(REPRINTED WITH ADOPTED AMENDMENTS)
SECOND REPRINT S.B. 544
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.
~
EXPLANATION
– Matter in bolded italics is new; matter
between brackets [omitted material] is material to be omitted.
Green numbers along left margin indicate location on the printed bill (e.g., 5-15 indicates page 5, line 15).
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 assistant who:
3-23 (a) Holds a license issued by the board of medical examiners; and
3-24 (b) Is authorized by the board to possess, administer, prescribe or
3-25 dispense controlled substances, poisons, dangerous drugs or devices under
3-26 the supervision of a physician as required by chapter 630 of NRS;[.]
3-27 5. An osteopathic physician’s assistant who:
3-28 (a) Holds a certificate issued by the state board of osteopathic medicine;
3-29 and
3-30 (b) Is authorized by the board to possess, administer, prescribe or
3-31 dispense controlled substances, poisons, dangerous drugs or devices under
3-32 the supervision of an osteopathic physician as required by chapter 633 of
3-33 NRS [.] ; or
3-34 6. An optometrist who is certified by the Nevada state board of
3-35 optometry to prescribe and administer therapeutic pharmaceutical agents
3-36 pursuant to NRS 636.288, when he prescribes or administers therapeutic
3-37 pharmaceutical agents within the scope of his certification.
3-38 Sec. 6. NRS 639.230 is hereby amended to read as follows:
3-39 639.230 1. A pharmacy or a person operating as a pharmacy shall
3-40 not use the word “drug” or “drugs,” “prescription” or “pharmacy,” or
3-41 similar words or words of similar import, without first having secured a
3-42 license from the board.
3-43 2. Each license must be issued to a specific person and for a specific
3-44 location and is not transferable. The original license must [show the name
3-45 of the owner and the name of the managing pharmacist and] be displayed
3-46 on the licensed premises as provided in NRS 639.150. [If the owner is a
3-47 partnership or corporation, the names of the partners or officers must also
3-48 be shown. Any change of partners or corporate officers must be
3-49 immediately reported to the board.] The original license and the fee
4-1 required for reissuance of a license must be submitted to the board before
4-2 the reissuance of the license.
4-3 3. If the owner of a pharmacy is a partnership or corporation, any
4-4 change of partners or corporate officers must be reported to the board at
4-5 such a time as is required by a regulation of the board.
4-6 4. In addition to the requirements for renewal set forth in NRS
4-7 639.180, every person holding a license to operate a pharmacy must satisfy
4-8 the board that the pharmacy is conducted according to law.
4-9 [4.] 5. Any violation of any of the provisions of this chapter by a
4-10 managing pharmacist or by personnel of the pharmacy under the
4-11 supervision of the managing pharmacist is cause for the suspension or
4-12 revocation of the license of the pharmacy by the board.
4-13 Sec. 7. NRS 639.2328 is hereby amended to read as follows:
4-14 639.2328 1. Every pharmacy located outside Nevada that provides
4-15 mail order service to or solicits or advertises for orders for drugs available
4-16 with a prescription from a resident of Nevada must be licensed by the
4-17 board.
4-18 2. To be licensed or to renew a license, such a pharmacy [located
4-19 outside Nevada] must:
4-20 (a) Be licensed as a pharmacy, or the equivalent, by the state or
4-21 country in which its dispensing facilities are located.
4-22 (b) Comply with all applicable federal laws, regulations and standards.
4-23 (c) Submit an application in the form furnished by the board.
4-24 (d) Provide the following information to the board:
4-25 (1) The name and address of the owner;
4-26 (2) The location of the pharmacy;
4-27 (3) The name of the pharmacist who is the managing pharmacist; and
4-28 (4) Any other information the board deems necessary.
4-29 (e) Pay the fee required by regulation of the board.
4-30 (f) Submit evidence satisfactory to the board that the facility, records
4-31 and operation of the pharmacy comply with the laws and regulations of the
4-32 state or country in which the pharmacy is located.
4-33 (g) Submit certification satisfactory to the board that the pharmacy
4-34 complies with all lawful requests and directions from the regulatory board
4-35 or licensing authority of the state or country in which the pharmacy is
4-36 located relating to the shipment, mailing or delivery of drugs.
4-37 3. In addition to the requirements of subsection 2, the board may
4-38 require [that the pharmacy located outside of Nevada] such a pharmacy to
4-39 be inspected by the board.
4-40 Sec. 8. NRS 639.23282 is hereby amended to read as follows:
4-41 639.23282 Before issuing a license to a pharmacy located outside [of
4-42 Nevada to provide] Nevada that provides mail order service to [residents]
4-43 a resident of Nevada, the board shall consider:
4-44 1. The qualifications and credentials of the applicant; and
4-45 2. Any suspension or revocation of a license or restriction on a license
4-46 held by the applicant.
4-47 Sec. 9. NRS 639.23284 is hereby amended to read as follows:
4-48 639.23284 Every pharmacy [that is] located outside Nevada [and] that
4-49 provides mail order service to a resident of Nevada:
5-1 1. Shall report to the board any change of information that appears on
5-2 its license and pay the fee required by regulation of the board.
5-3 2. Shall make available for inspection all pertinent records, reports,
5-4 documents or other material or information required by the board.
5-5 3. As required by the board, must be inspected by the board or:
5-6 (a) The regulatory board or licensing authority of the state or country in
5-7 which the pharmacy is located; or
5-8 (b) The Drug Enforcement Administration.
5-9 4. As required by the board, shall provide the following information
5-10 concerning each prescription for a drug that is shipped, mailed or delivered
5-11 to a resident of Nevada:
5-12 (a) The name of the patient;
5-13 (b) The name of the prescriber;
5-14 (c) The number of the prescription;
5-15 (d) The date of the prescription;
5-16 (e) The name of the drug; and
5-17 (f) The strength and quantity of the dose.
5-18 Sec. 10. NRS 639.23286 is hereby amended to read as follows:
5-19 639.23286 A pharmacy [that is] located outside Nevada [and] that
5-20 provides mail order service to a resident of Nevada:
5-21 1. May substitute a drug if the substitution is made in accordance with
5-22 the provisions of the laws and regulations of the state or country in which
5-23 the pharmacy is located.
5-24 2. Shall provide a toll-free telephone service for its customers to a
5-25 pharmacist who has access to the records of the customers from Nevada.
5-26 The telephone service must be available for not less than 5 days per week
5-27 and for at least 40 hours per week. The telephone number must be
5-28 disclosed on the label attached to each container of drugs dispensed to a
5-29 resident of Nevada.
5-30 Sec. 11. NRS 639.2353 is hereby amended to read as follows:
5-31 639.2353 Except as otherwise provided in a regulation adopted
5-32 pursuant to NRS 453.385:
5-33 1. A prescription must be given:
5-34 (a) Directly from the practitioner to a pharmacist;
5-35 (b) Indirectly by means of an order signed by the practitioner;
5-36 (c) By an oral order transmitted by an agent of the practitioner; or
5-37 (d) By electronic transmission or transmission by a facsimile machine
5-38 pursuant to the regulations of the board.
5-39 2. A written prescription must contain:
5-40 (a) [The] Except as otherwise provided in this section, the name and
5-41 signature of the practitioner, and his address if not immediately available to
5-42 the pharmacist;
5-43 (b) The classification of his license;
5-44 (c) [His registration number assigned by the Drug Enforcement
5-45 Administration if the prescription is for a controlled substance;
5-46 (d)] The name of the patient, and his address if not immediately
5-47 available to the pharmacist;
5-48 [(e)] (d) The name, strength and quantity of the drug or drugs
5-49 prescribed;
6-1 [(f)] (e) Directions for use; and
6-2 [(g)] (f) The date of issue.
6-3 3. The directions for use must be specific in that they indicate the
6-4 portion of the body to which the medication is to be applied or, if to be
6-5 taken into the body by means other than orally, the orifice or canal of the
6-6 body into which the medication is to be inserted or injected.
6-7 4. A prescription that is given by electronic transmission is not
6-8 required to contain the signature of the practitioner if:
6-9 (a) It contains a facsimile signature, security code or other mark that
6-10 uniquely identifies the practitioner; or
6-11 (b) A voice recognition system, biometric identification technique or
6-12 other security system approved by the board is used to identify the
6-13 practitioner.
6-14 5. Each written prescription must be written in such a manner that any
6-15 registered pharmacist would be able to dispense it. A prescription must be
6-16 written in Latin or English and may include any character, figure, cipher or
6-17 abbreviation which is generally used by pharmacists and practitioners in
6-18 the writing of prescriptions.
6-19 Sec. 12. NRS 639.255 is hereby amended to read as follows:
6-20 639.255 1. The holder of any certificate, license or permit issued by
6-21 the board, whose default has been entered or who has been heard by the
6-22 board and found guilty of the violations alleged in the accusation, may be
6-23 disciplined by the board by one or more of the following methods:
6-24 (a) Suspending judgment;
6-25 (b) Placing the certificate, license or permit holder on probation;
6-26 (c) Suspending the right of a certificate holder to practice, or the right to
6-27 use any license or permit, for a period [not to exceed 1 year;] to be
6-28 determined by the board;
6-29 (d) Revoking the certificate, license or permit;
6-30 (e) Public or private reprimand;
6-31 (f) Imposition of a fine [not to exceed $1,000] for each count of the
6-32 accusation [;] , in accordance with the schedule of fines established
6-33 pursuant to subsection 3; or
6-34 (g) Requiring the certificate, license or permit holder to pay all costs
6-35 and attorney’s fees incurred by the board relating to the discipline of the
6-36 person.
6-37 2. Such action by the board is final, except that the propriety of such
6-38 action is subject to review upon questions of law by a court of competent
6-39 jurisdiction.
6-40 3. The board shall by regulation establish a schedule of fines that
6-41 may be imposed pursuant to paragraph (f) of subsection 1. Each fine
6-42 must be commensurate with the severity of the applicable violation, but
6-43 must not exceed $10,000 for each violation.
6-44 Sec. 13. Section 2 of Senate Bill No. 52 of this session is hereby
6-45 amended to read as follows:
6-46 Sec. 2. NRS 639.0125 is hereby amended to read as follows:
6-47 639.0125 “Practitioner” means:
6-48 1. A physician, dentist, veterinarian or podiatric physician who
6-49 holds a [valid] license to practice his profession in this state;
7-1 2. A hospital, pharmacy or other institution licensed, registered or
7-2 otherwise permitted to distribute, dispense, conduct research with
7-3 respect to or administer drugs in the course of professional practice or
7-4 research in this state;
7-5 3. An advanced practitioner of nursing who has been authorized
7-6 to prescribe controlled substances, poisons, dangerous drugs and
7-7 devices;
7-8 4. A physician assistant who:
7-9 (a) Holds a license issued by the board of medical examiners; and
7-10 (b) Is authorized by the board to possess, administer, prescribe or
7-11 dispense controlled substances, poisons, dangerous drugs or devices
7-12 under the supervision of a physician as required by chapter 630 of
7-13 NRS;
7-14 5. An osteopathic physician’s assistant who:
7-15 (a) Holds a certificate issued by the state board of osteopathic
7-16 medicine; and
7-17 (b) Is authorized by the board to possess, administer, prescribe or
7-18 dispense controlled substances, poisons, dangerous drugs or devices
7-19 under the supervision of an osteopathic physician as required by
7-20 chapter 633 of NRS; or
7-21 6. An optometrist who is certified by the Nevada state board of
7-22 optometry to prescribe and administer therapeutic pharmaceutical
7-23 agents pursuant to NRS 636.288, when he prescribes or administers
7-24 therapeutic pharmaceutical agents within the scope of his certification.
7-25 Sec. 14. Section 81 of Senate Bill No. 91 of this session is hereby
7-26 repealed.
7-27 Sec. 15. 1. This section becomes effective upon passage and
7-28 approval.
7-29 2. Sections 1 and 12 of this act become effective upon passage and
7-30 approval for the purpose of adopting regulations and on October 1, 2001,
7-31 for all other purposes.
7-32 3. Sections 2, 3, 4, 6 to 10, inclusive, 13 and 14 of this act become
7-33 effective on July 1, 2001.
7-34 4. Section 5 of this act becomes effective at 12:01 a.m. on July 1,
7-35 2001.
7-36 5. Section 11 of this act becomes effective on October 1, 2001.
7-37 TEXT OF REPEALED SECTION
7-38 Section 81 of Senate Bill No. 91 of this session:
7-39 Sec. 81. Section 2 of Senate Bill No. 52 of this session is hereby
7-40 amended to read as follows:
7-41 Sec. 2. NRS 639.0125 is hereby amended to read as follows:
7-42 639.0125 “Practitioner” means:
7-43 1. A physician, dentist, veterinarian or podiatric physician who
7-44 holds a [valid] license to practice his profession in this state;
8-1 2. A hospital, pharmacy or other institution licensed, registered
8-2 or otherwise permitted to distribute, dispense, conduct research
8-3 with respect to or administer drugs in the course of professional
8-4 practice or research in this state;
8-5 3. An advanced practitioner of nursing who has been
8-6 authorized to prescribe controlled substances, poisons, dangerous
8-7 drugs and devices; or
8-8 4. A physician assistant who:
8-9 (a) Holds a license issued by the board of medical examiners;
8-10 and
8-11 (b) Is authorized by the board to possess, administer, prescribe
8-12 or dispense controlled substances, poisons, dangerous drugs or
8-13 devices under the supervision of a physician as required by chapter
8-14 630 of NRS.
8-15 5. An osteopathic physician’s assistant who:
8-16 (a) Holds a certificate issued by the state board of osteopathic
8-17 medicine; and
8-18 (b) Is authorized by the board to possess, administer, prescribe
8-19 or dispense controlled substances, poisons, dangerous drugs or
8-20 devices under the supervision of an osteopathic physician as
8-21 required by chapter 633 of NRS.
8-22 H