[Rev. 1/12/2009 9:39:59 AM]
CHAPTER 639 - PHARMACISTS AND PHARMACY
GENERAL PROVISIONS
639.010 Definitions.
639.030 “Date” interpreted.
639.032 “Facsimile machine” interpreted.
639.050 Storage and destruction of certain controlled substances.
639.060 Marketing codes of conduct: Adoption of certain codes by reference.
639.065 Marketing codes of conduct: Periodic review of adopted codes.
STATE BOARD OF PHARMACY
639.100 Seal of Board.
639.110 Inactive regulations: Duties of Executive Secretary.
639.120 Conduct of disciplinary hearings.
639.130 Representation by counsel at disciplinary hearings.
639.140 Petitions to adopt, amend or repeal regulations.
639.150 Declaratory orders and advisory opinions.
639.160 Required time for receipt of application.
639.170 Waiver of regulation upon declaration of emergency: Authority; required notices.
CERTIFICATES, LICENSES AND PERMITS
639.200 Temporary certificates, licenses and permits.
639.205 Application to register as pharmacist: Completion required within 1 year.
639.210 Educational qualifications: Approval of accredited programs of education in pharmacy.
639.212 Educational qualifications: Advanced degree in pharmacy.
639.214 Application for license to operate pharmacy: Information required.
639.215 Application for license to operate pharmacy: Appearance of applicant before Board; execution on behalf of partnership or corporation; payment of expenses for special meeting of Board.
639.219 Application for return to active status.
639.220 Schedule of fees; penalty for late renewal; exemptions from certain fees.
639.225 Notice to Executive Secretary of change of address.
639.227 Application or written notice to Board concerning change in ownership of pharmacy required under certain circumstances; suspension of license.
639.230 Voluntary surrender of certificate, license or registration to practice pharmacy in another state pursuant to agreement relating to disciplinary matter.
PHARMACEUTICAL TECHNICIANS
639.240 Requirements for registration of pharmaceutical technicians.
639.242 Registration of pharmaceutical technician in training; affidavit of managing pharmacist.
639.245 Maintenance and availability of records regarding certain pharmaceutical personnel on duty; activities of pharmaceutical technicians.
639.247 Establishment and maintenance of policies and procedures for personnel; maintenance and availability of personnel records.
639.250 Restrictions on supervision.
639.252 Initialing of prescriptions, records and reports; responsibility for filled prescriptions.
639.254 Initial and biennial in-service training of pharmaceutical technicians working in or for pharmacy; substitution of continuing education for in-service training.
639.256 Program of training: Approval by Board; testing of pharmaceutical technician in training for presence of alcohol or drug.
639.258 Participation in program of training for pharmaceutical technicians.
639.260 Disciplinary action against pharmacy.
INTERN PHARMACISTS
639.262 Application for registration; issuance of certificate of registration; maintenance of records relating to internship.
639.264 Employment at pharmacy as part of internship.
639.266 Supervision and training: Service as preceptor; duties; evaluation of internship.
639.268 Supervision and training: Responsibilities of registered pharmacist.
PHYSICIAN ASSISTANTS
639.269 “Physician assistant” defined.
639.270 Scope.
639.272 Requirements for registration certificate.
639.277 Change in location of practice or supervising physician.
639.280 Scope of authority to prescribe and dispense.
639.283 Prescriptions: Orders on charts of hospitalized patients.
639.285 Security and storage of controlled substances and drugs.
639.290 Substitution in case of illness or absence.
639.295 Grounds for denial of application or suspension or revocation of registration.
IMMUNIZATION BY PHARMACISTS AND INTERN PHARMACISTS
639.297 “Immunization” defined.
639.2971 Authorization; contents of and deviation from written protocol.
639.2972 Duties of authorizing physician.
639.2973 Training and certification to administer immunizations.
639.2974 Certification in basic cardiac life support; continuing education.
639.2975 Legal possession and control of drugs administered as immunizations; drugs to counteract adverse reactions.
639.2976 Notification of immunizations.
639.2977 Maintenance of records.
639.2978 Confidentiality of records.
CONTINUING PROFESSIONAL EDUCATION
639.300 Definitions.
639.305 “Acceptable materials” defined.
639.310 “Accredited material” defined.
639.315 “Continuing education unit” defined.
639.320 “Provider” defined.
639.330 Registration and reregistration: Continuing education required; submission of proof.
639.333 Registration and reregistration: Acceptance of certificate issued by another state as proof of compliance with requirements for continuing education.
639.335 Registration and reregistration: Exceptions to requirement of continuing education.
639.340 Providers of continuing education: Request for recognition; grant, denial or withdrawal of recognition.
639.345 Providers of continuing education: Records required; issuance of certificates of completion.
639.350 Providers of continuing education: List of participants; reference to accreditation; information to be transmitted to Board.
639.360 Accreditation of material, course or program.
639.365 Advertising, announcements and other promotional material.
639.370 Materials for continuing education: Formats of programs; subject matter.
639.380 Advisory Committee on Continuing Education: Creation; number of members.
639.385 Advisory Committee on Continuing Education: Composition; powers and duties; quorum; review of materials for continuing education.
639.390 Certificate of completion: Retention by pharmacist; copy to be submitted to Board upon request.
INTERNET PHARMACIES
General Provisions
639.420 Definitions.
639.422 “Certified Internet pharmacy” defined.
639.424 “Internet pharmacy” defined.
Certification
639.426 Requirements for approval of application.
639.428 Access to premises and records; suspension for noncompliance.
CANADIAN PHARMACIES
639.430 Licensure: Requirement; application.
639.432 Restrictions on dispensing drugs.
639.434 Standards of practice.
639.436 Dissemination of certain contact information; printing of certain information on label of prescription.
MEDICAL FACILITIES AND CORRECTIONAL INSTITUTIONS
General Provisions
639.440 Definitions.
639.441 “Administer” defined.
639.442 “Chart order” defined.
639.445 “Compound” and “compounding” defined.
639.446 “Consultant pharmacist” defined.
639.4465 “Correctional institution” defined.
639.447 “Deliver” and “delivery” defined.
639.448 “Device” defined.
639.449 “Direct copy” defined.
639.450 “Dispense” defined.
639.451 “Distribute” defined.
639.452 “Floor stock” defined.
639.453 “Formulary” defined.
639.455 “Investigational drug” defined.
639.456 “IV admixture” defined.
639.457 “Medical facility” defined.
639.4575 “Pharmacy” defined.
639.458 “Prescription” defined.
639.459 “Unit dose” defined.
639.460 “Unit of use” defined.
639.461 Licensing.
639.462 Biennial registration.
639.463 Change of ownership.
Standards of Operation
639.464 Scope of services in hospital or correctional institution.
639.4645 Maintenance of registration certificates required.
639.465 Managing pharmacist.
639.466 Consultant pharmacist.
639.467 Staff pharmacists.
639.468 Establishment of policies, procedures and systems.
639.4685 Handling of medications in correctional institutions without pharmacies.
639.469 Standards for premises.
639.470 Security of premises.
639.472 Maintenance of reference library.
639.473 Procurement and storage of drugs.
639.474 Development and use of formulary.
639.475 Preparation and labeling of admixtures.
639.476 Prepackaging of drugs.
639.477 Policies and procedures for distribution of drugs.
639.478 Limitations on distribution of drugs.
639.479 Withdrawal of drugs when full-time pharmacist is absent.
639.480 Withdrawal of drugs when part-time or consultant pharmacist is absent.
639.481 Withdrawal of drugs when facility uses floor stock and pharmacy is closed.
Records
639.482 Maintenance and availability of records.
639.483 Statutes applicable to maintenance of records.
639.484 Contents and maintenance of chart orders.
639.485 Maintenance of records for controlled substances.
639.486 Maintenance of records of controlled substances administered from floor stock.
639.487 Maintenance of additional records.
639.488 Maintenance of records for distribution of controlled substances to another pharmacy or practitioner.
639.489 Separation of certain records.
639.490 Permission to use centralized system for keeping records.
Chart Order Processing Services
639.491 Definitions.
639.4911 “Chart order” defined.
639.49115 “Chart order processing services” defined.
639.4912 “Correctional institution” defined.
639.4913 “Off-site pharmaceutical service provider” defined.
639.4914 “Remote chart order processing services” defined.
639.4915 Provision of services by pharmacies within certain hospitals and correctional institutions.
639.4916 Provision of remote services by pharmacist employed by off-site pharmaceutical service provider.
639.4917 Policies and procedures of off-site pharmaceutical service providers.
FACILITIES FOR INTERMEDIATE CARE AND FACILITIES FOR SKILLED NURSING
639.492 Definitions.
639.494 Prescriptions for controlled substances: Accountability record; handling of unused portions.
639.496 Maintenance of accountability record; examination of chart orders; issuance of receipt for controlled substances delivered to coroner.
639.498 Destruction of certain controlled substances: Requirement; procedure.
SURGICAL CENTERS FOR AMBULATORY PATIENTS
639.4992 Dispensing of controlled substances: Registration and licensing required.
639.4996 Establishment and periodic review of policies and procedures; duties of pharmacist.
PHARMACIES IN GENERAL
639.500 Ownership of pharmacies; application to conduct a pharmacy.
639.5005 Representative of pharmacy: General requirements; exceptions; approval; enforcement.
639.5007 Issuance of license to conduct pharmacy for applicant required to designate representative: Restricted and unrestricted licenses.
639.501 Inspections; provision of self-assessment form.
639.5012 Confidentiality and use of self-assessment and accompanying documentation.
639.5014 Completion of self-assessment form before annual inspections; suggestions relating to compliance by or improvement of pharmacy.
639.5016 Annual inspections: Review of self-assessment form; notes regarding discrepancies or deficiencies; correction of discrepancies or deficiencies.
639.5018 Protection of employee providing answers, information or suggestions on self-assessment form or during inspections.
639.5019 Annual review by Board of provisions of NAC 639.501 to 639.5019, inclusive.
639.503 Maintenance in pharmacy of current statutes, regulations and reference material.
639.505 Maintenance in pharmacy of reports of inspection, warning notices and special bulletins.
639.510 Maintenance and storage of pharmaceutical stock.
639.512 Class A and B packaging: Label; expiration date; log.
639.513 Class C packaging: Expiration date.
639.515 Stock of drugs in facility for skilled nursing or intermediate care.
639.517 Nurse employed by medical facility or agency to provide nursing in the home may maintain stock of certain drugs.
639.520 Security of prescription departments.
639.523 Physical address for delivery of drugs.
639.525 Minimum requirements for work area and equipment.
639.526 Drive-through facilities.
639.528 Preparation and storage of food in prescription department of pharmacy.
639.530 Sanitation; required washbasins; exception.
639.535 Remodeling or relocation of pharmacy or prescription department.
639.540 Notice of employment and termination of employment of certain pharmaceutical professionals.
639.542 Identification of persons employed by pharmacy.
639.556 Meal periods and rest periods for employees of pharmacy.
639.570 Involuntary closure of pharmacy.
639.575 Voluntary closure of pharmacy.
639.580 Permanent closure of pharmacy.
NUCLEAR PHARMACIES
639.5802 Definitions.
639.5804 “Agreement state” defined.
639.5806 “Authentication of product history” defined.
639.5808 “Procedures to assure the quality of radiopharmaceuticals” defined.
639.581 “Qualified nuclear pharmacist” defined.
639.5812 “Radiopharmaceutical services” defined.
639.5814 “Testing to control the quality of radiopharmaceutical” defined.
639.5816 “Radiopharmaceutical” interpreted.
639.5818 Nuclear pharmacist: Certification; training and instruction; affidavit of experience and training.
639.582 Permit to operate.
639.5822 Space and equipment requirements; floor plan.
639.5824 Security.
639.5826 Records.
639.5828 Quality assurance procedures for radiopharmaceuticals.
639.583 Dispensing or transferring radiopharmaceuticals.
639.5832 Oral order for radiopharmaceutical: Requirement to keep record; contents of record.
639.5834 Outer shield of radiopharmaceutical container: Label required; contents of label.
639.5836 Inner label of radiopharmaceutical container; contents.
639.5838 Records of nuclear pharmacy when radiopharmaceutical is dispensed pursuant to investigational new drug application: Contents.
639.584 Required equipment.
WHOLESALERS
639.585 Definitions.
639.587 “Facility” defined.
639.588 “Manufacturer” defined.
639.589 “Ongoing relationship” defined.
639.5895 “Purchaser” defined.
639.5897 “Purchasing wholesaler” defined.
639.5902 “Statement of prior sales” defined.
639.5905 “Supplier” defined.
639.592 “Wholesaler” defined.
639.593 Licensing requirements; consideration of transaction as wholesale transaction; transferability and renewal of license.
639.5931 Submission of fingerprints: Required method.
639.5932 Provisional license: Prerequisites for issuance.
639.5935 Representative of wholesaler: General requirements; exceptions; approval; enforcement.
639.5937 Bond or other security: Amount required from certain wholesalers; reduction of amount; substitution.
639.5938 Filing of single bond for multiple sites.
639.594 Establishment of ongoing relationship.
639.595 Qualifications of employees who engage in storage or distribution of drugs.
639.596 Facilities: General requirements; maintenance of stock.
639.597 Facilities: Security.
639.5975 Prescription drugs: Restrictions on purchase and receipt; disposal of certain drugs.
639.5977 Prescription drugs: Sale to purchasing wholesaler.
639.598 Prescription drugs: Storage.
639.599 Prescription drugs: Examination of shipments; actions upon determination of certain conditions.
639.601 Prescription drugs: Separation and disposal of certain drugs.
639.6015 Prescription drugs: Destruction.
639.602 Prescription drugs: Records.
639.603 Prescription drugs: Requirements regarding statements of prior sales.
639.6035 Prescription drugs: Exclusion of certain transactions from statements of prior sales.
639.604 Maintenance and availability of list of wholesalers with whom manufacturer has ongoing relationship.
639.605 Establishment and maintenance of policies and procedures regarding prescription drugs.
639.6053 Wholesaler who employs person to sell or market drug, medicine or chemical: Annual submission of certain information to Board; review and contents of marketing code of conduct; exemption.
639.6055 Submission of certain information regarding sales and marketing staff: Submission of form after initial submittal; method of submission.
639.6057 Submission of certain information regarding sales and marketing staff: Incomplete, improperly completed or noncompliant submittal; correction of deficiencies.
639.606 Establishment and maintenance of lists regarding certain personnel.
639.6065 Annual submission of certain reports or proof to Board.
639.607 Inspections; examination of records and procedures; copies of documents.
MANUFACTURERS
639.609 “Manufacturer” defined.
639.610 Minimum standards for premises.
639.615 Equipment and requirements for operation; employees.
639.616 Manufacturer who employs person to sell or market drug, medicine or chemical: Annual submission of certain information to Board; review and contents of marketing code of conduct.
639.617 Manufacturer who employs person to sell or market device or appliance: Annual submission of certain information to Board; review and contents of marketing code of conduct.
639.618 Submission of certain information regarding sales and marketing staff: Submission of form after initial submittal; method of submission.
639.619 Submission of certain information regarding sales and marketing staff: Incomplete, improperly completed or noncompliant submittal; correction of deficiencies.
WAREHOUSES
639.620 Definitions.
639.621 “Authorized person” defined.
639.622 “Authorized warehouse” defined.
639.623 “Chain warehouse” defined.
639.624 “Facility” defined.
639.625 “Goods” defined.
639.626 “Manufacturer” defined.
639.627 “Pharmacy” defined.
639.6282 “Third-party logistics provider” defined.
639.629 “Wholesaler” defined.
639.6305 Third-party logistics providers: General requirements.
639.631 Licensing: General requirements.
639.633 Contracts authorizing receipt, storage and shipment of prescription drugs and goods.
639.634 Enforcement of statutory liens.
639.635 Cessation of operation.
639.636 Change in legal ownership of facility resulting from legal proceeding.
639.637 Facilities: General requirements.
639.638 Facilities: Security.
639.639 Prescription drugs: Storage.
639.640 Prescription drugs: Shipment.
639.641 Prescription drugs: Records.
639.642 Establishment of policies and procedures regarding prescription drugs.
639.643 Inspections; examination of records and procedures.
639.644 Enforcement.
VETERINARY DRUGS
639.650 Fee for and scope of permit to sell; penalty for late registration; prohibited sales; refrigeration.
639.660 Restriction on use of rabies vaccine.
COMPOUNDING AND DISPENSING PARENTERAL SOLUTIONS
639.661 Definitions.
639.663 “Cytotoxic” defined.
639.665 “Medical facility” defined.
639.667 “Nursing personnel” defined.
639.670 Adoption of certain standards by reference.
639.672 Reference materials required to be located in or immediately available to pharmacy.
639.674 Designated work area; equipment.
639.678 Preparation of cytotoxic agent: Certified vertical laminar airflow hood required.
639.680 Labeling of parenteral solution.
639.682 Record for each patient.
639.683 Delivery, storage and recordation of delivery of parenteral solution.
639.684 Program to ensure clean and sanitary environment for preparation of sterile products.
639.686 Written policies and procedures for disposal of infectious materials and materials containing cytotoxic residues.
639.688 Written policies and procedures regarding provision of services related to parenteral therapy.
639.690 Pharmacist: Consultation with patient; proper training in safe handling, compounding and therapy related to parenteral solutions.
PROVIDERS AND WHOLESALERS OF MEDICAL PRODUCTS
General Provisions
639.693 Definitions.
639.6931 “Assistive equipment” defined.
639.6932 “Consumer” defined.
639.6933 “Health professional” defined.
639.6934 “Life-sustaining equipment” defined.
639.6935 “Medical products” defined.
639.6936 “Medical products provider” defined.
639.6937 “Medical products wholesaler” defined.
639.6938 “Respiratory equipment” defined.
639.694 Administrator required.
639.6941 Unprofessional conduct; responsibility of owner for acts of others.
Licensing and Fees
639.6942 Application for license; license required for each location; notification of change in information; license nontransferable; expiration.
639.6943 Licensing of practicing health professionals.
639.6944 Licensing of applicants located outside of State.
639.6945 Waiver of license fee.
Medical Products Providers
639.6946 Duties of providers; repair and maintenance of medical products; hours of operation; consumer complaints.
639.6947 Change in controlling interest.
639.6948 Compliance with provisions by person or business who is not medical products provider.
639.6949 Provision of medical products to consumer with or without bona fide order or prescription; tracking requirements.
639.695 Maintenance of records.
639.6951 Communications and advisement of options and use of medical products; written record.
639.6952 Communications concerning use of medical products provided by written or oral order or prescription; written record.
639.6953 Assistive equipment.
639.6954 Medical gases and associated equipment or respiratory equipment.
639.6955 Life-sustaining equipment.
639.6956 Parenteral and enteral services and equipment.
Medical Products Wholesalers
639.6957 Duties of wholesalers; repair and maintenance of medical products; hours of operation; consumer complaints.
639.69573 Wholesaler who employs person to sell or market device or appliance: Annual submission of certain information to Board; review and contents of marketing code of conduct.
639.69575 Submission of certain information regarding sales and marketing staff: Submission of form after initial submittal; method of submission.
639.69577 Submission of certain information regarding sales and marketing staff: Incomplete, improperly completed or noncompliant submittal; correction of deficiencies.
Disciplinary Action
639.6958 Summary suspension of license.
TRADE PRACTICES
639.700 Performance of certain acts by pharmacists and pharmaceutical interns only.
639.701 Acts not required to be performed by pharmaceutical professionals.
639.702 Responsibility for acts and omissions of personnel who are not pharmacists.
639.704 Check of license or certification required before employment by pharmacy or wholesaler.
639.706 Marking of prescriptions with serial numbers; maintenance of files of prescriptions.
639.707 Counseling of patients: Duties of pharmacist or intern pharmacist; documentation.
639.708 Counseling of patients: Duties of pharmacy.
639.709 Persons to whom pharmacy may furnish certain restricted products.
639.710 Delivery of prescription drugs.
639.7102 Use of computer system for issuance and transmission of prescription.
639.7105 Electronic transmission of prescription.
639.711 Transmission of prescription by facsimile machine.
639.712 Transcribing prescription transmitted by oral order.
639.7125 Use of fulfillment pharmacy by dispensing pharmacy.
639.713 Transfer of information between pharmacies: Conditions; prohibitions.
639.714 Transfer of information between pharmacies: Procedure for oral transfers.
639.7145 Transfer of information between pharmacies: Requirements for transfer by facsimile machine.
639.715 Mechanical devices: Restrictions on use.
639.718 Mechanical devices: Use by pharmacy to furnish prescription drugs to patients.
639.720 Mechanical devices: Use to furnish drugs and medicines for administration to registered patients in medical facility and to patients receiving treatment in emergency room of hospital.
639.725 Use of mechanical counting device for dispensing medication to be taken orally.
639.730 Inspection of damaged pharmaceuticals.
639.740 Container for dispensing prescribed medicine.
639.742 Dispensing of controlled substances or dangerous drugs: Application by practitioner for certificate of registration; application by facility required under certain circumstances; duties of dispensing practitioner and facility relating to drugs; authority of dispensing practitioner and technician.
639.7425 Dispensing technician: Requirements; application and fee for registration; provisional registration; issuance of certificate of registration.
639.743 Dispensing technician: Access to drugs; performance of functions.
639.7435 Dispensing technician: Transferability, expiration and termination of registration; notice of change of address of employment; subsequent employment.
639.744 Dispensing practitioner: Fee for initial registration and renewal; registration of multiple dispensing technicians.
639.7445 Dispensing practitioner: Disciplinary action for violation of NAC 639.742 to 639.7445, inclusive.
639.745 Dispensing practitioner: Duties concerning dispensing of controlled substances and dangerous drugs.
639.748 Identification of person to whom controlled substance is dispensed.
639.750 Dispensing of medication at certain locations when local retail pharmacy is closed.
639.752 Restrictions on filling or dispensing certain prescriptions.
639.753 Declination of pharmacist to fill prescription.
639.754 Refilling prescriptions: Restrictions; authorization by patient without specific request for particular refill.
639.755 Sale of preparations for treatment of asthma.
639.757 Preparation and sale of compounded drugs by pharmacy or pharmacist: License as manufacturer not required under certain circumstances; unsafe or ineffective drug; restrictions on sale.
639.760 Return of unused drugs packaged in unit doses.
639.765 Disclosure by practitioner of certain ownership interests in pharmacy.
REPACKAGING OF PREVIOUSLY DISPENSED DRUGS
639.781 Definitions.
639.784 Duties of repackaging pharmacy.
639.788 Restrictions on repackaging pharmacy.
ADVANCED PRACTITIONERS OF NURSING
General Provisions
639.841 “Collaborating physician” defined.
639.846 Change in location of practice or collaborating physician.
Prescribing
639.850 Certificate of registration: Application; appearance before Board; collaborating physician.
639.854 Scope of authority to prescribe.
639.858 Authorization to write prescription in form of chart order or physician’s order.
Dispensing
639.870 Certificate of registration: Application; fee; period of validity; appearance before Board; collaborating physician; late renewal.
639.879 Scope of authority to dispense.
639.892 Use of child-proof container.
639.898 Security and storage of controlled substances and drugs.
Disciplinary Action
639.900 Grounds for denial of application or suspension or revocation of registration.
COMPUTERIZED SYSTEMS
Recording of Information
639.910 Information to be provided by system; procedure to ensure information not lost or destroyed.
639.912 Requirements for use of system; maintenance of physical records.
639.914 Maintenance and availability of information relating to operation; entrance of each prescription into system required; issuance of consecutive numbers for prescriptions.
639.918 Written record of refills.
639.921 Sharing information between systems: Conditions and requirements.
639.924 Computerized system to record prescriptions required for pharmacies licensed on or after August 27, 1996.
639.926 Transmission of information regarding dispensing of controlled substances to certain persons.
639.930 Safeguards against access to and modification or manipulation of information.
639.935 Printed record of contents.
639.938 Auxiliary procedure to document prescriptions when system not functioning.
Automated Dispensing Systems
639.940 “Computerized system to fill prescriptions” defined.
639.9405 Authority to use system.
639.941 Written policies and procedures of operation.
639.9415 Written program for quality assurance.
639.942 Written plan for recovery.
639.9425 Written program for preventative maintenance of system.
639.943 Required security of drugs and records.
DISCIPLINARY ACTION
639.945 Unprofessional conduct; owner responsible for acts of employees.
639.951 Violations by employees of pharmacy concerning controlled substances or other drugs; screening tests.
639.955 Imposition of fines; authority to take disciplinary action.
GENERAL PROVISIONS
NAC 639.010 Definitions. (NRS 639.070) As used in this chapter, unless the context otherwise requires:
1. “Board” means the State Board of Pharmacy.
2. “Controlled substances” has the meaning ascribed to it in NRS 0.031.
3. “Dangerous drug” has the meaning ascribed to it in NRS 454.201.
4. “Direct supervision” means the direction given by a supervising pharmacist who is:
(a) On the premises of the pharmacy at all times when the persons he is supervising are working at the pharmacy; and
(b) Aware of the activities of those persons related to the preparation of medications, including the maintenance of appropriate records.
5. “Executive Secretary” means the Executive Secretary employed by the Board pursuant to NRS 639.040.
6. “Pharmaceutical technician” means a person who performs technical services in a pharmacy under the direct supervision of a pharmacist and is registered with the Board pursuant to NAC 639.240.
7. “Pharmaceutical technician in training” means a person who is registered with the Board pursuant to NAC 639.242 in order to obtain the training and experience required to be a pharmaceutical technician pursuant to subparagraph (3) of paragraph (e) of subsection 2 of NAC 639.240, or who is enrolled in a program of training for pharmaceutical technicians that is approved by the Board.
8. “Practitioner” has the meaning ascribed to it in NRS 639.0125.
9. “Prescription drug” means a drug or medicine as defined in NRS 639.007 which:
(a) May be dispensed only upon a prescription order that is issued by a practitioner; and
(b) Is labeled with the symbol “Rx only” pursuant to federal law or regulation.
10. “Public or nonprofit agency” means a health center as defined in 42 U.S.C. § 254b(a) which:
(a) Provides health care primarily to medically underserved persons in a community;
(b) Is receiving a grant issued pursuant to 42 U.S.C. § 254b or, although qualified to receive such a grant directly from the Federal Government, is receiving money from such a grant under a contract with the recipient of that grant; and
(c) Is not a medical facility as defined in NRS 449.0151.
11. “Surgical center for ambulatory patients” has the meaning ascribed to it in NRS 449.019.
[Bd. of Pharmacy, § 639.010, 6-26-80]—(NAC A 3-27-90; 6-14-90; 10-1-93; 11-15-93; 5-22-96; 10-24-97; R014-99, 11-3-99; R019-03, 10-21-2003; R041-04, 5-25-2004; R036-07, 1-30-2008)
NAC 639.030 “Date” interpreted. (NRS 639.070, 639.2801) The Board interprets the term “date” as used in subsection 1 of NRS 639.2801 to mean the most recent date on which the drug was dispensed or the prescription was refilled.
(Added to NAC by Bd. of Pharmacy, eff. 6-16-86)
NAC 639.032 “Facsimile machine” interpreted. (NRS 639.070, 639.0745, 639.2353) As used in NRS 639.0745 and 639.2353, the Board will interpret the term “facsimile machine” to include, without limitation, a computer that has a facsimile modem through which documents can be sent and received.
(Added to NAC by Bd. of Pharmacy by R112-99, eff. 11-3-99)
NAC 639.050 Storage and destruction of certain controlled substances. (NRS 639.070)
1. Upon the discontinuance of a controlled substance, a controlled substance becoming outdated or the demise of a patient at a facility for skilled nursing or facility for intermediate care which is licensed by the Health Division, any remaining controlled substance dispensed to the patient must be placed in a secured locked compartment. The controlled substance must be secured in the locked container until destroyed in the manner prescribed in NAC 639.498.
2. Each practitioner or pharmacy shall physically separate each controlled substance which is outdated, damaged, deteriorated, misbranded or adulterated from the balance of its stock medications. The controlled substances must be held for destruction by an agent of the Board. The agent shall provide the practitioner or pharmacy with a copy of the Controlled Substance Enforcement Administration form 41 (“Registrants Inventory of Controlled Substances Surrendered”) acknowledging destruction of the controlled substances. The controlled substances must be destroyed at least once each year.
3. This section does not apply to controlled substances packaged in manufacturer’s unit-dose packages which are governed by the provisions of NRS 639.267.
(Added to NAC by Bd. of Pharmacy, eff. 12-3-84; A 7-1-92)
NAC 639.060 Marketing codes of conduct: Adoption of certain codes by reference. (NRS 639.070, 639.570) The Board hereby adopts by reference:
1. The Code on Interactions with Healthcare Professionals developed by the Pharmaceutical Research and Manufacturers of America. A copy of this publication may be obtained, free of charge, from the Pharmaceutical Research and Manufacturers of America at the Internet address http://www.phrma.org/code_on_interactions_with_healthcare_professionals.
2. The Code of Ethics on Interactions with Health Care Professionals adopted by the Advanced Medical Technology Association. A copy of this publication may be obtained, free of charge, from the Advanced Medical Technology Association at the Internet address http://www.advamed.org/MemberPortal/About/code.
(Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)
NAC 639.065 Marketing codes of conduct: Periodic review of adopted codes. (NRS 639.070, 639.570) The Board will periodically review:
1. The Code on Interactions with Healthcare Professionals, as adopted by reference in subsection 1 of NAC 639.060; and
2. The Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in subsection 2 of NAC 639.060,
Ê and determine, within 30 days after the review, whether any change made to a publication listed in subsection 1 or 2 is appropriate for application in this State. If the Board does not disapprove a change to an adopted publication within 30 days after the review, the change is deemed to be approved by the Board.
(Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)
STATE BOARD OF PHARMACY
NAC 639.100 Seal of Board. (NRS 639.070) The Board hereby adopts a seal for its own use. The seal has imprinted thereon the words and figures “Nevada State Board of Pharmacy-Organized May 6, 1901.” The care and custody of the seal is in the hands of the Executive Secretary.
[Bd. of Pharmacy, § 639.015, eff. 6-26-80]
NAC 639.110 Inactive regulations: Duties of Executive Secretary. (NRS 639.070) When any regulation adopted by the Board and filed with the Secretary of State expires by its own terms, is repealed or is declared unconstitutional by a court of competent jurisdiction, the Executive Secretary shall so inform the Secretary of State and request that it be placed in an inactive file.
[Bd. of Pharmacy, § 639.030, eff. 6-26-80]
NAC 639.120 Conduct of disciplinary hearings. (NRS 639.070, 639.247)
1. The Board will convene a disciplinary hearing at the time and place specified in the notice of hearing. The person presiding at the hearing may grant a continuance only upon:
(a) A joint stipulation of the parties;
(b) The existence of an emergency condition; or
(c) A written request by a party filed at least 5 days before the date of the hearing and actually served upon the other parties at least 1 day before the date of the hearing.
Ê A continuance based on a written request pursuant to paragraph (c) may be granted only upon a showing of good cause which term must be narrowly construed. A party requesting a continuance must appear on the date of the hearing and be prepared to proceed unless the request has been made pursuant to a joint stipulation.
2. The hearing must then proceed in the following manner unless the Board for good cause or to prevent manifest injustice orders otherwise:
(a) An opening statement may be made on behalf of the Board or waived.
(b) An opening statement on behalf of respondent may be made, reserved until the close of the Board’s case, or waived.
(c) The presentation of the Board’s case is followed by cross-examination.
(d) The presentation of the respondent’s case is followed by cross-examination.
(e) Any rebuttal is limited to issues previously raised. No new matter may be presented upon rebuttal unless the Board for good cause so permits.
(f) Argument on behalf of the Board is presented unless waived.
(g) Argument on behalf of the respondent is presented unless waived.
(h) The matter is submitted to the Board for decision.
3. After the matter is submitted, the Board will render a decision and its order.
[Bd. of Pharmacy, § 639.065, eff. 6-26-80]—(NAC A 12-3-84)
NAC 639.130 Representation by counsel at disciplinary hearings. (NRS 639.070, 639.247) No respondent may be represented by counsel in a disciplinary hearing unless the counsel is admitted to practice before the highest court of:
1. The State of Nevada; or
2. Another state and appears in association with counsel who has been admitted to practice in this State and maintains an office in this State.
[Bd. of Pharmacy, § 639.060, eff. 6-26-80]
NAC 639.140 Petitions to adopt, amend or repeal regulations. (NRS 639.070)
1. A petition requesting the Board to adopt, file, amend or repeal any regulation must be in writing and signed by the petitioner. The petition must be accompanied by a draft of the proposed regulation in a form suitable for submission to the Legislative Counsel.
2. The original and six legible copies of the petition and the original and seven legible copies of the proposed regulation must be filed with the Executive Secretary.
3. A petition filed other than in conformity with this section will be rejected.
[Bd. of Pharmacy, § 639.025, eff. 6-26-80]
NAC 639.150 Declaratory orders and advisory opinions. (NRS 639.070) A petition requesting a declaratory order or advisory opinion, pursuant to NRS 233B.120, must be in writing and signed by the petitioner. An original and six legible copies of the petition must be filed with the Executive Secretary. The petition will be considered by the Board at its next regularly scheduled meeting. Within 30 days thereafter the Board will issue the declaratory order or advisory opinion requested.
[Bd. of Pharmacy, § 639.055, eff. 6-26-80]
NAC 639.160 Required time for receipt of application. (NRS 639.070) Any application required to be submitted to the Board must be received in one of the offices of the Board at least 15 days before the meeting of the Board at which action on the application will be taken. An application which is not submitted by the time required may still be considered by the Board for good cause.
(Added to NAC by Bd. of Pharmacy, eff. 6-16-86; A 6-14-90)
NAC 639.170 Waiver of regulation upon declaration of emergency: Authority; required notices. (NRS 639.070)
1. The President, Executive Secretary or General Counsel of the Board may waive any of the requirements set forth in any regulation adopted by the Board governing the practice of pharmacy if a federal, state or local official authorized to issue a declaration of emergency concerning the health and welfare of the general public submits a notice of such declaration of emergency to the Board.
2. If the President, Executive Secretary or General Counsel of the Board issues a waiver pursuant to subsection 1, he shall:
(a) Provide written notification of the waiver, identifying the requirements of the applicable regulations that have been waived, any conditions of the waiver and the period of the waiver, to each pharmacy, pharmacist or other person to whom the Board deems necessary to effectuate the waiver; and
(b) Provide written notification of the termination of the waiver, by the most accessible and efficient means, to the same persons that were provided a written notification of the waiver pursuant to paragraph (a).
(Added to NAC by Bd. of Pharmacy by R189-01, eff. 3-4-2002)
CERTIFICATES, LICENSES AND PERMITS
NAC 639.200 Temporary certificates, licenses and permits. (NRS 639.070)
1. Except as otherwise provided in subsection 2, the Executive Secretary may issue a temporary certificate, license or permit required by chapter 453, 454 or 639 of NRS to a qualified person for a period of effectiveness which ends not more than 6 months after the next regular meeting of the Board following issuance, except for a temporary certificate of reciprocal registration of a pharmacist, which may not be effective for a period of more than 6 months after issuance.
2. The Executive Secretary may issue a temporary license to operate a pharmacy to a licensed pharmacy which, because of a change of location of the pharmacy, requires a new license before the next meeting of the Board. Before such a temporary license is issued, a satisfactory examination of the premises of the pharmacy must be conducted by the staff of the Board. At the next regular meeting of the Board following the issuance of the temporary license, the Board will consider an application for a permanent license for that pharmacy.
[Bd. of Pharmacy, § 639.020, eff. 6-26-80]—(NAC A 10-1-93; 11-9-95)
NAC 639.205 Application to register as pharmacist: Completion required within 1 year. (NRS 639.070, 639.127) An applicant for a certificate as a registered pharmacist must provide all information and make all appearances required by the Board within 1 year after having successfully passed the North American Pharmacist Licensure Examination prepared by the National Association of Boards of Pharmacy. An applicant who does not provide all information and make all appearances required by the Board within 1 year after having successfully passed the North American Pharmacist Licensure Examination must submit a new application.
[Bd. of Pharmacy, § 639.040, eff. 6-26-80]—(NAC A by R115-98, 9-9-98)
NAC 639.210 Educational qualifications: Approval of accredited programs of education in pharmacy. (NRS 639.070, 639.120) For the purpose of determining the educational qualifications of applicants to become registered pharmacists, the Board hereby approves all colleges of pharmacy and departments of pharmacy of universities which are accredited by the Accreditation Council for Pharmacy Education.
[Bd. of Pharmacy, § 639.035, eff. 6-26-80]
NAC 639.212 Educational qualifications: Advanced degree in pharmacy. (NRS 639.070, 639.120) In considering the educational qualifications of an applicant to become a registered pharmacist, the Board will not accept an advanced degree in pharmacy, gained through a university’s graduate program, as evidencing sufficient qualifications unless the applicant as an undergraduate earned all the required credits for a degree of bachelor of science in pharmacy or for a pharmaceutical doctorate at a college or department of pharmacy of a university accredited by the Accreditation Council for Pharmacy Education and was awarded the degree by that university.
(Added to NAC by Bd. of Pharmacy, eff. 10-26-83)
NAC 639.214 Application for license to operate pharmacy: Information required. (NRS 639.070, 639.231) In addition to any information required by NRS 639.231, each application to conduct a pharmacy must, if the applicant or any person having an ownership interest in the applicant is:
1. A joint venture, identify each member of the joint venture.
2. A partnership other than a limited partnership, identify each partner.
3. A limited partnership, identify each:
(a) General partner;
(b) Limited partner who holds 10 percent or more of the interest in the profits of the limited partnership; and
(c) General partner and limited partner who is a practitioner.
4. A corporation, none of whose shares are registered under the Securities Exchange Act of 1934, as amended (15 U.S.C. §§ 78a et seq.), identify each:
(a) Officer of the corporation;
(b) Shareholder who holds 10 percent or more of the shares of the corporation; and
(c) Shareholder who is a practitioner.
5. A corporation, any of whose shares are registered under the Securities Exchange Act of 1934, as amended (15 U.S.C. §§ 78a et seq.), identify:
(a) Each officer of the corporation; and
(b) Regarding each class of its shares registered under the Securities Exchange Act of 1934, as amended:
(1) The date of that registration;
(2) The number assigned to that registration by the Securities and Exchange Commission; and
(3) The securities exchange upon which those shares are listed.
(Added to NAC by Bd. of Pharmacy, eff. 10-1-93)
NAC 639.215 Application for license to operate pharmacy: Appearance of applicant before Board; execution on behalf of partnership or corporation; payment of expenses for special meeting of Board. (NRS 639.070, 639.231)
1. An applicant for a license to operate a pharmacy in the State of Nevada must appear before the Board in support of the application and must receive instructions relative to the pharmacy laws if the applicant:
(a) Is applying for a license to operate a pharmacy in this State for the first time;
(b) Responded affirmatively to any of the questions on the application regarding his character or competency;
(c) Is applying for the licensure of a pharmacy located outside the State that will be shipping compounded parenteral products into this State; or
(d) Is requested to do so by the Board.
2. If an applicant who is required to appear before the Board is:
(a) A partnership, all partners must appear.
(b) A corporation, a designated representative of the corporation must appear. If the designated representative is not an officer of the corporation, a letter authorizing him to appear on behalf of the corporation that is signed by an officer of the corporation must be submitted with the application. Documentation of the status of the person signing the letter of authorization must be submitted with the application.
3. If the applicant is a partnership or corporation, the application must be signed by a partner or by an officer of the corporation. Documentation of the status of the person signing the application must be submitted with the application.
4. A special meeting of the Board will not be called for the purpose of considering an application for a license to operate a pharmacy until the applicant has paid the Executive Secretary sufficient money to defray all expenses of the meeting.
[Bd. of Pharmacy, § 639.045, eff. 6-26-80]—(NAC A 3-17-92; 10-1-93)
NAC 639.219 Application for return to active status. (NRS 639.070)
1. An application for return to active status must be made on a form provided by the Board.
2. The Board will grant an application if:
(a) The applicant submits proof of completion of 30 units of continuing professional education within the 2 years immediately preceding the date on which the application for return to active status is filed;
(b) The applicant passes the examination on law; and
(c) An applicant who was granted inactive status because of a medical disability submits proof satisfactory to the Board that he is physically capable of resuming the practice of pharmacy. Unless the proof submitted by the applicant is otherwise satisfactory, the Board will require the applicant to submit to a medical examination to be conducted by a physician chosen by the Board. The applicant shall pay for the cost of the examination.
(Added to NAC by Bd. of Pharmacy, eff. 6-16-86)
NAC 639.220 Schedule of fees; penalty for late renewal; exemptions from certain fees. (NRS 639.070, 639.170)
1. The Board hereby adopts the following schedule of fees:
|
For the examination of an applicant for registration as a pharmacist........... |
...... Actual cost of the examination |
|
For the investigation or registration of an applicant as a registered pharmacist............................................................................................... |
................. $150 |
|
For the investigation, examination or registration of an applicant as a registered pharmacist by reciprocity........................................................ |
................... 150 |
|
For the investigation or issuance of an original license to conduct a retail pharmacy................................................................................................. |
................... 500 |
|
For the biennial renewal of a license to conduct a retail pharmacy.............. |
................... 500 |
|
For the investigation or issuance of an original license to conduct an institutional pharmacy............................................................................. |
................... 500 |
|
For the biennial renewal of a license to conduct an institutional pharmacy. |
................... 500 |
|
For the investigation or issuance of an original license to conduct a pharmacy in a correctional institution..................................................... |
................... 500 |
|
For the biennial renewal of a license to conduct a pharmacy in a correctional institution............................................................................. |
................... 500 |
|
For the issuance of an original or duplicate certificate of registration as a registered pharmacist............................................................................... |
..................... 50 |
|
For the biennial renewal of registration as a registered pharmacist.............. |
................... 150 |
|
For the reinstatement of a lapsed registration (in addition to the fees for renewal for the period of lapse).............................................................. |
................... 100 |
|
For the initial registration of a pharmaceutical technician or pharmaceutical technician in training...................................................... |
..................... 40 |
|
For the biennial renewal of registration of a pharmaceutical technician or pharmaceutical technician in training...................................................... |
..................... 40 |
|
For the investigation or registration of an intern pharmacist........................ |
..................... 15 |
|
For the biennial renewal of registration as an intern pharmacist.................. |
..................... 15 |
|
For the investigation or registration of an advanced practitioner of nursing or a physician assistant to prescribe drugs that are not controlled substances................................................................................................ |
..................... 80 |
|
For the biennial renewal of registration of an advanced practitioner of nursing or a physician assistant to prescribe drugs that are not controlled substances.............................................................................. |
..................... 80 |
|
For authorization of a physician, advanced practitioner of nursing, physician assistant, euthanasia technician, ambulatory surgical center, facility for treatment with narcotics, researcher, instructional user or any other authorized person to prescribe or possess controlled substances................................................................................................ |
..................... 80 |
|
For the biennial renewal of authorization of a physician, advanced practitioner of nursing, physician assistant, euthanasia technician, ambulatory surgical center, facility for treatment with narcotics, researcher, instructional user or any other authorized person to prescribe or possess controlled substances.............................................. |
..................... 80 |
|
For the investigation or issuance of an original license to engage in business as an authorized warehouse, medical products provider or medical products wholesaler................................................................... |
................... 300 |
|
For the biennial renewal of a license to engage in business as an authorized warehouse, medical products provider or medical products wholesaler................................................................................................ |
................... 300 |
|
For the investigation or issuance of an original license to a manufacturer or wholesaler........................................................................................... |
................... 500 |
|
For the biennial renewal of a license for a manufacturer or wholesaler....... |
................... 500 |
|
For the reissuance of a license issued to a pharmacy, when no change of ownership is involved, but the license must be reissued because of a change in the information required thereon............................................ |
..................... 50 |
|
For authorization of a practitioner to dispense controlled substances or dangerous drugs, or both, for each location where the practitioner will dispense controlled substances or dangerous drugs, or both.................. |
................... 300 |
|
For the biennial renewal of authorization of a practitioner to dispense controlled substances or dangerous drugs, or both, for each location where the practitioner will dispense controlled substances or dangerous drugs, or both.......................................................................................... |
................... 300 |
2. The penalty for failure to pay the renewal fee for any license, permit or certificate within the statutory period, as provided in subsection 4 of NRS 639.170, is 50 percent of the renewal fee for each period of delinquency in addition to the renewal fee for each period of delinquency.
3. Any person who has been registered as a pharmacist in this State for at least 50 years is not required to pay the fee for the biennial renewal of a certificate of registration as a registered pharmacist.
4. The provisions of this section concerning the fee for the biennial renewal of the authorization to dispense controlled substances or dangerous drugs do not apply to an advanced practitioner of nursing who is required to pay a fee pursuant to NAC 639.870.
5. A health center:
(a) Which is a federally qualified health center as defined in 42 U.S.C. § 1396d(l)(2)(B), as that section existed on March 1, 2000, that provides health care primarily to medically underserved persons in a community; and
(b) Which is not a medical facility as defined in NRS 449.0151,
Ê is not required to pay the fee for the collective certification of advanced practitioners of nursing in the employ of a public or nonprofit agency as set forth in subsection 1.
6. A practitioner employed by or serving as an independent contractor of a health center:
(a) Which is a federally qualified health center as defined in 42 U.S.C. § 1396d(l)(2)(B), as that section existed on March 1, 2000, that provides health care primarily to medically underserved persons in a community; and
(b) Which is not a medical facility as defined in NRS 449.0151,
Ê is not required to pay a fee to the Board for a change of address or for an additional address at which the practitioner dispenses drugs.
7. A practitioner who is exempt from the payment of a fee pursuant to subsection 6 shall notify the Board in writing of each change of address or additional address, or both.
[Bd. of Pharmacy, § 639.050, eff. 6-26-80]—(NAC A 6-25-82; 6-16-86; 2-18-88; 4-28-88; 8-10-89; 9-11-91; 10-17-91; 11-15-93; 1-10-94; 7-7-94; 11-9-95; 5-22-96; R155-99, 3-1-2000; R011-01, 11-1-2001; R012-02, 5-31-2002; R081-04, 8-25-2004; R217-05, 5-4-2006)
NAC 639.225 Notice to Executive Secretary of change of address. (NRS 639.070) Every registered pharmacist, pharmaceutical intern and pharmaceutical technician shall, within 10 days after changing his residence or place of practice, give written notice of the change to the Executive Secretary.
[Bd. of Pharmacy, § 639.185, eff. 6-26-80]—(NAC A 11-15-93)
NAC 639.227 Application or written notice to Board concerning change in ownership of pharmacy required under certain circumstances; suspension of license. (NRS 639.070, 639.230)
1. Not less than 15 business days before a change of 50 percent or more of the beneficial interest of a pharmacy as indicated on the application filed pursuant to NRS 639.231, the person to whom the license to operate the pharmacy was issued shall file with the Board an application for change of ownership.
2. If the person to whom the license to operate the pharmacy was issued is not a corporation whose securities are publicly traded, then not more than 5 calendar days after a change of less than 50 percent of the beneficial interest in a pharmacy as indicated on the application filed pursuant to NRS 639.231, the person to whom the license to operate the pharmacy was issued shall file with the Board written notice of the change.
3. If an application or notice required by this section is not filed, the Board may initiate proceedings, pursuant to NRS 639.241 to 639.2576, inclusive, to suspend the license to operate the pharmacy.
(Added to NAC by Bd. of Pharmacy by R011-99, eff. 11-3-99)
NAC 639.230 Voluntary surrender of certificate, license or registration to practice pharmacy in another state pursuant to agreement relating to disciplinary matter. (NRS 639.070) If a pharmacist voluntarily surrenders his certificate, license or registration to practice pharmacy in another state pursuant to an agreement entered into by the pharmacist and the authorizing agency of that state relating to a disciplinary matter, the Board will initiate proceedings, pursuant to NRS 639.241 to 639.2576, inclusive, to revoke the certificate of registration of the pharmacist to practice pharmacy in the State of Nevada.
(Added to NAC by Bd. of Pharmacy by R010-99, eff. 11-3-99)
PHARMACEUTICAL TECHNICIANS
NAC 639.240 Requirements for registration of pharmaceutical technicians. (NRS 639.070, 639.1371)
1. No person may perform the duties of a pharmaceutical technician until he has been issued a certificate of registration.
2. An applicant for registration as a pharmaceutical technician must:
(a) Be 18 years of age or older;
(b) Be a high school graduate or the equivalent;
(c) Not have been convicted of any felony or a misdemeanor involving moral turpitude, dishonesty or the unlawful possession, sale or use of drugs;
(d) Have no history of drug abuse; and
(e) Have complied with one of the following requirements:
(1) The successful completion of a program of training for pharmaceutical technicians, including, but not limited to, a program of training offered by a postsecondary school, that is approved by the Board pursuant to NAC 639.256.
(2) Registration in another state as a pharmaceutical technician if the requirements for registration in that state are equivalent to the requirements of this State.
(3) If the state in which the applicant has been employed does not offer registration, licensure or certification as a pharmaceutical technician:
(I) The successful completion of at least 1,500 hours of experience in a pharmacy in that state performing the duties set forth in paragraph (c) of subsection 3 of NRS 639.1371 during the 3 years immediately preceding the date on which his application was submitted;
(II) The successful completion of at least 350 hours of employment in a pharmacy in this State; and
(III) The acquisition of a written statement to the Board from the managing pharmacist of the pharmacy referred to in sub-subparagraph (II) stating that the applicant, during his employment, demonstrated competence to perform the tasks assigned to him.
Ê Such an applicant must register as a pharmaceutical technician in training before he completes the requirements of sub-subparagraph (II).
(4) The successful completion of at least 1,500 hours of training and experience as a pharmaceutical technician in training. A pharmaceutical technician in training may accumulate certified hours of training from each place of employment.
(5) The successful completion of a program of training for pharmaceutical technicians conducted by a branch of the Armed Forces of the United States.
(6) Certification by the Pharmacy Technician Certification Board as a pharmacy technician if:
(I) The applicant successfully completes a program of training for pharmaceutical technicians conducted by a postsecondary school in another state; and
(II) The program is accredited or otherwise approved by the appropriate regulatory authority in that state.
3. An applicant who attended a school outside the United States must submit to an organization which evaluates educational credentials a copy of the transcript of his academic record from that school for a determination of whether the grades the applicant received are substantially equivalent to the grades required for an applicant who attended a school, or a program of training for pharmaceutical technicians that is accredited by the American Society of Health-System Pharmacists, in the United States. The applicant must ensure that a copy of the organization’s evaluation of the transcript is submitted to the Board.
4. Upon receipt of an application and the required fee, the Executive Secretary shall, unless he has good cause to deny the registration, issue a certificate of registration to the pharmaceutical technician.
[Bd. of Pharmacy, § 639.200, eff. 6-26-80]—(NAC A 12-3-84; 3-27-90; 11-15-93; 11-9-95; 7-17-96; R012-01, 11-1-2001; R041-04, 5-25-2004; R036-07, 1-30-2008)
REVISER’S NOTE.
The regulation of the State Board of Pharmacy filed with the Secretary of State on January 30, 2008 (LCB File No. R036-07), which amended this section, contains the following provisions not included in NAC:
“Notwithstanding the provisions of NAC 639.256, if a program of training for pharmaceutical technicians has been approved by the State Board of Pharmacy before January 30, 2008:
1. The program is not required to be accredited by the American Society of Health-System Pharmacists until January 30, 2010; and
2. An applicant for registration as a pharmaceutical technician may satisfy the requirement set forth in subparagraph (1) of paragraph (e) of subsection 2 of NAC 639.240 if he successfully completes the program not later than January 30, 2010.”
NAC 639.242 Registration of pharmaceutical technician in training; affidavit of managing pharmacist. (NRS 639.070, 639.1371)
1. An applicant for registration as a pharmaceutical technician in training must:
(a) Be 18 years of age or older;
(b) Be a high school graduate or the equivalent;
(c) Not have been convicted of any felony or a misdemeanor involving moral turpitude, dishonesty or the unlawful possession, sale or use of drugs;
(d) Have no history of drug abuse; and
(e) Participate in training while on the job and acquire experience that is commensurate with the duties of his employment.
2. A person may perform the duties of a pharmaceutical technician while he is receiving the training and experience required by paragraph (e) of subsection 1 if he is registered with the Board.
3. Upon receipt of an application and the required fee, the Executive Secretary shall, unless he has good cause to deny the registration, issue a registration certificate for a pharmaceutical technician in training to the managing pharmacist of the pharmacy where the trainee will be employed.
4. Registration as a pharmaceutical technician in training is effective for 24 months after the date of issuance unless an extension is granted by the Board.
5. The registration certificate of a pharmaceutical technician in training who is receiving the training and experience required by paragraph (e) of subsection 1 will specify the pharmacy where he will be employed. Termination of that employment voids the registration, and the trainee must reapply for registration before his services may be used by another pharmacy. This subsection does not prohibit a trainee from accumulating certified hours of training from each place of employment.
6. The managing pharmacist of the pharmacy where a pharmaceutical technician in training is employed to receive the training and experience required by paragraph (e) of subsection 1 shall file with the Board a signed affidavit certifying:
(a) The number of hours of training and experience the trainee has successfully completed;
(b) The specific training and experience the trainee has completed; and
(c) That the trainee is competent to perform the duties of a pharmaceutical technician.
(Added to NAC by Bd. of Pharmacy, eff. 11-15-93; A 11-9-95; 7-17-96)
NAC 639.245 Maintenance and availability of records regarding certain pharmaceutical personnel on duty; activities of pharmaceutical technicians. (NRS 639.070, 639.1371)
1. A written record must be kept available for inspection showing the pharmacists, pharmaceutical technicians and pharmaceutical technicians in training on duty during the hours of business. This record must be:
(a) Readily retrievable; and
(b) Retained for 2 years.
2. A pharmaceutical technician under the direct supervision of a pharmacist may:
(a) Prepackage and label unit dose and unit of use and repackage drugs if a pharmacist:
(1) Inspects the final products; and
(2) Affixes his initials to the appropriate records for controlling quality.
(b) Prepare, package, compound and label prescription drugs pursuant to prescriptions or orders for medication if a pharmacist:
(1) Inspects the final product; and
(2) Affixes his initials to the appropriate records for controlling quality.
(c) Prepare bulk compounds if a pharmacist:
(1) Inspects the final product; and
(2) Affixes his initials to the appropriate records for controlling quality.
(d) Distribute routine orders and stock medications and supplies in the pharmacy or areas where care is provided to patients.
(e) Maintain inventories of supplies of drugs.
(f) Maintain pharmaceutical records.
(g) Request authorization to refill a prescription from the prescribing practitioner.
(h) Transfer a prescription through a computer network if the:
(1) Pharmaceutical technician is employed by a pharmacy that:
(I) Has more than one location; and
(II) Maintains a computer network which provides information between its pharmacies; and
(2) Prescription is transferred to one of the pharmacies within its computer network.
(i) Enter information into the pharmacy’s computer system, including, without limitation, information contained in a new prescription concerning the prescription drug and the directions for its use.
3. A pharmaceutical technician may not:
(a) Perform any action requiring a judgmental decision regarding a drug, the interpretation of a prescription or the instructions for the preparation of a prescription.
(b) Take new prescription or chart orders by telephone.
(c) Distribute medications pursuant to a chart order or dispense a prescription unless the order or prescription has been verified by a pharmacist.
4. A pharmaceutical technician shall prepare and distribute drugs only pursuant to written procedures and guidelines established by the pharmacy in which he performs his duties.
[Bd. of Pharmacy, § 639.205, eff. 6-26-80]—(NAC A 12-3-84; 6-16-86; 3-27-90; 11-15-93; R214-99, 3-13-2000; R037-07, 1-30-2008)
NAC 639.247 Establishment and maintenance of policies and procedures for personnel; maintenance and availability of personnel records. (NRS 639.070, 639.1371)
1. A pharmacy that uses the services of a pharmaceutical technician shall:
(a) Establish and maintain written policies and procedures that include:
(1) Job descriptions for all personnel.
(2) Procedures to ensure the quality and safety of pharmaceutical services.
(3) The duties that may be performed only by registered pharmacists.
(4) The minimum qualifications for supportive personnel, including the minimum educational and training requirements that must be completed by supportive personnel.
(5) Procedures for processing prescriptions and compounding medications.
(b) Maintain a written record that includes:
(1) Documentation of the completion of the orientation and training required for each pharmaceutical technician that demonstrates his competency to perform the tasks assigned to him.
(2) Evidence that each pharmaceutical technician has read and is familiar with the written policies of the pharmacy and state and federal laws relating to the practice of pharmacy.
2. The written record maintained pursuant to paragraph (b) of subsection 1 must be available for inspection upon the request of any person authorized to inspect the record for a period of at least 2 years.
(Added to NAC by Bd. of Pharmacy, eff. 11-15-93)
NAC 639.250 Restrictions on supervision. (NRS 639.070, 639.1371) Except as otherwise provided in NAC 639.258:
1. Except as otherwise provided in this section, in a hospital, a pharmacist who is dispensing prescriptions may not supervise more than three pharmaceutical technicians at one time. A pharmacist who is supervising distributive functions may not supervise more than two pharmaceutical technicians and one pharmaceutical technician in training while the trainee is performing technician functions in on-the-job training.
2. Except as otherwise provided in this section, in any pharmacy, other than a hospital pharmacy, a pharmacist may not supervise more than three pharmaceutical technicians or one pharmaceutical technician and two pharmaceutical technicians in training at one time.
3. A pharmacist may supervise more pharmaceutical technicians and pharmaceutical technicians in training at one time than are otherwise allowed pursuant to subsections 1 and 2 if:
(a) Not more than three of the pharmaceutical technicians or pharmaceutical technicians in training are performing the duties of a pharmaceutical technician as set forth in NAC 639.245; and
(b) The record kept by the pharmacy pursuant to NAC 639.245 identifies the pharmaceutical technicians and pharmaceutical technicians in training who are performing the duties of a pharmaceutical technician as set forth in NAC 639.245.
[Bd. of Pharmacy, § 639.215, eff. 6-26-80]—(NAC A 12-3-84; 2-18-88; 3-27-90; 11-15-93; 12-13-96; R016-99, 11-3-99; R037-07, 1-30-2008)
NAC 639.252 Initialing of prescriptions, records and reports; responsibility for filled prescriptions. (NRS 639.070, 639.1371)
1. A prescription and any record or report prepared by a pharmaceutical technician must bear the legible initials of the pharmaceutical technician and the pharmacist who is supervising him.
2. If a pharmaceutical technician performs one or more of the functions necessary to prepare a prescription, the pharmacist supervising the pharmaceutical technician is responsible for the filled prescription, including, but not limited to, verifying:
(a) The selection and strength of the drug;
(b) The dosage form; and
(c) The labeling of the prescription.
(Added to NAC by Bd. of Pharmacy, eff. 11-15-93)
NAC 639.254 Initial and biennial in-service training of pharmaceutical technicians working in or for pharmacy; substitution of continuing education for in-service training. (NRS 639.070, 639.1371)
1. The owner and managing pharmacist of a pharmacy shall provide training for pharmaceutical technicians working in or for the pharmacy that ensures the continuing competency of those technicians. Except as otherwise provided in this section, the training must consist of initial training upon employment and at least 12 hours of in-service training during the 2-year period immediately preceding the renewal of the registration of the pharmaceutical technician.
2. The managing pharmacist shall maintain a written record of the initial training and the annual training completed by each pharmaceutical technician working in or for the pharmacy that contains:
(a) The name and signature of the person receiving the training;
(b) The date or dates on which the training was received;
(c) The number of hours of training received;
(d) A general description of the topics covered; and
(e) The name of the person or provider conducting the training.
3. A pharmaceutical technician may substitute the completion of the continuing education necessary for recertification by the Pharmacy Technician Certification Board for the biennial in-service training required by subsection 1.
(Added to NAC by Bd. of Pharmacy, eff. 11-15-93; A by R033-02, 5-31-2002)
NAC 639.256 Program of training: Approval by Board; testing of pharmaceutical technician in training for presence of alcohol or drug. (NRS 639.070, 639.1371)
1. A program of training for pharmaceutical technicians must be approved by the Board before it is provided in this State. A request for approval must be filed with the Board. The Board will approve a program only if the program:
(a) Is accredited by the American Society of Health-System Pharmacists; and
(b) Administers at least one random test for the presence of alcohol or a controlled substance or other drug to each pharmaceutical technician in training before the pharmaceutical technician in training is allowed to participate in any part of the program that involves employment or training in a pharmacy. If the pharmaceutical technician in training tests positive for the presence of alcohol or a controlled substance or other drug for which the pharmaceutical technician in training does not have a lawfully issued prescription or the pharmaceutical technician in training refuses to submit to such a test, the administrator of the program must:
(1) Suspend the pharmaceutical technician in training from participating in any part of the program that involves employment or training in a pharmacy;
(2) Notify the Board that the pharmaceutical technician in training has tested positive for the presence of alcohol or a controlled substance or other drug for which the pharmaceutical technician in training does not have a lawfully issued prescription or has refused to submit to such a test; and
(3) Prevent the pharmaceutical technician in training from resuming participation in any part of the program that involves employment or training in a pharmacy without the approval of the Board.
2. The Board may refuse to approve a program of training for pharmaceutical technicians or may withdraw its approval of a program at any time for good cause shown.
3. A program of training for pharmaceutical technicians that is provided outside this State shall be deemed to be approved by the Board if the program is accredited by the American Society of Health-System Pharmacists.
4. For the purposes of this section, “program of training for pharmaceutical technicians” does not include on-the-job training that is provided to a pharmaceutical technician in training by his employer.
(Added to NAC by Bd. of Pharmacy, eff. 11-15-93; A by R036-07, 1-30-2008)
REVISER’S NOTE.
The regulation of the State Board of Pharmacy filed with the Secretary of State on January 30, 2008 (LCB File No. R036-07), which amended this section, contains the following provisions not included in NAC:
“Notwithstanding the provisions of NAC 639.256, if a program of training for pharmaceutical technicians has been approved by the State Board of Pharmacy before January 30, 2008:
1. The program is not required to be accredited by the American Society of Health-System Pharmacists until January 30, 2010; and
2. An applicant for registration as a pharmaceutical technician may satisfy the requirement set forth in subparagraph (1) of paragraph (e) of subsection 2 of NAC 639.240 if he successfully completes the program not later than January 30, 2010.”
NAC 639.258 Participation in program of training for pharmaceutical technicians. (NRS 639.070, 639.1371)
1. A pharmaceutical technician in training who is registered with the Board may perform the duties of a pharmaceutical technician while he is participating in a program of training for pharmaceutical technicians that is approved by the Board pursuant to NAC 639.256. The registration of such a pharmaceutical technician in training:
(a) Will specify the program of training in which he is participating; and
(b) Expires when the enrollment of the pharmaceutical technician in the program terminates.
2. A person who is participating in a program of training for pharmaceutical technicians that is approved by the Board pursuant to NAC 639.256 may be trained in more than one pharmacy as a part of the program.
3. A pharmacist who is acting as an instructor for a program of training for pharmaceutical technicians that is approved by the Board pursuant to NAC 639.256 may, while acting as an instructor, supervise one pharmaceutical technician in training, in addition to the persons that he may supervise pursuant to NAC 639.250, if the additional pharmaceutical technician in training:
(a) Has completed at least 9 months of a program of training for pharmaceutical technicians that is approved by the Board pursuant to NAC 639.256; and
(b) Has not yet successfully completed 240 hours of practical training.
4. A pharmacist shall not supervise an additional pharmaceutical technician in training pursuant to subsection 3 after that pharmaceutical technician in training has successfully completed 240 hours of practical training.
(Added to NAC by Bd. of Pharmacy, eff. 11-15-93; A 12-13-96; R036-07, 1-30-2008)
REVISER’S NOTE.
The regulation of the State Board of Pharmacy filed with the Secretary of State on January 30, 2008 (LCB File No. R036-07), which amended this section, contains the following provisions not included in NAC:
“Notwithstanding the provisions of NAC 639.256, if a program of training for pharmaceutical technicians has been approved by the State Board of Pharmacy before January 30, 2008:
1. The program is not required to be accredited by the American Society of Health-System Pharmacists until January 30, 2010; and
2. An applicant for registration as a pharmaceutical technician may satisfy the requirement set forth in subparagraph (1) of paragraph (e) of subsection 2 of NAC 639.240 if he successfully completes the program not later than January 30, 2010.”
NAC 639.260 Disciplinary action against pharmacy. (NRS 639.070, 639.1371, 639.210) A pharmacy that requires or allows a pharmacist to use the services of a pharmaceutical technician in violation of any provision of this chapter or chapter 639 of NRS is subject to the disciplinary actions set forth in NRS 639.210.
(Added to NAC by Bd. of Pharmacy, eff. 11-15-93)
INTERN PHARMACISTS
NAC 639.262 Application for registration; issuance of certificate of registration; maintenance of records relating to internship. (NRS 639.070, 639.137)
1. As required by NRS 639.137, an application for registration as an intern pharmacist must be made on a form furnished by the Board. If the applicant is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board, the application must include the name, telephone number and mailing address of the person at the college of pharmacy or the department of pharmacy of the university who will be making and maintaining the records relating to the internship of the applicant.
2. Upon approval of the application, the Executive Secretary shall issue a certificate of registration as required by NRS 639.137.
3. Except as otherwise provided in subsection 4, if an applicant is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board, the college of pharmacy or the department of pharmacy of the university at which the applicant is enrolled shall prepare and maintain records relating to the participation of the applicant in his internship as an intern pharmacist. The records must include, without limitation, a copy of the documentation provided to the college of pharmacy or the department of pharmacy of the university pursuant to subsection 5 of NAC 639.266, if any.
4. If an applicant participates in an internship after he has graduated from a college of pharmacy, a department of pharmacy of a university or a foreign school, the applicant shall prepare and maintain records relating to his participation in the internship. The records must include, without limitation, a copy of the documentation provided to the applicant pursuant to subsection 5 of NAC 639.266, if any.
(Added to NAC by Bd. of Pharmacy by R019-03, eff. 10-21-2003)
NAC 639.264 Employment at pharmacy as part of internship. (NRS 639.070, 639.137) A pharmacy for which an intern pharmacist works as part of an internship to fulfill the requirements of paragraph (d) of subsection 1 of NRS 639.120 may:
1. Allow the intern pharmacist to work at the pharmacy without pay if the intern pharmacist is receiving credit for the internship from the college of pharmacy or the department of pharmacy of the university approved by the Board at which the intern pharmacist is enrolled; or
2. Employ the intern pharmacist with pay if the intern pharmacist:
(a) Has graduated from a college of pharmacy, a department of pharmacy of a university or a foreign school; or
(b) Is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board and is working for the pharmacy during a break from his attendance at the college of pharmacy or the department of pharmacy of the university, including, without limitation, the summer vacation months or a holiday break.
(Added to NAC by Bd. of Pharmacy by R019-03, eff. 10-21-2003)
NAC 639.266 Supervision and training: Service as preceptor; duties; evaluation of internship. (NRS 639.070, 639.137)
1. Except as otherwise prohibited by law or by an order of the Board, any registered pharmacist may serve as preceptor to an intern pharmacist.
2. If an intern pharmacist is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board, the college of pharmacy or the department of pharmacy of the university at which the intern pharmacist is enrolled shall establish a scope of duties that may be engaged in by the intern pharmacist during his internship and shall provide the scope of duties to the intern pharmacist before his internship begins. The scope of duties must be based upon the courses that the intern pharmacist has completed. The intern pharmacist shall, before his internship begins, provide the scope of duties established for him by the college of pharmacy or the department of pharmacy of the university to any preceptor responsible for his supervision and training.
3. Except as otherwise provided in subsection 4, a preceptor shall allow an intern pharmacist under his supervision to perform duties to the fullest extent practicable that are primarily related to:
(a) The selling of controlled substances, poisons, dangerous drugs and devices;
(b) The compounding of prescription drugs;
(c) The filling of prescriptions and the dispensing of prescription drugs;
(d) Preparing and maintaining such records and reports as are required by state and federal law;
(e) Counseling patients as required by NAC 639.707 concerning prescription drugs dispensed to the patients; and
(f) The practice of pharmacy as that term is defined in NRS 639.0124.
4. A preceptor shall not allow an intern pharmacist under his supervision to perform any duties that:
(a) Are outside of the scope of duties established for the intern pharmacist pursuant to subsection 2; or
(b) In the professional judgment of the preceptor, the intern pharmacist is not able to perform safely and professionally.
5. A preceptor shall:
(a) Document the number of hours worked by each intern pharmacist under his supervision;
(b) Maintain that documentation; and
(c) Provide a copy of that documentation to:
(1) The college of pharmacy or the department of pharmacy of the university at which the intern pharmacist is enrolled if the intern pharmacist is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board; or
(2) The intern pharmacist if the intern pharmacist has graduated from a college of pharmacy, a department of pharmacy of a university or a foreign school.
6. If the intern pharmacist is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board, the preceptor supervising the intern pharmacist shall provide written notice to the college of pharmacy or the department of pharmacy of the university at which the intern pharmacist is enrolled if the preceptor or the pharmacy for which the preceptor works terminates the internship of the intern pharmacist. The notice must state with specificity the reasons for the termination of the internship.
7. In addition to the notice provided pursuant to subsection 6, a preceptor supervising an intern pharmacist who is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board shall provide written notice to the Board if the internship of the intern pharmacist is terminated because the intern pharmacist:
(a) Was arrested for, charged with or convicted of a crime that was alleged to have been committed by the intern pharmacist while participating in his internship at the pharmacy;
(b) Committed an act that, in the judgment of the preceptor, was a violation of one or more provisions of Nevada or federal law relating to the practice of pharmacy; or
(c) Committed an act that, in the judgment of the preceptor, was a violation of one or more of the policies or procedures of the pharmacy at which the intern pharmacist was participating in his internship.
Ê The notice must state with specificity the reasons for the termination of the internship.
8. Except as otherwise provided in subsection 9, the college of pharmacy or the department of pharmacy of the university at which any intern pharmacist is enrolled shall provide the intern pharmacist with a form to evaluate the quality of his internship at a pharmacy upon completion of the internship at the pharmacy. If a representative of the college of pharmacy or the department of pharmacy of the university discusses any of the comments made on the evaluation form with a preceptor who supervised the intern pharmacist or with any representative of the pharmacy at which the intern pharmacist was participating in his internship, the representative of the college of pharmacy or the department of pharmacy of the university shall not attribute any of the comments made on the evaluation to the intern pharmacist.
9. A college of pharmacy or a department of pharmacy of a university is not required to provide an intern pharmacist who participates in an internship after he has graduated from the college of pharmacy or the department of pharmacy of the university with a form to evaluate the quality of his internship at a pharmacy.
10. As used in this section, “preceptor” means a registered pharmacist who:
(a) Has accepted responsibility for the supervision and training of an intern pharmacist; and
(b) Provides direct and immediate supervision to the intern pharmacist.
(Added to NAC by Bd. of Pharmacy by R019-03, eff. 10-21-2003)
NAC 639.268 Supervision and training: Responsibilities of registered pharmacist. (NRS 639.070, 639.137) A registered pharmacist who has accepted responsibility for the supervision and training of an intern pharmacist is responsible for all acts performed by the intern pharmacist working under his supervision. All prescriptions compounded, dispensed or filled by an intern pharmacist and all records and reports prepared by an intern pharmacist must bear the legible initials of both the intern and the registered pharmacist who is supervising him.
[Bd. of Pharmacy, § 639.195, eff. 6-26-80]—(Substituted in revision for NAC 639.705)
PHYSICIAN ASSISTANTS
NAC 639.269 “Physician assistant” defined. (NRS 639.070) As used in NAC 639.269 to 639.295, inclusive, unless the context otherwise requires, “physician assistant” includes a physician assistant as defined in NRS 633.107.
(Added to NAC by Bd. of Pharmacy by R015-03, eff. 10-21-2003)
NAC 639.270 Scope. (NRS 639.070, 639.1373) The provisions of NAC 639.269 to 639.295, inclusive:
1. Regulate the issuance of registration certificates to physician assistants;
2. Control the prescribing and dispensing of controlled substances, poisons, dangerous drugs and devices by physician assistants;
3. Set registration fees; and
4. Establish grounds for the suspension or revocation of registration certificates of physician assistants.
[Bd. of Pharmacy, § 639.350, eff. 6-26-80]—(NAC A 2-6-90; 9-10-90; 10-24-97)
NAC 639.272 Requirements for registration certificate. (NRS 639.070, 639.1373)
1. The application of a physician assistant for:
(a) A registration certificate to prescribe controlled substances, poisons, dangerous drugs and devices or to prescribe poisons, dangerous drugs and devices; or
(b) A registration certificate to prescribe and dispense controlled substances, poisons, dangerous drugs and devices or to prescribe and dispense poisons, dangerous drugs and devices,
Ê must be in writing and filed with the Executive Secretary.
2. Each application for a registration certificate to prescribe controlled substances, poisons, dangerous drugs and devices or to prescribe poisons, dangerous drugs and devices must include:
(a) The name, address, social security number and telephone number of the applicant;
(b) A copy of the license issued by the Board of Medical Examiners or certificate issued by the State Board of Osteopathic Medicine that authorizes the applicant to prescribe controlled substances, poisons, dangerous drugs and devices or to prescribe poisons, dangerous drugs and devices;
(c) The name, address and telephone number of the applicant’s supervising physician; and
(d) Any other information requested by the Board.
3. Each application for a registration certificate to prescribe and dispense controlled substances, poisons, dangerous drugs and devices or to prescribe and dispense poisons, dangerous drugs and devices must include:
(a) The name, address, social security number and telephone number of the applicant;
(b) A copy of the license issued by the Board of Medical Examiners or certificate issued by the State Board of Osteopathic Medicine that authorizes the applicant to prescribe and dispense controlled substances, poisons, dangerous drugs and devices or to prescribe and dispense poisons, dangerous drugs and devices;
(c) The name, address and telephone number of the applicant’s supervising physician; and
(d) Any other information requested by the Board.
4. Each physician assistant who applies for a registration certificate pursuant to subsection 3 must:
(a) Personally appear before the Board for determination and assignment of the specific authority to be granted to the physician assistant if the physician assistant:
(1) Responded affirmatively to any of the questions on the application regarding his character or competency; or
(2) Is requested to do so by the Board;
(b) Submit a statement, signed by the applicant and a pharmacist who is registered with the Board, indicating that the pharmacist is available to the applicant as a consultant concerning the dispensing of controlled substances, poisons, dangerous drugs and devices; and
(c) Pass an examination administered by the Board on the law relating to pharmacy.
5. Each physician assistant to whom a registration certificate is issued must be registered to a supervising physician.
(Added to NAC by Bd. of Pharmacy, eff. 10-26-83; A 2-6-90; 9-10-90; 10-17-91; 10-1-93; 10-24-97; R006-01, 11-1-2001)
NAC 639.277 Change in location of practice or supervising physician. (NRS 639.070) A physician assistant shall notify the Board in writing of a change in the location of his practice or a change of his supervising physician not later than 10 days after the change occurs.
(Added to NAC by Bd. of Pharmacy, eff. 2-6-90; A 9-10-90; 10-24-97)
NAC 639.280 Scope of authority to prescribe and dispense. (NRS 639.070, 639.1373)
1. Except as otherwise provided in subsections 2 and 3, a physician assistant who is authorized to prescribe and dispense controlled substances, poisons, dangerous drugs and devices or to prescribe and dispense poisons, dangerous drugs and devices may prescribe and dispense a controlled substance, poison, dangerous drug and device or a poison, dangerous drug and device, as applicable, only:
(a) For a legitimate medical purpose; and
(b) In such amounts as are authorized by his supervising physician except that the amounts must not exceed a 365-day supply.
2. A physician assistant who is authorized to prescribe and dispense dangerous drugs may dispense any method of birth control in any quantity ordered by prescription.
3. The limitation set forth in paragraph (b) of subsection 1 does not apply to any method of birth control prescribed or dispensed by a physician assistant.
4. A physician assistant who prescribes or dispenses drugs to a patient under the direction of a supervising physician or pursuant to NRS 454.00958 shall do so by a written prescription, unless the prescription is issued as an oral order to a pharmacy.
[Bd. of Pharmacy, § 639.360, eff. 6-26-80]—(NAC A 10-17-86; 2-6-90; 9-10-90; 5-22-96; 10-24-97; R015-03, 10-21-2003)
NAC 639.283 Prescriptions: Orders on charts of hospitalized patients. (NRS 639.070, 639.1373) A physician assistant shall not write a prescription in the form of an order on the chart of a patient in a hospital unless he is authorized by the hospital’s rules and has filed a copy of his form for prescriptions with the pharmacy of the hospital. The form must be approved by the Board.
(Added to NAC by Bd. of Pharmacy, eff. 2-6-90)
NAC 639.285 Security and storage of controlled substances and drugs. (NRS 639.070, 639.1373)
1. All controlled substances and dangerous drugs which are in the possession of a physician assistant must be kept in a locked storage area. Access to the storage area must be restricted to the persons described in NRS 453.375.
2. Physician assistants working intermittently at satellite facilities, such as clinics, must transport the drugs on each trip to and from those locations unless authorized by the Board to store them at those locations.
3. Biologicals and other drugs must be refrigerated if that requirement is stated on the manufacturer’s label.
[Bd. of Pharmacy, § 639.370, eff. 6-26-80]—(NAC A 2-6-90)
NAC 639.290 Substitution in case of illness or absence. (NRS 639.070, 639.1373) When a physician assistant possessing a registration certificate to prescribe and dispense controlled substances, poisons, dangerous drugs and devices or to prescribe and dispense poisons, dangerous drugs and devices is ill or absent from his duties, another physician assistant possessing such a registration certificate may perform the duties of the absent physician assistant with the consent and under the supervision of the supervising physician of the absent physician assistant. An inventory of drugs must be taken before the substitute begins his duties and again taken when the returning physician assistant resumes his duties. The inventories must be attested to by the signature of the supervising physician and copies submitted to the Executive Secretary upon the request of the Board.
[Bd. of Pharmacy, § 639.365, eff. 6-26-80]—(NAC A 2-6-90; 9-10-90; 10-24-97)
NAC 639.295 Grounds for denial of application or suspension or revocation of registration. (NRS 639.070, 639.1373, 639.210) The Board may deny the application of any physician assistant or suspend or revoke his registration if he:
1. Is not of good moral character;
2. Is guilty of habitual intemperance;
3. Becomes or is under the influence of liquor, any depressant drug or a controlled substance while on duty, unless the drug or substance has been taken pursuant to a physician’s prescription;
4. Is guilty of unprofessional conduct or conduct contrary to the public interest;
5. Is addicted to the use of any controlled substance;
6. Has been convicted of a violation of any federal law or law of any other state relating to controlled substances;
7. Has been convicted of a felony or other crime involving moral turpitude, dishonesty or corruption;
8. Has willfully made to the Board or its authorized representative any false written statement which is material to the administration or enforcement of any provision of chapter 453, 454 or 639 of NRS;
9. Has obtained registration by filing any application, record or affidavit, or any information in support thereof, which is false or fraudulent;
10. Has violated any provision of the Federal Food, Drug and Cosmetic Act or any other state or federal law or regulation relating to prescription drugs;
11. Has violated, attempted to violate, assisted or abetted in the violation of, or conspired to violate any law or regulation relating to the practice of pharmacy;
12. Has failed to renew his registration by failing to pay the renewal fee;
13. Has failed to maintain the security of his drug supply;
14. Has violated, attempted to violate, assisted or abetted in the violation of, or conspired to violate any provision of this regulation;
15. Has supplied patients with prescriptions that are presigned in blank by the physician; or
16. Has violated any provision of chapter 453, 454, 585 or 639 of NRS.
[Bd. of Pharmacy, § 639.375, eff. 6-26-80]—(NAC A 2-6-90)
IMMUNIZATION BY PHARMACISTS AND INTERN PHARMACISTS
NAC 639.297 “Immunization” defined. (NRS 639.070) As used in NAC 639.297 to 639.2978, inclusive, unless the context otherwise requires, “immunization” means the act of inducing antibody formation through the introduction of a drug into the human body.
(Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001)
NAC 639.2971 Authorization; contents of and deviation from written protocol. (NRS 454.213, 639.070, 639.137)
1. A pharmacist may administer immunizations by an intranasal, intramuscular or subcutaneous injection in compliance with a written protocol from a physician that authorizes a pharmacist to administer such an immunization. Such a protocol must contain:
(a) The name of the physician who is authorizing the administration of immunizations by a pharmacist;
(b) The name of the pharmacist authorized to administer immunizations;
(c) The location or locations at which the pharmacist may administer immunizations;
(d) The immunizations that may be administered by the pharmacist;
(e) Detailed policies and procedures that the pharmacist must follow while administering immunizations, including, without limitation, procedures to follow in the case of adverse reactions or emergencies following administration;
(f) A procedure requiring the pharmacist to report the administration of immunizations to the physician issuing the written protocol, including, without limitation:
(1) A specification of the time within which such reporting must occur; and
(2) A requirement that the pharmacist submit a periodic status report concerning any problems, complications or emergencies encountered while administering immunizations;
(g) A procedure for the review of the protocol and its operation by the pharmacist and the physician at least once annually, and the making and keeping of a record of the review;
(h) A restriction that the pharmacist may not administer any immunization to a patient who is less than 14 years of age;
(i) Except as otherwise provided in subsection 2, a restriction that the pharmacist may not delegate his authority to administer an immunization;
(j) A restriction that the pharmacist may not administer an immunization except at the authorized location, which location may not be the home of the patient, unless the patient resides in a licensed facility for long-term care or in a hospital;
(k) A requirement that the immunizations will be administered according to all applicable federal, state and local laws;
(l) A restriction that the pharmacist, the pharmacy or the business at which the immunizations will be administered is prohibited from paying, offering or otherwise giving any remuneration to the physician for providing a written protocol or authorizing the administration of an immunization to any patient; and
(m) The signature of the physician authorizing the administration of the immunizations and the effective dates of the written protocol.
2. An intern pharmacist may administer immunizations by an intranasal, intramuscular or subcutaneous injection under the direct and immediate supervision of a pharmacist who has received a written protocol from a physician that authorizes the pharmacist to administer such an immunization.
3. If a physician orders a deviation from the written protocol with a pharmacist for the benefit of a specific patient, the physician shall note the deviations from the written protocol in the record of the patient.
(Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R142-03, 4-8-2004; R180-05, 12-29-2005)
NAC 639.2972 Duties of authorizing physician. (NRS 454.213, 639.070, 639.137) A physician who has authorized a pharmacist to administer immunizations pursuant to a written protocol shall supervise the implementation of the protocol by the pharmacist or an intern pharmacist acting under the direct and immediate supervision of the pharmacist by:
1. Retaining responsibility for the quality of care rendered by the pharmacist or intern pharmacist;
2. Being readily accessible to the pharmacist or intern pharmacist or the patient when the pharmacist is authorized to administer the immunizations for consultation, assistance and direction; and
3. Reviewing a periodic status report from the pharmacist or intern pharmacist concerning any problems, complications or emergencies encountered while administering immunizations.
(Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005)
NAC 639.2973 Training and certification to administer immunizations. (NRS 454.213, 639.070, 639.137)
1. Before a pharmacist may enter into a written protocol with a physician to administer immunizations or before an intern pharmacist acting under the direct and immediate supervision of a pharmacist may administer immunizations, the pharmacist or intern pharmacist must be trained and certified to administer immunizations by completing a course provided by the Office of Pharmacy Education, the University of Nevada School of Medicine or a provider approved by the Accreditation Council for Pharmacy Education that includes:
(a) Certification in life-saving techniques pursuant to the American Heart Association’s Basic Cardiac Life Support for Health Care Providers or its equivalent;
(b) Education and practical training, including, without limitation, written study materials regarding techniques for administering immunizations;
(c) Evaluation of the knowledge and technique of the pharmacist or intern pharmacist in administering immunizations;
(d) Instruction consistent with the current training guidelines of the Centers for Disease Control and Prevention; and
(e) Except as otherwise provided in subsection 2, a minimum of 20 hours of instruction and practical training concerning:
(1) The standards for pediatric, adolescent and adult immunization practices recommended and approved by the United States Public Health Service Advisory Committee on Immunization Practices;
(2) Basic immunology, and vaccine and immunization protection;
(3) Diseases that are preventable through vaccination and immunization;
(4) Recommended immunization schedules;
(5) Vaccine and immunization storage and management;
(6) Informed consent;
(7) Physiology and techniques for administration of immunizations;
(8) Preimmunization and postimmunization assessment and counseling;
(9) Immunization reporting and records management; and
(10) Identification, response, documentation and reporting of adverse events.
2. In lieu of complying with the requirements of paragraph (e) of subsection 1, a pharmacist or an intern pharmacist who administers immunizations consisting exclusively of live attenuated influenza vaccine through the nasal passages of a person may complete a program of less than 20 hours of instruction which is accredited by the Accreditation Council for Pharmacy Education and includes instruction relating to:
(a) The epidemiology of influenza;
(b) The pathophysiology, clinical presentation, diagnosis, prevention and treatment of influenza;
(c) The administration, storage and handling of influenza vaccines; and
(d) The counseling of patients who will be immunized with the vaccine.
(Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R187-03, 4-8-2004; R180-05, 12-29-2005)
NAC 639.2974 Certification in basic cardiac life support; continuing education. (NRS 454.213, 639.070, 639.137) A pharmacist who administers immunizations or an intern pharmacist acting under the direct and immediate supervision of a pharmacist who administers immunizations shall:
1. Maintain certification in basic cardiac life support from the American Heart Association; and
2. On or before October 31 of each year, complete:
(a) At least 2 hours of continuing education in a course or courses that address the life cycle of diseases, drugs and administration of immunizations; or
(b) A course provided by the Centers for Disease Control and Prevention regarding epidemiology and prevention of diseases which are preventable through immunization.
(Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005)
NAC 639.2975 Legal possession and control of drugs administered as immunizations; drugs to counteract adverse reactions. (NRS 454.213, 639.070, 639.137)
1. The drugs administered as immunizations by a pharmacist or an intern pharmacist acting under the direct and immediate supervision of a pharmacist must be in the legal possession of:
(a) The pharmacy that employs the pharmacist or intern pharmacist who will be administering the immunizations, which pharmacy is responsible for the drugs and the maintenance of records of administration of the immunizations; or
(b) The physician who has authorized the pharmacist to administer the immunizations, which physician is responsible for the drugs and the maintenance of records of administration of the immunizations.
2. The drugs used for immunizations must be transported and stored at the proper temperatures indicated for the drugs by the manufacturer.
3. While engaged in the administration of immunizations, a pharmacist or an intern pharmacist acting under the direct and immediate supervision of a pharmacist may have in his custody and control the drugs for immunization that are identified in the written protocol and any other dangerous drugs listed in the written protocol to treat an adverse reaction.
4. If a pharmacist or an intern pharmacist acting under the direct and immediate supervision of a pharmacist administers immunizations at a location other than a pharmacy, the pharmacist or intern pharmacist must return all unused drugs to the pharmacy or physician responsible for the drugs.
(Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005)
NAC 639.2976 Notification of immunizations. (NRS 454.213, 639.070, 639.137)
1. A pharmacist or an intern pharmacist acting under the direct and immediate supervision of a pharmacist who administers immunizations shall notify:
(a) The physician who issued the written protocol within 14 days after administering the immunizations;
(b) The primary care physician of the patient, as provided by the patient or agent of the patient, within 14 days after administering the immunizations;
(c) The county health department of the county where the immunization was administered and the State of Nevada as required by statute, regulation, ordinance or rule; and
(d) The statewide immunization registry maintained by the Health Division of the Department of Health and Human Services.
2. The notifications required pursuant to subsection 1:
(a) Must include the name and address of the patient; and
(b) May include:
(1) The name of the primary care physician of the patient as provided by the patient or the agent of the patient;
(2) The name, manufacturer and lot number of the drug administered;
(3) The amount of the drug administered;
(4) The date the immunization was administered;
(5) The place on the body of the patient where the immunization was administered;
(6) The route of administration of the immunization;
(7) The name, address and title of the person administering the immunization;
(8) Any adverse reactions suffered by the patient as a result of the immunization; and
(9) Any other information required by federal, state or local law.
(Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005)
NAC 639.2977 Maintenance of records. (NRS 454.213, 639.070, 639.137)
1. Each record required to be made pursuant to NAC 639.297 to 639.2978, inclusive, must be kept for at least 2 years by the pharmacist or intern pharmacist administering the immunization and the pharmacy or physician who possessed the drugs administered. Such records must be available for inspection and copying by the Board or its representative, or any other authorized federal, state or local law enforcement or regulatory agency.
2. Records required pursuant to this section may be maintained in an alternative data retention system, including, without limitation, a computer data processing system or direct imaging system, if:
(a) The records maintained in the alternative system contain all the information required for a written record; and
(b) The data processing system is capable of producing a printed copy of the record upon the request of the Board, its representative or any other authorized federal, state or local law enforcement or regulatory agency.
(Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005)
NAC 639.2978 Confidentiality of records. (NRS 454.213, 639.070, 639.137)
1. A pharmacist or an intern pharmacist acting under the direct and immediate supervision of a pharmacist shall provide adequate security to prevent unauthorized access to confidential records of immunizations. If confidential health information is not transmitted directly between a pharmacy and a physician, but is transmitted through a data communication device, the confidential health information must not be viewed or used by the operator of the data communication device unless the operator is specifically authorized to obtain confidential information pursuant to this subsection.
2. Except as otherwise provided in NRS 49.245, the confidential records of immunizations are privileged and may be released only to:
(a) The patient or the authorized agent of the patient;
(b) Physicians and other pharmacists or intern pharmacists acting under the direct and immediate supervision of pharmacists when, in the professional judgment of the pharmacist or intern pharmacist, such release is necessary to protect the health and well-being of the patient;
(c) The Board or other federal, state or local agencies authorized by law to receive such information;
(d) A law enforcement agency engaged in the investigation of a suspected violation involving a controlled substance or dangerous drug;
(e) A person employed by any state agency that licenses a physician if such a person is engaged in the performance of his official duties; or
(f) An insurance carrier or other third party payor authorized by a patient to receive such information.
3. The provisions of this section must not be construed to affect or alter the provisions of NRS 49.215 to 49.245, inclusive, relating to the confidentiality of communications between a doctor and a patient.
(Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005)
CONTINUING PROFESSIONAL EDUCATION
NAC 639.300 Definitions. (NRS 639.070, 639.2176) As used in NAC 639.300 to 639.390, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.305 to 639.320, inclusive, have the meanings ascribed to them in those sections.
[Bd. of Pharmacy, § 639.070, eff. 6-26-80]—(NAC A 10-17-86)
NAC 639.305 “Acceptable materials” defined. (NRS 639.070, 639.2176) “Acceptable materials” means material for continuing education which:
1. Complies with the statutory limits regarding the scope of continuing education; and
2. Is offered by a provider although the material is not endorsed by the Board, or has been submitted to and endorsed by the Board.
[Bd. of Pharmacy, § 639.075, eff. 6-26-80]—(NAC A 10-17-86)
NAC 639.310 “Accredited material” defined. (NRS 639.070, 639.2176) “Accredited material” means material for continuing education which has been endorsed by the Board after review by the Board, by its advisory committee on continuing education, by the Accreditation Council for Pharmacy Education or by a board of pharmacy of another state.
[Bd. of Pharmacy, § 639.080, eff. 6-26-80]—(NAC A 10-17-86)
NAC 639.315 “Continuing education unit” defined. (NRS 639.070, 639.2176) “Continuing education unit” means 1 full hour devoted to approved continuing education, consisting of accredited or acceptable material.
[Bd. of Pharmacy, § 639.085, eff. 6-26-80]—(NAC A 10-17-86)
NAC 639.320 “Provider” defined. (NRS 639.070, 639.2176) “Provider” means any person recognized by the Board as responsible and competent to provide material for continuing education which is accredited or acceptable.
[Bd. of Pharmacy, § 639.090, eff. 6-26-80]—(NAC A 10-17-86)
NAC 639.330 Registration and reregistration: Continuing education required; submission of proof. (NRS 639.070, 639.2176)
1. Except as otherwise provided in NAC 639.335, the Board will not issue a certificate as a registered pharmacist to any person pursuant to NRS 639.133, or renew the certificate of any registered pharmacist, until the applicant submits proof to the Board of receipt of 30 continuing education units within the biennium immediately preceding the current renewal period. The continuing education units must include not less than:
(a) Fifteen continuing education units in accredited programs; and
(b) One continuing education unit earned:
(1) In a jurisprudence program approved or presented by the Board relating to the practice of pharmacy or the law relating to pharmacy in this State; or
(2) By attending an entire day of any meeting of the Board if:
(I) The Board meets for not less than 4 hours on that day; and
(II) The registered pharmacist attends the entire day of the meeting regardless of the length of time that the Board meets on that day.
2. A registered pharmacist who attends a meeting of the Board as set forth in subsection 1 is entitled to receive credit for four continuing education units.
3. No applicant may carry over any excess continuing education units earned in a previous biennium for purposes of compliance with the requirements of this section.
4. Work-related experience acquired in fields other than the practice of pharmacy is not acceptable as credit toward the requirements of continuing education established by NRS 639.2171 to 639.2176, inclusive, and NAC 639.300 to 639.390, inclusive.
[Bd. of Pharmacy, § 639.100, eff. 6-26-80]—(NAC A 10-17-91; R068-02, 8-6-2002; R040-07, 10-31-2007)
NAC 639.333 Registration and reregistration: Acceptance of certificate issued by another state as proof of compliance with requirements for continuing education. (NRS 639.070, 639.2176) The Board will accept a certificate of registration issued by another state as proof of compliance with the requirements for continuing professional education if:
1. The certificate of registration is valid for no more than 2 years;
2. The requirements for continuing professional education in the state which issued the certificate of registration are equal to or exceed the requirements for continuing professional education in this State; and
3. The pharmacist is registered in Nevada but does not currently practice in Nevada.
(Added to NAC by Bd. of Pharmacy, eff. 6-16-86)
NAC 639.335 Registration and reregistration: Exceptions to requirement of continuing education. (NRS 639.070, 639.2176)
1. Applicants within the following categories are excused from full compliance with NAC 639.330:
(a) An applicant for certification or renewal is exempt for 2 years after receipt of a degree in pharmacy conferred by an accredited school or college of pharmacy.
(b) An applicant who is registered pursuant to NRS 639.134 need complete only a number of continuing education units proportional to the number of months remaining until the next date for biennial renewal following his registration. Proration will be made at the rate of 1 1/4 units per month.
(c) An applicant who is residing and practicing outside of this State is exempt from the requirement of one continuing education unit in a jurisprudence program.
2. An applicant may earn all his required continuing education units in acceptable programs which are not accredited if he is:
(a) A student of a health profession and has attended at least 15 hours of classroom instruction during a calendar year;
(b) On active duty in the Armed Forces and stationed outside of this State; or
(c) Residing and practicing outside of this State.
[Bd. of Pharmacy, § 639.105, eff. 6-26-80]—(NAC A 10-17-86; 10-17-91)
NAC 639.340 Providers of continuing education: Request for recognition; grant, denial or withdrawal of recognition. (NRS 639.070, 639.2176) Any person seeking recognition as a provider must notify the Board of his intent to provide material or programs for continuing education and request recognition by the Board. The request will be granted if the Board finds that the person applying for recognition is competent to provide material or programs for continuing education, and the Board will communicate its recognition by mail. Recognition may be denied or withdrawn if the Board finds that the person has:
1. Failed to furnish material as advertised;
2. Engaged in any misleading or deceptive practice;
3. Failed to furnish material as required by law or NAC 639.300 to 639.390, inclusive;
4. Failed to comply with the laws or regulations governing continuing professional education in this State; or
5. If the material or programs are not accredited by the Accreditation Council for Pharmacy Education, failed to submit the material or programs to the Board at least 60 days before providing the material or programs.
[Bd. of Pharmacy, § 639.110, eff. 6-26-80]—(NAC A 10-17-86; R130-05, 11-17-2005)
NAC 639.345 Providers of continuing education: Records required; issuance of certificates of completion. (NRS 639.070, 639.2176) Each provider shall:
1. Keep records sufficient to document:
(a) The participation of each pharmacist;
(b) The course or program in which the pharmacist participated;
(c) Whether the pharmacist completed the program or course; and
(d) The number of continuing education units awarded to the pharmacist.
Ê Such records must be maintained for a period of 4 years after completion of the course or program.
2. Furnish to each participant who completes a course or program a certificate of completion which contains the following information:
(a) The name of the participant.
(b) The name of the provider of the course or program.
(c) A description of the course or program.
(d) The number of continuing education units completed.
(e) The date of completion.
(f) The course designation, either accredited or acceptable.
[Bd. of Pharmacy, § 639.115, eff. 6-26-80]—(NAC A 10-17-86)
NAC 639.350 Providers of continuing education: List of participants; reference to accreditation; information to be transmitted to Board. (NRS 639.070, 639.2176)
1. Each provider of material:
(a) Shall maintain a list of all participants in the program for 4 years; and
(b) May use only the wording authorized in NAC 639.365 with reference to his accreditation in this State.
2. In the case of any material, course or program intended to be presented at a specific time and place, the provider shall, within 60 days after completion of the course or program, transmit to the Board the following information:
(a) The names and the number of participants in the program or course.
(b) Any material changes in the program or course made since notice of accreditation was issued by the Board.
(c) The date, time and location of the presentation.
(d) The number of hours awarded for continuing education units.
(e) A brief description of the program, including the principal objective of the presentation.
[Bd. of Pharmacy, § 639.120, eff. 6-26-80]—(NAC A 10-17-86)
NAC 639.360 Accreditation of material, course or program. (NRS 639.070, 639.2176)
1. A provider who seeks accreditation for any material, course or program must submit it to the Board or its designee for review. The Board will notify the provider of the accreditation or denial thereof within 60 days after the submission of a completed application. In a notice of accreditation, the Board will designate the number of units of continuing education for which the course or program is accredited. Accreditation expires 2 years after issuance, unless sooner renewed.
2. In determining whether or not any submitted material, course or program should be accredited, the Board must be satisfied that:
(a) The material, course or program is presented by a provider;
(b) A certificate of completion will be issued to each participant who completes the course or program;
(c) The program includes some mechanism whereby each participant is allowed to evaluate the course with respect to the comprehensibility of the material;
(d) A complete syllabus is included;
(e) The material, course or program is accurate, applicable to pharmacy and of adequate technical quality; and
(f) If the material, course or program is not accredited by the Accreditation Council for Pharmacy Education, the material, course or program is submitted to the Board at least 60 days before the material, course or program is provided.
[Bd. of Pharmacy, § 639.130, eff. 6-26-80]—(NAC A 10-26-83; 10-17-86; 4-28-88; R130-05, 11-17-2005)
NAC 639.365 Advertising, announcements and other promotional material. (NRS 639.070, 639.2176)
1. A provider may hold himself out as a provider of the material, course or program for continuing education under NRS 639.2171 to 639.2176, inclusive.
2. A provider of any accredited material, course or program may state in advertising, announcements or other promotional materials:
This course (or program) has been designated ACCREDITED by the State Board of Pharmacy for ................ continuing education units. This designation expires on ................................ (date)
3. A provider of any acceptable material, course or program may state in announcements, advertising or other promotional materials:
This course (or program) has been designated as ACCEPTABLE under the guidelines for continuing education of the State Board of Pharmacy and has been assigned ................ units of credit toward continuing education.
[Bd. of Pharmacy, § 639.135, eff. 6-26-80]—(NAC A 10-17-86)
NAC 639.370 Materials for continuing education: Formats of programs; subject matter. (NRS 639.070, 639.2176)
1. Approved programs for continuing education may consist of lectures, seminars, classes or correspondence courses. Presentations may be live or be given by audiotape or videotape. Material may be studied privately or in groups.
2. A provider of material for continuing education has primary responsibility for the format and presentation of the material and may designate or restrict the manner in which the material is presented.
3. Material for continuing education may cover any subject pertinent to the socioeconomic and legal aspects of health care, the properties and actions of drugs and dosage forms, and the etiology, characteristics and therapeutics of the disease state and may include:
(a) Pharmacology.
(b) Biochemistry.
(c) Physiology.
(d) Pharmaceutical chemistry.
(e) Pharmacy administration.
(f) Pharmacy jurisprudence.
(g) Public health and communicable diseases.
(h) Management of a professional practice.
(i) Anatomy.
(j) Histology.
(k) Other subject matter in the curricula of the accredited colleges and schools of pharmacy.
Ê Matter outside of these areas is subject to acceptance or rejection by the Board.
[Bd. of Pharmacy, § 639.140, eff. 6-26-80]
NAC 639.380 Advisory Committee on Continuing Education: Creation; number of members. (NRS 639.070, 639.2176) The Advisory Committee on Continuing Education is hereby created. The Committee consists of five members.
[Bd. of Pharmacy, § 639.150, eff. 6-26-80]—(NAC A 10-17-86)
NAC 639.385 Advisory Committee on Continuing Education: Composition; powers and duties; quorum; review of materials for continuing education. (NRS 639.070, 639.2176)
1. The composition of the Committee is as follows:
(a) A member of the Board, who is Chairman of the Committee.
(b) The Executive Secretary, who is Vice Chairman of the Committee.
(c) Three members appointed by the Chairman of the Committee and approved by the Board.
2. The Committee:
(a) May adopt internal administrative policies and procedures.
(b) With the approval of the Board, shall establish criteria for accrediting and evaluating any material, course or program for continuing education which is not already accredited by the Accreditation Council for Pharmacy Education.
(c) May select a panel of reviewers to assist in the evaluation of various categories of materials, courses and programs for continuing education.
(d) Shall evaluate the material, course or program based on the Committee’s own criteria, together with any reports from reviewers, and recommend to the Board for its final decision the accreditation of programs and the number of units of continuing education to be awarded to the programs.
(e) May adopt such rules as are necessary for its operation.
(f) Shall advise the Board on all matters relating to continuing education.
(g) May collect from each provider of continuing education a fee sufficient to allow this function of the Board to be self-supporting.
3. A quorum of the Committee is three members, at least one of whom must be the Chairman or Vice Chairman.
4. A provider wishing to have any material, course or program accredited must submit to the Committee:
(a) All the printed or recorded material intended to be distributed to participants;
(b) Biographical information on the persons who are responsible for the content of the course;
(c) Outlines of specifications for and the overall objectives of the presentations, if a major portion of the course or program consists of oral presentations;
(d) A copy of the provider’s statement of evaluation; and
(e) An estimate of the appropriate number of units of continuing education to be awarded for completing the course or program.
5. The material so submitted may be evaluated by the Committee or, where appropriate, may be transmitted to members of a panel for its evaluation.
[Bd. of Pharmacy, § 639.155, eff. 6-26-80]—(NAC A 10-26-83; 10-17-86)
NAC 639.390 Certificate of completion: Retention by pharmacist; copy to be submitted to Board upon request. (NRS 639.070, 639.2176) A certificate of completion awarded to a participating pharmacist must be retained by him for 4 years following his completion of the course or program of continuing education, but a copy of the certificate must be submitted to the Board upon its request for the purpose of verifying his completion of the course or program.
[Bd. of Pharmacy, § 639.160, eff. 6-26-80]—(NAC A 10-26-83)
INTERNET PHARMACIES
General Provisions
NAC 639.420 Definitions. (NRS 639.070, 639.0725, 639.23288) As used in NAC 639.420 to 639.428, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.422 and 639.424 have the meanings ascribed to them in those sections.
(Added to NAC by Bd. of Pharmacy by R165-01, eff. 12-17-2001)
NAC 639.422 “Certified Internet pharmacy” defined. (NRS 639.070, 639.0725, 639.23288) “Certified Internet pharmacy” means an Internet pharmacy that has been certified by the Board pursuant to NAC 639.426.
(Added to NAC by Bd. of Pharmacy by R165-01, eff. 12-17-2001)
NAC 639.424 “Internet pharmacy” defined. (NRS 639.070, 639.0725, 639.23288) “Internet pharmacy” has the meaning ascribed to it in NRS 639.00865.
(Added to NAC by Bd. of Pharmacy by R165-01, eff. 12-17-2001)
Certification
NAC 639.426 Requirements for approval of application. (NRS 639.070, 639.0725, 639.23288)
1. A licensed pharmacy may practice as an Internet pharmacy only if the pharmacy is certified by the Board pursuant to this section. To be certified by the Board pursuant to this section, a pharmacy must apply to the Board for certification on an application provided by the Board.
2. The Board will grant an application for certification as an Internet pharmacy pursuant to this section if:
(a) The pharmacy is certified by the Verified Internet Pharmacy Practice Sites Program of the National Association of Boards of Pharmacy; or
(b) The Board determines that the pharmacy satisfies the requirements of subsection 3.
3. The Board will grant an application for certification pursuant to paragraph (b) of subsection 2 if the Board determines that the pharmacy:
(a) Is licensed to practice pharmacy in each state in which the pharmacy will practice pharmacy;
(b) Maintains and enforces policies and procedures which ensure that:
(1) The pharmacy is able to establish the authenticity of a prescription which the pharmacy receives;
(2) The pharmacy will not fill any prescription which has been previously filled by another pharmacy, and if the pharmacy fills any prescription, that prescription will not also be filled by another pharmacy;
(3) The identity of the patient and the prescribing practitioner is verified to be authentic;
(4) A prescription is filled in compliance with all applicable federal and state laws;
(5) A patient or the caregiver of the patient may make a complaint to the pharmacy regarding the prescription of the patient, and if such a complaint is made, the complaint will be investigated thoroughly, the results of the investigation will be communicated to the patient or caregiver, and if the investigation reveals that the operations of the pharmacy resulted in an error in the processing or filling of the prescription, appropriate remedial action will be taken by the pharmacy;
(6) The pharmacy will communicate to a patient or a prescribing practitioner any delay that might jeopardize or alter the drug therapy of the patient with respect to delivering the prescribed drug or device; and
(7) The pharmacy will communicate to a patient information regarding recalls of drugs and the appropriate means to dispose of expired, damaged or unusable drugs or devices;
(c) Obtains and maintains patient information necessary to facilitate review of drug utilization and counseling of patients pursuant to any applicable statutes;
(d) Provides review of drug utilization and counseling of patients pursuant to the applicable statutes in the state in which the patient resides;
(e) Maintains controls of its computer system, information concerning patients and other such confidential information and documents to prevent unauthorized or unlawful access to all such confidential information and documents;
(f) Complies with applicable federal and state laws regarding:
(1) The dispensing of prescription drugs;
(2) Recordkeeping related to the patients served by the pharmacy, the purchase of prescription drugs, and the sale and dispensing of prescription drugs; and
(3) The sale of over-the-counter products, including, without limitation, any special requirements related to products that have been identified as precursors to the manufacture or compounding of illegal drugs;
(g) Ships prescriptions to a patient using a secure and traceable means; and
(h) Ships prescriptions to a patient using packaging or devices which will ensure that the prescription is maintained within appropriate standards pertaining to temperature, light and humidity as described in the United States Pharmacopeia, 25th edition, 2002, which is hereby adopted by reference. A copy of the publication may be obtained from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, Maryland 20852, for the price of $589, plus $13 for shipping and handling.
(Added to NAC by Bd. of Pharmacy by R165-01, eff. 12-17-2001)
NAC 639.428 Access to premises and records; suspension for noncompliance. (NRS 639.070, 639.0725, 639.23288)
1. By applying for and being granted certification as a certified Internet pharmacy pursuant to NAC 639.426, a certified Internet pharmacy shall be deemed to have given its consent to:
(a) Allow free access, at all times during business hours, to all places where drugs, medicines, poisons, devices or appliances are kept and to all records regarding the purchase, sale, dispensing and shipping of, and all other dealings with, such drugs, medicines, poisons, devices or appliances, to members of the Board and its inspectors and investigators, investigators of the Investigation Division of the Department of Public Safety, inspectors for the Food and Drug Administration, and other persons authorized by the Board to inspect or investigate at the Board’s direction and control.
(b) Provide records or copies of records by mail, electronic mail or other means, within a reasonable time as established by the person making the request for the records or copies of records, to members of the Board and its inspectors and investigators, investigators of the Investigation Division of the Department of Public Safety, inspectors for the Food and Drug Administration, and other persons authorized by the Board to inspect or investigate at the Board’s direction and control.
2. If a certified Internet pharmacy fails to comply with any provision of this section, the Executive Secretary may summarily suspend the certification and license of the Internet pharmacy until proceedings can be initiated pursuant to NRS 639.241 to 639.2576, inclusive. The Executive Secretary may lift a summary suspension imposed under this subsection if the Executive Secretary determines that the Internet pharmacy has provided the requested access or records.
(Added to NAC by Bd. of Pharmacy by R165-01, eff. 12-17-2001)
CANADIAN PHARMACIES
NAC 639.430 Licensure: Requirement; application. (NRS 639.070, 639.0725, 639.2328)
1. A pharmacy located in Canada shall not dispense, sell or otherwise provide prescription drugs to a resident of this State unless the pharmacy holds a valid license issued by the Board pursuant to NRS 639.2328.
2. A pharmacy located in Canada that wishes to obtain a license pursuant to NRS 639.2328 must submit an application to the Board on a form provided by the Board. The application must be signed by the owner or chief executive officer of the pharmacy, who must certify that the contents of the application are true and correct to the best of his knowledge, information and belief.
3. The staff of the Board shall not forward to the Board for the Board’s consideration an application for licensure submitted by a Canadian pharmacy until the staff determines that the application is complete.
(Added to NAC by Bd. of Pharmacy by R040-06, eff. 5-4-2006)
NAC 639.432 Restrictions on dispensing drugs. (NRS 639.070, 639.0725, 639.23284)
1. A Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 may dispense under those provisions only a drug that:
(a) Appears in:
(1) The Orange Book; and
(2) The HC-DPD;
(b) Has been manufactured in accordance with standards established by:
(1) The Food and Drug Administration of the United States Department of Health and Human Services; or
(2) The Therapeutic Products Directorate of Health Canada;
(c) Is in a strength that appears in both the Orange Book and the HC-DPD; and
(d) Is drawn from the inventory of the pharmacy that is maintained at the pharmacy.
2. A Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 may not dispense under those provisions:
(a) A drug that is in any of the following forms:
(1) A liquid form, except for ophthalmic solutions;
(2) An intravenous form; or
(3) A form that requires refrigeration or other special handling for shipment;
(b) A generic version of a drug, unless the generic version of the drug is “A-rated” in the Orange Book; or
(c) A drug that has been approved for sale without a prescription in Canada but for which a prescription is required in the United States, unless the patient has provided a prescription for the drug to the pharmacy.
3. As used in this section:
(a) “HC-DPD” means the Drug Product Database, copyright Her Majesty the Queen in Right of Canada, as amended, that is managed by Health Canada. Access to the database may be obtained on the Internet at the Internet address http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index_e.html.
(b) “Orange Book” means the list of “Approved Drug Products with Therapeutic Equivalence Evaluations,” as amended, that is published by the Center for Drug Evaluation and Research of the Food and Drug Administration of the United States Department of Health and Human Services. A copy of the list may be obtained on the Internet at the Internet address http://www.fda.gov/cder/orange/obannual.pdf.
(Added to NAC by Bd. of Pharmacy by R040-06, eff. 5-4-2006)
NAC 639.434 Standards of practice. (NRS 639.070, 639.0725)
1. A Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 shall:
(a) Maintain a toll-free telephone number and an electronic mail address at which a patient may contact and communicate with a pharmacist employed by the pharmacy;
(b) Ensure that a pharmacist employed by the pharmacy contacts a patient’s prescribing practitioner in the United States regarding a prescription for the patient:
(1) If the prescription was electronically transmitted to the pharmacy in any manner other than directly from the office of the prescribing practitioner in the United States, to verify the authenticity and contents of the prescription; and
(2) Before making any change to the prescription that deviates from the prescription as written by the prescribing practitioner in the United States;
(c) Ensure that, before a prescription from a prescribing practitioner in the United States is transmitted to a prescribing practitioner in Canada for approval, a pharmacist employed by the pharmacy:
(1) Personally enters the data regarding the prescription into the pharmacy’s computer system; or
(2) Verifies that the data regarding the prescription was entered correctly into the pharmacy’s computer system by another employee of the pharmacy; and
(d) Ensure that the pharmacists employed by the pharmacy make and maintain a record, either on paper or in the pharmacy’s computer system, that readily identifies the pharmacist who, with respect to a prescription:
(1) Entered or verified the data regarding the prescription pursuant to paragraph (c); and
(2) Filled the prescription or verified the correctness of the prescription, if the prescription was filled by an employee other than a pharmacist.
Ê The records required pursuant to this paragraph must be maintained by the pharmacy for at least 2 years and be made available, upon request, for inspection by the staff of the Board.
2. A Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 shall not direct or otherwise allow a patient to have his prescription dispensed by or to otherwise use the services of a pharmacy that is not licensed by the Board.
3. If a Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 does not have in stock a drug with which to dispense a patient’s prescription and is unable to transfer the prescription to another pharmacy licensed pursuant to NRS 639.2328 that is able to dispense the prescription, the Canadian pharmacy shall:
(a) Ensure that a pharmacist employed by the pharmacy contacts the patient’s prescribing practitioner in the United States to obtain authorization to change the prescription to a drug that the pharmacy has in stock; or
(b) Within sufficient time to ensure that the drug therapy of the patient will not be interrupted or disturbed, contact the patient to inform him that the pharmacy cannot dispense the prescription.
(Added to NAC by Bd. of Pharmacy by R040-06, eff. 5-4-2006)
NAC 639.436 Dissemination of certain contact information; printing of certain information on label of prescription. (NRS 639.070, 639.0725)
1. In addition to complying with the requirements of NRS 639.23286 and NAC 639.708, a Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 shall ensure that each of the following is published on the Internet website, if any, of the pharmacy and printed upon any written materials provided by the pharmacy to a patient:
(a) The normal business hours of the pharmacy;
(b) The toll-free telephone number of the pharmacy; and
(c) The electronic mail address of the pharmacy.
2. In addition to complying with the requirements of NRS 639.2801, a Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 shall ensure that each of the following is printed on the label of a prescription:
(a) The name of the prescribing practitioner in the United States with a designator proximate to the name such as “US” or “USA” or a similar designator indicating that the practitioner is from the United States; and
(b) The name of the prescribing practitioner in Canada with a designator proximate to the name such as “CAN” or “CANADA” or a similar designator indicating that the practitioner is from Canada.
Ê If the pharmacy is unable to print one or both of the names of the prescribing practitioners or their proximate national designators directly upon the label of the prescription, the pharmacy may include such information on auxiliary labels affixed to the container in which the prescription is dispensed.
(Added to NAC by Bd. of Pharmacy by R040-06, eff. 5-4-2006)
MEDICAL FACILITIES AND CORRECTIONAL INSTITUTIONS
General Provisions
NAC 639.440 Definitions. (NRS 639.070) As used in NAC 639.440 to 639.490, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.441 to 639.460, inclusive, have the meanings ascribed to them in those sections.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.441 “Administer” defined. (NRS 639.070) “Administer” means the direct application of a drug or medicine, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or the subject of research.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.442 “Chart order” defined. (NRS 639.070) “Chart order” means an order entered on the chart of an inpatient in a medical facility licensed by the Health Division of the Department of Health and Human Services or on the chart of a patient under emergency treatment in a hospital by a practitioner or on the written or oral order of a practitioner authorizing the administration of a drug to the patient.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.445 “Compound” and “compounding” defined. (NRS 639.070) “Compound” or “compounding” means to form or create a composite product by combining two or more different ingredients.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.446 “Consultant pharmacist” defined. (NRS 639.070) “Consultant pharmacist” means a pharmacist retained by a medical facility or correctional institution under contract to consult with the facility or institution in areas that relate to the practice of pharmacy.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.4465 “Correctional institution” defined. (NRS 639.070) “Correctional institution” means any penal facility used for confinement of persons or any facility used for detention of juveniles, which is operated by or under the supervision of a subdivision of the State. The term includes a jail.
(Added to NAC by Bd. of Pharmacy, eff. 9-12-91)
NAC 639.447 “Deliver” and “delivery” defined. (NRS 639.070) “Deliver” or “delivery” means the actual, constructive, or attempted transfer of a controlled substance or dangerous drug from one person to another, whether or not there is an agency relationship.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.448 “Device” defined. (NRS 639.070) “Device” means any instrument, apparatus or contrivance, including its components, parts and accessories, intended:
1. For use in the diagnosis, cure, mitigation, treatment or prevention of disease in persons or animals; or
2. To affect the structure of any function of the body of a person or an animal.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.449 “Direct copy” defined. (NRS 639.070) “Direct copy” includes an electronic or carbonized copy.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.450 “Dispense” defined. (NRS 639.070) “Dispense” means the furnishing of a controlled substance or dangerous drug in any amount greater than that necessary for the present and immediate needs of the ultimate user. The term does not include the furnishing of a controlled substance or dangerous drug by a pharmacy in a medical facility to an inpatient of the medical facility in which the pharmacy is located.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.451 “Distribute” defined. (NRS 639.070) “Distribute” means to deliver other than by administering or dispensing a controlled substance, dangerous drug or other drug.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.452 “Floor stock” defined. (NRS 639.070) “Floor stock” means drugs or devices not labeled for a specific patient and maintained at a nursing station or other department of a medical facility or correctional institution, excluding the pharmacy, for the purpose of administering to a patient of the facility or institution.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.453 “Formulary” defined. (NRS 639.070) “Formulary” means a list of drugs approved by an appropriate committee that evaluates, appraises and selects from among the various available drugs and drug products those drugs considered most useful in caring for patients.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.455 “Investigational drug” defined. (NRS 639.070) “Investigational drug” means a new drug intended for investigational use by experts qualified to evaluate the safety and effectiveness of the drug as authorized by the Food and Drug Administration.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.456 “IV admixture” defined. (NRS 639.070) “IV admixture” means the compounding of parenteral solutions by aseptic procedures.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.457 “Medical facility” defined. (NRS 639.070) “Medical facility” includes:
1. A surgical center for ambulatory patients;
2. An obstetric center;
3. An independent center for emergency medical care;
4. An agency to provide nursing in the home;
5. A facility for intermediate care;
6. A facility for skilled nursing;
7. A hospice;
8. A hospital;
9. A psychiatric hospital;
10. A facility for the treatment of irreversible renal disease; and
11. A rural clinic.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.4575 “Pharmacy” defined. (NRS 639.070) “Pharmacy” means an area in a medical facility or correctional institution where drugs are stored, compounded, delivered, dispensed and distributed to other areas or departments of the facility or institution or dispensed to an ultimate user.
(Added to NAC by Bd. of Pharmacy, eff. 9-12-91)
NAC 639.458 “Prescription” defined. (NRS 639.070)
1. “Prescription” means:
(a) An order given individually for the person for whom a drug is prescribed, directly from a practitioner, or his agent, to a pharmacist or indirectly by means of an order signed by the practitioner.
(b) A chart order written for an inpatient specifying drugs that he is to take home upon his discharge.
2. The term does not include a chart order written for an inpatient for use while he is an inpatient.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.459 “Unit dose” defined. (NRS 639.070) “Unit dose” means medication packaged in packages containing only a single unit of medication.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.460 “Unit of use” defined. (NRS 639.070) “Unit of use” means:
1. Medication intended to provide a specific dosage as a single dose; or
2. More than one dose of medication packaged as a single unit to provide a specific dosage.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90)
NAC 639.461 Licensing. (NRS 639.070, 639.071)
1. A separate license to conduct a pharmacy in a hospital must be obtained for each location of a hospital which is required to obtain a license from the Bureau of Regulatory Health Services of the Health Division of the Department of Health and Human Services. A hospital may apply for more than one license to conduct an institutional pharmacy at a location.
2. Retail, nuclear and other pharmaceutical functions may be performed within a hospital under the license to conduct a pharmacy. If a hospital is required to obtain only one license from the Bureau of Regulatory Health Services of the Health Division of the Department of Health and Human Services for a pharmacy, the pharmacy may serve inpatients in an institutional satellite operation without obtaining a separate license to conduct such a pharmacy. A pharmacy which serves outpatients in an institutional satellite operation is required to obtain a separate license to conduct such a pharmacy.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-11-91; 9-12-91)
NAC 639.462 Biennial registration. (NRS 639.070, 639.071, 639.072)
1. A pharmacy shall register biennially with the Board on a form provided by the Board. A list of each type of pharmaceutical service provided by the pharmacy that would otherwise be required to be licensed must be included.
2. For a pharmacy in a medical facility, the registration form must be signed by:
(a) The managing pharmacist of the pharmacy; and
(b) The chief executive officer of the hospital in which the pharmacy is located.
3. The chief executive officer must agree to comply with the regulations adopted by the Board governing pharmacies.
4. The registration form must state whether the pharmacy is a sole ownership and, if so, include the name of the owner. If the pharmacy is owned by a partnership, the registration form must include the names of the partners. If the pharmacy is owned by a corporation, the registration form must include the names of the corporate officers.
5. If the pharmacy is owned or operated by a management or consulting firm:
(a) The registration form must include the name of the firm or the operator; and
(b) The firm must be registered by the Drug Enforcement Administration, unless the firm:
(1) Enters into a contract with the hospital in which the pharmacy is located that assigns the responsibility for the controlled substances to the hospital; and
(2) The firm maintains dual responsibility for the controlled substances.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.463 Change of ownership. (NRS 639.070, 639.170)
1. If a pharmacy changes ownership, it must obtain a new and separate registration from the Board.
2. The fee established in NRS 639.170 will be charged for the issuance of a new certificate of registration.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
Standards of Operation
NAC 639.464 Scope of services in hospital or correctional institution. (NRS 639.070, 639.071, 639.072) In a hospital or correctional institution:
1. The scope of services provided by a pharmacy must be consistent with the needs of the patients for medication as determined by the medical staff, managing pharmacist and other health care professionals involved in delivering or administering drugs in the hospital or correctional institution in which the pharmacy is located.
2. Pharmaceutical services may include, but are not limited to:
(a) Interpreting orders for prescriptions and medication.
(b) Compounding, dispensing, distributing, labeling and administering drugs and devices.
(c) Monitoring drug therapy.
(d) Therapeutic interchange.
(e) Participating in evaluations of the uses of drugs and the selection of drug products.
(f) Ensuring the proper and safe storage and distribution of drugs and devices, and the maintenance of proper records related thereto.
(g) Providing information related to drugs, including, but not limited to, the proper dosages, hazards and the optimal use of drugs and devices.
(h) Supervising pharmaceutical technicians and pharmaceutical technicians in training.
(i) Conducting research.
3. As used in this section, “therapeutic interchange” means the dispensing of one drug in place of another pursuant to guidelines approved by an appropriate committee of the medical staff.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; 11-15-93)
NAC 639.4645 Maintenance of registration certificates required. (NRS 639.070, 639.071) If the primary function of a pharmacy in a hospital is the provision of inpatient services, the pharmacy shall maintain registration certificates and current renewal receipts thereof for all pharmacists, intern pharmacists and pharmaceutical technicians together in one location within the pharmacy. The certificates must be readily available for review upon the request of the Board.
(Added to NAC by Bd. of Pharmacy, eff. 10-17-91)
NAC 639.465 Managing pharmacist. (NRS 639.070, 639.071, 639.072)
1. A pharmacy located in a:
(a) Hospital with 100 beds or more; or
(b) Correctional institution housing 1,500 inmates or more,
Ê must have one full-time managing pharmacist. That pharmacist may be a managing pharmacist for only one such pharmacy.
2. Each pharmacy located in a:
(a) Hospital with less than 100 beds; or
(b) Correctional facility housing less than 1,500 inmates,
Ê must have one managing pharmacist who is retained as a consultant, or who is employed part-time or full-time.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; R015-05, 10-31-2005; R098-07, 12-4-2007)
NAC 639.466 Consultant pharmacist. (NRS 639.070, 639.071, 639.072)
1. A consultant pharmacist may be the managing pharmacist of a pharmacy.
2. A consultant pharmacist and the medical facility or correctional institution that employs him must enter into a written employment contract. The contract must be made available to the Board upon request.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.467 Staff pharmacists. (NRS 639.070, 639.071, 639.072)
1. The managing pharmacist of a pharmacy must be assisted by a sufficient number of additional registered pharmacists as are required to operate the pharmacy competently and safely, and to meet adequately the needs of the hospital or correctional institution in which the pharmacy is located.
2. Staff pharmacists shall assist the managing pharmacist in carrying out the duties enumerated in NAC 639.468.
3. A staff pharmacist is responsible for any delegated act performed by pharmaceutical technicians under his supervision.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.468 Establishment of policies, procedures and systems. (NRS 639.070, 639.071, 639.072) The managing pharmacist of a pharmacy shall establish policies, procedures and systems related to the following matters, without limitation:
1. Preparation of parenteral medications compounded within the pharmacy.
2. Supervision of the admixture of parenteral products and training of personnel in incompatible admixtures if they are not performed within the pharmacy.
3. Supervision of the bulk compounding of drugs.
4. Procurement and storage of all materials in the pharmacy, including drugs, chemicals and biologicals.
5. Participation in the development of a formulary for the medical facility or correctional institution in which the pharmacy is located, subject to the approval of the appropriate committee at the facility or institution.
6. Distribution of drugs to be administered to patients, pursuant to an original or a direct copy of a practitioner’s order for medication.
7. Filling and labeling of all containers from which drugs are to be distributed or dispensed.
8. Maintenance and availability in the pharmacy, and in areas where care is provided to inpatients, of:
(a) A sufficient inventory of emergency drugs;
(b) The telephone numbers of poison control centers and other organizations for emergency assistance; and
(c) Such other materials and information as are considered necessary by the appropriate committee.
9. Recording of all transactions of the pharmacy required by applicable state and federal laws.
10. Participation in those aspects of the medical facility’s program to evaluate care provided to patients that relate to the use and effectiveness of pharmaceutical materials.
11. Participation in teaching and research programs at the medical facility.
12. Carrying out the policies and decisions of the appropriate committee relating to pharmaceutical services of the medical facility.
13. Labeling, storage and distribution of investigational drugs, and maintenance of information in the pharmacy and nursing stations where such drugs are being administered concerning the dosage form, route of administration, strength, uses, side effects, interactions and symptoms of toxicity of those drugs.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.4685 Handling of medications in correctional institutions without pharmacies. (NRS 639.070, 639.072) A correctional institution that does not have a pharmacy may store medications to be dispensed to an ultimate user pursuant to the following requirements:
1. The responsible practitioner or authority shall develop written plans, establish procedures and provide space and accessories for the secure storage, control, administration and disposal of all such drugs in consultation with a pharmacist and the manager of the facility. Such plans, procedures, space or accessories must include:
(a) Cabinets, closets and refrigeration units that are lockable.
(b) Procedures for administration or delivery of medicines to inmates as prescribed.
(c) Procedures for confirming the fact that the inmate has ingested the medication.
(d) A procedure for recording the fact that prescribed medications have or have not been administered, by whom the medication was administered and, if the medication was not administered, the reason it was not administered.
(e) A policy prohibiting the administration, distribution, delivery or dispensing of drugs by inmates.
(f) A policy limiting the length of time medications may be administered without further medical evaluation.
(g) A requirement that the pharmacist prepare, at least annually, a written report on the status of services by the pharmacy in the institution which must be delivered to the responsible practitioner or authority and the manager of the facility.
(h) Procedures describing the circumstances and methods for contacting the pharmacist.
2. Procedures related to the handling of medication and the classifications of personnel who are authorized to handle medication must include provisions for the:
(a) Procurement of medication;
(b) Storage of medication;
(c) Administration of medication;
(d) Disposal of medication; and
(e) Providing of medication to inmates upon their release.
(Added to NAC by Bd. of Pharmacy, eff. 9-12-91)
NAC 639.469 Standards for premises. (NRS 639.070, 639.071, 639.072)
1. A pharmacy shall have adequate space necessary for the storage, compounding, labeling, dispensing, distribution and sterile preparation of drugs prepared in the pharmacy.
2. The pharmacy must be kept clean and arranged in an orderly manner. All required equipment must be clean and in good operating condition.
3. A sink with hot and cold running water must be available to all personnel of the pharmacy and must be maintained in a sanitary condition at all times.
4. The pharmacy must be well lighted and ventilated.
5. The temperature of the pharmacy must be maintained within a range compatible with the proper storage of drugs. The temperature of the refrigerator must be maintained within a range compatible with the proper storage of drugs requiring refrigeration.
6. The pharmacy must have a locked storage area for controlled substances listed in schedule II and other controlled substances requiring additional security.
7. Flammable materials must be stored in a designated area. The area must meet the requirements of local and state fire laws.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.470 Security of premises. (NRS 639.070, 639.071, 639.072)
1. All areas occupied by a pharmacy must be able to be locked to prevent access by unauthorized personnel.
2. All personnel of the pharmacy, while on duty, are responsible for the security of the pharmacy and shall provide adequate safeguards against the theft or diversion of controlled substances and dangerous drugs and the records of those drugs.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.472 Maintenance of reference library. (NRS 639.070, 639.071, 639.072) A pharmacy must maintain a reference library that includes the following:
1. A current copy of:
(a) All state statutes and regulations relating to the practice of pharmacy and to the sale of drugs and controlled substances; and
(b) The Federal Controlled Substances Act (Title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242) and the regulations adopted pursuant thereto, or an official publication describing the requirements of that act and the regulations adopted pursuant thereto.
2. The American Hospital Formulary Service, with current supplements, or Facts and Comparisons, with current supplements.
3. At least one current text in one of the following subjects:
(a) Theoretical and practical pharmacy.
(b) Pharmacology.
(c) Therapeutics.
4. A current text relating to each of the following:
(a) Compatibility information, if parenteral admixture is performed by the pharmacy;
(b) Information concerning the interaction of drugs; and
(c) Information concerning antidotes.
5. Current copies of one of the following:
(a) United States Pharmacopeia - National Formulary;
(b) United States Pharmacopeia - Drug Information; or
(c) Remington’s Pharmaceutical Sciences.
6. A current copy of the Food and Drug Administration Approved Drug Products.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.473 Procurement and storage of drugs. (NRS 639.070, 639.071, 639.072)
1. The managing pharmacist of a pharmacy is responsible for the procurement and storage of drugs in that pharmacy. The managing pharmacist shall determine the specifications of all drugs procured by the medical facility or correctional institution in which the pharmacy is located.
2. A drug may not be dispensed or distributed after the expiration date of the drug.
3. Outdated drugs must be removed from stock and identified and maintained separately from other stock until disposal.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.474 Development and use of formulary. (NRS 639.070, 639.071, 639.072) A formulary must be developed and available for use by the managing or consultant pharmacist of a pharmacy.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.475 Preparation and labeling of admixtures. (NRS 639.070, 639.071, 639.072)
1. The managing pharmacist shall provide written guidelines for preparing parenteral admixture products to ensure that all pharmaceutical requirements are met.
2. A label must be affixed to the container of any admixture. The label must include, but is not limited to:
(a) The name of the patient for whom the admixture was prepared and the facility’s or institution’s identification of that patient;
(b) The name and amount of the drugs added;
(c) The name of the basic solution;
(d) The name, initials or identifying code of the pharmacist who prepared or verified the admixture; and
(e) The expiration date of the solution.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.476 Prepackaging of drugs. (NRS 639.070, 639.071, 639.072)
1. A pharmacy may prepackage drugs in quantities suitable for distribution within the facility or institution. The prepackaging may be performed only by a pharmacist or a pharmaceutical technician.
2. The label of a prepackaged unit must include:
(a) The generic or trade name of the drug, its strength and the dosage form;
(b) The lot number;
(c) The expiration date of the drug; and
(d) The quantity of the drug if the unit dose does not equal the unit of use.
3. A record of a prepackaged drug must be maintained that includes:
(a) The generic or trade name of the drug, its strength and the dosage form;
(b) The pharmacy’s lot number;
(c) The name of the manufacturer;
(d) The manufacturer’s lot number;
(e) The manufacturer’s expiration date for the drug;
(f) The quantity per package, if more than one tablet or capsule is in a unit dose package;
(g) The number of packages;
(h) The date it was packaged and the assigned expiration date; and
(i) The initials of the responsible pharmacist.
4. Stock packages, prepackaged units and control records must be inspected by the pharmacist before the drugs may be included in regular stock.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; 11-15-93)
NAC 639.477 Policies and procedures for distribution of drugs. (NRS 639.070, 639.071, 639.072)
1. All medical facilities and correctional institutions shall develop and carry out written policies and procedures for the distribution of drugs in that facility or institution. The standards for accreditation of the American Correctional Association and the National Commission of Correctional Health Care must be used as a guideline for these policies and procedures by a correctional institution. The standards for accreditation of the American Correctional Association may be obtained by writing to the American Correctional Association, Publishing and Periodicals Division, 206 North Washington Street, Suite 200, Alexandria, Virginia 22314, or by calling (800) 222-5646 ext. 0129. The standards of accreditation of the National Commission of Correctional Health Care may be obtained by writing to the National Commission of Correctional Health Care, 1145 West Diversey Parkway, Chicago, Illinois 60614.
2. The written policies and procedures must include procedures regarding:
(a) Controlled substances.
(b) Investigational drugs.
(c) Prepackaging and manufacturing.
(d) Stop orders.
(e) Orders for medication.
(f) Physicians’ orders.
(g) Floor stocks.
(h) Reports of adverse reactions.
(i) Drugs brought into the facility by patients.
(j) Medications for furloughs.
(k) The self-administration of drugs.
(l) Emergency supplies of drugs.
(m) A formulary.
(n) Monthly inspections of nursing stations and storage areas for drugs.
(o) Samples of drugs.
(p) Reports of defects in drug products.
(q) The recall of drugs.
(r) Outdated drugs.
(s) The routine distribution of medication for inpatients.
(t) The preparation and distribution of IV admixtures.
(u) The handling of orders for medication if a pharmacist is not on duty.
(v) Requests for drugs that are not listed on the formulary.
(w) Administering medication.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.478 Limitations on distribution of drugs. (NRS 639.070, 639.071, 639.072)
1. A drug may be given to a patient in a medical facility or correctional institution only on the order of a practitioner or an agent of the practitioner.
2. A drug may be distributed in a medical facility or correctional institution only from the original or a direct copy of the practitioner’s order for medication.
3. A controlled substance listed in schedule II may be distributed to outpatients only pursuant to a written prescription.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.479 Withdrawal of drugs when full-time pharmacist is absent. (NRS 639.070, 639.071, 639.072) If a medical facility or correctional institution encompasses a pharmacy with a full-time pharmacist, and a practitioner orders a drug for administration to a patient of the facility or institution while the pharmacy is closed:
1. Prescription drugs and devices may be removed from the pharmacy only in sufficient quantities for immediate therapeutic needs.
2. Only a designated licensed nurse or practitioner may remove those drugs and devices.
3. The person authorized to make the withdrawal shall make a record at the time of the withdrawal containing:
(a) The name of the patient;
(b) The name of the device or drug withdrawn;
(c) If a drug is withdrawn, its strength and the dosage form;
(d) The dose prescribed;
(e) The quantity taken;
(f) The time and date of the withdrawal; and
(g) The signature of the person making the withdrawal.
4. The original or a direct copy of the order for the medication must be forwarded to the pharmacy.
5. The pharmacist shall verify the withdrawal as soon as practicable, but not later than:
(a) Seventy-two hours after the time of the withdrawal for a pharmacist in a medical facility; or
(b) Ninety-six hours after the time of the withdrawal for a pharmacist in a correctional institution.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.480 Withdrawal of drugs when part-time or consultant pharmacist is absent. (NRS 639.070, 639.071, 639.072) If a medical facility or correctional institution has a pharmacy with a part-time or consultant pharmacist, and a practitioner orders a drug for administration to a patient of the facility or institution while the pharmacist is not on duty or the pharmacy is closed:
1. Controlled substances, dangerous drugs and devices may be removed from the pharmacy only in sufficient quantities for therapeutic needs.
2. Only a designated licensed nurse or practitioner may remove those drugs and devices.
3. The person authorized to remove the drugs and devices shall make a record at the time of the withdrawal containing:
(a) The name of the patient;
(b) The name of the device or drug withdrawn;
(c) If a drug is withdrawn, its strength and the dosage form;
(d) The dose prescribed;
(e) The quantity taken;
(f) The time and date of the withdrawal; and
(g) The signature of the person making the withdrawal.
4. The original or a direct copy of the order for the medication must be forwarded to the pharmacy.
5. The pharmacist shall verify the withdrawal after a reasonable interval, but not later than 30 days after the withdrawal.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-11-91; 9-12-91)
NAC 639.481 Withdrawal of drugs when facility uses floor stock and pharmacy is closed. (NRS 639.070, 639.071, 639.072) If a medical facility or correctional institution uses a full or partial floor stock to distribute drugs and its pharmacy is closed:
1. Controlled substances, dangerous drugs and devices may be removed from the pharmacy only in the original manufacturer’s container or prepackaged container.
2. Only a designated licensed nurse or practitioner may remove those drugs and devices.
3. The person authorized to make the withdrawal shall make a record at the time of the withdrawal containing:
(a) The name of the device or drug withdrawn;
(b) If a drug is withdrawn, its strength and the dosage form;
(c) The quantity removed;
(d) The location of the floor stock;
(e) The date and the time of the withdrawal; and
(f) The signature of the person making the withdrawal.
4. A pharmacist shall verify the withdrawal pursuant to the following schedule:
(a) In a facility or institution with a full-time pharmacist, the withdrawal must be verified as soon as practicable, but not later than:
(1) Seventy-two hours after the time of the withdrawal for a pharmacist in a medical facility; or
(2) Ninety-six hours after the time of the withdrawal for a pharmacist in a correctional institution.
(b) In a facility or institution with a part-time or consultant pharmacist, the withdrawal must be verified after a reasonable interval, but not later than 30 days after the withdrawal.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-11-91; 9-12-91)
Records
NAC 639.482 Maintenance and availability of records. (NRS 639.070, 639.071, 639.072)
1. Each record required to be kept pursuant to NAC 639.483 to 639.489, inclusive, must be kept by a pharmacy for at least 2 years after the date of the record.
2. Records maintained by a pharmacy must be made available for inspection and copying upon the request of the Board, its representatives, or another authorized local, state or federal law enforcement agency.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.483 Statutes applicable to maintenance of records. (NRS 639.070, 639.071, 639.072) A pharmacy must maintain records for outpatients pursuant to the provisions of chapters 453, 454 and 639 of NRS governing retail pharmacies.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.484 Contents and maintenance of chart orders. (NRS 639.070, 639.071, 639.072)
1. Each original chart order must contain:
(a) The patient’s name and the medical facility’s or correctional institution’s identification of that patient;
(b) The name of the drug, its strength and the route of administration;
(c) Directions for the use of the drug;
(d) The date; and
(e) The practitioner’s signature. Any verbal order signed by a practitioner’s agent must be cosigned by the practitioner.
2. An original chart order must be maintained in the medical records of the patient along with the record of the administration of the medication.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; R190-01, 3-4-2002)
NAC 639.485 Maintenance of records for controlled substances. (NRS 639.070, 639.071, 639.072)
1. A pharmacy shall maintain records for controlled substances:
(a) In a readily retrievable manner.
(b) In a manner that establishes the receipt, distribution and destruction of all controlled substances handled by the pharmacy.
2. A pharmacy shall maintain a perpetual inventory of any controlled substance listed in schedule II.
3. Records of the distribution of controlled substances listed in schedule II, schedule III or schedule IV must include:
(a) The name of the drug, dosage form and strength.
(b) The name of the pharmacist distributing or authorizing the distribution of the controlled substance.
(c) The name of the authorized person receiving the controlled substance. This information may be included on the record of administration.
(d) The location to which the controlled substance is being distributed.
(e) Controlled substances returned to the pharmacy.
(f) A record of any waste of any prepared or partially administered dose of a controlled substance, which must be witnessed and cosigned by another person who is licensed to provide medical care.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; R156-99, 3-1-2000)
NAC 639.486 Maintenance of records of controlled substances administered from floor stock. (NRS 639.070, 639.071, 639.072)
1. A pharmacy shall maintain records of controlled substances administered from floor stock. The records must include:
(a) The name of the patient to whom the controlled substance was administered.
(b) The name of the controlled substance, its dosage form and strength.
(c) The time and date on which the controlled substance was administered to the patient.
(d) The quantity of the controlled substance administered.
(e) The signature of the person removing the controlled substance.
(f) Controlled substances returned to the pharmacy.
(g) A record of any waste of a controlled substance which, except as otherwise provided in subsection 2, must be witnessed and cosigned by another person who is licensed to provide medical care.
2. A record of any waste of a controlled substance kept pursuant to subsection 1 is not required to be witnessed and cosigned as required by subsection 1 if:
(a) The record of waste is for a controlled substance which was administered by a practitioner authorized to administer anesthesia; and
(b) Other current, complete and accurate records for the controlled substance administered and wasted are created and maintained.
3. Records maintained pursuant to this section must be maintained separately from records of patients.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; 5-22-96; R157-99, 3-1-2000; R042-04, 5-25-2004)
NAC 639.487 Maintenance of additional records. (NRS 639.070, 639.071, 639.072) In addition to any other requirements for keeping records, a pharmacy shall maintain the following records:
1. Copy 3 of the order form of the Drug Enforcement Administration (DEA 222C), properly dated, initialed and filed, copies of each unaccepted or defective order form, and any attached statements or other documents.
2. Suppliers’ invoices of controlled substances and dangerous drugs. The pharmacist or other personnel of the pharmacy shall clearly record on each invoice the actual date on which the controlled substance or dangerous drug was received.
3. Suppliers’ credit memos for controlled substances and dangerous drugs.
4. The biennial inventory of controlled substances required by the Drug Enforcement Administration.
5. Any reports of theft or significant loss of controlled substances submitted to the Drug Enforcement Administration.
6. Reports of the surrender or destruction of controlled substances or dangerous drugs, or both, to an appropriate state or federal agency.
7. A register book for nonprescription drugs listed in schedule V.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.488 Maintenance of records for distribution of controlled substances to another pharmacy or practitioner. (NRS 639.070, 639.071, 639.072)
1. If a pharmacy distributes controlled substances listed in schedule III, IV or V to another pharmacy or a practitioner, it shall maintain invoices showing:
(a) The actual date of distribution;
(b) The name, strength and quantity of controlled substances distributed;
(c) The distributing pharmacy’s name, address and registration number given to it by the Drug Enforcement Administration; and
(d) The name, address and registration number of the pharmacy or practitioner to whom the controlled substances were distributed.
2. If a pharmacy distributes controlled substances listed in schedule I or II to another pharmacy or a practitioner, it shall maintain Copy 1 of the order form of the Drug Enforcement Administration (DEA 222C) furnished by the pharmacy or practitioner to whom the controlled substances were distributed. The form must show the quantity of controlled substances distributed and the actual date of distribution.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.489 Separation of certain records. (NRS 639.070, 639.071, 639.072)
1. Except for records of distributions from floor stock, records of controlled substances listed in schedules I and II must be maintained separately from other records maintained by a pharmacy.
2. Records of controlled substances listed in schedules III, IV and V may be maintained either separately from all other records maintained by the pharmacy or in such form that the records are readily retrievable.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
NAC 639.490 Permission to use centralized system for keeping records. (NRS 639.070, 639.071, 639.072) A pharmacy wishing to use a centralized system for keeping records must submit written notification to the Regional Director of the Drug Enforcement Administration by registered or certified mail. A copy of the notification must be submitted to the Board. Unless the pharmacy is informed by the Regional Director that permission to keep central records is denied, the pharmacy may begin to maintain such records 14 days after receipt of the notification by the Regional Director. A copy of the notification must be maintained by the pharmacy.
(Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)
Chart Order Processing Services
NAC 639.491 Definitions. (NRS 639.070) As used in NAC 639.491 to 639.4917, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.4911 to 639.4914, inclusive, have the meanings ascribed to them in those sections.
(Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005; A by R098-07, 12-4-2007)
NAC 639.4911 “Chart order” defined. (NRS 639.070) “Chart order” has the meaning ascribed to it in NAC 639.442.
(Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005)
NAC 639.49115 “Chart order processing services” defined. (NRS 639.070) “Chart order processing services” means nondispensary pharmaceutical services that are provided by a pharmacy to a hospital or correctional institution, including, without limitation:
1. Receiving, interpreting and clarifying a chart order received from a hospital or correctional institution;
2. Entering information regarding a chart order into the computerized data system of a hospital or correctional institution;
3. Interpreting clinical data regarding a patient of a hospital or correctional institution;
4. Performing therapeutic interventions regarding a patient of a hospital or correctional institution;
5. Providing information to the appropriate staff of a hospital or correctional institution regarding a chart order submitted by the hospital or correctional institution; and
6. Providing information regarding the treatment of a patient of a hospital or correctional institution.
(Added to NAC by Bd. of Pharmacy by R098-07, eff. 12-4-2007)
NAC 639.4912 “Correctional institution” defined. (NRS 639.070) “Correctional institution” has the meaning ascribed to it in NAC 639.4465.
(Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005)
NAC 639.4913 “Off-site pharmaceutical service provider” defined. (NRS 639.070) “Off-site pharmaceutical service provider” means a pharmacy that provides remote chart order processing services to a hospital or correctional institution that is owned by the same entity as the pharmacy or with which the pharmacy has contracted to provide remote chart order processing services.
(Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005)
NAC 639.4914 “Remote chart order processing services” defined. (NRS 639.070) “Remote chart order processing services” means chart order processing services provided by an off-site pharmaceutical service provider to a hospital or correctional institution, including, without limitation, transferring information regarding a chart order from the off-site pharmaceutical service provider to members of the staff of the hospital or correctional institution that submitted the chart order.
(Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005; A by R098-07, 12-4-2007)
NAC 639.4915 Provision of services by pharmacies within certain hospitals and correctional institutions. (NRS 639.070, 639.071, 639.072) A pharmacy located within a hospital or correctional institution that is required to have a full-time managing pharmacist pursuant to NAC 639.465 shall provide chart order processing services to the hospital or correctional institution. The pharmacy shall provide the chart order processing services by:
1. Operating at all times; or
2. Employing a pharmacist who is on duty at all times that the pharmacy is operating and either:
(a) Employing a pharmacist who is available at all times that the pharmacy is not operating; or
(b) Contracting with an off-site pharmaceutical service provider that is available at all times that the pharmacy is not operating.
(Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005; A by R098-07, 12-4-2007)
NAC 639.4916 Provision of remote services by pharmacist employed by off-site pharmaceutical service provider. (NRS 639.070)
1. A pharmacist who is employed by an off-site pharmaceutical service provider to provide remote chart order processing services to a hospital or correctional institution pursuant to NAC 639.4915 must:
(a) Be licensed to practice in Nevada;
(b) Be trained in the policies and procedures of the hospital or correctional institution regarding all policies and procedures of the hospital or correctional institution with which the pharmacist must comply, including, without limitation, the provision of pharmaceutical services, security and confidentiality of patient records;
(c) Except as otherwise provided in subsection 3, be provided with the same computerized system and access to data regarding a patient for whom a chart order has been submitted that would be available to a pharmacist employed by the pharmacy located within the hospital or correctional institution, including, without limitation:
(1) The height, weight and age of the patient and any allergies that the patient may have;
(2) The medical records regarding any medications prescribed to the patient;
(3) The results of any relevant laboratory tests, to the extent that those results are available in the computerized system of the hospital or correctional institution;
(4) The health history and notes regarding physical examinations, to the extent that the information is available in the computerized system of the hospital or correctional institution;
(5) Any notes provided by a physician, nurse or other medical staff of the institution, to the extent that those notes are available in the computerized system of the hospital or correctional institution;
(6) A legible copy of the chart order that is available through a scanned image in the computerized system of the hospital or correctional institution or by facsimile machine; and
(7) Any other information that is available in the computerized system of the hospital or correctional institution that is relevant or necessary for the pharmacist to provide pharmaceutical services; and
(d) Demonstrate to the off-site pharmaceutical service provider that the pharmacist is competent and knowledgeable in the use of the computerized system of the hospital or correctional institution and in providing pharmaceutical services in a hospital or correctional institution.
2. Before a pharmacist who is employed by an off-site pharmaceutical service provider provides remote chart order processing services to a hospital or correctional institution, the pharmacist must review any relevant information regarding the patient for whom a chart order has been submitted. The pharmacist must, before approving a chart order to be filled, evaluate:
(a) The overutilization or underutilization of a medication;
(b) Therapeutic duplication;
(c) The appropriateness of the prescribed dosage and route of administration;
(d) The appropriateness of the directions for use of the medication;
(e) The appropriateness of the duration of the treatment with the prescribed medication;
(f) Any contraindications of the medication and a particular disease, ailment or allergy of the patient;
(g) Any contraindications or interactions between multiple medications prescribed for the patient; and
(h) The potential abuse or misuse of a medication.
3. In an emergency, a pharmacist may render remote chart order processing services without being provided with all of the information required by paragraph (c) of subsection 1 if the pharmacist believes, in his professional judgment, that he has received sufficient information from the staff of the hospital or correctional institution to render the services.
4. A pharmacist who is employed by an off-site pharmaceutical service provider may refuse to approve the filling of a chart order if, in the judgment of the pharmacist, the chart order is not safe or reasonable for the patient. A pharmacist who refuses to approve the filling of a chart order pursuant to this subsection must notify the hospital or correctional institution as soon as practicable that he has refused to approve the filling of the chart order.
5. Each time that a pharmacist who is employed by an off-site pharmaceutical service provider provides remote chart order processing services pursuant to this section, the pharmacist shall make a notation in the computerized system of the hospital or correctional institution that indicates:
(a) The name or other identifier of the pharmacist;
(b) The date and time that the pharmacist provided the services and, if applicable, approved the filling of a chart order; and
(c) The specific services provided by the pharmacist.
6. The managing pharmacist of a pharmacy that has a contract with or is owned by the same entity as an off-site pharmaceutical service provider may limit the remote chart order processing services provided by a pharmacist employed by the off-site pharmaceutical service provider.
(Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005)
NAC 639.4917 Policies and procedures of off-site pharmaceutical service providers. (NRS 639.070) Each off-site pharmaceutical service provider shall establish and follow policies and procedures for:
1. Protecting the confidentiality and integrity of patient information;
2. Assuring that pharmacists employed by the off-site pharmaceutical service provider comply with the provisions of NAC 639.4916;
3. Complying with all applicable state and federal statutes, regulations and rules, including, without limitation, maintaining records;
4. Ensuring that its records are made readily accessible to members of the Board and employees, agents and designees of the Board;
5. Conducting an ongoing program for the improvement of the provision of pharmaceutical services that is designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, improve patient care and resolve problems identified by the program;
6. Performing an annual review of the program conducted pursuant to subsection 5;
7. Assuring that the pharmacists employed by the off-site pharmaceutical service provider are able to communicate with identified employees of the hospital or correctional institution as necessary to provide pharmaceutical services, including, without limitation, communicating with pharmacists employed by the hospital or correctional institution; and
8. The provision of pharmaceutical services at times when the off-site pharmaceutical service provider temporarily or permanently cannot provide such services.
(Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005)
FACILITIES FOR INTERMEDIATE CARE AND FACILITIES FOR SKILLED NURSING
NAC 639.492 Definitions. (NRS 639.070, 639.071) As used in NAC 639.492 to 639.498, inclusive, unless the context otherwise requires:
1. “Director” means the director of nurses of a facility.
2. “Facility” means a facility for intermediate care as defined in NRS 449.0038 or a facility for skilled nursing as defined in NRS 449.0039.
(Added to NAC by Bd. of Pharmacy, eff. 7-1-92)
NAC 639.494 Prescriptions for controlled substances: Accountability record; handling of unused portions. (NRS 639.070, 639.071)
1. Each prescription for a controlled substance which is administered to a patient at a facility must be accompanied by the controlled substances accountability record. The record must include:
(a) The patient’s name;
(b) The name of the controlled substance;
(c) The date the facility received the controlled substance from the pharmacy;
(d) The signature of the employee of the facility who received the controlled substance;
(e) The number of the prescription;
(f) The total dosage units of the controlled substance;
(g) The strength of the controlled substance;
(h) The date and time each dosage of the controlled substance is administered and the signature of the person administering the controlled substance; and
(i) The number of dosage units of the controlled substance which remain after the administration of the controlled substance is completed, including:
(1) The number of dosage units disposed;
(2) The date of the disposition of the dosage units;
(3) The signature of the director or a licensed nurse designated by him; and
(4) The signature of the licensed consulting pharmacist of the facility or a pharmacist designated by him.
2. Any unused portion of the controlled substance must be immediately delivered to the director for destruction pursuant to NAC 639.498. The director shall ensure the security of those controlled substances.
3. The director shall establish a procedure to ensure that the number of dosage units remaining in each unused portion of a controlled substance corresponds to the information contained in the controlled substances accountability record.
(Added to NAC by Bd. of Pharmacy, eff. 7-1-92)
NAC 639.496 Maintenance of accountability record; examination of chart orders; issuance of receipt for controlled substances delivered to coroner. (NRS 639.070, 639.071)
1. The director shall keep each controlled substances accountability record which accompanies a prescription for a controlled substance in an alphabetical file by the patient’s name. The record must be kept on the premises of the facility for at least 2 years after the controlled substance is destroyed.
2. The Board may examine the chart orders of a physician at the facility in conjunction with the controlled substances accountability records for the prescription of the controlled substances prescribed by him.
3. A coroner shall issue a receipt to the director for any controlled substance which the facility delivers to him. The receipt must include the information set forth in paragraphs (a), (b), (e) and (f) of subsection 1 of NAC 639.494.
(Added to NAC by Bd. of Pharmacy, eff. 7-1-92)
NAC 639.498 Destruction of certain controlled substances: Requirement; procedure. (NRS 639.070, 639.071)
1. Except as otherwise provided in subsection 2:
(a) At least once each month, the director or a licensed consulting pharmacist shall destroy, on the premises of the facility, the controlled substances described in subsection 1 of NAC 639.050.
(b) If the director destroys the controlled substances, the licensed consulting pharmacist shall witness the destruction of the controlled substances. If the licensed consulting pharmacist destroys the controlled substances, the director shall witness the destruction of the controlled substances.
2. The director may designate a nurse licensed pursuant to chapter 632 of NRS to carry out his duties pursuant to this section. The licensed consulting pharmacist may designate a pharmacist licensed pursuant to chapter 639 of NRS to carry out his duties pursuant to this section.
3. The controlled substances must be destroyed by:
(a) Flushing them down the toilet or hopper;
(b) If a container for waste disposal is used, placing the controlled substances in the water in the container for disposal; or
(c) If the controlled substance is stored in a vial, ampule or other glass container, breaking the container and placing its contents into a container for waste disposal.
(Added to NAC by Bd. of Pharmacy, eff. 7-1-92)
SURGICAL CENTERS FOR AMBULATORY PATIENTS
NAC 639.4992 Dispensing of controlled substances: Registration and licensing required. (NRS 639.070, 639.071) Each surgical center for ambulatory patients shall:
1. Register with the Board and the Drug Enforcement Administration of the United States Department of Justice to dispense controlled substances;
2. Ensure that each practitioner who dispenses controlled substances in the surgical center is registered with the Board and the Drug Enforcement Administration of the United States Department of Justice; and
3. Require each person employed to work in a pharmacy of the surgical center for ambulatory patients and any person with whom the surgical center for ambulatory patients has entered into a contract to provide pharmaceutical services to possess a current state license or certificate to provide such services.
(Added to NAC by Bd. of Pharmacy, eff. 10-24-97)
NAC 639.4996 Establishment and periodic review of policies and procedures; duties of pharmacist. (NRS 639.070, 639.071)
1. A surgical center for ambulatory patients shall employ or enter into a contract with a pharmacist to establish policies and procedures which are consistent with the policies and procedures developed pursuant to NAC 639.477 for:
(a) The storage and dispensing of drugs to patients in the surgical center for ambulatory patients, including, without limitation, drugs that the patients take away from the surgical center for ambulatory patients; and
(b) The proper disposition or destruction of expired or contaminated drugs stored and dispensed at the surgical center for ambulatory patients.
2. The policies and procedures established pursuant to subsection 1 must be maintained, periodically reviewed and dated upon adoption and amendment.
3. The pharmacist employed pursuant to subsection 1 shall:
(a) Visit the surgical center for ambulatory patients at least once each quarter to evaluate the effectiveness of the policies and procedures established and to confirm that the surgical center for ambulatory patients is maintaining documentation of each transaction involving drugs;
(b) Maintain documentation of each visit that he makes pursuant to paragraph (a);
(c) Periodically audit the records of the surgical center for ambulatory patients that involve the dispensing of controlled substances to ensure that the surgical center for ambulatory patients is in compliance with all applicable state and federal laws; and
(d) Submit a report to the Board not later than 30 days after determining that the policies and procedures established pursuant to subsection 1 are ineffective, that the surgical center for ambulatory patients is not maintaining documentation of each transaction involving drugs or that the surgical center for ambulatory patients is not in compliance with any applicable state or federal law, explaining the basis for his determination.
(Added to NAC by Bd. of Pharmacy, eff. 10-24-97)
PHARMACIES IN GENERAL
NAC 639.500 Ownership of pharmacies; application to conduct a pharmacy. (NRS 639.070, 639.231)
1. A person, as that term is defined in NRS 0.039, or the State of Nevada or any of its political subdivisions, may own more than one pharmacy.
2. An applicant for a license to conduct a pharmacy in this State must submit to the Board a complete and accurate application on a form provided by the Board, along with the requisite fees. The staff of the Board shall return the application to the applicant if the application is incomplete or does not include the requisite fees.
[Bd. of Pharmacy, § 639.180, eff. 6-26-80]—(NAC A 1-26-94; R076-00, 9-5-2000)
NAC 639.5005 Representative of pharmacy: General requirements; exceptions; approval; enforcement. (NRS 639.070, 639.231)
1. Except as otherwise provided in this subsection, an applicant for a license, or a licensee with a license, to conduct a pharmacy shall designate at least one natural person who will be the representative of the pharmacy. The Board will not issue a license to an applicant or renew the license of a licensee that is required to designate a representative of a pharmacy pursuant to this section unless the Board determines that the designated natural person meets the qualifications set forth in subsection 2 and approves that natural person to be the designated representative of the pharmacy. The requirement to designate a representative set forth in this subsection does not apply to:
(a) An applicant or a licensee that is a publicly traded corporation;
(b) An applicant or licensee whose pharmacy is determined by the Board to be located within a large retail store, including, without limitation, a grocery store, variety store or department store under common ownership; or
(c) An applicant or licensee in which a majority interest of the applicant or licensee is owned by a pharmacist who is:
(1) Licensed by the Board; and
(2) A resident of this State.
2. Except as otherwise provided in subsection 3, the Board will approve a natural person to be a representative of a pharmacy if the applicant for a license to conduct a pharmacy or the licensee presents proof satisfactory to the Board that the natural person:
(a) Has been employed for at least 6,000 hours in a pharmacy or with a wholesaler in a capacity related to the dispensing and distribution of, and recordkeeping relating to, prescription drugs;
(b) Has received a score of at least 75 percent on an examination given by the Board regarding federal and state laws and pharmacy practices; and
(c) Is at least 21 years of age.
3. The Board may, based upon any of the grounds set forth in NRS 639.210, refuse to approve a natural person for service as the representative of a pharmacy, regardless of whether the person is otherwise qualified.
4. A representative of a pharmacy designated pursuant to this section:
(a) Must be actively involved in and aware of the actual daily operation of the pharmacy;
(b) Must be employed full-time in a managerial level position in the pharmacy;
(c) Must be physically present at the site of the pharmacy during regular business hours, except when the absence of the representative is authorized, including sick leaves, vacation leaves and other authorized absences; and
(d) May serve in this representative capacity for only one pharmacy at a time.
5. A pharmacy that is required to designate a natural person as its representative pursuant to this section shall not open or operate the pharmacy unless that representative is actually employed full-time in the operation of the pharmacy and is physically present at the site of the pharmacy during regular working hours, not including sick leave, vacation leave and other authorized absences from work. If the natural person designated as the representative of a pharmacy leaves the employ of the pharmacy, thus leaving the pharmacy without a representative in violation of this section, the pharmacy shall:
(a) Immediately cease conducting business until another qualified natural person is approved by the Board to serve as the representative of the pharmacy; and
(b) Not later than 48 hours after that person leaves its employ, notify the Board that the person designated as the representative of the pharmacy has left the employ of the pharmacy.
6. Before a pharmacy that is in violation of this section because the natural person designated as the representative of the pharmacy left the employ of the pharmacy may continue conducting business:
(a) The pharmacy must designate, on a form provided by the Board, a new natural person to serve as the representative of the pharmacy; and
(b) The Board must approve the natural person so designated.
7. A pharmacy that operates without a representative in violation of this section is subject to the immediate suspension of its license until it employs a qualified natural person to be its representative. The Board will consider such a suspension to be an involuntary closure subject to the provisions of NAC 639.570, entitling the staff of the Board to close the pharmacy until it designates and employs a qualified natural person as its representative.
(Added to NAC by Bd. of Pharmacy by R076-00, eff. 9-5-2000; A by R010-11, 11-1-2001)
NAC 639.5007 Issuance of license to conduct pharmacy for applicant required to designate representative: Restricted and unrestricted licenses. (NRS 639.070, 639.231)
1. If a license to conduct a pharmacy is issued for an applicant that is required to designate a natural person as a representative of the pharmacy pursuant to NAC 639.5005, the license is subject to the following restrictions:
(a) The license expires 90 days after the date the license is issued by the Board.
(b) The license entitles the pharmacy to purchase prescription drugs only to the extent necessary to fill prescriptions actually received by the pharmacy.
(c) The license prohibits the pharmacy from selling, transferring, distributing, dispensing or otherwise providing prescription drugs to anyone except to a patient who has a legal prescription.
2. A pharmacy subject to the provisions of this section may receive an unrestricted license after the pharmacy provides the Board with a copy of a fully executed contract with a long-term care facility, home care facility or other similar facility in which the pharmacy has contracted to be the primary provider of prescription drugs. The net proceeds for the pharmacy from such a contract must be at least 75 percent of the monthly payroll for the employees employed by or otherwise compensated by the pharmacy.
3. Before the Board issues an unrestricted license pursuant to this section, the Board will inspect the pharmacy and the records of the pharmacy to confirm that the pharmacy has complied with the requirements of this section and all other applicable laws.
4. If a restricted license expires, whether after the original period of 90 days or after any subsequent extension, because the pharmacy has not been able to comply with the requirements of this section:
(a) The Board will not issue an unrestricted license to the pharmacy; and
(b) The pharmacy is subject to involuntary closure pursuant to the provisions of NAC 639.570.
5. The owner of a pharmacy that has been involuntarily closed pursuant to subsection 4 and NAC 639.570 may not reapply for a pharmacy license sooner than 1 year after the date of the expiration of the restricted license.
6. A pharmacy that has been issued a restricted license pursuant to this section may apply for one extension of the license, which may not exceed 90 days. To apply for an extension of a restricted license, the pharmacy must:
(a) Apply in writing not later than 60 days after the date when the restricted license was issued on a form provided by the Board;
(b) Be in compliance with this section and all applicable laws; and
(c) Demonstrate that it has made a good faith effort to obtain a contract to provide pharmaceutical services.
(Added to NAC by Bd. of Pharmacy by R010-01, eff. 11-1-2001)
NAC 639.501 Inspections; provision of self-assessment form. (NRS 639.070)
1. Before the Board will issue a new license to operate a pharmacy to any person, a satisfactory inspection of the premises of the pharmacy must be conducted by a member of the staff of the Board.
2. A member of the staff of the Board shall inspect each licensed pharmacy annually and at any other time deemed necessary by the staff of the Board.
3. Before an annual inspection of a licensed pharmacy, the Board will provide a self-assessment form to the pharmacy that includes:
(a) A questionnaire concerning statutory and regulatory compliance pursuant to which the pharmacy must assess its physical plant and operations to assure that the pharmacy is in compliance with all applicable statutes and regulations; and
(b) An assessment of the workplace pursuant to which the pharmacy must assess its volume of work and prescriptions, personnel, workflow and technological devices that assist in the work of the pharmacy.
4. The managing pharmacist of a pharmacy or the designee of the owner of the pharmacy may obtain self-assessment forms from the Board in addition to the form provided pursuant to subsection 3 at any time for his own use.
(Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)
NAC 639.5012 Confidentiality and use of self-assessment and accompanying documentation. (NRS 639.070)
1. An assessment of the workplace completed by a pharmacy as part of the self-assessment, and all documentation accompanying the assessment, that are submitted to a member of the staff of the Board pursuant to NAC 639.5016 are confidential. The Board will destroy such an assessment of the workplace and all accompanying documentation within 6 months after the Board receives the assessment and documentation.
2. The staff of the Board may compile and analyze such data provided in assessments of the workplace as the Board deems appropriate, except that the staff shall not provide to any member of the Board or otherwise publish any compilation or analysis completed by the staff unless the staff has redacted from the compilation or analysis all information by which an individual pharmacy could be identified. The Board will not use data provided in an assessment of the workplace against the pharmacy that completed the assessment for any disciplinary purpose.
(Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)
NAC 639.5014 Completion of self-assessment form before annual inspections; suggestions relating to compliance by or improvement of pharmacy. (NRS 639.070)
1. The managing pharmacist of a pharmacy or the designee of the owner of the pharmacy shall complete a self-assessment form before each annual inspection of the pharmacy by a member of the staff of the Board.
2. The managing pharmacist or the designee of the owner who completes a self-assessment form may make:
(a) Notes and comments on the self-assessment form to explain his answers; and
(b) Suggestions on the self-assessment form relating to the compliance by or improvement of the pharmacy.
3. If the managing pharmacist or the designee of the owner makes any suggestion on a self-assessment form of the pharmacy relating to the compliance by or improvement of the pharmacy, he shall submit, in accordance with any policies and procedures of the pharmacy, a copy of the self-assessment form to the senior management of the pharmacy. If the managing pharmacist or designee of the owner believes that his suggestions are necessary for the care of the patients of the pharmacy and that the senior management of the pharmacy has not responded appropriately, the managing pharmacist or the designee of the owner may contact the Board, which will take such action relating to the suggestion as the Board deems appropriate.
(Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)
NAC 639.5016 Annual inspections: Review of self-assessment form; notes regarding discrepancies or deficiencies; correction of discrepancies or deficiencies. (NRS 639.070)
1. Whenever a member of the staff of the Board conducts an annual inspection of a pharmacy, the managing pharmacist of the pharmacy or the designee of the owner of the pharmacy shall provide the member of the staff of the Board with a completed self-assessment form of the pharmacy. A member of the staff of the Board conducting an annual inspection of a pharmacy shall review a self-assessment form of the pharmacy with the managing pharmacist of the pharmacy or a pharmacist on duty in the pharmacy at the time of the inspection to verify that all the information contained in the self-assessment form of the pharmacy is true and complete.
2. If, during the annual inspection of a pharmacy, the member of the staff of the Board conducting the inspection finds any discrepancies between the information contained in the self-assessment form of the pharmacy and the actual state or condition of the pharmacy, or if the member of the staff of the Board finds any other deficiencies or conditions in the pharmacy or its operation that are not otherwise in compliance with the applicable statutes and regulations governing the operation of a pharmacy and dispensing of drugs, the member of the staff of the Board shall make a note of the discrepancy, deficiency or condition in his inspection.
3. A pharmacy shall correct a discrepancy, deficiency or condition noted by a member of the staff of the Board pursuant to subsection 2 within a reasonable time, as determined by the member of the staff of the Board who noted the discrepancy, deficiency or condition. Any failure by a managing pharmacist or an owner of a pharmacy, or both, to correct a discrepancy, deficiency or condition in a timely manner as required by this subsection constitutes unprofessional conduct pursuant to subsection 4 of NRS 639.210 and may serve as the basis for such disciplinary action against the managing pharmacist or owner of the pharmacy, or both, as the staff of the Board deems appropriate.
(Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)
NAC 639.5018 Protection of employee providing answers, information or suggestions on self-assessment form or during inspections. (NRS 639.070) A pharmacy shall not terminate, or otherwise negatively affect in any way, the employment of an employee of the pharmacy who:
1. In good faith, provides truthful answers, information or suggestions relating to the compliance by or improvement of the pharmacy in the preparation or completion of a self-assessment form for the pharmacy;
2. Transmits a copy of a self-assessment form to the senior management of the pharmacy or the Board pursuant to subsection 3 of NAC 639.5014; or
3. In good faith, provides truthful information to any member of the staff of the Board as part of an inspection of the pharmacy pursuant to NAC 639.5016.
(Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)
NAC 639.5019 Annual review by Board of provisions of NAC 639.501 to 639.5019, inclusive. (NRS 639.070) The Board will review the provisions of NAC 639.501 to 639.5019, inclusive, at its first regularly scheduled meeting following July 1 of each year to consider and suggest amendments to and deletions from the provisions of NAC 639.501 to 639.5019, inclusive, including the repeal of the sections.
(Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)
NAC 639.503 Maintenance in pharmacy of current statutes, regulations and reference material. (NRS 639.070) Except as otherwise provided in NAC 639.472:
1. All licensed pharmacies must maintain at all times and make available to pharmacists, intern pharmacists and other employees, copies of all current state statutes and regulations relating to the practice of pharmacy and to the sale of drugs and controlled substances.
2. Each licensed pharmacy must maintain in its prescription department reference materials in the form of the latest editions of pharmaceutical texts, or their equivalent which are on a computer program or disc. The reference materials must be readily retrievable as necessary to conduct the practice of pharmacy and must include, without limitation, information on:
(a) Preparation and compounding of prescriptions;
(b) Biological and therapeutical equivalencies of drugs;
(c) Pharmacology and pharmacokinetics;
(d) Indications and usage of drugs;
(e) Contraindications of, adverse reactions to and warnings about drugs;
(f) Dosage and administrations of drugs; and
(g) Overdosages of drugs.
(Added to NAC by Bd. of Pharmacy, eff. 6-25-82; A 3-27-90; R158-99, 3-1-2000)
NAC 639.505 Maintenance in pharmacy of reports of inspection, warning notices and special bulletins. (NRS 639.070) A copy of each report of inspection, issued by a member of the Board or its administrative staff, together with any warning notice or special bulletin issued by the Board, must be maintained on the premises of the pharmacy in such a manner as to make these documents readily available on request for 2 years after the date of issue unless earlier destruction is authorized.
[Bd. of Pharmacy, § 639.230, eff. 6-26-80]
NAC 639.510 Maintenance and storage of pharmaceutical stock. (NRS 639.070)
1. The owner, manager, operator, managing pharmacist or pharmacist in charge of a licensed pharmacy shall maintain in the pharmacy a representative stock of dangerous drugs, controlled substances, chemicals, biologicals and devices in sufficient quantity to provide adequate pharmaceutical services for the people of the community which the pharmacy serves.
2. The managing pharmacist of a pharmacy:
(a) Is responsible for, and must have knowledge and control of, the acquisition and disposition by the pharmacy of the stock of the pharmacy; and
(b) Shall ensure that the records relating to the acquisition or disposition of the stock of the pharmacy are maintained as required by law.
3. The dangerous drugs, controlled substances, chemicals, biologicals and devices kept in the stock of a pharmacy must meet all of such standards of purity and strength as established by current official compendia or as established on the appropriate labels, and must be properly stored. Any preparation which varies from such standards of purity and strength or becomes unfit for use from deterioration or other cause must not be carried in stock and must be destroyed in a manner provided by law when so ordered by an agent of the Board.
[Bd. of Pharmacy, § 639.225, eff. 6-26-80]—(NAC A by R159-99, 3-1-2000)
NAC 639.512 Class A and B packaging: Label; expiration date; log. (NRS 639.070)
1. This section only applies to Class A and B packaging as defined in the United States Pharmacopoeia.
2. Each unit dose of a controlled substance or dangerous drug packaged or repackaged by a pharmacy must contain a label which specifies:
(a) The generic or trade name;
(b) The strength;
(c) The expiration date; and
(d) Where applicable, an internal control number or the lot number of the bulk package.
3. A unit dose of a controlled substance or dangerous drug packaged or repackaged by a pharmacy, including a hospital pharmacy, must be dispensed before the expiration date thereof. For the purposes of this section, “expiration date” means the date 12 months after the date of the packaging or repackaging of the substance or dangerous drug. No expiration date may exceed the original manufacturer’s expiration date.
4. Each pharmacy must maintain a log containing, with respect to each controlled substance or dangerous drug packaged or repackaged by the pharmacy:
(a) The generic name, trade name and manufacturer;
(b) The strength;
(c) The manufacturer’s expiration date;
(d) Where applicable, an internal control number;
(e) The lot number of the bulk packaging;
(f) The date of packaging or repackaging;
(g) The number of doses packaged or repackaged; and
(h) The initials of the pharmacist.
(Added to NAC by Bd. of Pharmacy, eff. 12-3-84; A by R016-01, 11-1-2001)
NAC 639.513 Class C packaging: Expiration date. (NRS 639.070) Each controlled substance or dangerous drug packaged as Class C or below as defined in the United States Pharmacopoeia must have an expiration date of 60 days after the packaging or repackaging unless a stability study satisfactory to the Board has been performed on the controlled substance or dangerous drug.
(Added to NAC by Bd. of Pharmacy, eff. 12-3-84)
NAC 639.515 Stock of drugs in facility for skilled nursing or intermediate care. (NRS 639.070, 639.2327)
1. A facility for skilled nursing or a facility for intermediate care may maintain a stock of the following drugs for emergency treatment for inpatients:
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Analgesic-CII |
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Analgesic-non CII |
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Anesthetics, local |
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Antiarrhythmics |
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Antibiotics |
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Orally |
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Intravenous |
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Anticholinergic |
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Antidiarrheal |
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Antihistamine |
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Antihypertensive |
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Antinauseants |
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Antipsychotic |
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Bronchodilators |
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Calcium injectable |
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Dextrose injection |
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Diazepam |
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Digoxin |
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Diuretic injectable |
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Epinephrine |
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Glucagon |
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Heparin |
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Insulin |
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Intravenous solutions |
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Magnesium sulfate |
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Muscle relaxant |
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Naloxone |
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Nitroglycerin tablets |
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Normal saline |
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Phenobarbital |
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Phenytoin |
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Potassium chloride |
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Pressor amine |
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Protamine |
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Sodium bicarbonate |
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Steroids |
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Vitamin K |
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Water for injection |
2. The Pharmacy and Therapeutic Committee, as defined by 405 C.F.R. § 1127, of the facility shall determine the quantity of each drug to be stocked, but quantities stocked must not exceed 20 units of each drug at each nursing station in the facility.
3. All drugs must be stored and maintained in unit dosages, if manufactured in that form.
[Bd. of Pharmacy, § 639.425, eff. 6-26-80]—(NAC A 12-3-84; 6-16-86; 2-18-88; 11-9-95)
NAC 639.517 Nurse employed by medical facility or agency to provide nursing in the home may maintain stock of certain drugs. (NRS 639.070)
1. A registered nurse employed by a medical facility or an agency to provide nursing in the home may, at the direction of the medical director of the facility or agency, maintain a stock of the following drugs for the emergency treatment of patients:
(a) Diphenhydramine;
(b) Epinephrine;
(c) Heparin;
(d) Normal saline;
(e) Thrombolytics; and
(f) Water for injection.
2. As used in this section:
(a) “Agency to provide nursing in the home” has the meaning ascribed to it in NRS 449.0015.
(b) “Medical facility” has the meaning ascribed to it in NRS 449.0151.
(Added to NAC by Bd. of Pharmacy by R015-99, eff. 11-3-99)
NAC 639.520 Security of prescription departments. (NRS 639.070)
1. The prescription department of every pharmacy must be separated from the merchandising or public areas of the premises by a barrier extending not less than 5 feet above the floor level and of sufficient width to make dangerous drugs, controlled substances, narcotics, poisons or restricted devices inaccessible to unauthorized persons. The barrier must be constructed of solid material and contain at least one gate or door permitting access by the pharmacist. Each gate or door must be secured by a dead-bolt lock that can be opened from the outside only by a key. The gate or door may be secured by a combination lock during the hours of business.
2. The registered pharmacist on duty:
(a) Shall maintain possession of the key to the prescription department. Any additional keys to the prescription department must be kept in a locked box which is:
(1) Operated with a key that is accessible to only licensed pharmacists within the pharmacy department; and
(2) Maintained in a secure place that is inaccessible to unauthorized persons.
(b) Is responsible for securing the prescription department at all times when he is not personally present in the department except when he is in the immediate area and can observe and exercise control over the prescription department.
(c) If the pharmacy is located within a store or business, shall ensure that all dangerous drugs, controlled substances, narcotics, poisons and restricted devices that are delivered onto the premises of the store or business are immediately placed and secured in the pharmacy department under the physical control of the pharmacist on duty.
3. The Executive Secretary may permit an alternative type of physical security if, in his opinion, the alternative type will be sufficient to make the drugs, controlled substances, narcotics, poisons and restricted devices inaccessible to any unauthorized person.
4. Except as otherwise provided by law or regulation, no person other than a registered pharmacist may enter the prescription department of a pharmacy unless he is on business directly concerning the operation, maintenance or repair of the prescription department and a pharmacist employed in the prescription department is physically present at the same time.
5. Except as otherwise provided in subsection 6 or 7, a pharmacy shall maintain on its premises an alarm system that is operational 24 hours a day and that is monitored by a central station for control which is approved by Underwriters Laboratories Inc.
6. Except as otherwise provided in subsection 7, a pharmacy that is located within a building in which at least one employee of the person who owns the building is present 24 hours a day may, in lieu of the alarm system required pursuant to subsection 5, maintain on the premises of the pharmacy an alarm system that is:
(a) Equipped with an audible alarm that is:
(1) Operational 24 hours a day;
(2) Of sufficient decibels to alert more than one person in the building that an unauthorized entry has been made into the pharmacy; and
(3) Devised in such a manner as to provide notification to the managing pharmacist or his designee when such an authorized entry has been made; and
(b) Not monitored by a central station for control.
7. A pharmacy in a hospital or correctional institution and any pharmacy that is staffed 24 hours a day is exempt from the provisions of subsections 5 and 6.
[Bd. of Pharmacy, § 639.245, eff. 6-26-80]—(NAC A 12-3-84; R116-98, 9-9-98; R160-99, 3-1-2000)
NAC 639.523 Physical address for delivery of drugs. (NRS 639.070)
1. A pharmacy which purchases drugs and which is required pursuant to NAC 639.5005 to designate a natural person as a representative of the pharmacy shall have the drugs shipped to the pharmacy and shall physically receive the drugs at the physical address for which the Board has issued the license of the pharmacy.
2. The drugs purchased by a pharmacy must not be drop-shipped to any address other than the physical address of the pharmacy to which the Board has issued the license of the pharmacy. As used in this subsection, “drop-shipped” means a direct shipment of drugs to any location other than the pharmacy by the manufacturer or wholesaler of the drugs.
3. A pharmacist employed by a pharmacy shall acknowledge on every invoice that the drugs listed in the invoice were physically received by the pharmacy at the physical address to which the Board has issued the license of the pharmacy.
(Added to NAC by Bd. of Pharmacy by R010-01, eff. 11-1-2001)
NAC 639.525 Minimum requirements for work area and equipment. (NRS 639.070) The prescription department in each licensed pharmacy must contain the following minimum work area and equipment for the compounding and dispensing of drugs:
1. A prescription counter on which to work, with a free working surface of not less than 3 feet in width and 2 feet in depth for each person who is compounding or dispensing drugs within the prescription department, including, without limitation, each registered pharmacist and pharmaceutical technician who is compounding or dispensing drugs within the prescription department. This working surface must be reserved for and restricted solely to the compounding and dispensing of drugs.
2. A free floor space behind the prescription counter that is not less than 8 feet in length and 4 feet in width.
3. A refrigerator that is equipped with a thermometer to ensure proper control of temperature, a sink that is suitable for cleaning the required pharmaceutical equipment and is supplied with hot and cold running water, soap and detergent, and a clean and sanitary disposal container for wastes.
4. If the pharmacy compounds prescriptions that require the measurement of weight, scales and balances for medium and light weighing, at least one of which must be sensitive to 1/2 grain, with weights, including, without limitation, apothecary and avoirdupois, from 1/2 grain to 4 ounces and from 0.02 gm to 100 gm.
5. If the pharmacy prepares sterile products, a laminar airflow hood that is certified at least annually.
6. Capsule and tablet counters and other devices and equipment necessary to compound and dispense drugs.
7. A facsimile machine that:
(a) Uses paper of such quality; and
(b) Prints in such a manner,
Ê that documents printed by the machine are usable and readable for at least 2 years. As used in this subsection, “facsimile machine” includes, without limitation, a computer that has a facsimile modem through which documents can be sent and received.
[Bd. of Pharmacy, § 639.220, eff. 6-26-80]—(NAC A 3-27-90; 8-27-96; 9-6-96; R117-98, 9-9-98; R013-99 & R112-99, 11-3-99)
NAC 639.526 Drive-through facilities. (NRS 639.070)
1. Except as otherwise provided in subsection 3, if a licensee provides pharmaceutical services by means of a drive-through facility, the drive-through facility must:
(a) Be constructed and maintained in a manner, and with materials, that secures the premises of the pharmacy from unlawful or unauthorized access.
(b) Be readily accessible to the personnel of the pharmacy who are authorized to be in the prescription department.
(c) Provide two-way visual and auditory communication between the personnel of the pharmacy and a patient receiving pharmaceutical services by means of the drive-through facility.
(d) Be equipped with a computer terminal that is part of the pharmacy’s computerized system for recording information concerning prescriptions. The terminal must be so located within the prescription department that personnel of the pharmacy when providing pharmaceutical services to a patient by means of the drive-through facility can use the computer terminal without losing visual or auditory communication with the patient.
(e) Be so equipped that a pharmacist, or intern pharmacist under the supervision of a pharmacist, can provide a patient receiving pharmaceutical services by means of the drive-through facility with the counseling required in NAC 639.707 without losing visual or auditory communication with the patient.
2. A licensee shall not provide pharmaceutical services by means of a drive-through facility that does not include a window, or other opening, in the exterior wall of the pharmacy unless the licensee first applies for, and obtains, the approval of the Board.
3. The Board may, upon application, and for good cause shown, waive or modify any requirement set forth in this section.
4. As used in this section:
(a) “Drive-through facility” means any combination of structural, mechanical, electronic or other elements located within and without the prescription department of a licensed pharmacy that enables the personnel of the pharmacy to provide pharmaceutical services to a patient who drives a vehicle to the pharmacy without the personnel of the pharmacy leaving the prescription department or the patient leaving his vehicle. The term includes, without limitation, a window or other opening in the exterior wall of a prescription department of a licensed pharmacy, alone, or in conjunction with one or more mechanical, electronic or other devices.
(b) “Licensee” means a person licensed by the Board pursuant to NRS 639.231 to conduct a pharmacy.
(c) “Patient” includes a person caring for a patient.
(Added to NAC by Bd. of Pharmacy by R154-04, eff. 10-22-2004)
NAC 639.528 Preparation and storage of food in prescription department of pharmacy. (NRS 639.070) Food for consumption by the public must not be:
1. Prepared in the prescription department of a pharmacy; or
2. Stored in the refrigerator of the prescription department of a pharmacy.
Ê A pharmacist or a member of the staff of a pharmacy may prepare food in the prescription department of the pharmacy or store food in the refrigerator of the prescription department of the pharmacy if the food is for his own personal consumption.
(Added to NAC by Bd. of Pharmacy by R117-98, eff. 9-9-98)
NAC 639.530 Sanitation; required washbasins; exception. (NRS 639.070)
1. Waste material must not be allowed to collect on the floors, counters or other portions of a pharmacy, and adequate waste receptacles must be provided.
2. All persons authorized to work within the prescription department must keep themselves and their apparel in a clean and sanitary condition.
3. Each pharmacy must have a washbasin which is supplied with hot and cold running water. The washbasin must be located within the pharmacy and be readily available to any person authorized by law to work in the prescription department.
4. In addition to the washbasin required pursuant to subsection 3, and except as otherwise provided in this subsection, a pharmacy that is built or remodeled after November 1, 1996, must contain a lavatory with a toilet and washbasin within or adjoining the pharmacy. A pharmacy that is remodeled after November 1, 1996, may ask the Board for an exception to this requirement and the Board will, if it deems it appropriate, grant the exception.
[Bd. of Pharmacy, § 639.235, eff. 6-26-80]—(NAC A 9-6-96)
NAC 639.535 Remodeling or relocation of pharmacy or prescription department. (NRS 639.070) Before undertaking a structural remodeling or relocation of a pharmacy or a prescription department within the premises of a licensed pharmacy, the licensee shall notify the Executive Secretary in writing and pay to the Board an inspection fee of $75.
[Bd. of Pharmacy, § 639.240, eff. 6-26-80]
NAC 639.540 Notice of employment and termination of employment of certain pharmaceutical professionals. (NRS 639.070) The owner, manager, operator or other person in charge of any pharmacy, as that term is defined in NRS 639.012, shall, within 10 days after the employment or termination of employment of a registered pharmacist, intern pharmacist, pharmaceutical technician or pharmaceutical technician in training, give written notice to the Executive Secretary of that employment or termination. The notice must include the name, residential address and certificate number of the employee or former employee.
[Bd. of Pharmacy, § 639.190, eff. 6-26-80]—(NAC A 11-15-93)
NAC 639.542 Identification of persons employed by pharmacy. (NRS 639.070) Each person employed by a pharmacy shall wear identification that clearly identifies him by name and the classification of his registration.
(Added to NAC by Bd. of Pharmacy, eff. 11-15-93)
NAC 639.556 Meal periods and rest periods for employees of pharmacy. (NRS 639.070, 639.220)
1. Except as otherwise provided in this section and NRS 639.220:
(a) The owner of a pharmacy shall permit each employee of the pharmacy to take meal periods and rest periods as required by NRS 608.019 or any applicable collective bargaining agreement; and
(b) A pharmacy may schedule a regular time during which a pharmacist employed by the pharmacy may take a meal period.
2. If there is more than one pharmacist on duty at the time that a pharmacist takes a meal period, the pharmacist who is taking the meal period may, at his discretion, remain on the premises of the pharmacy or leave the premises of the pharmacy.
3. Except as otherwise provided in NRS 639.220, if a pharmacist is the only pharmacist on duty at the time he takes a meal period, the pharmacist may, at his discretion, remain on the premises of the pharmacy or leave the premises of the pharmacy. If the pharmacist chooses to remain on the premises of the pharmacy, the pharmacist may not be interrupted or disturbed to conduct his work as a pharmacist, unless the pharmacist has agreed to such an interruption. If the pharmacist chooses to leave the premises of the pharmacy, the pharmacist shall:
(a) Close and secure the pharmacy pursuant to NAC 639.520; and
(b) Post a sign that is visible to the public stating the time the pharmacist will return from the meal break.
4. A pharmacy that is closed and secured during the meal period of a pharmacist pursuant to subsection 3 may accept a prescription during the meal period if:
(a) The prescription is placed by the patient or the patient’s agent or representative in a secure container or receptacle that ensures that the prescription cannot be seen, removed or damaged until it is retrieved by a pharmacist or other authorized employee of the pharmacy; or
(b) An authorized employee of the pharmacy personally accepts and secures the prescription from the patient or the patient’s agent or representative outside the closed and secured premises of the pharmacy.
5. A pharmacy may require a pharmacist to remain on the premises of the pharmacy during a rest period, but may not require the pharmacist to serve the public during the rest period. The pharmacist may, at his discretion, agree to have his rest period interrupted.
6. The provisions of this section do not affect any other provision of law regarding the practice of pharmacy.
(Added to NAC by Bd. of Pharmacy by R152-05, eff. 12-29-2005)
NAC 639.570 Involuntary closure of pharmacy. (NRS 639.070)
1. Upon an involuntary closure of a pharmacy, the licensee shall immediately surrender to the Board all controlled substances and dangerous drugs, and all order forms therefor, which are owned or controlled by the licensee on the premises of the pharmacy. A member of the Board or one of its inspectors shall immediately take possession of and hold all such substances, drugs and forms.
2. The controlled substances, dangerous drugs and forms so surrendered will be held in trust by the Board for the licensee. The substances and drugs so held will forthwith be inventoried, packaged, sealed and stored at the expense of the licensee in a place determined by the Board to be appropriately secure.
3. A licensee has 60 days after the effective date of the involuntary closure to make arrangements for the lawful sale or other disposition of the controlled substances and dangerous drugs so inventoried and stored. If no such sale or disposition is made by the licensee within the 60-day period, the Board will make arrangements for the sale or other disposition of the substances and drugs for the benefit of the licensee, and will account for them to the licensee. Upon disposition of the substances and drugs, the order forms will be returned to the Drug Enforcement Administration.
4. The licensee shall cooperate with the Board to promote the efficient administration of this section.
5. As used in this section, “involuntary closure” of a pharmacy includes:
(a) Closure as a result of action by the Federal Government, the State of Nevada or the governing body of any county or city within the State of Nevada;
(b) The revocation or suspension of any license issued to a pharmacy by the Board; or
(c) Any other involuntary closure, including an involuntary adjudication of bankruptcy, an appointment of a receiver or an entry of an order of closure by a court of competent jurisdiction.
[Bd. of Pharmacy, § 639.275, eff. 6-26-80]
NAC 639.575 Voluntary closure of pharmacy. (NRS 639.070)
1. Whenever any pharmacy licensed by the Board is closed for more than 5 consecutive days for any reason other than an involuntary closure, the licensee shall notify the Board of the closure. The notice must be in writing, be given not more than 5 days after the closure, and state the reason or reasons for the closure and the anticipated period of the closure. Upon receipt of the notice, the Board will make such arrangements as it deems appropriate to provide adequate and continued security of all the controlled substances, dangerous drugs, chemicals and poisons which are owned or controlled by the licensee or on the premises of the pharmacy.
2. If the licensee of a pharmacy dies or becomes legally disabled by a cause other than a mental illness for which provision is made in NRS 639.211 and the disability does not result in an involuntary closure, a member of the Board or one of its inspectors shall forthwith take custody of all controlled substances and dangerous drugs which are owned or controlled by the licensee or are on the premises of the pharmacy and thereupon proceed in the manner provided in NAC 639.570. The Board will also make such arrangements as it deems appropriate to provide adequate and continued security for all the chemicals and poisons which are owned or controlled by the licensee or are on the premises of the pharmacy.
3. The licensee shall cooperate with the Board to promote the efficient administration of this section.
[Bd. of Pharmacy, § 639.280, eff. 6-26-80]
NAC 639.580 Permanent closure of pharmacy. (NRS 639.070)
1. If the licensee of a pharmacy ceases to do business and permanently closes the pharmacy he must:
(a) Place a sign in the front window of the pharmacy notifying the public of the name and address of the pharmacy to which the prescription files have been transferred. The sign must remain so placed for a period of 30 days unless sooner removed by the landlord or a new tenant.
(b) Return to the Executive Secretary his pharmacy license and license renewal certificates.
(c) Prepare separate inventories in duplicate of the controlled substances and dangerous drugs on the premises at the time of the closure and provide the purchaser thereof with copies of the inventories. Copies of the inventories must be retained by the seller and the purchaser for 2 years.
(d) If he is transferring prescription files for controlled substances or dangerous drugs, comply with the provisions of NAC 639.713 and 639.714, and ensure that:
(1) The information relating to the refill of each prescription is included on the prescription; or
(2) If he maintains his prescription files on a computer system, the information relating to the refill of each prescription is accessible by the computer system of the pharmacy to which the information is transferred.
(e) Notify the Executive Secretary in writing of:
(1) The method of disposition of the controlled substances and dangerous drugs;
(2) The name of the purchaser; and
(3) The kinds and amounts transferred.
2. The licensee shall cooperate with the Board to promote the efficient administration of this section.
[Bd. of Pharmacy, § 639.285, eff. 6-26-80]—(NAC A 7-17-96)
NUCLEAR PHARMACIES
NAC 639.5802 Definitions. (NRS 639.070) As used in NAC 639.5802 to 639.584, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.5804 to 639.5814, inclusive, have the meanings ascribed to them in those sections.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5804 “Agreement state” defined. (NRS 639.070) “Agreement state” means any state with which the Nuclear Regulatory Commission has entered into an effective agreement pursuant to section 274(b) of the Atomic Energy Act of 1954, 42 U.S.C. § 2021(b).
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5806 “Authentication of product history” defined. (NRS 639.070) “Authentication of product history” means identifying the purchasing source, the ultimate destination and any intermediate handling of any component of a radiopharmaceutical or other drug.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5808 “Procedures to assure the quality of radiopharmaceuticals” defined. (NRS 639.070) “Procedures to assure the quality of radiopharmaceuticals” means all activities necessary to assure the quality of the process used to provide radiopharmaceutical services, including, but not limited to, authentication of product history and maintenance of any records required by an appropriate regulatory agency.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.581 “Qualified nuclear pharmacist” defined. (NRS 639.070) “Qualified nuclear pharmacist” means a nuclear pharmacist who meets the requirements set forth in NAC 639.5818.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5812 “Radiopharmaceutical services” defined. (NRS 639.070) “Radiopharmaceutical services” means the procurement, storage, handling, compounding, preparation, labeling, testing to control the quality of, dispensation, distribution, transfer, recordkeeping and disposal of radiochemicals, radiopharmaceuticals and ancillary drugs. The term includes procedures to assure the quality of radiopharmaceuticals, radiological health activities, consulting activities associated with the use of radiopharmaceuticals, health physics and any other activities required for the provision of pharmaceutical care.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5814 “Testing to control the quality of radiopharmaceutical” defined. (NRS 639.070) “Testing to control the quality of radiopharmaceutical” means the performance of appropriate chemical, biological and physical tests on a compounded radiopharmaceutical and the interpretation of the resulting data to determine its suitability for use in humans and animals.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5816 “Radiopharmaceutical” interpreted. (NRS 639.070) The Board interprets the term “radiopharmaceutical” as defined in NRS 639.0143 to include any biological product which is labeled with a radionuclide or intended solely to be labeled with a radionuclide.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5818 Nuclear pharmacist: Certification; training and instruction; affidavit of experience and training. (NRS 639.070) A nuclear pharmacist must hold a current license issued by the Board and must:
1. Be certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties, an affiliate of the American Pharmacists Association; or
2. Satisfy each of the following requirements:
(a) Meets minimum standards of training for status as an authorized user of radioactive material and is licensed by the Nuclear Regulatory Commission or an agreement state.
(b) Has successfully completed a minimum of 200 contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from a nationally accredited college of pharmacy or a training program recognized by the Nuclear Regulatory Commission or an agreement state. The minimum required hours must be apportioned as follows:
(1) Radiation physics and instrumentation (85 hours);
(2) Protection against radiation (45 hours);
(3) Mathematics pertaining to the use and measurement of radioactivity (20 hours);
(4) Radiation biology (20 hours); and
(5) Radiopharmaceutical chemistry (30 hours).
(c) Has attained a minimum of 500 hours of clinical or practical training in nuclear pharmacy under the supervision of a qualified nuclear pharmacist in the following areas, as described in the current Nuclear Pharmacy Practice Standards adopted by the American Pharmacists Association:
(1) Procuring radioactive materials;
(2) Compounding radiopharmaceuticals;
(3) Performing routine testing to control the quality of radiopharmaceuticals;
(4) Dispensing radiopharmaceuticals;
(5) Distributing radiopharmaceuticals;
(6) Carrying out basic procedures for protection against radiation; and
(7) Consulting and educating persons engaged in nuclear medicine, patients, pharmacists, other health professionals and the general public.
(d) Has submitted an affidavit of experience and training to the Board.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.582 Permit to operate. (NRS 639.070) The Board will issue a permit to operate a nuclear pharmacy only to a person who is a qualified nuclear pharmacist or who employs a qualified nuclear pharmacist. The permit to operate a nuclear pharmacy is effective only as long as the pharmacy also holds a current license issued by the Nuclear Regulatory Commission. Copies of reports of any inspection conducted by the Nuclear Regulatory Commission must be made available on request for inspection by the Board.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5822 Space and equipment requirements; floor plan. (NRS 639.070) A nuclear pharmacy must have adequate space and equipment commensurate with the scope of services it provides and must meet the minimum space requirements established for all pharmacies in the State. A nuclear pharmacy must include, but is not limited to, an area for the:
1. Preparation and dispensation of radiopharmaceuticals.
2. Shipment and receipt of radioactive material.
3. Storage of radioactive material.
4. Decay of radioactive waste.
Ê An application for a permit to operate a nuclear pharmacy must include a detailed floor plan of the nuclear pharmacy. The Board must approve any subsequent material change to the floor plan.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5824 Security. (NRS 639.070) A nuclear pharmacy must be totally enclosed and be able to be locked to prevent access by unauthorized personnel.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5826 Records. (NRS 639.070) The records of acquisition, inventory and disposition of all radioactive drugs and other radioactive materials of a nuclear pharmacy must be maintained in accordance with the statutes and regulations of the Board, the Nuclear Regulatory Commission or an agreement state.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5828 Quality assurance procedures for radiopharmaceuticals. (NRS 639.070) A nuclear pharmacy must compound and dispense radiopharmaceuticals in accordance with the accepted procedures to assure the quality of radiopharmaceuticals.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.583 Dispensing or transferring radiopharmaceuticals. (NRS 639.070) A radiopharmaceutical must be dispensed only pursuant to a prescription order received from a licensed practitioner authorized by the Nuclear Regulatory Commission or an agreement state to possess, use and administer such a drug. A radiopharmaceutical may be transferred to a person who is authorized to possess and use such a drug for nonclinical applications.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5832 Oral order for radiopharmaceutical: Requirement to keep record; contents of record. (NRS 639.070) After receiving an oral order for a radiopharmaceutical, a nuclear pharmacy immediately must reduce the order to writing or record the order in a data processing system and must include, without limitation, the following information:
1. The name of the institution and the prescriber or prescriber’s agent.
2. The date of dispensation and the calibration time of the radiopharmaceutical.
3. The name of the procedure.
4. The name of the radiopharmaceutical.
5. The dose or quantity of the radiopharmaceutical.
6. The serial number assigned to the order for the radiopharmaceutical.
7. Any specific instructions of the prescriber.
8. The initials of the person who received the order.
9. The initials of the person who dispensed the order.
10. If an order is for a radiopharmaceutical for therapeutic use or use in a blood product, the name of the patient must be obtained and recorded before dispensing the radiopharmaceutical.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5834 Outer shield of radiopharmaceutical container: Label required; contents of label. (NRS 639.070) The immediate outer shield of the container of a radiopharmaceutical to be dispensed must be labeled with:
1. The name and address of the pharmacy.
2. The name of the prescriber.
3. The date of dispensation.
4. The serial number assigned to the order for the radiopharmaceutical.
5. The standard radiation symbol.
6. The words “CAUTION RADIOACTIVE MATERIAL.”
7. The name of the procedure.
8. The radionuclide and chemical form.
9. The amount of radioactivity and the date and time of the calibration.
10. If the radiopharmaceutical is a liquid, the volume.
11. If the radiopharmaceutical is a solid, the number of items or weight.
12. If the radiopharmaceutical is a gas, the number of ampules or vials.
13. The molybdenum 99 content in accordance with the limitations prescribed in the United States Pharmacopeia.
14. The name of the patient or the words “Physician’s Use Only” in the absence of a patient’s name.
15. If the prescription is for a radiopharmaceutical for therapeutic use or use in a blood product, the patient’s name must appear on the label. The requirements of this subsection are met if the name of the patient is readily retrievable from the prescriber upon demand.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5836 Inner label of radiopharmaceutical container; contents. (NRS 639.070) The immediate inner label of a container of a radiopharmaceutical to be dispensed must be labeled with:
1. The name of the pharmacy.
2. The standard radiation symbol.
3. The words “CAUTION RADIOACTIVE MATERIAL.”
4. The identity of the radionuclide.
5. The chemical form.
6. The name of the procedure.
7. The serial number assigned to the order for the radiopharmaceutical.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.5838 Records of nuclear pharmacy when radiopharmaceutical is dispensed pursuant to investigational new drug application: Contents. (NRS 639.070) If a radiopharmaceutical is dispensed pursuant to the authority of an investigational new drug application approved by the United States Food and Drug Administration, the records of a nuclear pharmacy must include:
1. An investigator’s protocol for the preparation of the radiopharmaceutical;
2. A copy of the approval form or letter of the internal review board of the institution; and
3. A letter from the manufacturer or sponsor indicating that the physician requesting the radiopharmaceutical is a qualified investigator.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
NAC 639.584 Required equipment. (NRS 639.070) A nuclear pharmacy must have the following equipment:
1. A radionuclide dose calibrator.
2. A refrigerator.
3. A single or multiple channel well scintillation counter containing the isotopes sodium iodide, thallium, germanium and lithium.
4. A radiochemical fume hood and filter system with suitable equipment for sampling air.
5. An area survey meter.
6. At least two Geiger Mueller survey meters, including one high-range meter.
7. A microscope and hemacytometer.
8. A laminar airflow hood and appropriate supplies to ensure sterile practices for parenteral solutions.
9. Radiation shields for syringes and vials.
10. A lead-shielded drawing station.
11. Decontamination supplies.
12. Appropriate supplies to perform procedures to assure the quality of radiopharmaceuticals.
13. Lead transport shields for syringes and vials.
14. USA Type A, 7A transport containers approved by the Department of Transportation and other labels and supplies for shipping radioactive materials.
(Added to NAC by Bd. of Pharmacy, eff. 11-9-95)
WHOLESALERS
NAC 639.585 Definitions. (NRS 639.070) As used in NAC 639.585 to 639.607, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.587 to 639.592, inclusive, have the meanings ascribed to them in those sections.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A 10-1-93; R013-01, 11-1-2001; R049-04, 2-28-2005; R218-05, 5-4-2006; R097-07, 10-31-2007; R051-07, 12-4-2007; R122-07, 1-30-2008)
NAC 639.587 “Facility” defined. (NRS 639.070) “Facility” means a facility of a wholesaler where prescription drugs are stored, handled, repackaged or offered for sale.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92)
NAC 639.588 “Manufacturer” defined. (NRS 639.070) “Manufacturer” has the meaning ascribed to it in NRS 639.009.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92)
NAC 639.589 “Ongoing relationship” defined. (NRS 639.070) “Ongoing relationship” means a continuing business relationship in which a wholesaler distributes a manufacturer’s prescription drugs which is established pursuant to NAC 639.594.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92)
NAC 639.5895 “Purchaser” defined. (NRS 639.070) “Purchaser” means a pharmacy or practitioner that purchases a prescription drug from a wholesaler licensed pursuant to NRS 639.233.
(Added to NAC by Bd. of Pharmacy by R049-04, eff. 2-28-2005)
NAC 639.5897 “Purchasing wholesaler” defined. (NRS 639.070) “Purchasing wholesaler” means a wholesaler that purchases a prescription drug from a wholesaler licensed pursuant to NRS 639.233.
(Added to NAC by Bd. of Pharmacy by R049-04, eff. 2-28-2005)
NAC 639.5902 “Statement of prior sales” defined. (NRS 639.070) “Statement of prior sales” has the meaning ascribed to it in NRS 639.535.
(Added to NAC by Bd. of Pharmacy by R218-05, eff. 5-4-2006)
NAC 639.5905 “Supplier” defined. (NRS 639.070) “Supplier” means a wholesaler that sells a prescription drug to a wholesaler licensed pursuant to NRS 639.233.
(Added to NAC by Bd. of Pharmacy by R049-04, eff. 2-28-2005)
NAC 639.592 “Wholesaler” defined. (NRS 639.070) “Wholesaler” has the meaning ascribed to it in NRS 639.016.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92)
NAC 639.593 Licensing requirements; consideration of transaction as wholesale transaction; transferability and renewal of license. (NRS 639.070, 639.100, 639.500)
1. Each applicant for a license to engage in the wholesale distribution of prescription drugs must submit an application to the Board. The application must be made on a form furnished by the Board. The application must include:
(a) The name, business address and telephone number of the applicant and the address of the facility, if different from the address of the applicant;
(b) All trade or business names used by the applicant;
(c) The address, telephone number and name of the person who manages the facility;
(d) The type of ownership or operation of the facility;
(e) Except as otherwise provided in subsection 7:
(1) A complete set of fingerprints from each person required to submit fingerprints pursuant to NRS 639.500; and
(2) Written permission from each person who submitted fingerprints authorizing the Board to forward his fingerprints to the Central Repository for Nevada Records of Criminal History for submission to the Federal Bureau of Investigation for its report; and
(f) If the applicant is a:
(1) Natural person, the name of the person.
(2) Partnership, the name of the partnership and the name of each partner.
(3) Corporation, the name and title of each officer and director of the corporation, the corporate name and the state of incorporation, and the name of the parent company, if any.
(4) Sole proprietorship, the name of the sole proprietor and the name of the business entity.
2. If a wholesaler distributes prescription drugs from more than one facility, the wholesaler must obtain a license for each facility.
3. The Board will not consider the sale or distribution of a prescription drug to be a wholesale transaction if the sale, distribution or other transaction involving the prescription drug is a sale, distribution or other transaction in which:
(a) A wholesaler licensed by the Board or the relevant authority of another state sells, distributes or otherwise provides a prescription drug to a wholesaler or pharmacy licensed by the Board;
(b) Both the transferring wholesaler and the transferee are wholly owned by a common owner; and
(c) The common owner is a publicly traded corporation.
Ê For the purposes of this subsection, a wholesaler whose transaction does not comply with the provisions of paragraphs (a), (b) and (c) may apply to the Board to consider the transaction of the wholesaler not to be a wholesale transaction if the wholesaler provides proof that is satisfactory to the Board that the proposed transaction will not endanger the public and is not proposed for the purpose of evading the provisions of this chapter and chapter 639 of NRS. The Board will consider such a transaction to be a wholesale transaction until the Board approves the application of the wholesaler.
4. An applicant shall submit to the Board any change in the information required by this section within 30 days after the change occurs.
5. A license issued by the Board is not transferable.
6. Except as otherwise provided in subsection 7, each wholesaler applying for renewal of a license to engage in the wholesale distribution of prescription drugs must submit:
(a) A complete set of fingerprints from each person required to submit fingerprints pursuant to NRS 639.500; and
(b) Written permission from each person who submitted fingerprints authorizing the Board to forward his fingerprints to the Central Repository for Nevada Records of Criminal History for submission to the Federal Bureau of Investigation for its report.
7. Unless the Board otherwise requires, a wholesaler is not required to submit fingerprints pursuant to subsection 6 if:
(a) The wholesaler’s securities are publicly traded and regulated by the Securities Exchange Act of 1934, as amended, 15 U.S.C. §§ 78a et seq.;
(b) The wholesaler is owned by a corporation whose securities are publicly traded and regulated by the Act;
(c) The wholesaler is accredited by the National Association of Boards of Pharmacy under the Verified-Accredited Wholesale Distributors program;
(d) The wholesaler is a manufacturer of prescription drugs; or
(e) The wholesaler is a facility that distributes prescription drugs manufactured by a single manufacturer.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R013-01, 11-1-2001; R049-04, 2-28-2005; R218-05, 5-4-2006; R051-07, 12-4-2007)
NAC 639.5931 Submission of fingerprints: Required method. (NRS 639.070, 639.500, 639.505) A person who is required to submit a complete set of his fingerprints to the Board pursuant to NRS 639.500 or 639.505 or NAC 639.593 must submit the fingerprints electronically in a format prescribed by the Board.
(Added to NAC by Bd. of Pharmacy by R097-07, eff. 10-31-2007)
NAC 639.5932 Provisional license: Prerequisites for issuance. (NRS 639.070, 639.500) The Board may issue a provisional license to an applicant pursuant to subsection 3 of NRS 639.500, if the applicant:
1. Submits evidence satisfactory to the Board establishing that the applicant is licensed in another state as a wholesaler, that such license is in good standing and that he is not:
(a) Under investigation;
(b) Subject to an administrative action; or
(c) Otherwise engaged in litigation,
Ê for a matter related to the practice of the applicant.
2. Provides to the Board a list of all sources from which the applicant obtained prescription drugs during the 12 months immediately preceding the date on which the application was submitted.
3. Provides to the Board a list of all customers to whom the applicant sold or otherwise provided prescription drugs during the 12 months immediately preceding the date on which the application was submitted.
4. Provides all other documents as may be requested by the Board.
(Added to NAC by Bd. of Pharmacy by R218-05, eff. 5-4-2006)
NAC 639.5935 Representative of wholesaler: General requirements; exceptions; approval; enforcement. (NRS 639.070, 639.100)
1. Except as otherwise provided in this subsection, an applicant for a license, or a licensee with a license, to operate as a wholesaler shall designate at least one natural person to serve as the representative of the wholesaler. The Board will not issue or renew a license of an applicant or licensee that is required to designate a representative of a wholesaler pursuant to this section unless the Executive Secretary determines that the designated natural person meets the qualifications set forth in subsection 2 and approves that natural person to be the designated representative of the wholesaler. The requirement to designate a representative set forth in this subsection does not apply to:
(a) An applicant that is a publicly traded corporation; or
(b) An applicant in which a majority interest of the applicant is owned by a pharmacist who is:
(1) Licensed by the Board;
(2) A resident of this State; and
(3) Not an owner of any interest in a pharmacy licensed by the Board.
2. Except as otherwise provided in subsection 3, the Board will approve a natural person as the representative of a wholesaler if the applicant for a license to operate as a wholesaler or the licensee presents proof satisfactory to the Executive Secretary that the natural person:
(a) Has been employed for at least 6,000 hours in a pharmacy or with a wholesaler in a capacity related to the dispensing and distribution of, and recordkeeping relating to, prescription drugs;
(b) Has received a score of at least 75 percent on an examination given by the Board regarding federal and state laws and wholesaler practices; and
(c) Is at least 21 years of age.
3. The Board may, based upon any of the grounds set forth in NRS 639.210, refuse to approve a natural person for service as the representative of a wholesaler, regardless of whether the person is otherwise qualified.
4. A representative of a wholesaler designated pursuant to this section:
(a) Must be actively involved in and aware of the actual daily operation of the wholesaler;
(b) Must be employed full-time in a managerial level position with the wholesaler;
(c) Must be physically present at the facility of the wholesaler during regular business hours, except when the absence of the representative is authorized, including sick leave, vacation leave and other authorized absences; and
(d) May serve in this representative capacity for only one wholesaler at a time.
5. A wholesaler that is required to designate a natural person as its representative pursuant to this section shall not open or operate a facility unless that representative is actually employed full-time in the operation of the wholesaler and is physically present at the facility of the wholesaler during regular working hours, not including sick leave, vacation leave and other authorized absences from work. If the natural person designated as the representative of a wholesaler leaves the employ of the wholesaler, thus leaving the wholesaler without a representative in violation of this section, the wholesaler shall:
(a) Immediately cease conducting business until another qualified natural person is approved by the Board to serve as the representative of the wholesaler; and
(b) Not later than 48 hours after that person leaves its employ, notify the Board that the person designated as the representative of the wholesaler has left the employ of the wholesaler.
6. Before a wholesaler that is in violation of this section because the natural person designated as the representative of the wholesaler left the employ of the wholesaler may continue conducting business:
(a) The wholesaler must designate, on a form provided by the Board, a new natural person to serve as the representative of the wholesaler; and
(b) The Executive Secretary must approve the natural person so designated.
7. A wholesaler that operates without a representative in violation of this section is subject to the immediate suspension of its license until it employs a qualified natural person to be its representative. The Executive Secretary may take such action as deemed necessary to secure the facility of the wholesaler and to ensure that the wholesaler does not conduct business during the period of the suspension.
(Added to NAC by Bd. of Pharmacy by R013-01, eff. 11-1-2001)
NAC 639.5937 Bond or other security: Amount required from certain wholesalers; reduction of amount; substitution. (NRS 639.070, 639.515)
1. Unless the Board otherwise requires, a wholesaler shall file with the Board a bond or other security in the amount of $25,000 pursuant to NRS 639.515 if the wholesaler is:
(a) Accredited by the National Association of Boards of Pharmacy under the Verified-Accredited Wholesale Distributors program;
(b) A manufacturer of prescription drugs; or
(c) A facility that distributes prescription drugs manufactured by a single manufacturer.
2. The Board will reduce the bond or other security to the amount of $5,000 if any wholesaler described in subsection 1 has been licensed with the Board for 5 consecutive years or more.
3. Any bond or other security filed with the Board pursuant to subsection 1 may be substituted by a different bond or other security of equal value. The Board will release the previous bond or other security to the applicant upon receipt of the new bond or security.
(Added to NAC by Bd. of Pharmacy by R051-07, eff. 12-4-2007)
NAC 639.5938 Filing of single bond for multiple sites. (NRS 639.070, 639.515) Upon application from a wholesaler, the Board may allow a single bond:
1. Of $100,000 to serve as the bond required pursuant to NRS 639.515, for multiple sites if all sites are owned by a common owner who has a net worth of more than $25,000,000. The owner must provide evidence satisfactory to the Board demonstrating adequate net worth.
2. In an amount determined by the Board to serve as the bond required pursuant to NRS 639.515, for multiple sites where the wholesaler participates exclusively in transactions that the Board considers not to be a wholesale transaction pursuant to subsection 3 of NAC 639.593.
(Added to NAC by Bd. of Pharmacy by R218-05, eff. 5-4-2006)
NAC 639.594 Establishment of ongoing relationship. (NRS 639.070, 639.100, 639.595)
1. An ongoing relationship between a wholesaler and a manufacturer must be established by:
(a) A written franchise, license or other agreement between a manufacturer and wholesaler to distribute prescription drugs;
(b) The presence of the wholesaler on a list of distributors with which the manufacturer does business, created by the manufacturer and located on a publicly accessible website maintained by the manufacturer; or
(c) The existence of the purchase by the wholesaler of at least 5,000 sales units of prescription drugs from the manufacturer within the 12 months immediately preceding the transaction for which the wholesaler claims to have an ongoing relationship and:
(1) The Board or a purchasing wholesaler verifying the purchase with the manufacturer at its main corporate office in the United States; or
(2) The wholesaler maintaining invoices showing that the purchase was made directly from the manufacturer which include an account number assigned by the manufacturer to the wholesaler’s address of record on file with the Board.
2. The records establishing an ongoing relationship between a wholesaler and a manufacturer must be:
(a) If the facility is located within this State, maintained at the facility of the wholesaler throughout the period that such a relationship exists;
(b) Maintained for 3 years after the termination of any such relationship; and
(c) Available for review and copying by the Board or by any authorized representative of a federal, state or local agency.
3. An ongoing relationship between a wholesaler and a manufacturer may be attributed to an affiliated wholesaler if:
(a) The affiliated wholesaler is licensed by the Board or the relevant authority of another state;
(b) The wholesaler who has the ongoing relationship with the manufacturer and the affiliated wholesaler are wholly owned by a common owner; and
(c) The common owner is a publicly traded corporation.
4. As used in this section, “sales unit” means any standard container or unit of packaging used by the manufacturer for the prescription drug.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R013-01, 11-1-2001; R049-04, 2-28-2005)
NAC 639.595 Qualifications of employees who engage in storage or distribution of drugs. (NRS 639.070) Each wholesaler licensed by the Board shall ensure that any person he employs who engages in the storage or distribution of drugs in a facility has the education and experience necessary to engage safely and lawfully in the storage or distribution of those drugs.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92)
NAC 639.596 Facilities: General requirements; maintenance of stock. (NRS 639.070)
1. Each facility must:
(a) Provide adequate lighting of at least 25 foot-candles;
(b) Provide an adequate area for the storage of the prescription drugs within the facility in such a manner as to facilitate access to those drugs;
(c) Be maintained in a clean and orderly condition;
(d) Be free from infestation by insects, rodents, birds or vermin;
(e) Be secure from entry by unauthorized persons;
(f) Be equipped with an alarm system to detect entry to the facility after business hours; and
(g) Maintain a stock of prescription drugs on its shelves sufficient to serve the expected and ordinary needs of the practitioners and pharmacies with which it ordinarily transacts business.
2. If a wholesaler sells or deals in controlled substances, the wholesaler shall maintain a representative stock sufficient to serve the expected and ordinary needs of the practitioners and pharmacies with which it ordinarily transacts business.
3. A wholesaler shall not maintain any stock of controlled substances unless it ordinarily sells controlled substances to the practitioners and pharmacies with which it ordinarily transacts business.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R013-01, 11-1-2001)
NAC 639.597 Facilities: Security. (NRS 639.070)
1. Access to the facility must be kept to a minimum and be well-controlled.
2. The outside perimeter of the facility must be properly lighted.
3. Access to the area of the facility where the controlled substances are stored must be limited to authorized persons.
4. The area of the facility where controlled substances are stored must be securely enclosed with a material made of steel of at least 10 gauge in thickness with openings not more than 2 1/2 inches wide. The material must be mounted on steel posts which must be at least 1 inch in diameter. The posts must be placed not more than 10 feet apart. If the material does not extend to the structural ceiling of the facility, the ceiling of the enclosed area must be constructed of material made of steel at least 10 gauge in thickness with openings not more than 2 1/2 inches wide. A lighter gauge mesh may be used for the ceiling of a large enclosed area if the walls of the area are at least 14 feet in height.
5. Access to the enclosed area must be limited to persons who are responsible for ensuring the security of the controlled substances stored within that enclosed area. The enclosed area must be equipped with a security system which includes an alarm that will transmit a signal to a local law enforcement agency or a private business which provides security services if an unauthorized person obtains access to the enclosed area.
6. The Executive Secretary may approve an alternate method for ensuring the security of the area where the controlled substances are stored if he determines that the method will ensure that entry to the area is accessible only to authorized persons.
(Added to NAC by Bd. of Pharmacy, eff. 7-16-92)
NAC 639.5975 Prescription drugs: Restrictions on purchase and receipt; disposal of certain drugs. (NRS 639.070, 639.595)
1. Except as otherwise provided in this section, a wholesaler shall not purchase or otherwise receive a prescription drug from:
(a) Any person who is not a wholesaler or manufacturer; or
(b) A wholesaler if any previous seller of the drug was not a wholesaler or a manufacturer.
2. A wholesaler may receive a prescription drug from a person who is not a wholesaler or manufacturer if the prescription drug was originally purchased by that person from the wholesaler.
3. A wholesaler that was not the original wholesaler which sold prescription drugs to a person who is not a wholesaler or manufacturer may receive the prescription drugs if:
(a) The person no longer does business with the original wholesaler;
(b) The original wholesaler no longer does business with the person; or
(c) The original wholesaler refuses to allow the return of the prescription drugs.
4. A wholesaler shall not:
(a) Receive from a person who is not a wholesaler or manufacturer an amount or quantity of a prescription drug larger than the amount or quantity that was originally sold by the original wholesaler to that person;
(b) Pay that person an amount, either in cash or credit, that is more than:
(1) The amount the person originally paid to the original wholesaler for the prescription drug; or
(2) The price the receiving wholesaler would have charged that person for the prescription drug at the time of the return; or
(c) Purchase a contraband drug or a counterfeit drug.
5. A wholesaler that receives a prescription drug from a person who is not a wholesaler or manufacturer pursuant to this section may dispose of the prescription drug by:
(a) Destroying the prescription drug;
(b) Selling the prescription drug to another person who is not a wholesaler or manufacturer;
(c) Selling the prescription drug to another wholesaler; or
(d) Providing the prescription drug to another wholesaler or the manufacturer of the prescription drug solely for the purposes of destruction or disposal.
6. If a wholesaler:
(a) Sells a prescription drug to another person who is not a wholesaler or manufacturer pursuant to paragraph (b) of subsection 5, the wholesaler is not required to provide a “Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act” described in NAC 639.603.
(b) Sells or provides a prescription drug to another wholesaler or the manufacturer of the prescription drug pursuant to paragraph (c) or (d) of subsection 5, the wholesaler must provide a “Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act” as described in NAC 639.603 for that sale and must indicate on the statement that the prescription drug was received from the person from whom the wholesaler accepted the prescription drug.
(Added to NAC by Bd. of Pharmacy by R013-01, eff. 11-1-2001; A by R049-04, 2-28-2005)
NAC 639.5977 Prescription drugs: Sale to purchasing wholesaler. (NRS 639.070, 639.595)
1. For each sale of a prescription drug to a purchasing wholesaler, the wholesaler must, as a reasonable assurance that the purchasing wholesaler is in compliance with the provisions of subparagraph (2) of paragraph (c) of subsection 2 of NRS 639.595:
(a) Before the sale of the prescription drug, obtain from the purchasing wholesaler a written statement that contains a representation by the purchasing wholesaler that, for transactions which occur in this State, the purchasing wholesaler will only sell the prescription drug to a pharmacy or practitioner;
(b) Possess written correspondence between the wholesaler and the purchasing wholesaler or between the purchasing wholesaler and other purchasers that evidences the compliance by the purchasing wholesaler with the provisions of subparagraph (2) of paragraph (c) of subsection 2 of NRS 639.595; and
(c) Ensure that the following statement is written on the face of the invoice or other document which evidences the sale and on