Chapter
251
2006 -- S 3081 AS AMENDED
Enacted 07/03/06
A N A
C T
RELATING TO FOOD AND
DRUGS -- UNIFORM CONTROLLED SUBSTANCE ACT
Introduced By: Senators
Perry, Goodwin, Sheehan, Roberts, and C Levesque
Date Introduced: May 04, 2006
It is
enacted by the General Assembly as follows:
SECTION
1. Section 21-28-3.18 of the General Laws in Chapter 21-28 entitled
"Uniform
Controlled
Substances Act" is hereby amended to read as follows:
ARTICLE III
REGULATION OF MANUFACTURING, DISTRIBUTING,
PRESCRIBING,
ADMINISTERING, AND DISPENSING CONTROLLED SUBSTANCES
21-28-3.18.
Prescriptions. -- (a) An apothecary in good faith may sell and dispense
controlled
substances in schedule II to any person upon a written prescription by a practitioner
licensed
by law to prescribe or administer those substances, dated and signed by the
person
prescribing
on the day when issued and bearing the full name and address of the patient to
whom,
or of
the owner of the animal for which the substance is dispensed and the full name,
address and
registration
number under the federal law of the person prescribing, if he or she is
required by that
law to
be registered. If the prescription is for an animal, it shall state the species
of the animal for
which
the substance is prescribed.
(b) The apothecary filling the prescription shall sign his or her full name and
shall write
the date
of filling on the face of the prescription.
(c) The prescription shall be retained on file by the proprietor of the
pharmacy in which
it was
filled for a period of two (2) years so as to be readily accessible for
inspection by any
public
officer or employee engaged in the enforcement of this chapter.
(d) (1) Prescriptions for controlled substances in schedule II shall be filed
separately and
shall
not be refilled. The form of record for prescription slips for controlled
substances in
schedule
II shall consist of two (2) parts, an original and a duplicate which are
required to be
presented
to the pharmacy by the ultimate user or his or her representative. Pharmacies
dispensing
controlled substances in schedule II are required to deliver to the director of
health all
duplicate
copies of the prescriptions on or before the fifth day of the month following
the date of
dispensing.
The prescription slip shall be a form provided by the director of health.
(2) The director of health may, after appropriate notice and hearing pursuant
to section
42-35-3,
promulgate rules and regulations for the purpose of adopting a system for
electronic data
transmission
of prescriptions for controlled substances in schedule II and III, and needles
and
syringes.
This system, when operational, shall negate the necessity to utilize the
two-part
prescription
described in subdivision (1) of this subsection.
(e) A prescription for a schedule II narcotic substance to be compounded for
the direct
administration
to a patient by parenteral, intravenous, intramuscular, subcutaneous, or
intraspinal
infusion
may be transmitted by the practitioner or practitioner's agent to the pharmacy
by
facsimile.
The facsimile will serve as the original prescription.
(f) A prescription written for a schedule II substance for a resident of a long
term care
facility
may be transmitted by the practitioner or the practitioner's agent to the
dispensing
pharmacy
by facsimile. The facsimile serves as the original prescription.
(g) A prescription for a schedule II narcotic substance for a patient residing
in a hospice
certified
by Medicare under title XVIII of the Social Security Act, 42 U.S.C. section
1395 et seq.,
or
licensed by the state, may be transmitted by the practitioner or practitioner's
agent to the
dispensing
pharmacy by facsimile. The practitioner or the practitioner's agent will note
on the
prescription
that the patient is a hospice patient. The facsimile serves as the original
written
prescription.
(h) An apothecary, in lieu of a written prescription, may sell and dispense
controlled
substances
in schedules III, IV, and V to any person upon an oral prescription of a
practitioner. In
issuing
an oral prescription the prescriber shall furnish the apothecary with the same
information
as is
required by subsection (a) of this section in the case of a written
prescription for controlled
substances
in schedule II, except for the written signature of the person prescribing, and
the
apothecary
who fills the prescription, shall immediately reduce the oral prescription to
writing
and
shall inscribe the information on the written record of the prescription made.
This record shall
be filed
and preserved by the proprietor of the pharmacy in which it is filled in
accordance with
the
provisions of subsection (c) of this section. In no case may a prescription for
a controlled
substance
listed in schedules III, IV, or V be filled or refilled more than six (6)
months after the
date on
which the prescription was issued and no prescription shall be authorized to be
refilled
more
than five (5) times. Each refilling shall be entered on the face or back of the
prescription
and note
the date and amount of controlled substance dispensed, and the initials or
identity of the
dispensing
apothecary.
(i) In the case of an emergency situation as defined in federal law, an
apothecary may
dispense
a controlled substance listed in schedule II upon receiving an oral
authorization of a
prescribing
practitioner provided that:
(1) The quantity prescribed and dispensed is limited to the amount adequate to
treat the
patient
during the emergency period and dispensing beyond the emergency period must be
pursuant
to a written prescription signed by the prescribing practitioner.
(2) The prescription shall be immediately reduced to writing and shall contain
all the
information
required in subsection (a) of this section.
(3) The prescription must be dispensed in good faith in the normal course of
professional
practice.
(4) Within seven (7) days after authorizing an emergency oral prescription, the
prescribing
practitioner shall cause a written prescription for the emergency quantity
prescribed to
be
delivered to the dispensing apothecary. The prescription shall have written on
its face
"Authorization
for emergency dispensing" and the date of the oral order. The written
prescription
upon
receipt by the apothecary shall be attached to the oral emergency prescription
which had
earlier
been reduced to writing.
(j) (1) The partial filling of a prescription for a controlled substance listed
in schedule II
is
permissible, if the apothecary is unable to supply the full quantity called for
in a written
prescription
or emergency oral prescription and he or she makes a notation of the quantity
supplied
on the face of the written prescription or oral emergency prescription which
has been
reduced
to writing. The remaining portion of the prescription may be filled within
seventy-two
(72)
hours of the first partial filling, however, if the remaining portion is not,
or cannot be filled
within
seventy-two (72) hours, the apothecary shall notify the prescribing
practitioner. No further
quantity
may be supplied beyond seventy-two (72) hours without a new prescription.
(2) (i) A prescription for a schedule II controlled substance written for a
patient in a long
term
care facility (LTCF), or for a patient with a medical diagnosis documenting a
terminal
illness,
may be filled in partial quantities to include individual dosage units. If
there is a question
whether
a patient may be classified as having a terminal illness, the pharmacist must
contact the
practitioner
prior to partially filling the prescription. Both the pharmacist and the
prescribing
practitioner
have a corresponding responsibility to assure that the controlled substance is
for a
terminally
ill patient.
(ii) The pharmacist must record on the prescription whether the patient is
"terminally ill"
or an
"LTCF patient." A prescription that is partially filled, and does not
contain the notation
"terminally
ill" or "LTCF patient", shall be deemed to have been filled in
violation of this chapter.
(iii) For each partial filling, the dispensing pharmacist shall record on the
back of the
prescription
(or on another appropriate record, uniformly maintained, and readily
retrievable),
the:
(A) Date of the partial filling;
(B) Quantity dispensed;
(C) Remaining quantity authorized to be dispensed; and
(D) Identification of the dispensing pharmacist.
(iv) The total quantity of schedule II controlled substances dispensed in all
partial fillings
must not
exceed the total quantity prescribed.
(v) Schedule II prescriptions for patients in a LTCF, or patients with a
medical diagnosis
documenting
a terminal illness, are valid for a period not to exceed sixty (60) days from
the issue
date,
unless sooner terminated by the discontinuance of medication.
(k) Automated data processing systems. - As an alternative to the prescription
record
keeping
provision of subsection (h) of this section, an automated data processing
system may be
employed
for the record keeping system, if the following conditions have been met:
(1) The system shall have the capability of producing sight-readable documents of
all
original
and refilled prescription information. The term "sight-readable"
means that an authorized
agent
shall be able to examine the record and read the information. During the course
of an on-
site
inspection, the record may be read from the CRT, microfiche, microfilm,
printout, or other
method
acceptable to the director. In the case of administrative proceedings, records
must be
provided
in a paper printout form.
(2) The information shall include, but not be limited to, the prescription requirements
and
records of dispensing as indicated in subsection (h) of this section.
(3) The individual pharmacist responsible for completeness and accuracy of the
entries
to the
system must provide documentation of the fact that prescription information
entered into
the
computer is correct. In documenting this information, the pharmacy shall have
the option to
either:
(i) Maintain a bound log book, or separate file, in which each individual
pharmacist
involved
in the dispensing shall sign a statement each day, attesting to the fact that
the
prescription
information entered into the computer that day has been reviewed and is correct
as
shown.
The book or file must be maintained at the pharmacy employing that system for a
period
of at least
two (2) years after the date of last dispensing; or
(ii) Provide a printout of each day's prescription information. That printout
shall be
verified,
dated, and signed by the individual pharmacist verifying that the information
indicated is
correct.
The printout must be maintained at least two (2) years from the date of last
dispensing.
(4) An auxiliary record keeping system shall be established for the
documentation of
refills,
if the automated data processing system is inoperative for any reason. The
auxiliary
system
shall ensure that all refills are authorized by the original prescription, and
that the
maximum
number of refills is not exceeded. When this automated data processing system
is
restored
to operation, the information regarding prescriptions filled and refilled
during the
inoperative
period, shall be entered into the automated data processing system within
ninety-six
(96)
hours.
(5) Any pharmacy using an automated data processing system must comply with all
applicable
state and federal laws and regulations.
(6) A pharmacy shall make arrangements with the supplier of data processing
services or
materials
to ensure that the pharmacy continues to have adequate and complete
prescription and
dispensing
records if the relationship with the supplier terminates for any reason. A
pharmacy
shall
ensure continuity in the maintenance of records.
(7) The automated data processing system shall contain adequate safeguards for
security
of the
records, to maintain the confidentiality and accuracy of the prescription
information.
Safeguards
against unauthorized changes in data after the information has been entered and
verified
by the registered pharmacist shall be provided by the system.
(l) Prescriptions for controlled substances as found in schedules II, except
those listed in
subsection
(n) of this section, III and IV of section 21-28-2.08 will become void unless
dispensed
within
thirty (30) days of the original date of the prescription. The prescriptions in
schedules III,
IV, and
V cannot be written for more than one hundred (100) dosage units and not more
than one
hundred
(100) dosage units may be dispensed at one time, unless a duly licensed physician
shall,
by
prescription, increase the dosage units up to a maximum of three hundred (300)
dosage units
for
schedules IV and V to provide a patient with a three (3) month supply. For purposes of this
section,
a "dosage unit" shall be defined as a single capsule, tablet or
suppository, or not more
than one
teaspoon of an oral liquid.
(m) Prescriptions for controlled substances as found in schedule II, except
those listed in
subsection
(n) below, may be written for up to a thirty (30) day supply, with a maximum of
two
hundred
and fifty (250) dosage units, as determined by the prescriber's directions for
use of the
medication.
In no event shall more than a thirty (30) days' supply, up to a maximum of two
hundred and
fifty (250) dosage units, be dispensed at one time.
(n) Prescriptions written for amphetamine sulfate, dextro amphetamine sulfate,
methamphetamine
hydrochloride, methylphenidate and amphetamine mixtures, may be written
for up
to a sixty (60) day supply with a maximum of two hundred fifty (250) dosage
units, as
determined
by the prescriber's directions for use of the medication. In no event shall
more than a
sixty
(60) day supply, up to a maximum of two hundred fifty (250) dosage units, be
dispensed at
one
time.
SECTION
2. This act shall take effect upon passage.
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LC03138
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