2013 -- H 5756 SUBSTITUTE B
A N A C T
RELATING TO FOOD AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT
Introduced By: Representatives McNamara, Azzinaro, Bennett, Corvese, and Handy
Date Introduced: February 28, 2013
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, III, IV and V to
any person upon a
written valid 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.
filling a hard-copy prescription for a schedule II controlled substance, 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.
Hard copy prescriptions for controlled substances in schedule II shall
be filed separately and shall not be refilled.
(2) The director of health may, after appropriate notice and hearing pursuant to § 42-35-3,
promulgate rules and regulations for the purpose of adopting a system for electronic data
transmission of prescriptions for controlled substances in
and, III and IV.
(3) A practitioner may sign and transmit electronic prescriptions for controlled substances
and a pharmacy may dispense an electronically transmitted prescription in accordance with the
code of federal regulations, title 21 part 1300, et seq.
(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
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. § 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
(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
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
(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
(4) Within seven (7) days after authorizing an emergency oral prescription, the
prescribing practitioner shall cause a
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
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
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
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),
(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
(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
(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, 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. 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.
SECTION 2. Chapter 21-28 of the General Laws entitled “Uniform Controlled
Substances Act” is hereby amended by adding thereto the following section:
21-28-3.32. Electronic prescription database. -- (a) The information contained in any
prescription drug monitoring database maintained by the department of health pursuant to section
3.18 of this chapter shall be disclosed only:
(1) To a practitioner who certifies that the requested information is for the purpose of
evaluating the need for or providing medical treatment for a current patient to whom the
practitioner is prescribing or considering prescribing a controlled substance;
(2) To a pharmacist who certifies that the requested information is for a current client to
whom the pharmacist is dispensing or considering dispensing a controlled substance;
(3) Pursuant to a valid search warrant based on probable cause to believe a violation of
federal or state criminal law has occurred and that specified information contained in the database
would assist in the investigation of the crime;
(4) To a patient who requests his or her own prescription information, or the parent or
legal guardian of a minor child who requests the minor child's prescription information;
(5) To a health professional regulatory board that documents, in writing, that the
requested information is necessary for an investigation related to licensure, renewal or
disciplinary action involving the applicant, licensee or registrant to whom the requested
(6) To any vendor or contractor with whom the department has contracted to establish or
maintain the electronic system of the prescription drug monitoring database; or
(7) To public or private entities for statistical, research, or educational purposes, after
removing the patient and prescriber information that could be used to identify individual patients.
This shall not include entities receiving a waiver
from the institutional review board.
(b) Information stored in the prescription drug monitoring database shall include only the
(1) Patient’s first and last name, and/or patient identification number; provided, however,
the patient’s social security number shall not be recorded in whole or in part, patient sex, patient
date of birth, and patient address;
(2) Prescribing practitioner’s name and drug enforcement administration prescriber
(3) Prescribing practitioner’s office or hospital contact information;
(4) Prescription name, prescription number, prescription species code, national drug code
number, prescription dosage, prescription quantity, days' supply, new-refill code, number of
refills authorized, date the prescription was written, date the prescription was filled, payment
type; provided, however, no credit card number shall be recorded in whole or in part; and
(5) The drug enforcement administration pharmacy number of the pharmacy filling the
(c) The department shall disclose any information relating to a patient maintained in the
prescription drug monitoring database to that patient, at no cost to the patient, within thirty (30)
business days after the department receives a written request from the patient for the information.
This information shall include the records maintained by the department pursuant to subsection
(e). Notwithstanding the above, the department may, at the request of the law enforcement
agency, withhold for up to sixty (60) days following the conclusion of a law enforcement
investigation, the disclosure to the patient that information has been obtained pursuant to
(d) A patient may request from the dispensing pharmacy correction of any inaccurate
information contained within the prescription drug monitoring database in accordance with the
procedure specified by subsection 5-37.3-5(c).
(e) The department shall, for the period of time that prescription information is
maintained, maintain records of the information disclosed through the prescription drug
monitoring database, including, but not limited to:
(1) The identity of each person who requests or receives information from the
prescription drug monitoring database and the organization, if any, the person represents;
(2) The information released to each person or organization and the basis for its release
under subsection (a); and
(3) The dates the information was requested and provided.
(f) Prescription information contained within the prescription drug monitoring database
shall be removed no later than five (5) years from the date the information is entered into the
database. Records in existence prior to the enactment of this section shall be removed no later
than ten (10) years from the date the information is entered into the database.
(g) The department shall promptly notify any affected individual of an improper
disclosure of information from the prescription drug monitoring database or a breach in the
security of the prescription drug monitoring database that poses a significant risk of disclosure of
patient information to an unauthorized individual.
(h) At the time of signing a prescription which is required by the department to be entered
into the prescription drug monitoring database, the prescribing practitioner shall inform the
patient in writing of the existence of the prescription drug monitoring database, the patient’s right
to access their own prescription information, and the name and contact information of the agency
operating the program.
(i) No person shall access information in the prescription monitoring database except to
the extent and for the purposes authorized by subsection (a).
(j) In any civil action allowing a violation of this chapter, the court may award damages,
including punitive damages, and reasonable attorneys’ fees and costs to a prevailing plaintiff, and
injunctive and any other appropriate relief.
(k) Any pharmacist who, in his or her professional judgment, refuses to fill a prescription
based on information contained within the prescription drug monitoring database shall inform the
prescribing physician within twenty-four (24) hours.
SECTION 3. This act shall take effect upon passage.