Chapter 358
2021 -- H 5707 SUBSTITUTE A
Enacted 07/12/2021

A N   A C T
RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES

Introduced By: Representatives McEntee, Caldwell, Fogarty, Baginski, Carson, and Kazarian

Date Introduced: February 24, 2021

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
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, 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
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) "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 A1c 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 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 "nonprescription 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 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
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) "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. This act shall take effect upon passage.
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LC001460/SUB A/2
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