§ 5-19.1-2. Definitions.
(a) "Biological product� means a "biological product� as defined in the "Public Health
Service Act,â€� 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 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, 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.