2020 -- H 7527

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LC004602

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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: Representatives McEntee, Craven, O'Brien, Speakman, and Caldwell

     Date Introduced: February 12, 2020

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

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

is hereby amended to read as follows:

     5-19.1-2. Definitions.

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

Service Act", 42 U.S.C. § 262.

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

     (c) "Change of ownership" means:

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

that results in a new partner acquiring a controlling interest in the partnership;

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

transfer of the title and property to another person;

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

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

and assets of the corporation; or

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

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

corporation; or

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

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

corporation; or

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

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

the corporation.

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

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

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

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

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

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

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

routine, regularly observed prescribing patterns.

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

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

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

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

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

parts, and accessories, intended:

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

other animals; or

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

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

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

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

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

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

dispensing.

     (k) "Drug" means:

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

Homeopathic Pharmacopoeia of the U.S.;

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

of disease in man, woman, or other animals;

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

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 subdivision

(1), (2), or (3) of this subsection, but not including devices or their component parts or accessories.

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

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

Pharmacopoeia or National Formulary, or their successors, if applicable, and not found in violation

of the requirements of the United States Food and Drug Administration, or its successor agency, or

the Rhode Island department of health.

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

Food and Drug Administration has:

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

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

biosimilarity or interchangeability evaluations; or

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

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

Therapeutic Equivalence Evaluations.

     (n) "Intern" means:

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

program of pharmacy;

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

program of pharmacy; or

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

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

Association of Boards of Pharmacy.

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

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

     (p) "Limited-function test" means those tests listed in the federal register under the Clinical

Laboratory Improvement Amendments of 1988 (CLIA) as waived tests. For the purposes of this

chapter, limited-function test shall include only the following: blood glucose, hemoglobin Alc,

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

the United States Food and Drug Administration for sale to the public without a prescription in the

form of an over-the-counter test kit.

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

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

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

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without a prescription.

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

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

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

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

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

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

response to a prescription after appropriate communication with the prescriber and the patient.

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

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

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

such pharmacy and personnel.

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

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

drugs.

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

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

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

pharmacist.

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

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

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

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

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

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

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

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

of § 5-19.1-31 and in accordance with regulations, to include necessary training requirements

specific to the administration of influenza immunizations to individuals between the ages of nine

(9) years and eighteen (18) years, inclusive, as promulgated by the department of health; provision

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

pharmaceutical care; and/or the responsibility for the supervision for compounding and labeling of

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

drugs and commercially packaged legend drugs and devices), proper and safe storage of drugs and

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devices, and maintenance of proper records for them; and the performance of clinical laboratory

tests, provided such testing is limited to limited-function tests as defined herein; the authority to

prescribe drugs and devices in accordance with regulations adopted by the board of pharmacy under

§ 5-19.1-34. Nothing in this definition shall be construed to limit or otherwise affect the scope of

practice of any other profession.

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

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

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

state who has the responsibility for training interns.

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

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

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

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

corporations, individuals, or entities other than consumers.

     SECTION 2. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby amended

by adding thereto the following section:

     5-19.1-36. Pharmacist prescriptive authority.

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

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

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

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

following applies:

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

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

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

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

U.S.C. § 263(a); or

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

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

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

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

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

     SECTION 3. This act shall take effect upon passage.

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LC004602

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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 to

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

prescribe an indicated drug or device.

     This act would take effect upon passage.

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LC004602

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