[Rev. 2/10/2015 5:35:40
PM--2014R2]
CHAPTER 453B - DRUG DONATION PROGRAMS
HIV/AIDS DRUG DONATION PROGRAM
NRS 453B.010 Definitions.
NRS 453B.020 “Board”
defined.
NRS 453B.030 “HIV/AIDS
drug” defined.
NRS 453B.040 “Medical
facility” defined.
NRS 453B.050 “Pharmacy”
defined.
NRS 453B.060 “Program”
defined.
NRS 453B.070 “Provider
of health care” defined.
NRS 453B.080 Establishment
of Program; handling fee; conditions for acceptance, distribution and
dispensing of donated drugs; certain restrictions.
NRS 453B.090 Maintenance
and content of records; storage of HIV/AIDS drugs.
NRS 453B.100 Dispensing
of donated drug.
NRS 453B.110 Compliance
with applicable laws; authority to distribute donated drug to another
participant in Program.
NRS 453B.120 Regulations.
NRS 453B.130 Limitation
on civil and criminal liability; limitation on disciplinary action by
professional licensing board; waiver of liability.
CANCER DRUG DONATION PROGRAM
NRS 453B.150 Definitions.
NRS 453B.160 “Cancer
drug” defined.
NRS 453B.170 “Medical
facility” defined.
NRS 453B.180 “Program”
defined.
NRS 453B.190 “Provider
of health care” defined.
NRS 453B.200 Establishment
of Program; handling fee; conditions for acceptance, distribution and
dispensing of donated drugs; certain restrictions.
NRS 453B.210 Dispensing
of donated drug.
NRS 453B.220 Compliance
with applicable laws; authority to distribute donated drug to another
participant in Program.
NRS 453B.230 Regulations.
NRS 453B.240 Limitation
on civil and criminal liability; limitation on disciplinary action by
professional licensing board.
_________
HIV/AIDS DRUG DONATION PROGRAM
NRS 453B.010 Definitions. As
used in NRS 453B.010 to 453B.130,
inclusive, unless the context otherwise requires, the words and terms defined
in NRS 453B.020 to 453B.070,
inclusive, have the meanings ascribed to them in those sections.
(Added to NRS by 2013, 2257)
NRS 453B.020 “Board” defined. “Board”
means the State Board of Pharmacy.
(Added to NRS by 2013, 2257)
NRS 453B.030 “HIV/AIDS drug” defined. “HIV/AIDS
drug” means a prescription drug that is used to treat the human
immunodeficiency virus or acquired immunodeficiency syndrome.
(Added to NRS by 2013, 2257)
NRS 453B.040 “Medical facility” defined. “Medical
facility” has the meaning ascribed to it in NRS
449.0151.
(Added to NRS by 2013, 2257)
NRS 453B.050 “Pharmacy” defined. “Pharmacy”
has the meaning ascribed to it in NRS
639.012.
(Added to NRS by 2013, 2257)
NRS 453B.060 “Program” defined. “Program”
means the HIV/AIDS Drug Donation Program established pursuant to NRS 453B.080.
(Added to NRS by 2013, 2257)
NRS 453B.070 “Provider of health care” defined. “Provider
of health care” has the meaning ascribed to it in NRS 629.031.
(Added to NRS by 2013, 2257)
NRS 453B.080 Establishment of Program; handling fee; conditions for
acceptance, distribution and dispensing of donated drugs; certain restrictions.
1. The Board shall establish and maintain
the HIV/AIDS Drug Donation Program to accept, distribute and dispense HIV/AIDS
drugs donated to the Program.
2. Any person or governmental entity may
donate an HIV/AIDS drug to the Program. An HIV/AIDS drug may be donated at a
pharmacy, medical facility, health clinic or provider of health care that
participates in the Program.
3. A pharmacy, medical facility, health
clinic or provider of health care that participates in the Program may charge a
patient who receives an HIV/AIDS drug a handling fee in accordance with the
regulations adopted by the Board pursuant to NRS
453B.120.
4. A pharmacy, medical facility, health
clinic or provider of health care that participates in the Program must
establish written procedures for receiving and inspecting donated HIV/AIDS
drugs which are approved by the Board.
5. An HIV/AIDS drug may be accepted,
distributed or dispensed pursuant to the Program only if the HIV/AIDS drug:
(a) Is in its original, unopened, sealed and
tamper-evident unit dose packaging or, if packaged in single-unit doses, the
single-unit dose packaging is unopened;
(b) Is not adulterated or misbranded; and
(c) Bears an expiration date that is 180 days or
more after the date on which the drug is donated.
6. An HIV/AIDS drug donated to the Program
may not be:
(a) Resold; or
(b) Designated by the donor for a specific person.
7. The provisions of this section do not
require a pharmacy, medical facility, health clinic or provider of health care
to participate in the Program.
(Added to NRS by 2013, 2257)
NRS 453B.090 Maintenance and content of records; storage of HIV/AIDS drugs. A pharmacy, medical facility, health clinic or
provider of health care that participates in the Program shall:
1. Maintain the records for any HIV/AIDS
drug that is donated to the Program separate from all other records kept by the
pharmacy, medical facility, health clinic or provider of health care. Records
for any HIV/AIDS drug donated to the Program must include, without limitation:
(a) The date the pharmacy, medical facility,
health clinic or provider of health care received the drug;
(b) The date the drug was dispensed pursuant to
the original prescription;
(c) The original prescription number of the drug;
(d) The name of the drug;
(e) The dosage of the drug;
(f) The quantity of the drug that is donated;
(g) The date of expiration of the drug;
(h) The name, address and telephone number of the
person who originally dispensed the drug;
(i) The name, address and telephone number of the
person who donated the drug; and
(j) The lot number of the drug.
2. Maintain the record of an HIV/AIDS drug
that is distributed to another pharmacy, medical facility, health clinic or
provider of health care which is participating in the Program separate from all
other records kept by the pharmacy, medical facility, health clinic or provider
of health care. The records for any HIV/AIDS drug distributed to another
pharmacy, medical facility, health clinic or provider of health care must
include, without limitation:
(a) The information required by subsection 1;
(b) The name, address and telephone number of the
pharmacy, medical facility, health clinic or provider of health care that is
distributing the drug;
(c) The quantity of the drug that is being
distributed; and
(d) The name, address and telephone number of the
pharmacy, medical facility, health clinic or provider of health care to which
the drug is distributed.
3. Record and retain the name and
telephone number of any person to whom a donated HIV/AIDS drug is dispensed.
4. Store an HIV/AIDS drug that is donated
to the Program:
(a) Pursuant to the recommendations of the
manufacturer of the drug concerning the storage conditions;
(b) Separate from all other drugs; and
(c) In a locked storage area.
(Added to NRS by 2013, 2258)
NRS 453B.100 Dispensing of donated drug. An
HIV/AIDS drug donated for use in the Program may only be dispensed:
1. By a pharmacist who is registered
pursuant to chapter 639 of NRS; and
2. To a person who is eligible to receive
HIV/AIDS drugs dispensed pursuant to the Program.
(Added to NRS by 2013, 2259)
NRS 453B.110 Compliance with applicable laws; authority to distribute donated
drug to another participant in Program. A
pharmacy, medical facility, health clinic or provider of health care that
participates in the Program:
1. Shall comply with all applicable state
and federal laws concerning the storage, distribution and dispensing of any
HIV/AIDS drugs donated to the Program; and
2. May distribute an HIV/AIDS drug donated
to the Program to another pharmacy, medical facility, health clinic or provider
of health care for use in the Program.
(Added to NRS by 2013, 2259)
NRS 453B.120 Regulations. The
Board shall adopt regulations to carry out the provisions of this chapter. The
regulations must prescribe, without limitation:
1. The requirements for the participation
of pharmacies, medical facilities, health clinics and providers of health care
in the Program;
2. The criteria for determining the
eligibility of persons to receive HIV/AIDS drugs dispensed pursuant to the
Program, including, without limitation, a requirement that a person apply to
the Board on a form prescribed by the Board for eligibility to receive HIV/AIDS
drugs dispensed or distributed pursuant to the Program;
3. The categories of HIV/AIDS drugs that
may be accepted for distribution or dispensing pursuant to the Program;
4. The maximum fee that a pharmacy,
medical facility, health clinic or provider of health care may charge to
distribute or dispense HIV/AIDS drugs pursuant to the Program; and
5. The requirements for the written
procedures established by a pharmacy, medical facility, health clinic or
provider of health care for receiving and inspecting donated HIV/AIDS drugs and
the manner in which a pharmacy, medical facility, health clinic or provider of
health care must submit such procedures for approval.
(Added to NRS by 2013, 2259)
NRS 453B.130 Limitation on civil and criminal liability; limitation on
disciplinary action by professional licensing board; waiver of liability.
1. A person who exercises reasonable care
in the donation of an HIV/AIDS drug in accordance with the provisions of this
chapter and the regulations adopted pursuant thereto is not subject to any
civil or criminal liability or disciplinary action by a professional licensing
board for any loss, injury or death that results from the donation of the
HIV/AIDS drug.
2. A pharmacy, medical facility, health
clinic or provider of health care which participates in the Program and which
exercises reasonable care in the acceptance, distribution or dispensation of an
HIV/AIDS drug is not subject to civil or criminal liability or disciplinary action
by a professional licensing board for any loss, injury or death that results
from the acceptance, distribution or dispensation of the HIV/AIDS drug.
3. A manufacturer of an HIV/AIDS drug is
not subject to civil or criminal liability for any claim or injury arising from
the donation, acceptance, distribution or dispensation of the HIV/AIDS drug
pursuant to this chapter and the regulations adopted pursuant thereto.
4. An HIV/AIDS drug may not be dispensed
pursuant to the Program unless the person to whom the drug is dispensed has
signed a waiver of liability for any action described in this section performed
by any person, pharmacy, medical facility, health clinic, provider of health
care or manufacturer of the HIV/AIDS drug.
(Added to NRS by 2013, 2259)
CANCER DRUG DONATION PROGRAM
NRS 453B.150 Definitions. As
used in NRS 453B.150 to 453B.240,
inclusive, unless the context otherwise requires, the words and terms defined
in NRS 453B.160 to 453B.190,
inclusive, have the meanings ascribed to them in those sections.
(Added to NRS by 2009, 454)—(Substituted
in revision for NRS 457.400)
NRS 453B.160 “Cancer drug” defined. “Cancer
drug” means a prescription drug that is used to treat cancer.
(Added to NRS by 2009, 454)—(Substituted
in revision for NRS 457.410)
NRS 453B.170 “Medical facility” defined. “Medical
facility” has the meaning ascribed to it in NRS
449.0151.
(Added to NRS by 2009, 454)—(Substituted
in revision for NRS 457.420)
NRS 453B.180 “Program” defined. “Program”
means the Cancer Drug Donation Program established pursuant to NRS 453B.200.
(Added to NRS by 2009, 454)—(Substituted
in revision for NRS 457.430)
NRS 453B.190 “Provider of health care” defined. “Provider
of health care” has the meaning ascribed to it in NRS 629.031.
(Added to NRS by 2009, 455)—(Substituted
in revision for NRS 457.440)
NRS 453B.200 Establishment of Program; handling fee; conditions for
acceptance, distribution and dispensing of donated drugs; certain restrictions.
1. The State Board of Pharmacy shall
establish and maintain the Cancer Drug Donation Program to accept, distribute
and dispense cancer drugs donated to the Program.
2. Any person may donate a cancer drug to
the Program. A cancer drug may be donated at a pharmacy, medical facility,
health clinic or provider of health care that participates in the Program.
3. A pharmacy, medical facility, health
clinic or provider of health care that participates in the Program may charge a
patient who receives a cancer drug a handling fee in accordance with the
regulations adopted by the State Board of Pharmacy pursuant to NRS 453B.230.
4. A cancer drug may be accepted,
distributed or dispensed pursuant to the Program only if the cancer drug:
(a) Is in its original, unopened, sealed and
tamper-evident unit dose packaging or, if packaged in single-unit doses, the
single-unit dose packaging is unopened;
(b) Is not adulterated or misbranded; and
(c) Bears an expiration date that is later than
30 days after the drug is donated.
5. A cancer drug donated to the Program
may not be:
(a) Resold; or
(b) Designated by the donor for a specific
person.
6. The provisions of this section do not
require a pharmacy, medical facility, health clinic or provider of health care
to participate in the Program.
(Added to NRS by 2009, 455)—(Substituted
in revision for NRS 457.450)
NRS 453B.210 Dispensing of donated drug. A
cancer drug donated for use in the Program may only be dispensed:
1. By a pharmacist who is registered
pursuant to chapter 639 of NRS or by a
physician who is licensed pursuant to chapter 630
or 633 of NRS;
2. Pursuant to a prescription written by a
person who is authorized to write prescriptions; and
3. To a person who is eligible to receive
cancer drugs dispensed pursuant to the Program.
(Added to NRS by 2009, 455;
A 2013, 153)—(Substituted
in revision for NRS 457.460)
NRS 453B.220 Compliance with applicable laws; authority to distribute donated
drug to another participant in Program. A
pharmacy, medical facility, health clinic or provider of health care that
participates in the Program:
1. Shall comply with all applicable state
and federal laws concerning the storage, distribution and dispensing of the
cancer drugs; and
2. May distribute a cancer drug donated to
the Program to another pharmacy, medical facility, health clinic or provider of
health care for use in the Program.
(Added to NRS by 2009, 455)—(Substituted
in revision for NRS 457.470)
NRS 453B.230 Regulations. The
State Board of Pharmacy shall adopt regulations to carry out the provisions of NRS 453B.150 to 453B.240,
inclusive. The regulations must prescribe, without limitation:
1. The requirements for the participation
of pharmacies, medical facilities, health clinics and providers of health care
in the Program, including, without limitation:
(a) A requirement that each provider of health
care who participates in the Program provide, as a regular course of practice,
medical services and goods to persons with cancer; and
(b) A requirement that each medical facility that
participates in the Program provide, as a regular course of practice, medical
services and goods to persons with cancer;
2. The criteria for determining the
eligibility of persons to receive cancer drugs dispensed pursuant to the
Program, including, without limitation, a requirement that a person sign up
with the State Board of Pharmacy on a form prescribed by the Board to be
eligible to receive cancer drugs dispensed pursuant to the Program;
3. The categories of cancer drugs that may
be accepted for distribution or dispensing pursuant to the Program; and
4. The maximum fee that a pharmacy,
medical facility, health clinic or provider of health care may charge to
distribute or dispense cancer drugs pursuant to the Program.
(Added to NRS by 2009, 455)—(Substituted
in revision for NRS 457.480)
NRS 453B.240 Limitation on civil and criminal liability; limitation on
disciplinary action by professional licensing board.
1. A person who exercises reasonable care
in the donation of a cancer drug in accordance with the provisions of NRS 453B.150 to 453B.240,
inclusive, and the regulations adopted pursuant thereto, is not subject to any
civil or criminal liability or disciplinary action by a professional licensing
board for any loss, injury or death that results from the donation of the
cancer drug.
2. A pharmacy, medical facility, health
clinic or provider of health care which participates in the Program and which
exercises reasonable care in the acceptance, distribution or dispensation of a
cancer drug is not subject to civil or criminal liability or disciplinary
action by a professional licensing board for any loss, injury or death that
results from the acceptance, distribution or dispensation of the cancer drug.
3. A manufacturer of a cancer drug is not
subject to civil or criminal liability for any claim or injury arising from the
donation, acceptance, distribution or dispensation of the cancer drug pursuant
to NRS 453B.150 to 453B.240,
inclusive, and the regulations adopted pursuant thereto.
(Added to NRS by 2009, 456)—(Substituted
in revision for NRS 457.490)
