2020 -- S 2127

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LC003684

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2020

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A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES

     

     Introduced By: Senators Lawson, Murray, Valverde, Miller, and Euer

     Date Introduced: January 22, 2020

     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.

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     (a) "Biological product" means a "biological product" as defined in the "Public Health

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Service Act", 42 U.S.C. § 262.

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

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     (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 corporation,

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any transfer of corporate stock that results in a new person acquiring a controlling interest in the

 

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

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

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

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

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

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administration.

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

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dispensing.

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     (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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     (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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     (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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     (o) "Legend drugs" means any drugs that are required by any applicable federal or state

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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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     (p) "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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     (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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     (r) "Non-legend" or "non-prescription drugs" means any drugs that may be lawfully sold

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without a prescription.

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     (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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     (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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     (u) "Pharmacist in charge" means a pharmacist licensed in this state as designated by the

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

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

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of such pharmacy and personnel.

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

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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; the authority to prescribe drugs and devices in accordance with regulations adopted by the

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board of pharmacy under § 5-19.1-34. Nothing in this definition shall be construed to limit or

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otherwise affect the scope of practice of any other profession.

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

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this state who has the responsibility for training interns.

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     (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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     (bb) "Wholesaler" means a person who buys drugs or devices for resale and distribution

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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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     5-19.1-36. Pharmacist prescriptive authority.

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     (a) The department of health shall adopt regulations governing a pharmacist’s authority to

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prescribe drugs and devices. The regulations for a pharmacist prescribing shall include the

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conditions for which a pharmacist may prescribe an indicated drug or device.

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     (b) Pharmacist prescriptive authority shall be limited to conditions for which one of the

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following applies:

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     (1) The condition does not require a new diagnosis;

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     (2) The condition is minor and generally self-limiting;

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     (3) Diagnosis of the condition or other clinical decision-making can be guided by a test

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that has received a waiver under the Clinical Laboratory Improvement Amendments of 1988, 42

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U.S.C. § 263(a); or

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     (4) In the professional judgment of the pharmacist, immediate dispensing of a drug or

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device is necessary to avoid significant harm to the patient’s health and safety.

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     (c) When prescribing a drug to treat a condition described in subsection (b)(4) of this

 

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section, a pharmacist may prescribe the drug only in an amount necessary to address the condition

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until the patient can be seen by another health care professional.

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     SECTION 3. 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 amend the definition of the practice of pharmacy to include the authority

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to prescribe drugs and devices. The act would also provide the conditions for which a pharmacist

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may prescribe an indicated drug or device.

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     This act would take effect upon passage.

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