all forms of influenza

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immunizations to individuals between the ages of nine (9) years and eighteen (18) years,

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inclusive, pursuant to a valid prescription or prescriber approved protocol, in accordance with the

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provisions of section 5-19.1-31 and in accordance with regulations, to include necessary training

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requirements specific to the administration of influenza immunizations to individuals between the

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ages of nine (9) years and eighteen (18) years, inclusive, as promulgated by the department of

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health; provision of patient counseling and the provision of those acts or services necessary to

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provide pharmaceutical care; and/or the responsibility for the supervision for compounding and

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labeling of drugs and devices (except labeling by a manufacturer, repackager, or distributor of

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non-prescription drugs and commercially packaged legend drugs and devices), proper and safe

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storage of drugs and devices, and maintenance of proper records for them and the performance of

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clinical laboratory tests, provided such testing is limited to limited function tests as defined

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herein. Nothing in this definition shall be construed to limit or otherwise affect the scope of

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practice of any other profession.

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      (v)(w) "Practitioner" means a physician, dentist, veterinarian, nurse or other person duly

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authorized by law in the state in which they practice to prescribe drugs.

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      (w)(x) "Preceptor" means a pharmacist registered to engage in the practice of pharmacy

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in this state, who has the responsibility for training interns.

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      (x)(y) "Prescription" means an order for drugs or devices issued by the practitioner duly

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authorized by law in the state in which he or she practices to prescribe drugs or devices in the

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course of his or her professional practice for a legitimate medical purpose.

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      (y)(z) "Wholesaler" means a person who buys drugs or devices for resale and

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distribution to corporations, individuals, or entities other than consumers.

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     SECTION 2. Section 5-19.2-2 of the General Laws in Chapter 5-19.2 entitled

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"Collaborative Pharmacy Practice" is hereby amended to read as follows:

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     5-19.2-2. Definitions. -- (a) "Collaborative practice agreement" is a written and signed

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agreement, entered into voluntarily, between a pharmacist with advanced training and experience

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relevant to the scope of collaborative practice and one or more physicians that defines the

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collaborative pharmacy practice in which the pharmacist and physician(s) propose to engage.

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Collaborative practice agreements shall be made in the best interest of public health.

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      (b) "Collaborative practice committee" shall consist of six (6) individuals: three (3)

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individuals to be appointed by the board of pharmacy from nominees provided by the Rhode

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Island Pharmacists Association; three (3) individuals to be appointed by the board of medical

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licensure and discipline from nominees provided by the Rhode Island Medical Society. The

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collaborative practice committee shall advise the director on all issues pertinent to the regulation

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of collaborative practice agreements.

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      (c) "Collaborative pharmacy practice" is that practice of pharmacy whereby a pharmacist

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with advanced training and experience relevant to the scope of collaborative practice agrees to

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work in collaboration with one or more physicians for the purpose of drug therapy management

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of patients, such management to be pursuant to a protocol or protocols authorized by the

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physician(s) and subject to conditions and/or limitations as set forth by the department. A health

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care professional who has prescribing privileges and is employed by a collaborating physician

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may be in such an agreement.

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      (d) "Drug therapy management" means the review, in accordance with a collaborative

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practice agreement, of drug therapy regimen or regimens of patients by a pharmacist for the

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purpose of rendering advice to one or more physicians that are party to the agreement, or their

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physician designees, regarding adjustment of the regimen. Decisions involving drug therapy

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management shall be made in the best interests of the patient. In accordance with a collaborative

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practice agreement, drug therapy management may include:

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      (1) Modifying and managing drug therapy;

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      (2) Collecting and reviewing patient histories;

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      (3) Obtaining and checking vital signs, including pulse, temperature, blood pressure, and

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respiration; and

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      (4) Under the supervision of, or in direct consultation with a physician, ordering and

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evaluating the results of laboratory tests directly related to drug therapy when performed in

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accordance with approved protocols applicable to the practice setting and providing such

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evaluation does not include any diagnostic component.

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     (e) "Limited function test" means those tests listed in the federal register under the

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clinical laboratory improvement amendments of 1988 (CLIA) as waived tests.

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     (e)(f) "Pharmacist with advanced training and experience relevant to the scope of

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collaborative practice" means a licensed pharmacist in this state with post-graduate educational

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training. Such training shall include, but not limited to, residency training, board certification,

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certification from an accredited professional organization educational institution, or any other

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continuing education provider approved by the director of health, relevant to the proposed scope

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of the collaborative practice agreement.

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      (f)(g) "Practice of pharmacy" means the interpretation, evaluation, and implementation

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of medical orders; including the performance of clinical laboratory tests provided such testing is

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limited to limited function tests as described herein conducted in conformity with the federal

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Clinical Laboratories Improvement Act, as amended, 42 U.S.C. section 263a; the dispensing of

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prescription drug orders; participation in drug and device selection; drug regiment reviews and

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drug or drug related research; provision of patient counseling and the provision of those acts or

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services necessary to provide pharmaceutical care; drug therapy management pursuant to a

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collaborative practice agreement; and the responsibility for the supervision for compounding and

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labeling of drugs and devices (except labeling by a manufacturer, repackager, or distributor of

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nonprescription drugs and commercially packaged legend drugs and devices), proper and safe

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storage of drugs and devices, and maintenance of proper records for them.

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     SECTION 3. Section 23-16.2-3 of the General Laws in Chapter 23-16.2 entitled

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"Laboratories" is hereby amended to read as follows:

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     23-16.2-3. Application of law -- Exceptions. -- The provisions of this chapter shall

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apply to all laboratories and stations performing analytical or clinical laboratory services or

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specimens in this state except:

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      (1) A laboratory maintained by a hospital licensed under chapter 17 of this title, or by a

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licensed physician or group of licensed physicians who make the tests referred to in section 23-

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16.2-2 personally and solely in connection with the treatment of their own patients; however, an

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independent laboratory which makes the tests on its own responsibility for a single physician or

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group of physicians is subject to this chapter.

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      (2) Any temporary or ad hoc health promotion or screening program conducted for the

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general public which offers generally accepted mass screening procedures; provided the health

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promotion or screening program is conducted pursuant to a permit issued by the department of

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health.

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      (3) Any person performing only limited function tests as defined in regulation by the

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director.

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     (4) Licensed pharmacists performing limited function tests as defined in subsection 5-

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19.1-2(m).

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     SECTION 4. Section 23-16.3-4 of the General Laws in Chapter 23-16.3 entitled "Clinical

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Laboratory Science Practice" is hereby amended to read as follows:

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     23-16.3-4. Exceptions. -- This chapter shall not apply to:

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      (1) Any person performing clinical laboratory tests within the scope of his or her practice

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and for which he or she is licensed pursuant to any other provisions of the general laws.

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      (2) Clinical laboratory science practitioners employed by the United States government

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or any bureau, division, or agency of the United States government while in the discharge of the

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employee's official duties.

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      (3) Clinical laboratory science practitioners engaged in teaching or research, provided

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that the results of any examination performed are not used in health maintenance, diagnosis, or

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treatment of disease.

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      (4) Students or trainees enrolled in a clinical laboratory science education program

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provided that these activities constitute a part of a planned course in the program, that the persons

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are designated by title such as intern, trainee, or student, and the persons work directly under the

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supervision of an individual licensed by this state to practice laboratory science.

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      (5) Individuals performing limited function tests.

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      (6) Licensed pharmacists performing limited function tests as defined in subsection 5-

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19.1-2 (m).

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     SECTION 5. This act shall take effect upon passage.

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LC01583

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N A C T

RELATING TO BUSINESSES AND PROFESSIONS - PHARMACIES

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     This act would permit pharmacists to perform limited function clinical laboratory tests.

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     This act would take effect upon passage.

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LC01583

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