2019 -- S 0826

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LC001651

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2019

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A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES

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

     Date Introduced: April 30, 2019

     Referred To: Senate Health & Human Services

     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

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body, of man, woman, or other animals; or

     (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.

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     (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

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

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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 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:

     5-19.1-34. 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

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

until the patient can be seen by another healthcare professional.

     SECTION 3. This act shall take effect upon passage.

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LC001651

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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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LC001651

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