Chapter 183
2009 -- H 5479 SUBSTITUTE B
Enacted 11/02/09
A N A C T
RELATING TO FOOD
AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT
Introduced By: Representatives McNamara, Guthrie, and Ehrhardt
Date Introduced: February 12, 2009
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:
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, will become void unless dispensed within ninety (90)
days of the
original date of the prescription, and in no event shall more
than a thirty (30) day supply be
dispensed at any one time.
(1) In prescribing
controlled substances in schedule II, practitioners may write up to three
(3) separate prescriptions,
each for up to a one-month supply, each signed and dated on the date
written. For those prescriptions for the second and/or third
month, the practitioner must write the
earliest date each of those subsequent prescription may be
filled, with directions to the pharmacist
to fill no earlier than the date specified on the face
of the prescription.
(m) The
prescriptions in schedules III, IV, and V will become void unless dispensed
within one hundred eighty (180) days of the original date of
the prescription. and 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 practitioner 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 up to 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 five (5) ml. of an oral liquid.
(1) Prescriptions in
Schedule III 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.
(2) Prescriptions in
Schedule IV and V may be written for up to a ninety (90) day supply
based on directions. No more than three hundred and sixty
(360) dosage units may be dispensed
at one time.
(m) 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. In no event shall more
than a sixty (60) day supply be dispensed
at one time.
SECTION 2. This act shall take effect on September 1, 2009.
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LC01287/SUB B
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