Chapter
053
2007 -- H 5678 SUBSTITUTE A
Enacted 06/20/07
A N A C T
RELATING
TO BUSINESS AND PROFESSIONS - PHARMACIES
Introduced
By: Representatives Serpa, Mattiello, Williamson, Slater, and Church
Date
Introduced: February 28, 2007
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) "Board" means the Rhode Island board of
pharmacy.
(b) "Change
of ownership" means:
(1) In the case
of a pharmacy, manufacturer, or wholesaler which is a partnership any
change which results in a new partner acquiring
a controlling interest in the partnership;
(2) In the case
of a pharmacy, manufacturer or wholesaler which is a sole proprietorship,
the transfer of the title and property to
another person;
(3) In the case
of a pharmacy, manufacturer, or wholesaler which 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 which is a business
corporation, any transfer of corporate stock
which results in a new person acquiring a controlling
interest in the corporation; or
(v) In the case
of a pharmacy, manufacturer, or wholesaler which is a nonbusiness
corporation, any change in membership which
results in a new person acquiring a controlling
vote in the corporation.
(c)
"Compounding" shall be 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)
"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)
"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)
"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)
"Director" means the director of the Rhode Island state department of
health.
(h)
"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)
"Distribute" means the delivery of a drug or device other than by
administering or
dispensing.
(j)
"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 or other animals;
(3) Substances
(other than food) intended to affect the structure or any function of the
body of man or other animals; or
(4) Substances
intended for use as a component of any substances specified in
subdivisions (1), (2), or (3) of this subsection
and section 5-19-1(16), but not including devices or
their component parts or accessories.
(k)
"Equivalent and interchangeable" means 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.
(l)
"Intern" means a graduate of an American Council on Pharmaceutical
Education
(ACPE) accredited program of pharmacy, or a
student who is enrolled in at least the first year of a
professional ACPE accredited program of
pharmacy, or 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) "Legend
drugs" means any drugs which 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.
(n)
"Manufacture" means the production, preparation, propagation,
compounding, or
processing of a drug or other substance or
device or the packaging or repackaging.
(o)
"Nonlegend" or "nonprescription drugs" means any drugs
which may be lawfully
sold without a prescription.
(p)
"Person" means an individual, corporation, government, subdivision or
agency,
business trust, estate, trust, partnership or
association, or any other legal entity.
(q)
"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.
(r)
"Pharmacist-in-charge" means a pharmacist licensed in this state is
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.
(s)
"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.
(t)
"Pharmacy technician" means an individual who meets minimum
qualifications
established by the board, which are less than
those established by this chapter as necessary for
licensing as a pharmacist; and works under the
direction and supervision of a licensed pharmacist.
(u)
"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; 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. Nothing in this
definition shall be construed to limit or otherwise affect
the scope of practice of any other profession.
(v)
"Practitioner" means a physician, dentist, veterinarian, nurse or
other person duly
authorized by law in the state in which they
practice to prescribe drugs.
(w)
"Preceptor" means a pharmacist registered to engage in the practice
of pharmacy in
this state, who has the responsibility for
training interns.
(x)
"Prescription" means an order for drugs or devices issued by the
practitioner duly
authorized by law in the state in which he
practices to prescribe drugs or devices in the course of
his or her professional practice for a
legitimate medical purpose.
(y)
"Wholesaler" shall mean 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 on October 1, 2007.
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LC02029/SUB A/3
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