CHAPTER 639 - PHARMACISTS AND PHARMACY

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…

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, b…

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 r…

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 interpretat…

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 …

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 Spec…

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…

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 nucle…

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 Commiss…

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…

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…

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 …

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 pres…

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 RADIOACT…

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 Unit…

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 lith…

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 639.5905, inclusive, have the meanings ascribed to them in those sections. (Added to NAC by Bd. of Pharmacy, e…

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 documented in a manner prescribed in NAC 639.594. (Added to NAC by Bd. of Pharm…

NAC 639.5893 “Person who exercises significant influence over the operation” defined. (NRS 639.070) “Person who exercises significant influence over the operation” means: 1. A partner in any form of partnership; 2. An officer or director of a corporation; 3. A sole proprietor; 4.…

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; new application if change of ownership; nontransferability of license; exception to submission of fingerprints. (NRS 639.070, 639.100, 639.500) 1. Each applicant for a license to engage in …

NAC 639.59305 Submission of fingerprints of persons who exercise significant influence over the operation of wholesaler. (NRS 639.070) Except as otherwise provided in NAC 639.593, each licensed wholesaler that provides an updated list pursuant to NRS 639.505 must submit to the Bo…

NAC 639.5931 Submission of fingerprints: Required method. (NRS 639.070, 639.127, 639.1371, 639.500, 639.505) [Replaced in revision by NAC 639.223.]

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 …

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 l…

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 NR…

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 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 h…

NAC 639.594 Documentation of ongoing relationship; ongoing relationship attributed to affiliated wholesaler under certain circumstances. (NRS 639.070, 639.100, 639.595) 1. An ongoing relationship between a wholesaler and a manufacturer must be documented by: (a) A written franchi…

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 the wholesaler employs who engages in the storage or distribution of drugs in a facility has the education and …

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 fa…

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 …

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 who…

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 subpara…

NAC 639.598 Prescription drugs: Storage. (NRS 639.070) 1. Each wholesaler shall store prescription drugs held in the facility in the manner prescribed in the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (b) of subsection 1 of NAC 639.670. …

NAC 639.599 Prescription drugs: Examination of shipments; actions upon determination of certain conditions. (NRS 639.070, 639.595) 1. Each wholesaler shall, upon receiving a prescription drug, examine each outside shipping container of the drug and any accompanying document, incl…

NAC 639.601 Prescription drugs: Separation and disposal of certain drugs. (NRS 639.070) 1. A prescription drug that is outdated, damaged, deteriorated, misbranded or adulterated must be separated from other prescription drugs until it is destroyed or returned to the supplier. 2. …

NAC 639.6015 Prescription drugs: Destruction. (NRS 639.070) If a wholesaler in this State decides to destroy a prescription drug pursuant to NAC 639.5975, 639.599 or 639.601, the wholesaler shall: 1. Segregate the prescription drug in a manner that will ensure that the prescripti…

NAC 639.602 Prescription drugs: Records. (NRS 639.070, 639.595) 1. Each wholesaler shall make and maintain a readily retrievable record of its inventory and of each transaction relating to the receipt and distribution or other disposition of a prescription drug. The record must i…

NAC 639.603 Prescription drugs: Requirements regarding statements of prior sales. (NRS 639.070, 639.595) 1. Except as otherwise provided in paragraph (a) of subsection 6 of NAC 639.5975 and NAC 639.6035, each wholesaler shall provide a statement of prior sales identifying each sa…