CHAPTER 639 - PHARMACISTS AND PHARMACY

NAC 639.6611 “Active ingredient” defined. (NRS 639.070) “Active ingredient” means an ingredient added to a compounded drug product which provides the therapeutic effect desired from the compounded drug product. The term does not include an inert ingredient. (Added to NAC by Bd. o…

NAC 639.6613 “Ante-area” defined. (NRS 639.070) “Ante-area” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670. (Added to NAC by Bd. of Pharmacy by R035-06, …

NAC 639.6615 “Barrier isolator cabinet” defined. (NRS 639.070) “Barrier isolator cabinet” means a device the interior of which creates an ISO Class 5 environment and provides an impermeable barrier to outside air at all times while it is being used for compounding purposes. The t…

NAC 639.6617 “Beyond-use date” defined. (NRS 639.070) “Beyond-use date” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (b) of subsection 1 of NAC 639.670. (Added to NAC by Bd. of Pharmacy …

NAC 639.6619 “Buffer area” defined. (NRS 639.070) “Buffer area” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670. (Added to NAC by Bd. of Pharmacy by R035-…

NAC 639.6621 “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 R035-06, eff. 9-18-2008)

NAC 639.6623 “Component” defined. (NRS 639.070) “Component” means an ingredient that is used to compound a drug product, including, without limitation, an ingredient that does not appear on the labeling of the compounded drug product. (Added to NAC by Bd. of Pharmacy by R035-06, …

NAC 639.6625 “Compound” and “compounding” defined. (NRS 639.070) 1. Except as otherwise provided in subsection 2, “compound” and “compounding” mean: (a) The preparation, mixing or assembling of a drug product of which at least one component is a prescription drug; and (b) The pac…

NAC 639.6627 “Compounding aseptic containment isolator” defined. (NRS 639.070) “Compounding aseptic containment isolator” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (b) of subsection 1…

NAC 639.6629 “Compounding aseptic isolator” defined. (NRS 639.070) “Compounding aseptic isolator” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (b) of subsection 1 of NAC 639.670. (Added …

NAC 639.663 “Cytotoxic” defined. (NRS 639.070, 639.2807) “Cytotoxic” means having the capability of killing living cells. (Added to NAC by Bd. of Pharmacy, eff. 7-7-94)

NAC 639.66305 “Dispensing practitioner” defined. (NRS 639.070) “Dispensing practitioner” means a practitioner to whom the Board has issued a certificate of registration pursuant to NAC 639.742 or 639.7423 to dispense controlled substances or dangerous drugs, or both. (Added to NA…

NAC 639.6631 “Drug product” defined. (NRS 639.070) “Drug product” means a commercially manufactured drug or nutrient that has been evaluated for safety and efficacy by the Food and Drug Administration. (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

NAC 639.6633 “Gloved fingertip sampling” defined. (NRS 639.070) “Gloved fingertip sampling” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670. (Added to NAC…

NAC 639.6635 “Hazardous drug” defined. (NRS 639.070) “Hazardous drug” means: 1. A compounded drug product in which one or more of the components of the compounded drug product produce one or more of the following characteristics in humans or animals: (a) Carcinogenicity; (b) Tera…

NAC 639.6637 “High-risk sterile compounded drug product” defined. (NRS 639.070) “High-risk sterile compounded drug product” means a sterile compounded drug product which is compounded by a pharmacist or a pharmaceutical technician and which satisfies the requirements set forth in…

NAC 639.6639 “Immediate-use sterile compounded drug product” defined. (NRS 639.070) “Immediate-use sterile compounded drug product” means a sterile compounded drug product which is compounded by a pharmacist or a pharmaceutical technician and which satisfies the requirements set …

NAC 639.6641 “ISO Class 5” defined. (NRS 639.070) “ISO Class 5” means the classification of an atmospheric environment that is made by ISO 14644 - Cleanrooms and Associated Controlled Environments Package of the International Organization for Standardization, as adopted by refere…

NAC 639.6643 “ISO Class 7” defined. (NRS 639.070) “ISO Class 7” means the classification of an atmospheric environment that is made by ISO 14644 - Cleanrooms and Associated Controlled Environments Package of the International Organization for Standardization, as adopted by refere…

NAC 639.6645 “ISO Class 8” defined. (NRS 639.070) “ISO Class 8” means the classification of an atmospheric environment that is made by ISO 14644 - Cleanrooms and Associated Controlled Environments Package of the International Organization for Standardization, as adopted by refere…

NAC 639.6647 “Low-risk sterile compounded drug product” defined. (NRS 639.070) “Low-risk sterile compounded drug product” means a sterile compounded drug product which is compounded by a pharmacist or a pharmaceutical technician and which satisfies the requirements set forth in N…

NAC 639.6649 “Media fill test” defined. (NRS 639.070) “Media fill test” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670. (Added to NAC by Bd. of Pharmacy …

NAC 639.665 “Medical facility” defined. (NRS 639.070, 639.2807) “Medical facility” has the meaning ascribed to it in NRS 449.0151. (Added to NAC by Bd. of Pharmacy, eff. 7-7-94)

NAC 639.6655 “Medium-risk sterile compounded drug product” defined. (NRS 639.070) “Medium-risk sterile compounded drug product” means a sterile compounded drug product which is compounded by a pharmacist or a pharmaceutical technician and which satisfies the requirements set fort…

NAC 639.6665 “Nonsterile compounded drug product” defined. (NRS 639.070) “Nonsterile compounded drug product” means a drug product the preparation and dispensing of which require compounding and which is not required to be sterile as described in NAC 639.6677. (Added to NAC by Bd…

NAC 639.667 “Nursing personnel” defined. (NRS 639.070, 639.2807) “Nursing personnel” means an employee of: 1. A medical facility who is licensed pursuant to chapter 632 of NRS; 2. A nursing pool as defined in NRS 449.0153; or 3. An agency to provide nursing in the home as defined…

NAC 639.6673 “Parenteral nutrition” defined. (NRS 639.070) “Parenteral nutrition” means nutrients provided intravenously. (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

NAC 639.6677 “Sterile compounded drug product” defined. (NRS 639.070) “Sterile compounded drug product” means a drug product the preparation and dispensing of which require compounding and which is required to be sterile by either the provisions of chapter 797 of the United State…

NAC 639.670 Adoption of certain publications by reference; revision of publication after adoption. (NRS 639.070, 639.2807) 1. The Board hereby adopts by reference the following: (a) “ISO 14644 - Cleanrooms and Associated Controlled Environments Package of the International Organi…

NAC 639.6701 Inspection of materials and equipment; recordkeeping. (NRS 639.070) 1. A pharmacy or pharmacist engaged in the practice of compounding drug products shall: (a) Inspect and either approve or reject, without limitation, each component, container, closure, label and oth…

NAC 639.67013 Competency and proficiency of certain pharmaceutical personnel. (NRS 639.070) 1. A pharmacy engaged in the practice of compounding drug products and dispensing compounded drug products shall ensure that each pharmacist and pharmaceutical technician engaged in the pr…

NAC 639.67015 Establishment of policies and procedures. (NRS 639.070) 1. A pharmacy engaged in the practice of compounding drug products shall establish and maintain written policies and procedures for compounding drug products to ensure that each final compounded drug product ha…

NAC 639.67017 Use of automated compounding devices. (NRS 639.070) 1. A pharmacy may use an automated compounding device to: (a) Assist with the compounding of a drug product; or (b) Produce a final compounded drug product. 2. If a pharmacy uses an automated compounding device as …

NAC 639.670175 Compliance with certain laws and regulations. (NRS 639.070) A pharmacist, pharmaceutical technician or dispensing practitioner who is engaged in the compounding of drug products in this State shall: 1. Comply with the provisions of NAC 639.661 to 639.690, inclusive…

NAC 639.67018 Addition of flavoring. (NRS 639.070) 1. A pharmacist, pharmaceutical technician or dispensing practitioner may add flavoring to an oral drug product at the request of a patient or a legal guardian of the patient, as applicable. A pharmacist, pharmaceutical technicia…

NAC 639.670185 Mixture of certain ready-to-use products. (NRS 639.070) 1. A pharmacist, pharmaceutical technician or dispensing practitioner may mix components of commercially manufactured, ready-to-use products approved by the United States Food and Drug Administration. A pharma…

NAC 639.67019 Retention of records. (NRS 639.070) 1. Except as otherwise provided in NAC 639.67055, each record required to be made pursuant to NAC 639.661 to 639.690, inclusive, must be: (a) Maintained by the pharmacy for which the record was made for at least 2 years after the …

NAC 639.6702 Records concerning drug products compounded in excess and in bulk quantities. (NRS 639.070) For each compounded drug product that is in excess of the amount required by the prescription or chart order and each compounded drug product that is compounded in bulk quanti…

NAC 639.6703 Labeling; storage. (NRS 639.070) 1. Each pharmacist engaged in the practice of compounding nonsterile compounded drug products shall label each nonsterile compounded drug product, including, without limitation, any amount of the nonsterile compounded drug product tha…

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…