reglab/statecodes huggingface dataset:
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.581 - "Qualified nuclear pharmacist" defined

Current through June 11, 2024
"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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5812 - "Radiopharmaceutical services" defined

Current through June 11, 2024
"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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5814 - "Testing to control the quality of radiopharmaceutical" defined

Current through June 11, 2024
"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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5816 - "Radiopharmaceutical" interpreted

Current through June 11, 2024
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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5818 - Nuclear pharmacist: Certification; training and instruction; affidavit of experience and training

Current through June 11, 2024
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.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.582 - Permit to operate

Current through June 11, 2024
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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5822 - Space and equipment requirements; floor plan

Current through June 11, 2024
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.
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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5826 - Records

Current through June 11, 2024
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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5828 - Quality assurance procedures for radiopharmaceuticals

Current through June 11, 2024
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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.583 - Dispensing or transferring radiopharmaceuticals

Current through June 11, 2024
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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5832 - Oral order for radiopharmaceutical: Requirement to keep record; contents of record

Current through June 11, 2024
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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5834 - Outer shield of radiopharmaceutical container: Label required; contents of label

Current through June 11, 2024
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 - National Formulary
, as adopted by
			 reference in paragraph (c) of subsection 1 of NAC 639.670.
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; A by R035-06, 9-18-2008
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5836 - Inner label of radiopharmaceutical container; contents

Current through June 11, 2024
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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.5838 - Records of nuclear pharmacy when radiopharmaceutical is dispensed pursuant to investigational new drug application: Contents

Current through June 11, 2024
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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › NUCLEAR PHARMACIES › Section 639.584 - Required equipment

Current through June 11, 2024
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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.Sec. 2.2 - NEW

Current through June 11, 2024
"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. A person
			 designated as a representative pursuant to NAC
			 639.5935;
5. A person with a controlling interest of
			 ownership;
6. Any person owning
			 more than 10 percent of the corporate stock; or
7. Any other person identified by an
			 applicant, licensed wholesaler or the Board.
Added to NAC
				by Bd. of Pharmacy by
				R040-20A,
				eff. 8/26/2020
NRS
				639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.Sec. 3.2 - NEW

Current through June 11, 2024
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 Board:
1. A complete set of fingerprints from any
			 person contained on the updated list who:
(a)
			 Is a person who exercises significant influence over the operation of the
			 licensed wholesaler; and
(b) Has
			 not previously been required to submit a complete set of fingerprints pursuant
			 to
			 NRS
			 639.500 or NAC 639.593; and
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.Sec. 4 - NEW

Current through June 11, 2024
1. If a complete set of fingerprints from any
			 person required to submit fingerprints pursuant to subsection 2 of
			 NRS
			 639.127, as amended by section 5 of Senate
			 Bill No. 408, chapter 218, Statutes of Nevada 2021, at page 1018, subsection 4
			 of
			 NRS
			 639.1371, as amended by section 6 of Senate
			 Bill No. 408, chapter 218, Statutes of Nevada 2021, at page 1018,
			 NRS
			 639.500 or
			 639.505
			 or NAC
			 639.593
			 or section 3 of LCB File No. R040-20 is rejected by the Central Repository for
			 Nevada Records of Criminal History, the person shall submit a second complete
			 set of fingerprints and written permission authorizing the Board to forward the
			 second complete set of fingerprints to the Central Repository for submission to
			 the Federal Bureau of Investigation for its report.
2. If the second complete set of fingerprints
			 of any person pursuant to subsection 1 is rejected by the Central Repository
			 for Nevada Records of Criminal History, the Executive Secretary shall request a
			 name-based background check of the person.
Added to NAC
				by Bd. of Pharmacy by
				R040-20A,
				eff. 8/26/2020; A by
				R039-21A,
				eff. 4/11/2022
NRS
				639.070,
				639.127,
				as amended by section 5 of Senate Bill No. 408, chapter 218, Statutes of Nevada
				2021, at page 1018, and 639.1371, as amended by section 6 of Senate Bill No.
				408, chapter 218, Statutes of Nevada 2021, at page
				1018
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.585 - Definitions

Current through June 11, 2024
As used in NAC 639.585 to
				639.607, inclusive, and sections
				2, 3 and 4 of this regulation, unless the context otherwise requires, the words
				and terms defined in NAC
				639.587 to
				639.592, inclusive, and section 2
				of this regulation, 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;
				A by
				R040-20A,
				eff. 8/26/2020
NRS
				639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.587 - "Facility" defined

Current through June 11, 2024
"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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.589 - "Ongoing relationship" defined

Current through June 11, 2024
"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
				Pharmacy, eff. 7-16-92; A by
				R040-20A,
				eff. 8/26/2020
NRS
				639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5895 - "Purchaser" defined

Current through June 11, 2024
"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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5897 - "Purchasing wholesaler" defined

Current through June 11, 2024
"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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5902 - "Statement of prior sales" defined

Current through June 11, 2024
"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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5905 - "Supplier" defined

Current through June 11, 2024
"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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.592 - "Wholesaler" defined

Current through June 11, 2024
"Wholesaler" has the meaning ascribed to it in
				NRS
				639.016.
Added to NAC by Bd. of
				Pharmacy, eff. 7-16-92
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.593 - Licensing requirements; consideration of transaction as wholesale transaction; transferability and renewal of license

Current through June 11, 2024
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 6:
(1) A complete set
			 of fingerprints from each person required to submit fingerprints pursuant to
			 subsection 1 of
			 NRS
			 639.500;
(2) A complete set of fingerprints from any
			 person contained on the list provided by the applicant pursuant to subsection 2
			 of
			 NRS
			 639.500, if the person qualifies as a person
			 who exercises significant influence over the operations of the applicant;
			 and
(3) Written permission from
			 each person who is required to submit fingerprints pursuant to subparagraphs
			 (1) or (2), authorizing the Board to forward the 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 :
(I) The name and title of each officer and
			 director of the corporation documented with the registration entity in the
			 state of domicile;
(II) The
			 corporate name and the state of incorporation ; and
(III) The name of the parent company, if
			 any.
(4) Sole
			 proprietorship, the name of the sole proprietor and the name of the business
			 entity.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5931 - Submission of fingerprints: Required method

Current through June 11, 2024
A person who is required to submit a complete set of his or her
				fingerprints to the Board pursuant to subsection 2 of
				NRS
				639.127, as amended by section 5 of Senate
				Bill No. 408, chapter 218, Statutes of Nevada 2021, at page 1018, subsection 4
				of
				NRS
				639.1371, as amended by section 6 of Senate
				Bill No. 408, chapter 218, Statutes of Nevada 2021, at page 1018,
				NRS
				639.500 or
				639.505
				or NAC
				639.593
				or section 3 of LCB File No. R040-20 may 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; A by
				R040-20A,
				eff. 8/26/2020; A by
				R025-21A,
				eff. 4/11/2022
NRS
				639.070,
				639.127,
				as amended by section 5 of Senate Bill No. 408, chapter 218, Statutes of Nevada
				2021, at page 1018,, 639.1371, as amended by section 6 of Senate Bill No. 408,
				chapter 218, Statutes of Nevada 2021, at page
				1018
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5932 - Provisional license: Prerequisites for issuance

Current through June 11, 2024
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 the applicant is not:
(a) Under investigation;
(b) Subject to an administrative action;
			 or
(c) Otherwise engaged in
			 litigation,
for a matter related to the practice of the applicant.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5935 - Representative of wholesaler: General requirements; exceptions; approval; enforcement

Current through June 11, 2024
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.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5937 - Bond or other security: Amount required from certain wholesalers; reduction of amount; substitution

Current through June 11, 2024
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.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5938 - Filing of single bond for multiple sites

Current through June 11, 2024
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 has a documented net worth of more than
				$25,000,000.
Added to NAC by Bd. of
				Pharmacy by R218-05, eff. 5-4-2006; A by
				R040-20A,
				eff. 8/26/2020
NRS
				639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.594 - Establishment of ongoing relationship

Current through June 11, 2024
1. An ongoing
			 relationship between a wholesaler and a manufacturer must be documented 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) 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.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.595 - Qualifications of employees who engage in storage or distribution of drugs

Current through June 11, 2024
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 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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.596 - Facilities: General requirements; maintenance of stock

Current through June 11, 2024
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.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.597 - Facilities: Security

Current through June 11, 2024
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 or she 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
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5975 - Prescription drugs: Restrictions on purchase and receipt; disposal of certain drugs

Current through June 11, 2024
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.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.5977 - Prescription drugs: Sale to purchasing wholesaler

Current through June 11, 2024
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 the face of any "Statement Identifying Prior Sales of Prescription Drugs
			 by Wholesalers Required by the Prescription Drug Marketing Act" described in
			 NAC 639.603 that accompanied the sale of the prescription drug printed in all
			 capital letters and in at least 10-point type:
NEVADA LAW REQUIRES THAT YOU MUST SELL THE PRESCRIPTION DRUGS
				SOLD TO YOU AS SET FORTH IN THIS DOCUMENT ONLY TO PHARMACIES OR PRACTITIONERS.
				THE SALE OF ANY OF THE PRESCRIPTION DRUGS SOLD TO YOU AS SET FORTH IN THIS
				DOCUMENT TO ANY PERSON OR BUSINESS OTHER THAN A PHARMACY OR PRACTITIONER WILL
				RESULT IN A TERMINATION OF FUTURE SALES AND MAY SUBJECT YOU TO OTHER PENALTIES
				AS PRESCRIBED BY LAW.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.598 - Prescription drugs: Storage

Current through June 11, 2024
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 (c) of subsection 1 of NAC 639.670.
2. If there are no specific requirements
			 concerning the temperature at which a prescription drug must be stored, the
			 drug must be stored at a controlled room temperature as defined in the
United States Pharmacopeia - National Formulary
, as adopted by
			 reference in paragraph (c) of subsection 1 of NAC 639.670.
3. Each wholesaler shall provide the
			 appropriate manual, electromechanical or electrical equipment to record the
			 temperature and humidity of the area where the prescription drugs are
			 stored.
Added to NAC by Bd. of
				Pharmacy, eff. 7-16-92; A by R035-06, 9-18-2008
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.599 - Prescription drugs: Examination of shipments; actions upon determination of certain conditions

Current through June 11, 2024
1. Each wholesaler
			 shall, upon receiving a prescription drug, examine each outside shipping
			 container of the drug and any accompanying document, including, without
			 limitation, the invoice, the shipping record and the "Statement Identifying
			 Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription
			 Drug Marketing Act" described in NAC 639.603, to determine its identity and to
			 prevent the acceptance of a prescription drug that is:
(a) Counterfeit;
(b) Deemed to be adulterated or misbranded in
			 accordance with the provisions of chapter 585 of NRS;
(c) Mislabeled;
(d) Damaged or compromised by improper
			 handling, storage or temperature control;
(e) From a foreign or unlawful source;
			 or
(f) Manufactured, packaged,
			 labeled or shipped in violation of any state or federal law relating to
			 prescription drugs.
The examination must be sufficient to detect any damage to the
				container which would indicate contamination or other damage to the contents of
				the container.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.601 - Prescription drugs: Separation and disposal of certain drugs

Current through June 11, 2024
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. A prescription drug whose immediate or
			 sealed outer or secondary container has been opened or used must be identified
			 as such and separated from other prescription drugs until it is destroyed or
			 returned to the supplier.
3. If a
			 prescription drug is returned to a wholesaler by a purchaser or purchasing
			 wholesaler under conditions which cast doubt on the prescription drug's safety,
			 identity, strength, quality or purity, the wholesaler shall destroy the
			 prescription drug or return it to the supplier unless, after conducting an
			 examination, testing or other investigation, the wholesaler determines that the
			 prescription drug complies with the appropriate standards of safety, identity,
			 strength, quality and purity as prescribed in the package insert as approved by
			 the Food and Drug Administration or in the United States Pharmacopeia -
			 National Formulary , as adopted by reference in paragraph (c) of subsection 1
			 of NAC 639.670. The wholesaler shall
			 keep a readily retrievable record of any examination, testing or other
			 investigation conducted and make any records available for inspection by the
			 Board.
4. Unless the reason a
			 prescription drug must be destroyed or returned to the supplier is related to
			 the expiration date of the prescription drug, a wholesaler that is required to
			 destroy a prescription drug or return it to the supplier pursuant to subsection
			 3 shall maintain a readily retrievable record that includes:
(a) The name of the prescription
			 drug;
(b) The lot number and
			 expiration date of the prescription drug;
(c) The quantity of the prescription
			 drug;
(d) The name and address of
			 the business that returned the prescription drug to the wholesaler;
(e) Whether the wholesaler will:
(1) Return the prescription drug to the
			 supplier; or
(2) Destroy the
			 prescription drug; and
(f) The reason for the action taken by the
			 wholesaler.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.6015 - Prescription drugs: Destruction

Current through June 11, 2024
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 prescription drug cannot be sold or otherwise
			 used; and
2. Destroy the
			 prescription drug and its packaging in such a manner that the prescription drug
			 cannot be resold or used and which is in compliance with any applicable laws or
			 regulations concerning the destruction of drugs and drug packaging.
Added to NAC by Bd. of
				Pharmacy by R049-04, eff. 2-28-2005
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.602 - Prescription drugs: Records

Current through June 11, 2024
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 include, without limitation:
(a) The purchase order, correspondence and
			 any other document evidencing that the wholesaler ordered the prescription drug
			 from the supplier;
(b) The invoice
			 or other document provided to the wholesaler by the supplier concerning the
			 purchase of the prescription drug;
(c) The shipping record, which may be a
			 manifest, shipping label, shipping bill or any similar document, evidencing the
			 shipment of the prescription drug from the supplier to the
			 wholesaler;
(d) The purchase order,
			 correspondence and any other document evidencing that the purchaser or
			 purchasing wholesaler ordered the prescription drug from the
			 wholesaler;
(e) The invoice or
			 other document provided by the wholesaler when the purchaser or purchasing
			 wholesaler purchased the prescription drug;
(f) The shipping record evidencing the
			 shipment of the prescription drug from the wholesaler to the purchaser or
			 purchasing wholesaler;
(g) A copy
			 of the license of the supplier that sold the prescription drug to the
			 wholesaler;
(h) If the supplier has
			 an ongoing relationship with a manufacturer, a copy of the records maintained
			 pursuant to NAC
			 639.594 which must be obtained by
			 the wholesaler before the wholesaler may sell a prescription drug received from
			 the supplier; and
(i) One or more
			 of the documents required by NAC
			 639.5977 as reasonable assurance
			 that the purchasing wholesaler is in compliance with subparagraph (2) of
			 paragraph (c) of subsection 2 of
			 NRS
			 639.595.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.603 - Prescription drugs: Requirements regarding statements of prior sales

Current through June 11, 2024
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 sale of a prescription drug
			 before the prescription drug is sold to another wholesaler or to a pharmacy
			 when supplying prescription drugs if the wholesaler:
(a) Has not established an ongoing
			 relationship with the manufacturer from whom the prescription drug was
			 purchased; or
(b) Purchased the
			 prescription drug from another wholesaler.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.6035 - Prescription drugs: Exclusion of certain transactions from statements of prior sales

Current through June 11, 2024
A wholesaler shall not report the following transactions on a
				statement of prior sales:
1. A
			 transaction that the Board considers not to be a wholesale transaction pursuant
			 to subsection 3 of NAC 639.593.
2.
			 The return of a prescription drug to a wholesaler who appears on the statement
			 of prior sales for the prescription drug at an earlier point in the chain of
			 distribution.
Added to NAC by Bd. of
				Pharmacy by R218-05, eff. 5-4-2006
NRS
				  639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.604 - Maintenance and availability of list of wholesalers with whom manufacturer has ongoing relationship

Current through June 11, 2024
Each manufacturer shall maintain at its principal place of
				business a list of wholesalers with whom the manufacturer has an ongoing
				relationship. The list must be available for inspection upon a request by any
				authorized representative of a federal, state or local agency. The manufacturer
				shall provide a copy of the list upon request. The manufacturer may charge a
				fee to cover the cost of copying the list.
Added to NAC by Bd. of
				Pharmacy, eff. 7-16-92; A 10-1-93
NRS
				  639.070,
				  639.100,
				  639.595
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.605 - Establishment and maintenance of policies and procedures regarding prescription drugs

Current through June 11, 2024
1. Each wholesaler
			 shall establish written policies and procedures for the receipt, security,
			 storage, inventory and distribution of prescription drugs.
2. The written policies and procedures must
			 include:
(a) A procedure for identifying,
			 recording and reporting any losses or thefts of prescription drugs.
(b) A procedure for correcting any errors or
			 inaccuracies concerning the wholesaler's inventory.
(c) A procedure that requires the oldest
			 approved stock of a prescription drug to be distributed first. The procedure
			 may allow deviation from that requirement if the deviation is temporary and
			 appropriate.
(d) A procedure
			 relating to the recall or withdrawal of a prescription drug because of:
(1) Any action taken at the request of the
			 Food and Drug Administration or other federal agency or state or local law
			 enforcement agency or other governmental agency, including the Board;
(2) Any voluntary action taken by a
			 manufacturer to remove defective or potentially defective drugs from the
			 market; or
(3) Any action taken by
			 a manufacturer to promote public health and safety by the replacement of
			 existing prescription drugs with an improved product or new design of a
			 package.
(e) A procedure
			 for the operation of a facility in the event of a strike, fire, flood or other
			 natural disaster or emergency.
(f)
			 A procedure to ensure that any outdated prescription drug is separated from
			 other drugs that are not outdated and is destroyed or returned to the
			 manufacturer. The procedure must provide for the establishment and maintenance
			 of written records of the disposition of each outdated prescription drug. The
			 wholesaler shall keep the records for 3 years after the disposition of the
			 prescription drug.
(g) A procedure
			 to gather, make and maintain all records required pursuant to
			 NRS
			 639.234 and NAC
			 639.585 to
			 639.607, inclusive, and sections
			 2, 3 and 4 of this regulation, including a procedure to make records readily
			 retrievable, as applicable.
(h) A
			 procedure to ensure that all prescription drugs received are examined pursuant
			 to NAC 639.599 and
			 639.601.
(i) A procedure to ensure that the
			 prescription drugs are not contraband drugs or counterfeit drugs.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 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

Current through June 11, 2024
1. Except as
			 otherwise provided in subsections 2 and 6, on or before June 1 of each year, a
			 wholesaler who employs a person to sell or market a drug, medicine or chemical
			 in this State shall submit to the Board the information required pursuant to
			 subsection 2 of
			 NRS
			 639.570.
2. If a wholesaler described in subsection 1
			 uses, without modification, the
Code on Interactions with Healthcare
			 Professionals
, as adopted by reference in NAC 639.060, as its
			 marketing code of conduct, the wholesaler may indicate this on its submittal in
			 lieu of submitting a copy of its marketing code of conduct.
3. If a wholesaler described in subsection 1:
(a) Develops its own marketing code of
			 conduct; or
(b) Uses a modified
			 version of the
Code on Interactions with Healthcare
			 Professionals
, as adopted by reference in NAC 639.060, as its
			 marketing code of conduct,
the staff of the Board shall review the marketing code of
				conduct to ensure that it addresses the subjects listed in subsection 4.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › WHOLESALERS › Section 639.6055 - Submission of certain information regarding sales and marketing staff: Submission of form after initial submittal; method of submission

Current through June 11, 2024
1. If a wholesaler has submitted to the Board
			 the information required pursuant to NAC 639.6053 at least once, the wholesaler
			 may subsequently submit to the Board, on a form provided by the Board, the
			 information that has remained the same and the information that has changed
			 from the date of the previous submission, in lieu of submitting the information
			 required annually pursuant to NAC 639.6053.
2. The submission of information to the Board
			 pursuant to this section and NAC 639.6053 may be made by:
(a) Mail or personal delivery of a printed
			 copy of the information required;
(b) Electronic mail to the Board at the
			 electronic mail address
pharmacy@pharmacy.nv.gov
; or
(c) Such other technological means as the
			 Board may develop, including, without limitation, through the use of the
			 Internet website of the Board.