2016 -- S 2755 SUBSTITUTE B

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LC005328/SUB B

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2016

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A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS - PHARMACIES

     

     Introduced By: Senators Coyne, Lombardo, Cote, DiPalma, and Lombardi

     Date Introduced: March 10, 2016

     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) "Biological product" means a "biological product" as defined

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in the "Public Health Service Act", 42 U.S.C. §262.

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     (a)(b) "Board" means the Rhode Island board of pharmacy.

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      (b)(c) "Change of ownership" means:

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

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change that 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 that 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 that 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 that is a business

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corporation, any transfer of corporate stock that 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 that is a non-business

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

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in the corporation.

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

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

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

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

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

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Compounding shall only occur in the pharmacy where the drug or device is dispensed to the

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patient or caregiver and includes the preparation of drugs or devices in anticipation of

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prescription orders based upon routine, regularly observed prescribing patterns.

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

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

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

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

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

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

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

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dispensing.

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      (j)(k) "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, but not including devices or their component parts

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or accessories.

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      (k)(l) "Equivalent and interchangeable" means a drug, excluding a biological product,

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having the same generic name, dosage form, and labeled potency, meeting standards of the

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United States Pharmacopoeia or National Formulary, or their successors, if applicable, and not

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found in violation of the requirements of the United States Food and Drug Administration, or its

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successor agency, or the Rhode Island department of health.

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     (m) "Interchangeable biological product" means a biological product that the United

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States Food and Drug Administration has:

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     (1) Licensed and determined meets the standards for interchangeability pursuant to 42

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U.S.C. §262(k)(4) or lists of licensed biological products with reference product exclusivity and

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biosimilarity or interchangeability evaluations; or

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     (2) Determined is therapeutically equivalent as set forth in the latest edition of or

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supplement to the United States Food and Drug Administration's Approved Drug Products with

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Therapeutic Equivalence Evaluations.

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      (l)(n) "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)(o) "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. For the purposes

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of this chapter, limited function test shall include only the following: blood glucose, hemoglobin

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Alc, cholesterol tests, and/or other tests that are classified as waived under CLIA and are

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approved by the United States Food and Drug Administration for sale to the public without a

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prescription in the form of an over-the-counter test kit.

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      (n)(p) "Legend drugs" means any drugs that 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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      (o)(q) "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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      (p)(r) "Non-legend" or "nonprescription drugs" means any drugs that may be lawfully

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sold without a prescription.

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      (q)(s) "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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      (r)(t) "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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      (s)(u) "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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      (t)(v) "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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      (u)(w) "Pharmacy technician" means an individual who meets minimum qualifications

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

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

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pharmacist.

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      (v)(x) "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 § 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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      (w)(y) "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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      (x)(z) "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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      (y)(aa) "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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      (z)(bb) "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. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby

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amended by adding thereto the following section:

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     5-19.1-19.1. Pharmacists - Substitution of biological products. – (a) Pharmacists when

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dispensing a prescription for any biological product shall, unless requested otherwise by the

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individual presenting the prescription in writing, substitute such product with an interchangeable

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biological product in accordance with the provisions of §21-31-16.1(a). No substitution under this

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section shall be allowed if the prescribing physician orders the pharmacist to dispense as brand

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name necessary on the prescription form, or if the prescriber gives oral direction to that effect to

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the dispensing pharmacist. The requirements of this section shall not apply to an order to dispense

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a biological product for immediate administration to a licensed hospital, nursing facility, or

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hospice facility in-patient. The pharmacist will make a biological product selection from

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approved interchangeable prescription biological products in accordance with §21-31-16.1(g).

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When a biological product selection is made, the pharmacist shall inform the patient of the

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selection made and shall indicate the product dispensed on the written prescription or on the oral

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prescription, which has been reduced to writing, or product information may be maintained on a

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computerized system if information is readily retrievable.

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     (b) Within five (5) business days following the dispensing of a biological product, the

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dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the

 

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specific product provided to the patient, including the name of the product and the manufacturer.

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     (c) The communication shall be conveyed by making an entry electronically accessible to

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the prescriber through:

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     (1) An interoperable electronic medical records system;

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     (2) An electronic prescribing technology;

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     (3) A pharmacy benefit management system; or

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     (4) A pharmacy record.

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     (d) Entry into an electronic records system as described in this subsection is presumed to

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provide notice to the prescriber. Otherwise, the pharmacist shall communicate the biological

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product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other

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prevailing means, provided that the communication shall not be required where:

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     (1) There is no interchangeable biological product for the product prescribed approved by

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the United States Food and Drug Administration; or

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     (2) A refill prescription is not changed from the product dispensed on the prior filling of

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the prescription.

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     SECTION 3. Section 21-31-16.1 of the General Laws in Chapter 21-31 entitled "Rhode

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Island Food, Drugs, and Cosmetics Act" is hereby amended to read as follows:

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     21-31-16.1. Substitution of generic drugs. -- Substitution of generic drugs and

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biological products. -- (a) Product selection. Drug product selection. - The director shall permit

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substitution of less expensive generic, chemical, or brand name drugs and pharmaceuticals,

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excluding biological products, considered by the director as therapeutically equivalent and

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interchangeable with specific brand name drugs and pharmaceuticals, if they are found to be in

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compliance with § 21-31-16 and standards set forth by the United States Food and Drug

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Administration under §§ 505 and 507 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§

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355 and 357. The director shall consider, but not be limited to, the determination of the United

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States Food and Drug Administration, or its successor agency, as published under §§ 505 and 507

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of the Federal Food, Drug, and Cosmetic Act. The director shall provide for the distribution of

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copies of lists of prescription drug products that the director deems after evaluation not to be

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therapeutically equivalent, and revisions to the lists, among physicians and pharmacists licensed

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and actively engaged in practice within the state, and other appropriate individuals, and shall

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supply a copy to any person on request. The list shall be revised from time to time so as to

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include new pertinent information on approved prescription drug products, reflecting current

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information as to standards for quality, safety, effectiveness, and therapeutic equivalence.

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      (b) Appropriations. - The director shall provide necessary space, personnel, and material

 

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to carry out the provisions of this section.

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      (c) Liability. - There shall be no civil liability incurred and no cause of action of any

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nature shall arise against the director, designated agents, or employees, as a result of the listing or

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omission of drugs or pharmaceuticals or biological products for product selection.

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      (d) Annual reports. - The director shall make annual reports to the general assembly by

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February 10 of each year showing a list of approved prescription drug products with therapeutic

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equivalence and approved prescription interchangeable biological products, and an estimate of the

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average savings to the general public.

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      (e) Pharmacists. - When a pharmacist dispenses a therapeutically equivalent drug

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product or interchangeable biological product, there shall be no additional liability imposed on

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the prescriber who authorizes that product selection, or on the pharmacist dispensing the product

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selection from a physician's oral or written order.

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      (f) Enforcement provisions. - It is made the duty of the department of health, its agents

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designated by the director of health, and of all peace officers within the state to enforce all

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provisions of this section and of §§ 5-19.1-19, 5-37-18 -- 5-37-18.2, and 21-31-3.

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     (g) Biological product selection. The director shall permit substitution of a less expensive

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biological product, as defined in §5-19.1-2, for a prescribed biological product only if said less

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expensive biological product is an interchangeable biological product as defined in §5-19.1-2.

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The director shall maintain on the Rhode Island state department of health website, a link to the

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current list of each biological product determined by the United States Food and Drug

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Administration to be an interchangeable biological product.

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     SECTION 4. This act shall take effect upon passage.

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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 add biological products and interchangeable biological products to the

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medications pharmacies may dispense, and would regulate the procedures for dispensing and

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substitution.

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     This act would take effect upon passage.

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