Chapter 331
2013 -- H 5230 SUBSTITUTE A
Enacted 07/15/13
A N A C T
RELATING TO
HEALTH AND SAFETY - THE RETURN OR EXCHANGE OF DRUGS ACT
Introduced By: Representatives DeSimone, Palangio, Slater, and Palumbo
Date Introduced: January 31, 2013
It is enacted by the
General Assembly as follows:
SECTION 1. Chapter 23-25.4 of the General Laws entitled
"Utilization of Unused
Prescription Drugs
Act" is hereby repealed in its entirety.
CHAPTER
23-25.4
Utilization
of Unused Prescription Drugs Act
23-25.4-1.
Short title. -- This act may be
cited as the "Utilization of Unused Prescription
Drugs Act."
23-25.4-2.
Legislative purpose. -- The general
assembly has determined that the high
cost of prescription drugs is a burden on the uninsured
who may forego the drugs they need or
take only partial doses which can ultimately increase
health costs. The general assembly has also
determined that many nursing facilities and assisted living
residences destroy quantities of unused
but viable prescription medications when residents pass
away or when medications otherwise are
no longer needed by the resident. In an effort to
improve the quality, efficiency and utilization of
the state's health care system, the general assembly hereby
establishes a voluntary statewide pilot
program allowing nursing facilities and assisted living
residences to transfer from their facilities
unused prescription drugs to authorized participating
pharmacies for distribution to medically
indigent
23-25.4-3.
Definitions. -- For the purposes of
this chapter:
(1) "Assisted
living residence" has the same meaning as such term is defined in section
23-17.4-2 and the regulations promulgated thereunder.
(2) "Blister
packages" means multi-dose containers of a specific medication repackaged
by the pharmacy in accordance with section 13.7 of the
regulations promulgated under chapter
19.1 of title 5 and intended
for a specific patient.
(3) "Cancer
drugs" means any of several drugs that control or kill neoplastic
cells,
commonly referred to as "cancer-fighting
chemotherapy" to destroy cancer cells.
(4) "Charitable
clinic" means an organized ambulatory care facility licensed pursuant to
chapter 17 of title 23 organized as a nonprofit corporation
pursuant to section 7-6-2 that:
(i)
Holds a valid exemption from federal income taxation issued pursuant to Section
501(a) of the Internal Revenue Code, 26 U.S.C. section 501(1);
(ii) Has a licensed
outpatient pharmacy located at the organized ambulatory care facility
or a contract with a retail pharmacy to participate in
the program established under this chapter.
(5) "Health
care prescriber" means any of the following persons licensed and authorized
to prescribe drugs or to provide medical, dental, or
other health-related diagnoses, care or
treatment within the scope of their professional license:
(i)
A physician holding a current license to practice medicine pursuant to chapter
37 of
title 5;
(ii) A certified
registered nurse practitioner licensed pursuant to chapter 34 of title 5;
(iii) A physician
assistant licensed pursuant to chapter 54 of title 5;
(iv)
A dentist licensed pursuant to chapter 31.1 of title 5;
(v) An optometrist
licensed pursuant to chapter 35 of title 5; and
(vi)
A pharmacist licensed pursuant to chapter 19.1 of title 5.
(vii) A nurse --
midwife licensed pursuant to chapter 13 of title 23; and
(viii) A psychiatric
and mental health clinical nurse specialist licensed pursuant to
chapter 34 of title 5.
(6) "Medically
indigent" means a person eligible to receive Medicaid or Medicare or a
person who has no health insurance and who otherwise lacks
reasonable means to purchase
prescribed drugs.
(7)
"Prescription drug" means a drug that may be dispensed only upon
prescription by a
health care prescriber authorized by his or her licensing
authority and as defined in chapter 5-
19.1.
(8) "Unit-dose
container" is one that is designed to hold a quantity of a drug intended
for
use as a single dose and used promptly after the
container is opened. The immediate container,
and/or the outer container or protective packaging shall be
designed to show evidence of any
tampering with the contents. Each individual container shall be
fully identifiable containing a
single dose of a single entity and shall protect the
integrity of the dosage form. Labeling shall be
in accordance with USP standards compendia and federal
and state law and shall include the
identity, quantity, and strength of the product, name of the
manufacturer, and lot number and
expiration date of the article.
23-25.4-4.
Program established. -- (a) The
department of health and the board of
pharmacy shall jointly develop and implement a pilot program
consistent with public health and
safety through which unused prescription drugs, other than
prescription drugs defined as
controlled substances in section 21-28-1.02, shall be
transferred from nursing facilities, assisted
living residences, residential care facilities or community
health organizations that centrally store
prescription drugs and are licensed at the M1 licensure level by
the department of health to
charitable clinics for the purpose of re-dispensing the
medication to
are medically indigent.
(b) The pilot
program shall conform to the requirements established in rules promulgated
by the state department of health and the board of
pharmacy. The pilot program shall remain in
effect until January 1, 2012.
(c) The state
department of health and the board of pharmacy shall review and evaluate
the pilot program and shall submit a report and any
recommendations to the governor, the speaker
of the house of representatives, and the president of
the senate on or before January 1, 2012.
(d) Beginning April
1, 2010, the department of health and the board of pharmacy shall
implement statewide a program consistent with public health and
safety through which unused
prescription drugs, other than prescription drugs defined as
controlled substances in section 21-
28-1.02, shall be transferred from nursing facilities
or assisted living residences to charitable
clinics for the purpose of re-dispensing the unused
prescription drugs.
(e) The department
of health and the board of pharmacy shall promulgate rules and
establish procedures necessary to implement the program
established pursuant to this chapter.
(f) The board of pharmacy
shall provide technical assistance to entities who may wish to
participate in the program.
(g) The department
of health shall be required to provide written notification to all
eligible nursing homes, assisted living facilities, residential
care facilities and community health
organizations and to post a sign clearly and conspicuously in each
facility to notify its residents of
the program.
23-25.4-5.
Criteria. -- The following criteria
shall be used in soliciting and accepting
unused prescription drugs for use pursuant to this chapter:
(1) Nursing
facilities and assisted living residences that have entered into an agreement
to participate with a charitable clinic shall document
residents' participation in the program with a
written statement that their excess and otherwise eligible
unused prescription drugs shall be
donated to a charitable clinic for the purpose of
re-dispensing to medically indigent persons.
Participation in this program by residents of
participating nursing facilities and assisted living
residences shall be strictly voluntary.
(2) Only
prescription drugs in their original sealed multi-dose blister packages, unit
dose
containers or perforated blister packages shall be accepted and
re-dispensed;
(3) Expired or
beyond use date prescription drugs shall not be accepted;
(4) A prescription
drug shall not be accepted or re-dispensed if the pharmacist accepting
or re-dispensing the drug, in his or her judgment has reason
to believe that the drug is adulterated,
mislabeled, or has been improperly stored;
(5) No controlled
substances shall be accepted; and
(6) Subject to the
limitation specified in this section, unused prescription drugs dispensed
for purposes of a medical assistance program may be
accepted and re-dispensed pursuant to this
chapter.
23-25.4-6.
Participation. -- (a) Participation
in the program established in this chapter by
individual residents of any assisted living residence or nursing
facility, pharmacies, nursing
facilities, assisted living residences, charitable clinics or
prescription drug manufacturers shall be
voluntary. Nothing in this chapter shall require any resident
of any assisted living residence or
nursing facility, pharmacy, pharmacists, charitable clinic or
prescription drug manufacturer to
participate in the program.
(b) A pharmacy
operating in conjunction with a charitable clinic may:
(1) Re-dispense
prescription drugs donated pursuant to this chapter to persons who are
medically indigent residents of
(c) A pharmacy
operating in conjunction with a charitable clinic wherein both meet the
eligibility requirements established and authorized by this
chapter and that accepts donated
prescription drugs shall:
(1) Comply with all
applicable federal and state laws relating to the storage, distribution,
and dispensing of prescription drugs;
(2) Inspect all
prescription drugs prior to re-dispensing the prescription drugs to
determine that such drugs are not adulterated; and
(3) Re-dispense
prescription drugs only pursuant to a valid prescription issued by a
health care prescriber.
(d) Prescription
drugs donated pursuant to this chapter shall not be resold.
23-25.4-7.
Liability. -- (a) For
matters related only to the lawful donation, acceptance, or
re-dispensing of prescription drugs under this chapter, the
following persons and entities, in
compliance with the criteria set forth in this chapter, in the absence
of bad faith shall not be
subject to criminal or civil liability for injury, death, or
loss to person or property, or professional
disciplinary action:
(1) The board of
pharmacy;
(2) Any resident of
a nursing facility or assisted living residence who agrees to donate
unused prescription drugs, or his/her next of kin or legal
guardian or estate;
(3) The department
of mental health, retardation and hospitals;
(4) Any charitable
clinic, prescription drug manufacturer, governmental entity, nursing
facility, or assisted living residence who participates in the
program for the reuse of prescription
drugs pursuant to this chapter;
(5) Any prescription
drug manufacturer or its representative that directly donates
prescription drugs in professional samples to a charitable clinic
or a pharmacy pursuant to this
chapter;
(6) Any charitable
clinic, health care prescriber or pharmacy that accepts or re-dispenses
prescription drugs pursuant to this chapter; and
(7) Any pharmacy or
pharmacist operating in conjunction with a charitable clinic, or
other state-contracted pharmacy that employs a health care
professional who accepts or can
legally dispense prescription drugs pursuant to this chapter.
(b) For matters
related to the donation, acceptance, or dispensing of a prescription drug
manufactured by the prescription drug manufacturer that is donated
by any entity pursuant to this
chapter, a prescription drug manufacturer shall not, in the
absence of bad faith be subject to
criminal or civil liability for injury, death, or loss to
person or property including, but not limited
to, liability for failure to transfer or communicate
product or consumer information or the
expiration date of the donated prescription drug.
23-25.4-8.
Rules. -- (a) The
board of pharmacy shall promulgate rules by December 1,
2005, to implement the provisions
of this chapter. Such rules
may include:
(1) Eligibility
criteria for pharmacies and charitable clinics authorized to receive and
dispense donated prescription drugs pursuant to this chapter;
(2) Establishment of
a formulary which shall include all prescription drugs approved by
the federal Food and Drug Administration;
(3) Standards and procedures
for transfer, acceptance, safe storage, security, and
dispensing of donated prescription drugs;
(4) A process for
seeking input from the state department of health in establishing
provisions which affect nursing homes and assisted living
residences;
(5) A process for
seeking input form the department of mental health, retardation and
hospitals in establishing provisions which affect mental heath
and substance abuse clients;
(6) Standards and
procedures for inspecting donated prescription drugs to ensure that the
drugs are in compliance with the provisions of this chapter
and to ensure that, in the professional
judgment of the pharmacist, the medications meet all federal
and state standards for product
integrity;
(7) Procedures for
destruction of medications that are donated which are controlled
substances;
(8) Procedures for
verifying whether the pharmacy and responsible pharmacist
participating in the program are licensed and in good standing with
the board of pharmacy;
(9) Establishment of
standards for acceptance of unused prescription medications from
assisted living residences; and
(10) Any other
standards and procedures the board of pharmacy deems appropriate or
necessary to implement the provisions of this chapter.
(b) In accordance
with the rules and procedures of the program established pursuant to
this section, a resident of a nursing facility or assisted
living residence, or the representative or
guardian of a resident may donate unused prescription
medications, other than prescription drugs
defined as controlled dangerous substances, to charitable
clinics for dispensing to medically
indigent persons.
23-25.4-9.
Establishment of oversight commission on utilization of unused
prescription drugs -- Membership. -- (a) There is hereby established a commission on the
utilization of prescription drugs to oversee the development and
implementation of the pilot
program for the utilization of unused prescription drugs as
established pursuant to this chapter.
(b) The commission
shall consist of five (5) members to be appointed by the speaker of
the house, not more than three (3) from the same
political party. Any vacancy on the commission,
occurring for any reason prior to the expiration of the term,
shall be filled for the unexpired term
by the appointing authority in the same manner as the
original appointment.
SECTION 2. Title 23 of the General Laws entitled
"HEALTH AND SAFETY" is hereby
amended by adding thereto the following chapter:
CHAPTER
25.5
THE
RETURN OR EXCHANGE OF DRUGS ACT
23-25.5-1.
Short title. -- This act shall be known and may
be cited as "The Return or
Exchange of Drugs Act."
23-25.5-2.
Legislative purpose. -- The general assembly
finds that many nursing
facilities and assisted living residences destroy quantities of
unused but viable prescription
medication when residents pass away or when medications
otherwise are no longer needed by the
resident. In an effort to improve the quality, efficiency and
utilization of the state's healthcare
system, the general assembly hereby establishes a statewide
program allowing pharmacies to
accept for return and redispensing
certain prescription drugs.
23-25.5-3.
Definitions. – For the purposes of this
chapter:
(1) "Assisted
living residence" has the same meaning as such term is defined in section
23-17.4-2 and the regulations promulgated thereunder.
(2) "Blister
packages" means multi-dose containers of a specific medication repackaged
by the pharmacy in accordance with section 13.7 of the
regulations promulgated under chapter
19.1 of title 5 and intended
for a specific patient.
(3)
"Department" means the department of health.
(4) "Healthcare
prescriber" means any of the following persons licensed and authorized
to prescribe drugs or to provide medical, dental, or
other health-related diagnoses, care or
treatment within the scope of their professional license:
(i)
A physician holding a current license to practice medicine pursuant to chapter
37 of
title 5;
(ii) A certified
registered nurse practitioner licensed pursuant to chapter 34 of title 5;
(iii) A physician
assistant licensed pursuant to chapter 54 of title 5;
(iv)
A dentist licensed pursuant to chapter 31.1 of title 5;
(v) An optometrist
licensed pursuant to chapter 35 of title 5;
(vi)
A pharmacist licensed pursuant to chapter 19.1 of title 5;
(vii) A nurse –
midwife licensed pursuant to chapter 13 of title 23; and
(viii) A psychiatric
and mental health clinical nurse specialist licensed pursuant to chapter
34 of title 5.
(5)
"Pharmacy" means that portion or part of a premises
where prescriptions are
compounded and dispensed including that portion utilized for the
storage of prescription or
legend drugs.
(6)
"Prescription drug" means a drug that may be dispensed only upon
prescription by a
healthcare prescriber authorized by his or her licensing
authority and as defined in chapter 5-19.1.
(7) "Unit-dose
container" is one that is designed to hold a quantity of a drug intended
for
use as a single dose and used promptly after the
container is opened. The immediate container,
and/or the outer container or protective packaging shall be
designed to show evidence of any
tampering with the contents. Each individual container shall be
fully identifiable containing a
single dose of a single entity and shall protect the
integrity of the dosage form. Labeling shall be
in accordance with USP standards compendia and federal
and state law and shall include the
identity, quantity, and strength of the product, name of the
manufacturer, and lot number and
expiration date of the article.
(8)
"Wholesaler" means a person who buys drugs or devices for resale and
distribution to
corporations, individuals, or entities other than consumers.
23-25.5-4. Program
established. -- (a) The department of health
and the board of
pharmacy shall jointly develop and implement a program
consistent with public health and safety
through which unused prescription drugs, other than
prescription drugs defined as controlled
substances in section 21-28-1.02, and drugs that can only be
dispensed to a patient registered with
the drug’s manufacturer in accordance with federal Food
and Drug Administration requirements,
may be accepted by wholesalers or pharmacies, from which
they were purchased, for return from
nursing facilities, assisted living residences, residential
care facilities, community health
organizations and state correctional facilities that centrally
store prescription drugs and are
licensed at the M1 licensure level by the department of
health, within forty-five (45) days of
dispensing.
(b) The program shall
permit the wholesaler or pharmacy to which such medication is
returned to repackage, restock, and redistribute such
medication.
(c) The program shall
include the following prescription drugs:
(1) Unopened sections
of blister pack prescription medication, with seal intact;
(2) Unopened
unit-dose containers of liquids with the safety seal intact;
(3) Unopened
unit-dose containers of powders for oral solution with safety seal intact;
(4) Unused injectables, with safety seal intact;
(d) The unused
prescription drug shall not be accepted, repackaged or redispensed
if:
(1) The prescription
drug is expired or beyond use date;
(2) The pharmacist accepting
or redispensing the drug, in his or her judgment has
reason
to believe that the prescription drug is adulterated,
mislabeled, or has been improperly stored;
(3) The prescription
drug is defined as controlled substances in section 21-28-1.02; and
(4) It is a drug that
can only be dispensed to a patient registered with the drug’s
manufacturer in accordance with federal Food and Drug
Administration requirements.
(e) The wholesaler or
pharmacy shall be required to reimburse or credit the purchaser for
any such returned prescription drugs at original invoice
price plus a restocking fee not to exceed
five dollars ($5.00).
(f) The department
and the board of pharmacy shall promulgate rules and regulations
necessary to implement the program established pursuant to this
chapter within one hundred
eighty days (180) of passage of this act.
SECTION 3. This act shall take effect upon passage.
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LC00655/SUB A/3
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