2023 -- S 0585

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LC002269

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2023

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A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES

     Introduced By: Senators Miller, DiPalma, Euer, DiMario, Lawson, Valverde, Murray,
and Kallman

     Date Introduced: March 07, 2023

     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 humans

or other animals; or

     (2) To affect the structure or any function of the body of humans 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

product, 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 humans or other animals;

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

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body of humans or other animals; or

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

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

     (l) “HIV” means human immunodeficiency virus.

     (m) “HIV prevention drug” means a drug approved by the United States Food and Drug

Administration for the prevention of HIV, including, but not limited to, pre-exposure prophylaxis.

     (l)(n) “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)(o) “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)(p) “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)(q) “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)(r) “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

A1c, 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

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

     (q)(s) “Manufacture” means the production, preparation, propagation, compounding, or

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

     (r)(t) “Non-legend” or “nonprescription drugs” means any drugs that may be lawfully sold

without a prescription.

     (s)(u) “Person” means an individual, corporation, government, subdivision, or agency,

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

     (t)(v) “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)(w) “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)(x) “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)(y) “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)(z) “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 and, medications approved by the department

of health in consultation with the board of pharmacy for administration by a pharmacist except as

provided by § 5-25-7, 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

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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; the responsibility for the

supervision for compounding and labeling of drugs and devices (except labeling by a manufacturer,

repackager, or distributor of nonprescription 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. Nothing in this definition shall be construed to limit or otherwise affect the

scope of practice of any other profession.

     (y)(aa) “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)(bb) “Preceptor” means a pharmacist registered to engage in the practice of pharmacy

in this state who has the responsibility for training interns.

     (cc) “Pre-exposure prophylaxis” means a drug or drug combination that is taken or

administered to reduce the risk of HIV acquisition and meets the same clinical eligibility

recommendations provided in current guidelines of the federal Centers for Disease Control and

Prevention.

     (aa)(dd) “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)(ee) “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:

     5-19.1-19.2. Pharmacists -- Prescribing, dispensing and administering PrEP.

     (a) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs in

accordance with regulations promulgated by the department of health as set forth in this section.

     (b) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs

according to United States Food and Drug Administration guidance and product labeling if the

patient:

     (1) Is HIV negative, as documented by a negative HIV test result obtained within the

previous seven (7) days from an HIV antigen and antibody test or antibody-only test or from a

rapid, point-of-care fingerstick blood test approved by the United States Food and Drug

Administration; provided, however, that if the patient does not provide evidence of a negative HIV

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test in accordance with this clause, the pharmacist may order an HIV test prior to prescribing,

dispensing or administering the drugs; provided further, that if the test results are not transmitted

directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist’s satisfaction

prior to prescribing, dispensing or administering the drugs; and provided further, that if the patient

tests positive for HIV infection, the pharmacist or person administering the test shall direct the

patient to a primary care provider and provide the patient with a list of providers and clinics in the

region;

     (2) Does not report any signs or symptoms of acute HIV infection on a self-reported

checklist of acute HIV infection signs and symptoms; and

     (3) Does not report taking any contraindicated medication.

     (c) A licensed pharmacist that prescribes, dispenses or administers HIV prevention drugs

shall:

     (1) Provide counseling to the patient on the ongoing use of pre-exposure prophylaxis,

which may include education about side effects, safety during pregnancy and breastfeeding,

adherence to recommended dosing and the importance of timely testing and treatment, as

applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted infections and

pregnancy for individuals of child-bearing capacity;

     (2) Notify the patient that the patient is required to be seen by a primary care provider to

receive subsequent prescriptions for pre-exposure prophylaxis and that a pharmacist shall not

furnish a sixty (60) day supply of pre-exposure prophylaxis to a single patient more than once every

two (2) years:

     (3) Document, to the extent possible, the services provided to the patient by the pharmacist

in the patient’s record in the record system maintained by the pharmacy and maintain records of

pre-exposure prophylaxis furnished to each patient; and

     (4) Notify the patient’s primary care provider that the pharmacist completed the

requirements specified in this subsection; provided, however that, if the patient does not have a

primary care provider or refuses consent to notify the patient’s primary care provider, the

pharmacist shall provide the patient a list of physicians and surgeons, clinics or other health care

service providers to contact regarding ongoing care for pre-exposure prophylaxis.

     (d) The department of health shall promulgate regulations to establish statewide drug

therapy protocols for prescribing, dispensing and administering pre-exposure prophylaxis and other

HIV prevention drugs approved by the United States Food and Drug Administration that are

consistent with federal Centers for Disease Control and Prevention guidelines not later than six (6)

months after the effective date of this act. The regulations shall include, but not be limited to, rules

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stating that a pharmacist shall not furnish a sixty (60) day supply of pre-exposure prophylaxis to a

single patient more than once every two (2) years.

     SECTION 3. This act shall take effect upon passage.

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LC002269

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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 provide for the prescribing, dispensing and the administering human

immunodeficiency virus (HIV) prevention drugs.

     This act would take effect upon passage.

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LC002269

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