SB544_EN

Senate Bill No. 544–Committee on Human
Resources and Facilities

CHAPTER..........

AN ACT relating to the practice of pharmacy; requiring the state board of pharmacy to adopt requirements for the form, content and transmittal of prescriptions for controlled substances; clarifying the authority of the board to regulate pharmacies and wholesalers who offer services in this state via the Internet; revising the disciplinary action that may be taken by the board against the holder of a certificate, license or permit issued by the board; and providing other matters properly relating thereto.

THE PEOPLE OF THE STATE OF NEVADA, REPRESENTED IN

SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS:

Section 1. NRS 453.385 is hereby amended to read as follows:

453.385 1. Each prescription for a controlled substance [listed in

schedule II must be written on a separate prescription blank or as an order

on the chart of a patient. The chart of a patient may be used to order

multiple prescriptions for that patient.

2. A prescription for a controlled substance must contain:

(a) The name of the practitioner, his signature if the prescription was

not transmitted orally and his address if not immediately available to the

pharmacist;

(b) The classification of his license;

if it is not immediately available to the pharmacist;

(d) The name of the patient, and his address if not immediately

available to the pharmacist;

(e) The name, strength and quantity of the drug or drugs prescribed;

(f) Directions for use; and

(g) The date of issue.

3. A prescription for a controlled substance listed in:

(a) Schedule III, IV or V must be signed by the practitioner pursuant to

the regulations of the board and may be preprinted or written by an agent

of the practitioner, or may be transmitted electronically or by a facsimile

machine from the practitioner to a pharmacy pursuant to the regulations of

the board.

(b) Schedule II must be written and signed entirely by hand by the

practitioner who issued it, except that:

(1) The addresses of the patient and the practitioner may be added by

the pharmacist.

(2) The name of the practitioner, his address and the classification of

his license must be preprinted on the prescription form.

(3) The registration number of the practitioner assigned by the Drug

Enforcement Administration may be preprinted on the prescription form.

(4) The prescription may be transmitted by the practitioner or an

agent of the practitioner to a pharmacy by a facsimile machine if the

original written prescription is presented to the pharmacist for review

before the dispensing of the controlled substance, except that:

(I) If the controlled substance is to be compounded for the direct

administration to a patient by parenteral, intravenous, intramuscular,

subcutaneous or intraspinal infusion, the transmission from the facsimile

machine shall be deemed to be the original written prescription.

(II) If the controlled substance is prescribed for a resident of a

facility for long-term care, the transmission from the facsimile machine

shall be deemed to be the original written prescription and must be

maintained in accordance with 21 C.F.R. § 1304.04(h).

(5) If authorized by federal law, a prescription transmitted

electronically is not required to be written and signed entirely by hand by

the practitioner who issued the prescription.

4. Directions for use must be specific in that they must indicate the

portion of the body to which the medication is to be applied, or, if to be

taken into the body by means other than orally, the orifice or canal of the

body into which the medication is to be inserted or injected.] must comply

with the regulations of the board adopted pursuant to subsection 2.

2. The board shall, by regulation, adopt requirements for:

(a) The form and content of a prescription for a controlled substance.

The requirements may vary depending upon the schedule of the

controlled substance.

(b) Transmitting a prescription for a controlled substance to a

pharmacy. The requirements may vary depending upon the schedule of

the controlled substance.

for a patient in a medical facility and the requirements for keeping

records of such orders.

3. Except as otherwise provided in this subsection, the regulations

adopted pursuant to subsection 2 must ensure compliance with, but may

be more stringent than required by, applicable federal law governing

controlled substances and the rules, regulations and orders of any

federal agency administering such law. The regulations adopted

pursuant to paragraph (b) of subsection 2 for the electronic transmission

or transmission by a facsimile machine of a prescription for a controlled

substance must not be more stringent than federal law governing the

electronic transmission or transmission by a facsimile machine of a

prescription for a controlled substance or the rules, regulations or

orders of any federal agency administering such law.

Sec. 2. Chapter 639 of NRS is hereby amended by adding thereto the

provisions set forth as sections 3 and 4 of this act.

Sec. 3. 1. The board shall adopt such regulations as are necessary

for the safe and efficient operation of pharmacies and wholesalers that

offer their services to persons in this state via the Internet.

2. For the purposes of this section, “pharmacy” includes any person

who sells or offers to sell drugs to persons in this state via the Internet.

Sec. 4. For the purposes of NRS 639.2328 to 639.23286, inclusive, a

“pharmacy located outside Nevada that provides mail order service to a

resident of Nevada” includes any person who sells or offers to sell drugs

to persons in this state via the Internet.

Sec. 5. NRS 639.0125 is hereby amended to read as follows:

639.0125 “Practitioner” means:

1. A physician, dentist, veterinarian or podiatric physician who holds a

valid license to practice his profession in this state;

2. A hospital, pharmacy or other institution licensed, registered or

otherwise permitted to distribute, dispense, conduct research with respect

to or administer drugs in the course of professional practice or research in

this state;

3. An advanced practitioner of nursing who has been authorized to

prescribe poisons, dangerous drugs and devices; [or]

4. A physician assistant who:

(a) Holds a license issued by the board of medical examiners; and

(b) Is authorized by the board to possess, administer, prescribe or

dispense controlled substances, poisons, dangerous drugs or devices under

the supervision of a physician as required by chapter 630 of NRS;[.]

5. An osteopathic physician’s assistant who:

(a) Holds a certificate issued by the state board of osteopathic medicine;

and

(b) Is authorized by the board to possess, administer, prescribe or

dispense controlled substances, poisons, dangerous drugs or devices under

the supervision of an osteopathic physician as required by chapter 633 of

NRS [.] ; or

6. An optometrist who is certified by the Nevada state board of

optometry to prescribe and administer therapeutic pharmaceutical

agents pursuant to NRS 636.288, when he prescribes or administers

therapeutic pharmaceutical agents within the scope of his certification.

Sec. 6. NRS 639.230 is hereby amended to read as follows:

639.230 1. A pharmacy or a person operating as a pharmacy shall

not use the word “drug” or “drugs,” “prescription” or “pharmacy,” or

similar words or words of similar import, without first having secured a

license from the board.

2. Each license must be issued to a specific person and for a specific

location and is not transferable. The original license must [show the name

of the owner and the name of the managing pharmacist and] be displayed

on the licensed premises as provided in NRS 639.150. [If the owner is a

partnership or corporation, the names of the partners or officers must also

be shown. Any change of partners or corporate officers must be

immediately reported to the board.] The original license and the fee

required for reissuance of a license must be submitted to the board before

the reissuance of the license.

3. If the owner of a pharmacy is a partnership or corporation, any

change of partners or corporate officers must be reported to the board at

such a time as is required by a regulation of the board.

4. In addition to the requirements for renewal set forth in NRS

639.180, every person holding a license to operate a pharmacy must

satisfy the board that the pharmacy is conducted according to law.

[4.] 5. Any violation of any of the provisions of this chapter by a

managing pharmacist or by personnel of the pharmacy under the

supervision of the managing pharmacist is cause for the suspension or

revocation of the license of the pharmacy by the board.

Sec. 7. NRS 639.2328 is hereby amended to read as follows:

639.2328 1. Every pharmacy located outside Nevada that provides

mail order service to or solicits or advertises for orders for drugs available

with a prescription from a resident of Nevada must be licensed by the

board.

2. To be licensed or to renew a license, such a pharmacy [located

outside Nevada] must:

(a) Be licensed as a pharmacy, or the equivalent, by the state or

country in which its dispensing facilities are located.

(b) Comply with all applicable federal laws, regulations and standards.

(d) Provide the following information to the board:

(1) The name and address of the owner;

(2) The location of the pharmacy;

(3) The name of the pharmacist who is the managing pharmacist; and

(4) Any other information the board deems necessary.

(e) Pay the fee required by regulation of the board.

(f) Submit evidence satisfactory to the board that the facility, records

and operation of the pharmacy comply with the laws and regulations of the

state or country in which the pharmacy is located.

(g) Submit certification satisfactory to the board that the pharmacy

complies with all lawful requests and directions from the regulatory board

or licensing authority of the state or country in which the pharmacy is

located relating to the shipment, mailing or delivery of drugs.

3. In addition to the requirements of subsection 2, the board may

require [that the pharmacy located outside of Nevada] such a pharmacy to

be inspected by the board.

Sec. 8. NRS 639.23282 is hereby amended to read as follows:

639.23282 Before issuing a license to a pharmacy located outside [of

Nevada to provide] Nevada that provides mail order service to [residents]

a resident of Nevada, the board shall consider:

1. The qualifications and credentials of the applicant; and

2. Any suspension or revocation of a license or restriction on a license

held by the applicant.

Sec. 9. NRS 639.23284 is hereby amended to read as follows:

639.23284 Every pharmacy [that is] located outside Nevada [and] that

provides mail order service to a resident of Nevada:

1. Shall report to the board any change of information that appears on

its license and pay the fee required by regulation of the board.

2. Shall make available for inspection all pertinent records, reports,

documents or other material or information required by the board.

3. As required by the board, must be inspected by the board or:

(a) The regulatory board or licensing authority of the state or country in

which the pharmacy is located; or

(b) The Drug Enforcement Administration.

4. As required by the board, shall provide the following information

concerning each prescription for a drug that is shipped, mailed or

delivered to a resident of Nevada:

(a) The name of the patient;

(b) The name of the prescriber;

(d) The date of the prescription;

(e) The name of the drug; and

(f) The strength and quantity of the dose.

Sec. 10. NRS 639.23286 is hereby amended to read as follows:

639.23286 A pharmacy [that is] located outside Nevada [and] that

provides mail order service to a resident of Nevada:

1. May substitute a drug if the substitution is made in accordance with

the provisions of the laws and regulations of the state or country in which

the pharmacy is located.

2. Shall provide a toll-free telephone service for its customers to a

pharmacist who has access to the records of the customers from Nevada.

The telephone service must be available for not less than 5 days per week

and for at least 40 hours per week. The telephone number must be

disclosed on the label attached to each container of drugs dispensed to a

resident of Nevada.

Sec. 11. NRS 639.2353 is hereby amended to read as follows:

639.2353 Except as otherwise provided in a regulation adopted

pursuant to NRS 453.385:

1. A prescription must be given:

(a) Directly from the practitioner to a pharmacist;

(b) Indirectly by means of an order signed by the practitioner;

(d) Except as otherwise provided in subsection 5, by electronic

transmission or transmission by a facsimile machine, including, without

limitation, transmissions made from a facsimile machine to another

facsimile machine, a computer equipped with a facsimile modem to a

facsimile machine or a computer to another computer, pursuant to the

regulations of the board.

2. A written prescription must contain:

(a) [The] Except as otherwise provided in this section, the name and

signature of the practitioner, and his address if not immediately available

to the pharmacist;

(b) The classification of his license;

Administration if the prescription is for a controlled substance;

(d)] The name of the patient, and his address if not immediately

available to the pharmacist;

[(e)] (d) The name, strength and quantity of the drug or drugs

prescribed;

[(f)] (e) Directions for use; and

[(g)] (f) The date of issue.

3. The directions for use must be specific in that they indicate the

portion of the body to which the medication is to be applied or, if to be

taken into the body by means other than orally, the orifice or canal of the

body into which the medication is to be inserted or injected.

4. Each written prescription must be written in such a manner that any

registered pharmacist would be able to dispense it. A prescription must be

written in Latin or English and may include any character, figure, cipher

or abbreviation which is generally used by pharmacists and practitioners in

the writing of prescriptions.

5. A prescription for a controlled substance must not be given by

electronic transmission or transmission by a facsimile machine unless

authorized by federal law.

6. A prescription that is given by electronic transmission is not

required to contain the signature of the practitioner if:

(a) It contains a facsimile signature, security code or other mark that

uniquely identifies the practitioner; or

(b) A voice recognition system, biometric identification technique or

other security system approved by the board is used to identify the

practitioner.

Sec. 12. NRS 639.255 is hereby amended to read as follows:

639.255 1. The holder of any certificate, license or permit issued by

the board, whose default has been entered or who has been heard by the

board and found guilty of the violations alleged in the accusation, may be

disciplined by the board by one or more of the following methods:

(a) Suspending judgment;

(b) Placing the certificate, license or permit holder on probation;

use any license or permit, for a period [not to exceed 1 year;] to be

determined by the board;

(d) Revoking the certificate, license or permit;

(e) Public reprimand;

(f) Imposition of a fine [not to exceed $1,000] for each count of the

accusation [;] , in accordance with the schedule of fines established

pursuant to subsection 3; or

(g) Requiring the certificate, license or permit holder to pay all costs

and attorney’s fees incurred by the board relating to the discipline of the

person.

2. Such action by the board is final, except that the propriety of such

action is subject to review upon questions of law by a court of competent

jurisdiction.

3. The board shall by regulation establish a schedule of fines that

may be imposed pursuant to paragraph (f) of subsection 1. Each fine

must be commensurate with the severity of the applicable violation, but

must not exceed $10,000 for each violation.

Sec. 13. Section 2 of Assembly Bill No. 415 of this session is hereby

amended to read as follows:

Sec. 2. NRS 639.0745 is hereby amended to read as follows:

639.0745 1. The board may adopt regulations concerning[:

(a) The] the transfer of information between pharmacies relating to

prescriptions.

[(b)] 2. The board shall adopt regulations concerning the

electronic transmission and the transmission by a facsimile machine

of a prescription from a practitioner to a pharmacist for the

dispensing of a drug.

[2.] The regulations must establish procedures to:

(a) Ensure the security and confidentiality of the data that is

transmitted between:

(1) The practitioner and the pharmacy;

(2) The practitioner and an insurer of the person for whom the

prescription is issued; and

(3) The pharmacy and an insurer of the person for whom the

prescription is issued.

(b) Protect the identity of the practitioner to prevent misuse of the

identity of the practitioner or other fraudulent conduct related to

the electronic transmission of a prescription.

(1) By the computer or other electronic device; or

(2) Manually by the practitioner.

3. The board shall adopt regulations governing the exchange of

information between pharmacists and practitioners relating to

prescriptions filled by the pharmacists for persons who are suspected

of:

(a) Misusing prescriptions to obtain excessive amounts of drugs.

(b) Failing to use a drug in conformity with the directions for its

use or taking a drug in combination with other drugs in a manner that

could result in injury to that person.

The pharmacists and practitioners shall maintain the confidentiality of

the information exchanged pursuant to this subsection.

Sec. 14. Section 2 of Senate Bill No. 52 of this session is hereby

amended to read as follows:

Sec. 2. NRS 639.0125 is hereby amended to read as follows:

639.0125 “Practitioner” means:

1. A physician, dentist, veterinarian or podiatric physician who

holds a [valid] license to practice his profession in this state;

2. A hospital, pharmacy or other institution licensed, registered or

otherwise permitted to distribute, dispense, conduct research with

respect to or administer drugs in the course of professional practice or

research in this state;

3. An advanced practitioner of nursing who has been authorized

to prescribe controlled substances, poisons, dangerous drugs and

devices;

4. A physician assistant who:

(a) Holds a license issued by the board of medical examiners; and

(b) Is authorized by the board to possess, administer, prescribe or

dispense controlled substances, poisons, dangerous drugs or devices

under the supervision of a physician as required by chapter 630 of

NRS;

5. An osteopathic physician’s assistant who:

(a) Holds a certificate issued by the state board of osteopathic

medicine; and

(b) Is authorized by the board to possess, administer, prescribe or

dispense controlled substances, poisons, dangerous drugs or devices

under the supervision of an osteopathic physician as required by

chapter 633 of NRS; or

6. An optometrist who is certified by the Nevada state board of

optometry to prescribe and administer therapeutic pharmaceutical

agents pursuant to NRS 636.288, when he prescribes or administers

therapeutic pharmaceutical agents within the scope of his

certification.

Sec. 15. Section 81 of Senate Bill No. 91 of this session is hereby

repealed.

Sec. 16. 1. This section and section 15 of this act become effective

upon passage and approval.

2. Sections 1 and 12 of this act become effective upon passage and

approval for the purpose of adopting regulations and at 12:01 a.m. on

October 1, 2001, for all other purposes.

3. Sections 2, 3, 4 and 6 to 10, inclusive, of this act become effective

on July 1, 2001.

4. Section 5 of this act becomes effective at 12:01 a.m. on July 1,

2001.

5. Section 14 of this act becomes effective at 12:02 a.m. on July 1,

2001.

6. Sections 11 and 13 of this act become effective at 12:01 a.m. on

October 1, 2001.

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