Chapter 091
2011 -- S 0480 SUBSTITUTE A AS
AMENDED
Enacted 06/21/11
A N A C T
RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES
Introduced By: Senator William A. Walaska
Date Introduced: March 10, 2011
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
(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 non-business
corporation, any change in membership, which results in a new
person acquiring a controlling
vote in the corporation.
(c)
"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) "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
(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
(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 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
department of health.
(l) "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) "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)
"Non-legend" 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 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.
(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, 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 section 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
age 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. 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 or she practices to
prescribe drugs or devices in the
course of his or her professional practice for a legitimate
medical purpose.
(y)
"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:
5-19.1-31.
Administration of influenza immunizations to individuals between the
ages of nine (9) years and eighteen years (18), inclusive.
-- (a) Parental consent shall
be
required for all pharmacist-administered immunizations for
individuals under the age of eighteen
(18) years.
(b) The department of
health shall require a pharmacist who is authorized to administer
influenza immunizations to individuals between the ages of nine
(9) and eighteen (18) years,
inclusive, pursuant to section 5-19.1-2, to electronically
report to the department all
immunizations administered within seven (7) days of administration
in the format and for the
populations required by the department.
(c)(1) The department
of health shall require a pharmacist who is authorized to
administer influenza immunizations to individuals between the
ages of nine (9) years and
eighteen (18) years, inclusive, to provide notification of a
patient's immunization to the patient's
primary care provider, if known, within fourteen (14) days of
administration.
(2) The department of
health's rules and regulations shall include provisions to ensure
that the administering pharmacist makes a good faith
effort to obtain information relating to the
identity of a patient's primary care provider or primary care
practice, for the purposes of fulfilling
the reporting requirements of subdivision (c)(1) herein.
If a patient does not have an existing
relationship with a primary care provider or primary care
practice, the administering pharmacist
shall proceed with the reporting requirements contained in
subsection (b) herein.
SECTION 3. This act shall take effect upon passage.
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LC01856/SUB A
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