Chapter 176

2006 -- H 7748 SUBSTITUTE A AS AMENDED

Enacted 06/26/06

A N A C T

RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCE ACT

Introduced By: Representative John A. Savage

Date Introduced: February 28, 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.

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;

(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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LC02591/SUB A

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