Nevada Administrative Code

NAC 639.67033 Environmental standards. (NRS 639.070) A pharmacy engaged in the practice of compounding nonsterile compounded drug products shall: 1. Designate a specific area of the pharmacy in which nonsterile compounded drug products will be compounded; 2. Ensure that the area …

NAC 639.67035 Establishment of policies and procedures. (NRS 639.070) A pharmacy engaged in the practice of compounding nonsterile compounded drug products shall, in addition to the requirements of NAC 639.67015, establish and maintain written policies and procedures for compound…

NAC 639.67037 Safety procedures for storage, handling, compounding and disposal; training required. (NRS 639.070) 1. A pharmacy engaged in the practice of compounding nonsterile hazardous drugs shall: (a) Store the components of the hazardous drugs separately from all the other i…

NAC 639.6705 Environmental standards. (NRS 639.070) 1. Except as otherwise provided in NAC 639.67059, a pharmacy engaged in the practice of compounding sterile compounded drug products shall provide an ISO Class 5 environment. 2. If a pharmacy uses a laminar airflow hood as its I…

NAC 639.67051 Air quality testing and certification. (NRS 639.070) 1. Except as otherwise provided in NAC 639.67059, a pharmacy engaged in the practice of compounding sterile compounded drug products shall test the air in each of its controlled environments to ensure that the env…

NAC 639.67053 Compounding standards. (NRS 639.070) A pharmacy engaged in the practice of compounding and dispensing sterile compounded drug products shall require each pharmacist and pharmaceutical technician who compounds sterile compounded drug products to comply with the compo…

NAC 639.67055 Record verifying accuracy required to be made. (NRS 639.070) 1. For all sterile compounded drug products compounded by a pharmacy, other than an institutional pharmacy, and for all sterile drug products for parenteral nutrition and sterile antineoplastic drug produc…

NAC 639.67057 Procedures following breach of seal of multi-dose containers. (NRS 639.070) 1. If, in the course of compounding a drug product, the seal of a multi-dose container is breached: (a) The container must be stored according to the requirements of the manufacturer; and (b…

NAC 639.67059 Exemptions for certain institutional pharmacies. (NRS 639.070) The Board may, upon application and for good cause shown, waive or modify any requirement set forth in NAC 639.6705 and 639.67051 for an institutional pharmacy engaged in the practice of compounding drug…

NAC 639.67061 Low-risk sterile compounding: Process and storage. (NRS 639.070) 1. A compounded drug product is a low-risk sterile compounded drug product if: (a) The compounded drug product is required to be sterile for its effective administration; (b) The sterile compounded dru…

NAC 639.67063 Low-risk sterile compounding: Radiopharmaceutical drug products. (NRS 639.070) If a nuclear pharmacy compounds radiopharmaceutical drug products, the nuclear pharmacy shall ensure that, in addition to satisfying the requirements of NAC 639.5828: 1. The radiopharmace…

NAC 639.67065 Medium-risk sterile compounding: Process and storage. (NRS 639.070) 1. A compounded drug product is a medium-risk sterile compounded drug product if: (a) The compounded drug product is required to be sterile for its effective administration; (b) The sterile compound…

NAC 639.67067 High-risk sterile compounding: Process and storage. (NRS 639.070) 1. A compounded drug product is a high-risk sterile compounded drug product if: (a) The compounded drug product is required to be sterile for its effective administration; (b) The sterile compounded d…

NAC 639.67069 High-risk sterile compounding: Sterilization. (NRS 639.070) 1. Except as otherwise provided in subsection 5, a pharmacy engaged in the practice of compounding and dispensing high-risk sterile compounded drug products shall ensure that each such compounded drug produ…

NAC 639.67071 High-risk sterile compounding: Testing of certain drug products. (NRS 639.070) 1. A pharmacy engaged in the practice of compounding and dispensing high-risk sterile compounded drug products for injection into the vascular system or central nervous system shall test …

NAC 639.67073 Immediate-use sterile compounding: Labeling and storage. (NRS 639.070) 1. If an immediate-use sterile compounded drug product is not immediately administered by direct injection into a patient by the person who compounded it, the compounded drug product must bear a …

NAC 639.67075 Immediate-use sterile compounding: Compounding standards. (NRS 639.070) 1. An immediate-use sterile compounded drug product that contains three or less commercial sterile drug products that will be stored more than 1 hour before administration is begun must comply w…

NAC 639.67077 Sterile hazardous drugs: Safety procedures for storage, handling, compounding and disposal. (NRS 639.070) 1. A pharmacy engaged in the practice of compounding sterile hazardous drugs shall: (a) Store the components of the hazardous drugs separately from all the othe…

NAC 639.67079 Sterile hazardous drugs: Required training for certain pharmaceutical personnel. (NRS 639.070) 1. A pharmacy engaged in the practice of compounding sterile hazardous drugs and dispensing sterile compounded hazardous drugs shall require each pharmacist and pharmaceut…

NAC 639.672 Reference materials required to be located in or immediately available to pharmacy. (NRS 639.070, 639.2807) Any pharmacy engaged in the practice of compounding and dispensing parenteral solutions shall have current reference materials located in or immediately availab…

NAC 639.680 Labeling. (NRS 639.070, 639.2807) 1. In addition to any other requirements for labeling, the label of any parenteral solution must include: (a) The name and concentrations of all ingredients contained in the parenteral solution, including the primary solution; and (b)…

NAC 639.682 Record for each patient. (NRS 639.070, 639.2807) 1. A pharmacy engaged in the practice of compounding and dispensing parenteral solutions shall have on the premises or readily accessible: (a) A record for each patient being treated with parenteral therapy; (b) A summa…

NAC 639.683 Delivery, storage and recordation of delivery. (NRS 639.070, 639.2807) A managing pharmacist shall ensure that: 1. A sterile parenteral solution is furnished to a patient in a container which is capable of maintaining the appropriate temperature for the storage of the…

NAC 639.686 Written policies and procedures for disposal of infectious materials and materials containing cytotoxic residues. (NRS 639.070, 639.2807) In addition to the requirements of NAC 639.67015 and 639.67017, any pharmacy providing parenteral solutions shall have written pol…

NAC 639.688 Written policies and procedures regarding provision of services related to parenteral therapy. (NRS 639.070, 639.2807) In addition to the requirements of NAC 639.67015 and 639.67017, any pharmacy, other than an institutional pharmacy, engaged in the practice of compou…

NAC 639.690 Pharmacist: Consultation with patient; proper training in safe handling, compounding and therapy related to parenteral solutions. (NRS 639.070, 639.2807) 1. Any pharmacy furnishing parenteral solutions shall ensure that a pharmacist is available 24 hours a day for con…

NAC 639.691 Definitions. (NRS 639.070, 639.100) As used in NAC 639.691 to 639.6916, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.6911, 639.6912 and 639.6913 have the meanings ascribed to them in those sections. (Added to NAC by Bd. of P…

NAC 639.6911 “Compounding” defined. (NRS 639.070, 639.100) “Compounding” includes, without limitation, the combining, admixing, mixing, pooling, reconstituting or other altering of a drug or bulk drug substance, as defined in 21 C.F.R. § 207.3, to create a drug. (Added to NAC by …

NAC 639.6912 “Outsourcing facility” defined. (NRS 639.070, 639.100) “Outsourcing facility” means a facility at one geographic location or address that: 1. Is engaged in the compounding of sterile drugs; and 2. Has registered with the Secretary of Health and Human Services as an o…

NAC 639.6913 “Sterile drug” defined. (NRS 639.070, 639.100) “Sterile drug” means a drug that is: 1. Intended for parenteral administration; 2. An ophthalmic or oral inhalation drug in aqueous format; or 3. Required to be sterile pursuant to the provisions of federal law or the pr…

NAC 639.6915 Duties of facility. (NRS 639.070, 639.100) An outsourcing facility that is engaged in the compounding of sterile drugs in this State or for shipment into this State shall: 1. Obtain a license from the Board as a manufacturer in accordance with NRS 639.100 and 639.233…

NAC 639.6916 When licensure as pharmacy required. (NRS 639.070, 639.100) 1. Except as otherwise provided in subsection 2, an outsourcing facility is not required to be licensed as a pharmacy. 2. An outsourcing facility may dispense dangerous drugs or controlled substances for ide…

NAC 639.693 Definitions. (NRS 639.070) As used in NAC 639.693 to 639.6958, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.69305 to 639.6938, inclusive, have the meanings ascribed to them in those sections. (Added to NAC by Bd. of Pharmacy…

NAC 639.69305 “Accreditation and certification organization” defined. (NRS 639.070) “Accreditation and certification organization” means: 1. The American Board for Certification in Orthotics, Prosthetics & Pedorthics; or 2. The Board for Orthotist/Prosthetist Certification. (Adde…

NAC 639.6931 “Assistive equipment” defined. (NRS 639.070) “Assistive equipment” means a medical product intended to aid a consumer in the performance of one or more bodily activities. The term includes, without limitation, a customized orthotic or prosthetic device, and a wheelch…

NAC 639.6932 “Consumer” defined. (NRS 639.070) “Consumer” means the ultimate recipient or beneficiary of services and goods provided by a medical products provider. (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.69325 “Customized orthotic or prosthetic device” defined. (NRS 639.070) “Customized orthotic or prosthetic device” means a medical product that is built, assembled or altered specifically to accommodate the anatomy of a particular consumer, including, without limitation, …

NAC 639.6933 “Health professional” defined. (NRS 639.070) “Health professional” means a practitioner, a physical therapist, an occupational therapist, a registered nurse or a respiratory therapist. (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6934 “Life-sustaining equipment” defined. (NRS 639.070) “Life-sustaining equipment” means a medical product that is necessary for a consumer to avoid exposure to a medically reasonable expectation of imminent death or serious injury. The term includes, without limitation,…

NAC 639.6935 “Medical products” defined. (NRS 639.070) 1. “Medical products” includes medical devices, equipment, supplies and gases intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. 2. The term does not include: (a) Controlled substances; (…

NAC 639.6936 “Medical products provider” defined. (NRS 639.070) 1. “Medical products provider” means a person licensed pursuant to NAC 639.693 to 639.6958, inclusive, to sell, lease or otherwise provide medical products to a consumer in this State. 2. The term does not include: (…

NAC 639.6937 “Medical products wholesaler” defined. (NRS 639.070) 1. “Medical products wholesaler” means a person licensed as a wholesaler pursuant to chapter 639 of NRS who sells, leases or otherwise provides medical products to a health care facility, agency, practitioner or pr…

NAC 639.6938 “Respiratory equipment” defined. (NRS 639.070) “Respiratory equipment” means a medical product intended to assist a consumer in the act of breathing or intended to introduce a product or drug, other than a medical gas, into the lungs of a consumer. (Added to NAC by B…

NAC 639.6939 Adoption by reference of code of ethics and code of professional conduct; revision of codes after adoption. (NRS 639.070) 1. The State Board of Pharmacy hereby adopts by reference: (a) The most recent version of the “Code of Ethics” of the Board for Orthotist/Prosthe…

NAC 639.694 Employment of administrator required; duties; notice to Board of cessation of employment; sharing of common administrator at shared facility. (NRS 639.070) 1. Except as otherwise provided in subsection 4, each medical products provider or medical products wholesaler s…

NAC 639.6941 Unprofessional conduct; responsibility of owner for acts of others. (NRS 639.070) 1. In addition to the acts described in NAC 639.945 which are applicable to medical products providers or medical products wholesalers, the following acts or practices by a medical prod…

NAC 639.6942 Application for license; license required for each location; notification of change in information; license nontransferable; expiration. (NRS 639.070) 1. An applicant for a license to engage in business as a medical products provider or medical products wholesaler mu…