Nrs: Chapter 453B - Drug Donation Programs

Link to law: https://www.leg.state.nv.us/NRS/NRS-453B.html
Published: 2015

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
[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)