(REPRINTED WITH ADOPTED AMENDMENTS)
THIRD 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; 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:
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 (5) If authorized by federal law, a prescription transmitted
2-29 electronically is not required to be written and signed entirely by hand by
2-30 the practitioner who issued the prescription.
2-31 4. Directions for use must be specific in that they must indicate the
2-32 portion of the body to which the medication is to be applied, or, if to be
2-33 taken into the body by means other than orally, the orifice or canal of the
2-34 body into which the medication is to be inserted or injected.] must comply
2-35 with the regulations of the board adopted pursuant to subsection 2.
2-36 2. The board shall, by regulation, adopt requirements for:
2-37 (a) The form and content of a prescription for a controlled substance.
2-38 The requirements may vary depending upon the schedule of the
2-39 controlled substance.
2-40 (b) Transmitting a prescription for a controlled substance to a
2-41 pharmacy. The requirements may vary depending upon the schedule of
2-42 the controlled substance.
2-43 (c) The form and contents of an order for a controlled substance given
2-44 for a patient in a medical facility and the requirements for keeping
2-45 records of such orders.
2-46 3. Except as otherwise provided in this subsection, the regulations
2-47 adopted pursuant to subsection 2 must ensure compliance with, but may
2-48 be more stringent than required by, applicable federal law governing
2-49 controlled substances and the rules, regulations and orders of any
3-1 federal agency administering such law. The regulations adopted
3-2 pursuant to paragraph (b) of subsection 2 for the electronic transmission
3-3 or transmission by a facsimile machine of a prescription for a controlled
3-4 substance must not be more stringent than federal law governing the
3-5 electronic transmission or transmission by a facsimile machine of a
3-6 prescription for a controlled substance or the rules, regulations or orders
3-7 of any federal agency administering such law.
3-8 Sec. 2. Chapter 639 of NRS is hereby amended by adding thereto the
3-9 provisions set forth as sections 3 and 4 of this act.
3-10 Sec. 3. 1. The board shall adopt such regulations as are necessary
3-11 for the safe and efficient operation of pharmacies and wholesalers that
3-12 offer their services to persons in this state via the Internet.
3-13 2. For the purposes of this section, “pharmacy” includes any person
3-14 who sells or offers to sell drugs to persons in this state via the Internet.
3-15 Sec. 4. For the purposes of NRS 639.2328 to 639.23286, inclusive, a
3-16 “pharmacy located outside Nevada that provides mail order service to a
3-17 resident of Nevada” includes any person who sells or offers to sell drugs
3-18 to persons in this state via the Internet.
3-19 Sec. 5. NRS 639.0125 is hereby amended to read as follows:
3-20 639.0125 “Practitioner” means:
3-21 1. A physician, dentist, veterinarian or podiatric physician who holds a
3-22 valid license to practice his profession in this state;
3-23 2. A hospital, pharmacy or other institution licensed, registered or
3-24 otherwise permitted to distribute, dispense, conduct research with respect
3-25 to or administer drugs in the course of professional practice or research in
3-26 this state;
3-27 3. An advanced practitioner of nursing who has been authorized to
3-28 prescribe poisons, dangerous drugs and devices; [or]
3-29 4. A physician assistant who:
3-30 (a) Holds a license issued by the board of medical examiners; and
3-31 (b) Is authorized by the board to possess, administer, prescribe or
3-32 dispense controlled substances, poisons, dangerous drugs or devices under
3-33 the supervision of a physician as required by chapter 630 of NRS;[.]
3-34 5. An osteopathic physician’s assistant who:
3-35 (a) Holds a certificate issued by the state board of osteopathic medicine;
3-36 and
3-37 (b) Is authorized by the board to possess, administer, prescribe or
3-38 dispense controlled substances, poisons, dangerous drugs or devices under
3-39 the supervision of an osteopathic physician as required by chapter 633 of
3-40 NRS [.] ; or
3-41 6. An optometrist who is certified by the Nevada state board of
3-42 optometry to prescribe and administer therapeutic pharmaceutical agents
3-43 pursuant to NRS 636.288, when he prescribes or administers therapeutic
3-44 pharmaceutical agents within the scope of his certification.
3-45 Sec. 6. NRS 639.230 is hereby amended to read as follows:
3-46 639.230 1. A pharmacy or a person operating as a pharmacy shall
3-47 not use the word “drug” or “drugs,” “prescription” or “pharmacy,” or
3-48 similar words or words of similar import, without first having secured a
3-49 license from the board.
4-1 2. Each license must be issued to a specific person and for a specific
4-2 location and is not transferable. The original license must [show the name
4-3 of the owner and the name of the managing pharmacist and] be displayed
4-4 on the licensed premises as provided in NRS 639.150. [If the owner is a
4-5 partnership or corporation, the names of the partners or officers must also
4-6 be shown. Any change of partners or corporate officers must be
4-7 immediately reported to the board.] The original license and the fee
4-8 required for reissuance of a license must be submitted to the board before
4-9 the reissuance of the license.
4-10 3. If the owner of a pharmacy is a partnership or corporation, any
4-11 change of partners or corporate officers must be reported to the board at
4-12 such a time as is required by a regulation of the board.
4-13 4. In addition to the requirements for renewal set forth in NRS
4-14 639.180, every person holding a license to operate a pharmacy must satisfy
4-15 the board that the pharmacy is conducted according to law.
4-16 [4.] 5. Any violation of any of the provisions of this chapter by a
4-17 managing pharmacist or by personnel of the pharmacy under the
4-18 supervision of the managing pharmacist is cause for the suspension or
4-19 revocation of the license of the pharmacy by the board.
4-20 Sec. 7. NRS 639.2328 is hereby amended to read as follows:
4-21 639.2328 1. Every pharmacy located outside Nevada that provides
4-22 mail order service to or solicits or advertises for orders for drugs available
4-23 with a prescription from a resident of Nevada must be licensed by the
4-24 board.
4-25 2. To be licensed or to renew a license, such a pharmacy [located
4-26 outside Nevada] must:
4-27 (a) Be licensed as a pharmacy, or the equivalent, by the state or
4-28 country in which its dispensing facilities are located.
4-29 (b) Comply with all applicable federal laws, regulations and standards.
4-30 (c) Submit an application in the form furnished by the board.
4-31 (d) Provide the following information to the board:
4-32 (1) The name and address of the owner;
4-33 (2) The location of the pharmacy;
4-34 (3) The name of the pharmacist who is the managing pharmacist; and
4-35 (4) Any other information the board deems necessary.
4-36 (e) Pay the fee required by regulation of the board.
4-37 (f) Submit evidence satisfactory to the board that the facility, records
4-38 and operation of the pharmacy comply with the laws and regulations of the
4-39 state or country in which the pharmacy is located.
4-40 (g) Submit certification satisfactory to the board that the pharmacy
4-41 complies with all lawful requests and directions from the regulatory board
4-42 or licensing authority of the state or country in which the pharmacy is
4-43 located relating to the shipment, mailing or delivery of drugs.
4-44 3. In addition to the requirements of subsection 2, the board may
4-45 require [that the pharmacy located outside of Nevada] such a pharmacy to
4-46 be inspected by the board.
5-1 Sec. 8. NRS 639.23282 is hereby amended to read as follows:
5-2 639.23282 Before issuing a license to a pharmacy located outside [of
5-3 Nevada to provide] Nevada that provides mail order service to [residents]
5-4 a resident of Nevada, the board shall consider:
5-5 1. The qualifications and credentials of the applicant; and
5-6 2. Any suspension or revocation of a license or restriction on a license
5-7 held by the applicant.
5-8 Sec. 9. NRS 639.23284 is hereby amended to read as follows:
5-9 639.23284 Every pharmacy [that is] located outside Nevada [and] that
5-10 provides mail order service to a resident of Nevada:
5-11 1. Shall report to the board any change of information that appears on
5-12 its license and pay the fee required by regulation of the board.
5-13 2. Shall make available for inspection all pertinent records, reports,
5-14 documents or other material or information required by the board.
5-15 3. As required by the board, must be inspected by the board or:
5-16 (a) The regulatory board or licensing authority of the state or country in
5-17 which the pharmacy is located; or
5-18 (b) The Drug Enforcement Administration.
5-19 4. As required by the board, shall provide the following information
5-20 concerning each prescription for a drug that is shipped, mailed or delivered
5-21 to a resident of Nevada:
5-22 (a) The name of the patient;
5-23 (b) The name of the prescriber;
5-24 (c) The number of the prescription;
5-25 (d) The date of the prescription;
5-26 (e) The name of the drug; and
5-27 (f) The strength and quantity of the dose.
5-28 Sec. 10. NRS 639.23286 is hereby amended to read as follows:
5-29 639.23286 A pharmacy [that is] located outside Nevada [and] that
5-30 provides mail order service to a resident of Nevada:
5-31 1. May substitute a drug if the substitution is made in accordance with
5-32 the provisions of the laws and regulations of the state or country in which
5-33 the pharmacy is located.
5-34 2. Shall provide a toll-free telephone service for its customers to a
5-35 pharmacist who has access to the records of the customers from Nevada.
5-36 The telephone service must be available for not less than 5 days per week
5-37 and for at least 40 hours per week. The telephone number must be
5-38 disclosed on the label attached to each container of drugs dispensed to a
5-39 resident of Nevada.
5-40 Sec. 11. NRS 639.2353 is hereby amended to read as follows:
5-41 639.2353 Except as otherwise provided in a regulation adopted
5-42 pursuant to NRS 453.385:
5-43 1. A prescription must be given:
5-44 (a) Directly from the practitioner to a pharmacist;
5-45 (b) Indirectly by means of an order signed by the practitioner;
5-46 (c) By an oral order transmitted by an agent of the practitioner; or
5-47 (d) Except as otherwise provided in subsection 5, by electronic
5-48 transmission or transmission by a facsimile machine, including, without
5-49 limitation, transmissions made from a facsimile machine to another
6-1 facsimile machine, a computer equipped with a facsimile modem to a
6-2 facsimile machine or a computer to another computer, pursuant to the
6-3 regulations of the board.
6-4 2. A written prescription must contain:
6-5 (a) [The] Except as otherwise provided in this section, the name and
6-6 signature of the practitioner, and his address if not immediately available to
6-7 the pharmacist;
6-8 (b) The classification of his license;
6-9 (c) [His registration number assigned by the Drug Enforcement
6-10 Administration if the prescription is for a controlled substance;
6-11 (d)] The name of the patient, and his address if not immediately
6-12 available to the pharmacist;
6-13 [(e)] (d) The name, strength and quantity of the drug or drugs
6-14 prescribed;
6-15 [(f)] (e) Directions for use; and
6-16 [(g)] (f) The date of issue.
6-17 3. The directions for use must be specific in that they indicate the
6-18 portion of the body to which the medication is to be applied or, if to be
6-19 taken into the body by means other than orally, the orifice or canal of the
6-20 body into which the medication is to be inserted or injected.
6-21 4. Each written prescription must be written in such a manner that any
6-22 registered pharmacist would be able to dispense it. A prescription must be
6-23 written in Latin or English and may include any character, figure, cipher or
6-24 abbreviation which is generally used by pharmacists and practitioners in
6-25 the writing of prescriptions.
6-26 5. A prescription for a controlled substance must not be given by
6-27 electronic transmission or transmission by a facsimile machine unless
6-28 authorized by federal law.
6-29 6. A prescription that is given by electronic transmission is not
6-30 required to contain the signature of the practitioner if:
6-31 (a) It contains a facsimile signature, security code or other mark that
6-32 uniquely identifies the practitioner; or
6-33 (b) A voice recognition system, biometric identification technique or
6-34 other security system approved by the board is used to identify the
6-35 practitioner.
6-36 Sec. 12. NRS 639.255 is hereby amended to read as follows:
6-37 639.255 1. The holder of any certificate, license or permit issued by
6-38 the board, whose default has been entered or who has been heard by the
6-39 board and found guilty of the violations alleged in the accusation, may be
6-40 disciplined by the board by one or more of the following methods:
6-41 (a) Suspending judgment;
6-42 (b) Placing the certificate, license or permit holder on probation;
6-43 (c) Suspending the right of a certificate holder to practice, or the right to
6-44 use any license or permit, for a period [not to exceed 1 year;] to be
6-45 determined by the board;
6-46 (d) Revoking the certificate, license or permit;
6-47 (e) Public reprimand;
7-1 (f) Imposition of a fine [not to exceed $1,000] for each count of the
7-2 accusation [;] , in accordance with the schedule of fines established
7-3 pursuant to subsection 3; or
7-4 (g) Requiring the certificate, license or permit holder to pay all costs
7-5 and attorney’s fees incurred by the board relating to the discipline of the
7-6 person.
7-7 2. Such action by the board is final, except that the propriety of such
7-8 action is subject to review upon questions of law by a court of competent
7-9 jurisdiction.
7-10 3. The board shall by regulation establish a schedule of fines that
7-11 may be imposed pursuant to paragraph (f) of subsection 1. Each fine
7-12 must be commensurate with the severity of the applicable violation, but
7-13 must not exceed $10,000 for each violation.
7-14 Sec. 13. Section 2 of Assembly Bill No. 415 of this session is hereby
7-15 amended to read as follows:
7-16 Sec. 2. NRS 639.0745 is hereby amended to read as follows:
7-17 639.0745 1. The board may adopt regulations concerning[:
7-18 (a) The] the transfer of information between pharmacies relating to
7-19 prescriptions.
7-20 [(b)] 2. The board shall adopt regulations concerning the
7-21 electronic transmission and the transmission by a facsimile machine
7-22 of a prescription from a practitioner to a pharmacist for the dispensing
7-23 of a drug.
7-24 [2.] The regulations must establish procedures to:
7-25 (a) Ensure the security and confidentiality of the data that is
7-26 transmitted between:
7-27 (1) The practitioner and the pharmacy;
7-28 (2) The practitioner and an insurer of the person for whom the
7-29 prescription is issued; and
7-30 (3) The pharmacy and an insurer of the person for whom the
7-31 prescription is issued.
7-32 (b) Protect the identity of the practitioner to prevent misuse of the
7-33 identity of the practitioner or other fraudulent conduct related to the
7-34 electronic transmission of a prescription.
7-35 (c) Verify the authenticity of a signature that is produced:
7-36 (1) By the computer or other electronic device; or
7-37 (2) Manually by the practitioner.
7-38 3. The board shall adopt regulations governing the exchange of
7-39 information between pharmacists and practitioners relating to
7-40 prescriptions filled by the pharmacists for persons who are suspected
7-41 of:
7-42 (a) Misusing prescriptions to obtain excessive amounts of drugs.
7-43 (b) Failing to use a drug in conformity with the directions for its
7-44 use or taking a drug in combination with other drugs in a manner that
7-45 could result in injury to that person.
7-46 The pharmacists and practitioners shall maintain the confidentiality of
7-47 the information exchanged pursuant to this subsection.
8-1 Sec. 14. Section 2 of Senate Bill No. 52 of this session is hereby
8-2 amended to read as follows:
8-3 Sec. 2. NRS 639.0125 is hereby amended to read as follows:
8-4 639.0125 “Practitioner” means:
8-5 1. A physician, dentist, veterinarian or podiatric physician who
8-6 holds a [valid] license to practice his profession in this state;
8-7 2. A hospital, pharmacy or other institution licensed, registered or
8-8 otherwise permitted to distribute, dispense, conduct research with
8-9 respect to or administer drugs in the course of professional practice or
8-10 research in this state;
8-11 3. An advanced practitioner of nursing who has been authorized
8-12 to prescribe controlled substances, poisons, dangerous drugs and
8-13 devices;
8-14 4. A physician assistant who:
8-15 (a) Holds a license issued by the board of medical examiners; and
8-16 (b) Is authorized by the board to possess, administer, prescribe or
8-17 dispense controlled substances, poisons, dangerous drugs or devices
8-18 under the supervision of a physician as required by chapter 630 of
8-19 NRS;
8-20 5. An osteopathic physician’s assistant who:
8-21 (a) Holds a certificate issued by the state board of osteopathic
8-22 medicine; and
8-23 (b) Is authorized by the board to possess, administer, prescribe or
8-24 dispense controlled substances, poisons, dangerous drugs or devices
8-25 under the supervision of an osteopathic physician as required by
8-26 chapter 633 of NRS; or
8-27 6. An optometrist who is certified by the Nevada state board of
8-28 optometry to prescribe and administer therapeutic pharmaceutical
8-29 agents pursuant to NRS 636.288, when he prescribes or administers
8-30 therapeutic pharmaceutical agents within the scope of his certification.
8-31 Sec. 15. Section 81 of Senate Bill No. 91 of this session is hereby
8-32 repealed.
8-33 Sec. 16. 1. This section and section 15 of this act become effective
8-34 upon passage and approval.
8-35 2. Sections 1 and 12 of this act become effective upon passage and
8-36 approval for the purpose of adopting regulations and at 12:01 a.m. on
8-37 October 1, 2001, for all other purposes.
8-38 3. Sections 2, 3, 4 and 6 to 10, inclusive, of this act become effective
8-39 on July 1, 2001.
8-40 4. Section 5 of this act becomes effective at 12:01 a.m. on July 1,
8-41 2001.
8-42 5. Section 14 of this act becomes effective at 12:02 a.m. on July 1,
8-43 2001.
8-44 6. Sections 11 and 13 of this act become effective at 12:01 a.m. on
8-45 October 1, 2001.
9-1 TEXT OF REPEALED SECTION
9-2 Section 81 of Senate Bill No. 91 of this session:
9-3 Sec. 81. Section 2 of Senate Bill No. 52 of this session is hereby
9-4 amended to read as follows:
9-5 Sec. 2. NRS 639.0125 is hereby amended to read as follows:
9-6 639.0125 “Practitioner” means:
9-7 1. A physician, dentist, veterinarian or podiatric physician who
9-8 holds a [valid] license to practice his profession in this state;
9-9 2. A hospital, pharmacy or other institution licensed, registered
9-10 or otherwise permitted to distribute, dispense, conduct research
9-11 with respect to or administer drugs in the course of professional
9-12 practice or research in this state;
9-13 3. An advanced practitioner of nursing who has been
9-14 authorized to prescribe controlled substances, poisons, dangerous
9-15 drugs and devices; or
9-16 4. A physician assistant who:
9-17 (a) Holds a license issued by the board of medical examiners;
9-18 and
9-19 (b) Is authorized by the board to possess, administer, prescribe
9-20 or dispense controlled substances, poisons, dangerous drugs or
9-21 devices under the supervision of a physician as required by chapter
9-22 630 of NRS.
9-23 5. An osteopathic physician’s assistant who:
9-24 (a) Holds a certificate issued by the state board of osteopathic
9-25 medicine; and
9-26 (b) Is authorized by the board to possess, administer, prescribe
9-27 or dispense controlled substances, poisons, dangerous drugs or
9-28 devices under the supervision of an osteopathic physician as
9-29 required by chapter 633 of NRS.
9-30 H