Chapter 193
2016 -- H 7816 SUBSTITUTE A AS AMENDED
Enacted 06/28/2016

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

Introduced By: Representatives Serpa, Canario, Marshall, Naughton, and Edwards
Date Introduced: March 02, 2016

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.
     (a)(b) "Board" means the Rhode Island board of pharmacy.
      (b)(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.
      (c)(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.
      (d)(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.
      (e)(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.
      (f)(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.
      (g)(h) "Director" means the director of the Rhode Island state department of health.
      (h)(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.
      (i)(j) "Distribute" means the delivery of a drug or device other than by administering or
dispensing.
      (j)(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
      (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.
      (k)(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.
      (l)(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.
      (m)(o) "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.
      (n)(p) "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.
      (o)(q) "Manufacture" means the production, preparation, propagation, compounding, or
processing of a drug or other substance or device or the packaging or repackaging.
      (p)(r) "Non-legend" or "non-prescription drugs" means any drugs that may be lawfully
sold without a prescription.
      (q)(s) "Person" means an individual, corporation, government, subdivision, or agency,
business trust, estate, trust, partnership or association, or any other legal entity.
      (r)(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.
      (s)(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.
      (t)(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.
      (u)(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.
      (v)(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 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.
      (w)(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.
      (x)(z) "Preceptor" means a pharmacist registered to engage in the practice of pharmacy
in this state who has the responsibility for training interns.
      (y)(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.
      (z)(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:
     5-19.1-19.1. Pharmacists - Substitution of biological products. – (a) Pharmacists when
dispensing a prescription for any biological product shall, unless requested otherwise by the
individual presenting the prescription in writing, substitute such product with an interchangeable
biological product in accordance with the provisions of §21-31-16.1(g). No substitution under this
section shall be allowed if the prescribing physician orders the pharmacist to dispense as brand-
name necessary on the prescription form, or if the prescriber gives oral direction to that effect to
the dispensing pharmacist. The requirements of this section shall not apply to an order to dispense
a biological product for immediate administration to a licensed hospital, nursing facility, or
hospice facility in-patient. The pharmacist will make a biological product selection from
approved interchangeable prescription biological products in accordance with §21-31-16.1(g).
When a biological product selection is made, the pharmacist shall inform the patient of the
selection made and shall indicate the product dispensed on the written prescription or on the oral
prescription, which has been reduced to writing, or product information may be maintained on a
computerized system if information is readily retrievable.
     (b) Within five (5) business days following the dispensing of a biological product, the
dispensing pharmacist, or the pharmacist's designee, shall communicate to the prescriber the
specific product provided to the patient, including the name of the product and the manufacturer.
     (c) The communication shall be conveyed by making an entry electronically accessible to
the prescriber through:
     (1) An interoperable, electronic medical-records system;
     (2) An electronic prescribing technology;
     (3) A pharmacy benefit management system; or
     (4) A pharmacy record.
     (d) Entry into an electronic records system as described in this subsection is presumed to
provide notice to the prescriber. Otherwise, the pharmacist shall communicate the biological
product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other
prevailing means; provided that the communication shall not be required where:
     (1) There is no interchangeable biological product for the product prescribed approved by
the United States Food and Drug Administration; or
     (2) A refill prescription is not changed from the product dispensed on the prior filling of
the prescription.
     SECTION 3. Section 21-31-16.1 of the General Laws in Chapter 21-31 entitled "Rhode
Island Food, Drugs, and Cosmetics Act" is hereby amended to read as follows:
     21-31-16.1. Substitution of generic drugs. -- Substitution of generic drugs and
biological products. -- (a) Product selection. Drug product selection. - The director shall permit
substitution of less expensive generic, chemical, or brand-name drugs and pharmaceuticals,
excluding biological products, considered by the director as therapeutically equivalent and
interchangeable with specific, brand-name drugs and pharmaceuticals, if they are found to be in
compliance with § 21-31-16 and standards set forth by the United States Food and Drug
Administration under §§ 505 and 507 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§
355 and 357. The director shall consider, but not be limited to, the determination of the United
States Food and Drug Administration, or its successor agency, as published under §§ 505 and 507
of the Federal Food, Drug, and Cosmetic Act. The director shall provide for the distribution of
copies of lists of prescription drug products that the director deems, after evaluation, not to be
therapeutically equivalent, and revisions to the lists, among physicians and pharmacists licensed
and actively engaged in practice within the state, and other appropriate individuals, and shall
supply a copy to any person on request. The list shall be revised from time to time so as to
include new, pertinent information on approved prescription-drug products, reflecting current
information as to standards for quality, safety, effectiveness, and therapeutic equivalence.
      (b) Appropriations. - The director shall provide necessary space, personnel, and material
to carry out the provisions of this section.
      (c) Liability. - There shall be no civil liability incurred, and no cause of action of any
nature shall arise, against the director, designated agents, or employees, as a result of the listing or
omission of drugs or pharmaceuticals or biological products for product selection.
      (d) Annual reports. - The director shall make annual reports to the general assembly by
February 10 of each year showing a list of approved prescription-drug products with therapeutic
equivalence and approved prescription interchangeable biological products, and an estimate of the
average savings to the general public.
      (e) Pharmacists. - When a pharmacist dispenses a therapeutically equivalent drug
product or interchangeable biological product, there shall be no additional liability imposed on
the prescriber who authorizes that product selection, or on the pharmacist dispensing the product
selection from a physician's oral or written order.
      (f) Enforcement provisions. - It is made the duty of the department of health, its agents
designated by the director of health, and of all peace officers within the state to enforce all
provisions of this section and of §§ 5-19.1-19, 5-37-18 -- 5-37-18.2, and 21-31-3.
     (g) Biological-product selection. The director shall permit substitution of a less-expensive
biological product, as defined in §5-19.1-2, for a prescribed biological product only if said less-
expensive biological product is an interchangeable biological product as defined in §5-19.1-2.
The director shall maintain on the Rhode Island state department of health website, a link to the
current list of each biological product determined by the United States Food and Drug
Administration to be an interchangeable biological product.
     SECTION 4. This act shall take effect upon passage.
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LC004664/SUB A/2
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