Nac: Chapter 453B - Cancer Drug Donation Program

Link to law: http://www.leg.state.nv.us/nac/NAC-453B.html
Published: 2015

[Rev. 7/15/2015 11:20:44 AM]

[NAC-453B Revised Date: 8-15]

CHAPTER 453B - CANCER DRUG DONATION

PROGRAM

General Provisions

453B.010         Definitions.

453B.015         “Board” defined.

453B.020         “Cancer drug” defined.

453B.025         “Dispense” defined.

453B.030         “Distribute” defined.

453B.035         “Health clinic” defined.

453B.040         “Medical facility” defined.

453B.045         “Pharmacy” defined.

453B.050         “Program” defined.

453B.055         “Provider of health care” defined.

Participation of

Persons in Program

453B.070         Eligibility for participation in

Program to receive cancer drug.

453B.075         Submission of application to

participate; written notice of approval or denial by Board.

Participation of

Pharmacists, Medical Facilities, Health Clinics and Providers of Health Care in

Program

453B.080         Eligibility for participation in

Program.

453B.085         Submission of application to

participate; written notice of approval or denial by Board.

453B.090         Compliance with federal and state

laws and regulations required.

Administration of

Program; Fees

453B.100         Board to establish and maintain

registry of participants; notification to Board of certain changes in

information or status.

453B.105         Donating, dispensing and storage of

cancer drugs.

453B.110         Restrictions on donated cancer

drugs.

453B.115         Maintenance of records by pharmacy,

medical facility, health clinic or provider of health care that participates in

Program.

453B.120         Handling fee.

 

 

 

General Provisions

      NAC 453B.010  Definitions. (NRS 453B.230)  As used

in this chapter, unless the context otherwise requires, the words and terms

defined in NAC 453B.015 to 453B.055,

inclusive, have the meanings ascribed to them in those sections.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.500)

      NAC 453B.015  “Board” defined. (NRS 453B.230)  “Board”

means the State Board of Pharmacy.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.505)

      NAC 453B.020  “Cancer drug” defined. (NRS 453B.230)  “Cancer

drug” has the meaning ascribed to it in NRS 453B.160.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.510)

      NAC 453B.025  “Dispense” defined. (NRS 453B.230)  “Dispense”

has the meaning ascribed to it in NRS

639.0065.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.515)

      NAC 453B.030  “Distribute” defined. (NRS 453B.230)  “Distribute”

means to deliver, other than by administering or dispensing, a cancer drug.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.520)

      NAC 453B.035  “Health clinic” defined. (NRS 453B.230)  “Health

clinic” means a facility which provides, as a regular course of practice,

medical services and goods to persons with cancer and is operated by a

physician who is licensed pursuant to chapter

630 or 633 of NRS.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.525)

      NAC 453B.040  “Medical facility” defined. (NRS 453B.230)  “Medical

facility” has the meaning ascribed to it in NRS 449.0151.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.530)

      NAC 453B.045  “Pharmacy” defined. (NRS 453B.230)  “Pharmacy”

has the meaning ascribed to it in NRS

639.012.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.535)

      NAC 453B.050  “Program” defined. (NRS 453B.230)  “Program”

has the meaning ascribed to it in NRS

453B.180.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.540)

      NAC 453B.055  “Provider of health care” defined. (NRS 453B.230)  “Provider

of health care” has the meaning ascribed to it in NRS 629.031.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.545)

Participation of Persons in Program

      NAC 453B.070  Eligibility for participation in Program to receive cancer drug. (NRS 453B.230)  A person

who wishes to receive a cancer drug dispensed pursuant to the Program must be:

     1.  A resident of this State;

     2.  Diagnosed as having cancer; and

     3.  Approved to participate in the Program

pursuant to NAC 453B.075.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.555)

      NAC 453B.075  Submission of application to participate; written notice of

approval or denial by Board. (NRS 453B.230)

     1.  A person who wishes to participate in the

Program must submit an application to the Board on a form prescribed by the

Board.

     2.  The Board will review the application and

determine if the person is qualified to participate in the Program.

     3.  If the Board approves a person to

participate in the Program, the Board will provide written notice of its

approval of the application to the person not later than 30 days after its

decision.

     4.  If the Board denies a person from

participating in the Program, the Board will provide written notice of its

denial of the application to the person not later than 30 days after its

decision.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.560)

Participation of Pharmacists, Medical Facilities, Health

Clinics and Providers of Health Care in Program

      NAC 453B.080  Eligibility for participation in Program. (NRS 453B.230)  To be

eligible to participate in the Program:

     1.  A pharmacy must be:

     (a) Licensed in this State; and

     (b) Approved to participate in the Program pursuant

to NAC 453B.085.

     2.  A medical facility must:

     (a) Be licensed in this State;

     (b) Provide, as a regular course of practice,

medical services and goods to persons with cancer; and

     (c) Be approved to participate in the Program

pursuant to NAC 453B.085.

     3.  A health clinic must be approved to

participate in the Program pursuant to NAC 453B.085.

     4.  A provider of health care must:

     (a) Be licensed in this State;

     (b) Provide, as a regular course of practice,

medical services and goods to persons with cancer; and

     (c) Be approved to participate in the Program

pursuant to NAC 453B.085.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.565)

      NAC 453B.085  Submission of application to participate; written notice of

approval or denial by Board. (NRS 453B.230)

     1.  A pharmacy, medical facility, health

clinic or provider of health care that wishes to participate in the Program

must submit an application to the Board on a form prescribed by the Board.

     2.  The Board will review the application and

determine if the pharmacy, medical facility, health clinic or provider of

health care is qualified to participate in the Program.

     3.  If the Board approves a pharmacy, medical

facility, health clinic or provider of health care for participation in the

Program, the Board will provide written notice of its approval of the

application to the pharmacy, medical facility, health clinic or provider of

health care not later than 30 days after its decision.

     4.  If the Board denies a pharmacy, medical

facility, health clinic or provider of health care from participating in the

Program, the Board will provide written notice of its denial of the application

to the pharmacy, medical facility, health clinic or provider of health care not

later than 30 days after its decision.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.570)

      NAC 453B.090  Compliance with federal and state laws and regulations required. (NRS 453B.200, 453B.230)  A

pharmacy, medical facility, health clinic or provider of health care that

participates in the Program must comply with all applicable federal and state

laws and regulations when accepting, distributing and dispensing a cancer drug

pursuant to the Program.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.575)

Administration of Program; Fees

      NAC 453B.100  Board to establish and maintain registry of participants;

notification to Board of certain changes in information or status. (NRS 453B.230)

     1.  The Board will establish and maintain a

registry of pharmacies, medical facilities, health clinics and providers of

health care that participate in the Program, which must include, without

limitation, the name, address and telephone number of each pharmacy, medical

facility, health clinic and provider of health care that is authorized by the

Board to participate in the Program.

     2.  A pharmacy, medical facility, health

clinic or provider of health care must notify the Board, on a form prescribed

by the Board, if the pharmacy, medical facility, health clinic or provider of

health care:

     (a) Has a change in its name, address or telephone

number; or

     (b) No longer wishes to participate in the Program.

     3.  The Board will post the registry on the

Internet website maintained by the Board.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.580)

      NAC 453B.105  Donating, dispensing and storage of cancer drugs. (NRS 453B.230)

     1.  Except as otherwise required for the

storage of cancer drugs pursuant to subsection 3, a pharmacy, medical facility,

health clinic or provider of health care shall not limit the amount of cancer

drugs that a person may donate to the Program.

     2.  In addition to the requirements of NRS 453B.210, a pharmacist may

dispense a cancer drug to a person who is participating in the Program if:

     (a) The pharmacist has inspected the packaging of

the cancer drug to determine if the cancer drug meets the requirements of

subsection 4 of NRS 453B.200;

     (b) The person requesting the cancer drug presents

to the pharmacist the written notice of approval from the Board which states

that the person is approved to participate in the Program; and

     (c) The person requesting the cancer drug presents

to the pharmacist a prescription written by a person who is authorized to write

prescriptions.

     3.  A pharmacy, medical facility, health

clinic or provider of health care shall store a cancer drug that is donated to

the Program:

     (a) Pursuant to the recommendations of the

manufacturer of the cancer drug concerning the storage conditions;

     (b) Separately from all other drugs; and

     (c) In a locked storage area.

     4.  If a cancer drug that is donated to the

Program expires before it is dispensed, the pharmacy, medical facility, health

clinic or provider of health care shall destroy the cancer drug.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.585)

      NAC 453B.110  Restrictions on donated cancer drugs. (NRS 453B.230)

     1.  In addition to the requirements of NRS 453B.200, a cancer drug that

is donated to the Program:

     (a) Must not be a controlled substance.

     (b) Must not be a compounded drug product.

     (c) Must not be dispensed by a pharmacist if the

pharmacist suspects that the cancer drug is adulterated or misbranded.

     (d) Must not be dispensed by a pharmacist if, in

the professional judgment of the pharmacist, there is a reasonable concern

relating to the safety or efficacy of the cancer drug.

     (e) Must not require refrigeration or freezing or

other temperature requirements that are not a controlled room temperature.

     (f) Must not be a cancer drug for which a program

of restrictive distribution has been established by the manufacturer of the

cancer drug.

     (g) Must not be a cancer drug for which an ongoing

clinical trial or study is being conducted.

     (h) Must be a cancer drug that was dispensed

pursuant to an original prescription by a pharmacy licensed pursuant to chapter 639 of NRS.

     2.  As used in this section, “program of

restrictive distribution” means a program that is developed in collaboration

with the United States Food and Drug Administration by a manufacturer of a drug

to reduce the risks associated with that drug by limiting the persons who can

prescribe the drug and who can receive the drug.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.587)

      NAC 453B.115  Maintenance of records by pharmacy, medical facility, health

clinic or provider of health care that participates in Program. (NRS 453B.230)

     1.  In addition to the requirements of NRS 639.2801 and NAC 639.708, a pharmacy, medical facility,

health clinic or provider of health care that participates in the Program shall

maintain records for a cancer drug that is donated to the Program. The records

must include, without limitation:

     (a) The date the pharmacy, medical facility, health

clinic or provider of health care received the cancer drug;

     (b) The date the cancer drug was dispensed pursuant

to the original prescription;

     (c) The original prescription number of the cancer

drug;

     (d) The name of the cancer drug;

     (e) The dosage of the cancer drug;

     (f) The quantity of the cancer drug that is

donated;

     (g) The date of expiration of the cancer drug;

     (h) The name, address and telephone number of the

person who originally dispensed the cancer drug;

     (i) The name, address and telephone number of the

person who is donating the cancer drug; and

     (j) The lot number of the cancer drug.

     2.  A pharmacy, medical facility, health

clinic or provider of health care shall maintain records of a cancer drug that

is distributed to another pharmacy, medical facility, health clinic or provider

of health care that is participating in the Program. The records must include,

without limitation:

     (a) The information required pursuant to 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 cancer drug;

     (c) The quantity of the cancer drug that is being

distributed; and

     (d) The name and address of the pharmacy, medical

facility, health clinic or provider of health care to which the cancer drug is

distributed.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.590)

      NAC 453B.120  Handling fee. (NRS 453B.200, 453B.230)  A

pharmacy, medical facility, health clinic or provider of health care may charge

a handling fee of not more than $10 for distributing or dispensing a cancer

drug that is donated to the Program.

     (Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted

in revision for NAC 457.595)
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