(REPRINTED WITH ADOPTED AMENDMENTS)

 

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

 

(On Behalf of Pharmacy Board)

 

March 26, 2001

____________

 

Referred to Committee on Commerce and Labor

 

SUMMARY—Makes various changes to provisions governing practice of pharmacy. (BDR 40‑400)

 

FISCAL NOTE:    Effect on Local Government: No.

                                 Effect on the State: No.

 

~

 

EXPLANATION – Matter in bolded italics is new; matter between brackets [omitted material] is material to be omitted.

 

AN ACT relating to the practice of pharmacy; authorizing 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:

 

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

1-2    453.385  1.  Each prescription for a controlled substance [listed in

1-3  schedule II must be written on a separate prescription blank or as an order

1-4  on the chart of a patient. The chart of a patient may be used to order

1-5  multiple prescriptions for that patient.

1-6    2.  A prescription for a controlled substance must contain:

1-7    (a) The name of the practitioner, his signature if the prescription was

1-8  not transmitted orally and his address if not immediately available to the

1-9  pharmacist;

1-10    (b) The classification of his license;

1-11    (c) His registration number from the Drug Enforcement Administration

1-12  if it is not immediately available to the pharmacist;

1-13    (d) The name of the patient, and his address if not immediately

1-14  available to the pharmacist;

1-15    (e) The name, strength and quantity of the drug or drugs prescribed;

1-16    (f) Directions for use; and

2-1    (g) The date of issue.

2-2    3.  A prescription for a controlled substance listed in:

2-3    (a) Schedule III, IV or V must be signed by the practitioner pursuant to

2-4  the regulations of the board and may be preprinted or written by an agent

2-5  of the practitioner, or may be transmitted electronically or by a facsimile

2-6  machine from the practitioner to a pharmacy pursuant to the regulations of

2-7  the board.

2-8    (b) Schedule II must be written and signed entirely by hand by the

2-9  practitioner who issued it, except that:

2-10      (1) The addresses of the patient and the practitioner may be added by

2-11  the pharmacist.

2-12      (2) The name of the practitioner, his address and the classification of

2-13  his license must be preprinted on the prescription form.

2-14      (3) The registration number of the practitioner assigned by the Drug

2-15  Enforcement Administration may be preprinted on the prescription form.

2-16      (4) The prescription may be transmitted by the practitioner or an

2-17  agent of the practitioner to a pharmacy by a facsimile machine if the

2-18  original written prescription is presented to the pharmacist for review

2-19  before the dispensing of the controlled substance, except that:

2-20          (I) If the controlled substance is to be compounded for the direct

2-21  administration to a patient by parenteral, intravenous, intramuscular,

2-22  subcutaneous or intraspinal infusion, the transmission from the facsimile

2-23  machine shall be deemed to be the original written prescription.

2-24          (II) If the controlled substance is prescribed for a resident of a

2-25  facility for long-term care, the transmission from the facsimile machine

2-26  shall be deemed to be the original written prescription and must be

2-27  maintained in accordance with 21 C.F.R. § 1304.04(h).

2-28    4.  Directions for use must be specific in that they must indicate the

2-29  portion of the body to which the medication is to be applied, or, if to be

2-30  taken into the body by means other than orally, the orifice or canal of the

2-31  body into which the medication is to be inserted or injected.] must comply

2-32  with the regulations of the board adopted pursuant to subsection 2.

2-33    2.  The board shall, by regulation, adopt requirements for:

2-34    (a) The form and content of a prescription for a controlled substance.

2-35  The requirements may vary depending upon the schedule of the

2-36  controlled substance.

2-37    (b) Transmitting a prescription for a controlled substance to a

2-38  pharmacy. The requirements may vary depending upon the schedule of

2-39  the controlled substance.

2-40    (c) The form and contents of an order for a controlled substance given

2-41  for a patient in a medical facility and the requirements for keeping

2-42  records of such orders.

2-43    3.  The regulations adopted pursuant to subsection 2 must ensure

2-44  compliance with, but may be more stringent than required by, applicable

2-45  federal law governing controlled substances and the rules, regulations

2-46  and orders of any federal agency administering such law.

 

 

 

3-1    Sec. 2.  Chapter 639 of NRS is hereby amended by adding thereto the

3-2  provisions set forth as sections 3 and 4 of this act.

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

3-4  for the safe and efficient operation of pharmacies and wholesalers that

3-5  offer their services to persons in this state via the Internet.

3-6    2.  For the purposes of this section, “pharmacy” includes any person

3-7  who sells or offers to sell drugs to persons in this state via the Internet.

3-8    Sec. 4.  For the purposes of NRS 639.2328 to 639.23286, inclusive, a

3-9  “pharmacy located outside Nevada that provides mail order service to a

3-10  resident of Nevada” includes any person who sells or offers to sell drugs

3-11  to persons in this state via the Internet.

3-12    Sec. 5.  NRS 639.0125 is hereby amended to read as follows:

3-13    639.0125  “Practitioner” means:

3-14    1.  A physician, dentist, veterinarian or podiatric physician who holds a

3-15  valid license to practice his profession in this state;

3-16    2.  A hospital, pharmacy or other institution licensed, registered or

3-17  otherwise permitted to distribute, dispense, conduct research with respect

3-18  to or administer drugs in the course of professional practice or research in

3-19  this state;

3-20    3.  An advanced practitioner of nursing who has been authorized to

3-21  prescribe poisons, dangerous drugs and devices; [or]

3-22    4.  A physician’s assistant who:

3-23    (a) Holds a license issued by the board of medical examiners or

3-24  certificate issued by the state board of osteopathic medicine; and

3-25    (b) Is authorized by the board to possess, administer, prescribe or

3-26  dispense controlled substances, poisons, dangerous drugs or devices under

3-27  the supervision of a physician or osteopathic physician as required by

3-28  chapter 630 or 633 of NRS[.] ; or

3-29    5.  An optometrist who is certified by the Nevada state board of

3-30  optometry to prescribe and administer therapeutic pharmaceutical agents

3-31  pursuant to NRS 636.288, when he prescribes or administers therapeutic

3-32  pharmaceutical agents within the scope of his certification.

3-33    Sec. 6.  NRS 639.230 is hereby amended to read as follows:

3-34    639.230  1.  A pharmacy or a person operating as a pharmacy shall

3-35  not use the word “drug” or “drugs,” “prescription” or “pharmacy,” or

3-36  similar words or words of similar import, without first having secured a

3-37  license from the board.

3-38    2.  Each license must be issued to a specific person and for a specific

3-39  location and is not transferable. The original license must [show the name

3-40  of the owner and the name of the managing pharmacist and] be displayed

3-41  on the licensed premises as provided in NRS 639.150. [If the owner is a

3-42  partnership or corporation, the names of the partners or officers must also

3-43  be shown. Any change of partners or corporate officers must be

3-44  immediately reported to the board.] The original license and the fee

3-45  required for reissuance of a license must be submitted to the board before

3-46  the reissuance of the license.

3-47    3.  If the owner of a pharmacy is a partnership or corporation, any

3-48  change of partners or corporate officers must be reported to the board at

3-49  such a time as is required by a regulation of the board.

4-1    4.  In addition to the requirements for renewal set forth in NRS

4-2  639.180, every person holding a license to operate a pharmacy must satisfy

4-3  the board that the pharmacy is conducted according to law.

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

4-5  managing pharmacist or by personnel of the pharmacy under the

4-6  supervision of the managing pharmacist is cause for the suspension or

4-7  revocation of the license of the pharmacy by the board.

4-8    Sec. 7.  NRS 639.2328 is hereby amended to read as follows:

4-9    639.2328  1.  Every pharmacy located outside Nevada that provides

4-10  mail order service to or solicits or advertises for orders for drugs available

4-11  with a prescription from a resident of Nevada must be licensed by the

4-12  board.

4-13    2.  To be licensed or to renew a license, such a pharmacy [located

4-14  outside Nevada] must:

4-15    (a) Be licensed as a pharmacy, or the equivalent, by the state or

4-16  country in which its dispensing facilities are located.

4-17    (b) Comply with all applicable federal laws, regulations and standards.

4-18    (c) Submit an application in the form furnished by the board.

4-19    (d) Provide the following information to the board:

4-20      (1) The name and address of the owner;

4-21      (2) The location of the pharmacy;

4-22      (3) The name of the pharmacist who is the managing pharmacist; and

4-23      (4) Any other information the board deems necessary.

4-24    (e) Pay the fee required by regulation of the board.

4-25    (f) Submit evidence satisfactory to the board that the facility, records

4-26  and operation of the pharmacy comply with the laws and regulations of the

4-27  state or country in which the pharmacy is located.

4-28    (g) Submit certification satisfactory to the board that the pharmacy

4-29  complies with all lawful requests and directions from the regulatory board

4-30  or licensing authority of the state or country in which the pharmacy is

4-31  located relating to the shipment, mailing or delivery of drugs.

4-32    3.  In addition to the requirements of subsection 2, the board may

4-33  require [that the pharmacy located outside of Nevada] such a pharmacy to

4-34  be inspected by the board.

4-35    Sec. 8.  NRS 639.23282 is hereby amended to read as follows:

4-36    639.23282  Before issuing a license to a pharmacy located outside [of

4-37  Nevada to provide] Nevada that provides mail order service to [residents]

4-38  a resident of Nevada, the board shall consider:

4-39    1.  The qualifications and credentials of the applicant; and

4-40    2.  Any suspension or revocation of a license or restriction on a license

4-41  held by the applicant.

4-42    Sec. 9.  NRS 639.23284 is hereby amended to read as follows:

4-43    639.23284  Every pharmacy [that is] located outside Nevada [and] that

4-44  provides mail order service to a resident of Nevada:

4-45    1.  Shall report to the board any change of information that appears on

4-46  its license and pay the fee required by regulation of the board.

4-47    2.  Shall make available for inspection all pertinent records, reports,

4-48  documents or other material or information required by the board.

4-49    3.  As required by the board, must be inspected by the board or:

5-1    (a) The regulatory board or licensing authority of the state or country in

5-2  which the pharmacy is located; or

5-3    (b) The Drug Enforcement Administration.

5-4    4.  As required by the board, shall provide the following information

5-5  concerning each prescription for a drug that is shipped, mailed or delivered

5-6  to a resident of Nevada:

5-7    (a) The name of the patient;

5-8    (b) The name of the prescriber;

5-9    (c) The number of the prescription;

5-10    (d) The date of the prescription;

5-11    (e) The name of the drug; and

5-12    (f) The strength and quantity of the dose.

5-13    Sec. 10.  NRS 639.23286 is hereby amended to read as follows:

5-14    639.23286  A pharmacy [that is] located outside Nevada [and] that

5-15  provides mail order service to a resident of Nevada:

5-16    1.  May substitute a drug if the substitution is made in accordance with

5-17  the provisions of the laws and regulations of the state or country in which

5-18  the pharmacy is located.

5-19    2.  Shall provide a toll-free telephone service for its customers to a

5-20  pharmacist who has access to the records of the customers from Nevada.

5-21  The telephone service must be available for not less than 5 days per week

5-22  and for at least 40 hours per week. The telephone number must be

5-23  disclosed on the label attached to each container of drugs dispensed to a

5-24  resident of Nevada.

5-25    Sec. 11.  NRS 639.2353 is hereby amended to read as follows:

5-26    639.2353  Except as otherwise provided in a regulation adopted

5-27  pursuant to NRS 453.385:

5-28    1.  A prescription must be given:

5-29    (a) Directly from the practitioner to a pharmacist;

5-30    (b) Indirectly by means of an order signed by the practitioner;

5-31    (c) By an oral order transmitted by an agent of the practitioner; or

5-32    (d) By electronic transmission or transmission by a facsimile machine

5-33  pursuant to the regulations of the board.

5-34    2.  A written prescription must contain:

5-35    (a) [The] Except as otherwise provided in this section, the name and

5-36  signature of the practitioner, and his address if not immediately available to

5-37  the pharmacist;

5-38    (b) The classification of his license;

5-39    (c) [His registration number assigned by the Drug Enforcement

5-40  Administration if the prescription is for a controlled substance;

5-41    (d)] The name of the patient, and his address if not immediately

5-42  available to the pharmacist;

5-43    [(e)] (d) The name, strength and quantity of the drug or drugs

5-44  prescribed;

5-45    [(f)] (e) Directions for use; and

5-46    [(g)] (f) The date of issue.

5-47    3.  The directions for use must be specific in that they indicate the

5-48  portion of the body to which the medication is to be applied or, if to be

6-1  taken into the body by means other than orally, the orifice or canal of the

6-2  body into which the medication is to be inserted or injected.

6-3    4.  A prescription that is given by electronic transmission is not

6-4  required to contain the signature of the practitioner if:

6-5    (a) It contains a facsimile signature, security code or other mark that

6-6  uniquely identifies the practitioner; or

6-7    (b) A voice recognition system, biometric identification technique or

6-8  other security system approved by the board is used to identify the

6-9  practitioner.

6-10    5.  Each written prescription must be written in such a manner that any

6-11  registered pharmacist would be able to dispense it. A prescription must be

6-12  written in Latin or English and may include any character, figure, cipher or

6-13  abbreviation which is generally used by pharmacists and practitioners in

6-14  the writing of prescriptions.

6-15    Sec. 12.  NRS 639.255 is hereby amended to read as follows:

6-16    639.255  1.  The holder of any certificate, license or permit issued by

6-17  the board, whose default has been entered or who has been heard by the

6-18  board and found guilty of the violations alleged in the accusation, may be

6-19  disciplined by the board by one or more of the following methods:

6-20    (a) Suspending judgment;

6-21    (b) Placing the certificate, license or permit holder on probation;

6-22    (c) Suspending the right of a certificate holder to practice, or the right to

6-23  use any license or permit, for a period [not to exceed 1 year;] to be

6-24  determined by the board;

6-25    (d) Revoking the certificate, license or permit;

6-26    (e) Public or private reprimand;

6-27    (f) Imposition of a fine [not to exceed $1,000] for each count of the

6-28  accusation [;] , in accordance with the schedule of fines established

6-29  pursuant to subsection 3; or

6-30    (g) Requiring the certificate, license or permit holder to pay all costs

6-31  and attorney’s fees incurred by the board relating to the discipline of the

6-32  person.

6-33    2.  Such action by the board is final, except that the propriety of such

6-34  action is subject to review upon questions of law by a court of competent

6-35  jurisdiction.

6-36    3.  The board shall by regulation establish a schedule of fines that

6-37  may be imposed pursuant to paragraph (f) of subsection 1. Each fine

6-38  must be commensurate with the severity of the applicable violation, but

6-39  must not exceed $10,000 for each violation.

6-40    Sec. 13.  1.  This section becomes effective upon passage and

6-41  approval.

6-42    2.  Sections 1 and 12 of this act become effective upon passage and

6-43  approval for the purpose of adopting regulations and on October 1, 2001,

6-44  for all other purposes.

6-45    3.  Sections 2 to 10, inclusive, of this act become effective on July 1,

6-46  2001.

6-47    4.  Section 11 of this act becomes effective on October 1, 2001.

 

6-48  H