reglab/statecodes huggingface dataset:
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6633 - "Gloved fingertip sampling" defined

Current through June 11, 2024
"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 by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6635 - "Hazardous drug" defined

Current through June 11, 2024
"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) Teratogenicity or other developmental
				toxicity;
(c) Reproductive
				toxicity;
(d) Organ toxicity at low
				doses; or
(e) Genotoxicity;
				or
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6637 - "High-risk sterile compounded drug product" defined

Current through June 11, 2024
"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
				  639.67067.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6639 - "Immediate-use sterile compounded drug product" defined

Current through June 11, 2024
"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 forth in NAC
				  639.67073.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6641 - "ISO Class 5" defined

Current through June 11, 2024
"ISO Class 5" means the classification of an atmospheric
				  environment that is made by the International Organization for Standardization
				  based on an adaptation of Federal Standard 209E, as adopted by reference in
				  paragraph (a) of subsection 1 of NAC 639.670, in which the atmospheric
				  environment contains:
1. Less than
				3,520 particles that are 0.5 micron or larger in diameter per cubic meter of
				air; or
2. Less than 100 particles
				that are 0.5 micron or larger in diameter per cubic foot of air.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6643 - "ISO Class 7" defined

Current through June 11, 2024
"ISO Class 7" means the classification of an atmospheric
				  environment that is made by the International Organization for Standardization
				  based on an adaptation of Federal Standard 209E, as adopted by reference in
				  paragraph (a) of subsection 1 of NAC 639.670, in which the atmospheric
				  environment contains:
1. Less than
				352,000 particles that are 0.5 micron or larger in diameter per cubic meter of
				air; or
2. Less than 10,000
				particles that are 0.5 micron or larger in diameter per cubic foot of
				air.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6645 - "ISO Class 8" defined

Current through June 11, 2024
"ISO Class 8" means the classification of an atmospheric
				  environment that is made by the International Organization for Standardization
				  based on an adaptation of Federal Standard 209E, as adopted by reference in
				  paragraph (a) of subsection 1 of NAC 639.670, in which the atmospheric
				  environment contains:
1. Less than
				3,520,000 particles that are 0.5 micron or larger in diameter per cubic meter
				of air; or
2. Less than 100,000
				particles that are 0.5 micron or larger in diameter per cubic foot of
				air.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6647 - "Low-risk sterile compounded drug product" defined

Current through June 11, 2024
"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 NAC
				  639.67061.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6649 - "Media fill test" defined

Current through June 11, 2024
"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 by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.665 - "Medical facility" defined

Current through June 11, 2024
"Medical facility" has the meaning ascribed to it in
				  NRS
				  449.0151.
Added to NAC by Bd. of
				  Pharmacy, eff. 7-7-94
NRS
					 639.070,
					 639.2807
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6655 - "Medium-risk sterile compounded drug product" defined

Current through June 11, 2024
"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 forth in NAC
				  639.67065.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6665 - "Nonsterile compounded drug product" defined

Current through June 11, 2024
"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. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.667 - "Nursing personnel" defined

Current through June 11, 2024
"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 in
				NRS
				449.0015.
Added to NAC by Bd. of
				  Pharmacy, eff. 7-7-94
NRS
					 639.070,
					 639.2807
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6673 - "Parenteral nutrition" defined

Current through June 11, 2024
"Parenteral nutrition" means nutrients provided
				  intravenously.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.6677 - "Sterile compounded drug product" defined

Current through June 11, 2024
"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
				  States Pharmacopeia - National Formulary
, as adopted by reference in
				  paragraph (c) of subsection 1 of NAC 639.670, or the provisions of NAC 639.661
				  to 639.690, inclusive.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › General Provisions › Section 639.670 - Adoption of certain publications by reference; revision of publication after adoption

Current through June 11, 2024
1. The Board hereby
				adopts by reference the following:
(a)
				Federal Standard 209E, "Airborne Particulate Cleanliness Classes in Cleanrooms
				and Clean Zones," as revised on September 11, 1992, by the Institute of
				Environmental Sciences. A copy of this publication may be obtained free of
				charge at the Internet address
http://www.set3.com/papers/209e.pdf
.
(b) NSF International Standard 49, "Class II
				(Laminar Flow) Biosafety Cabinetry," NSF/ANSI 49-2007, 2007 edition. A copy of
				this standard may be obtained from Techstreet, 3916 Ranchero Drive, Ann Arbor,
				Michigan 48108, or at the Internet address
http://www.techstreet.com/
, for
				the price of $160.
(c)
United States Pharmacopeia - National Formulary
, 2008 edition,
				published by the United States Pharmacopeial Convention. A copy of this
				publication may be obtained from the United States Pharmacopeial Convention,
				Customer Service Department, 12601 Twinbrook Parkway, Rockville, Maryland
				20852, or at the Internet address
http://www.usp.org/products/
,
				for the price of $755.
(d) The
Food Chemicals Codex
, 6th edition, published by the United
				States Pharmacopeial Convention. A copy of this publication may be obtained
				from the United States Pharmacopeial Convention, Customer Service Department,
				12601 Twinbrook Parkway, Rockville, Maryland 20852, or at the Internet address
http://www.usp.org/products/
,
				for the price of $495.
(e)
Reagent Chemicals: Specifications and Procedures
, 10th
				edition, published by the American Chemical Society. A copy of this publication
				may be obtained from the Oxford University Press, 2001 Evans Road, Cary, North
				Carolina 27513, or at the Internet address
http://www.oup-usa.org [File
				Link Not Available]
, for the price of $274.50.
(f) Appendix A of
Publication No.
				2004-165
, "Alert: Preventing Occupational Exposures to Antineoplastic
				and Other Hazardous Drugs in Health Care Settings," published by the National
				Institute for Occupational Safety and Health. A copy of this publication may be
				obtained free of charge by telephone at (800) 232-4636 or at the Internet
				address
http://www.cdc.gov/niosh/docs/2004-165/
.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Generally › Section 639.6701 - Inspection of materials and equipment; recordkeeping

Current through June 11, 2024
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 other
				material used in the process of compounding each drug product;
(b) Ensure the proper use, cleanliness and
				maintenance of any equipment used in the process of compounding each drug
				product; and
(c) Prepare the
				records required to be prepared pursuant to NAC 639.661 to 639.690, inclusive,
				concerning the compounding of each drug product to ensure that an error has not
				occurred in the process of compounding each drug product.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Generally › Section 639.67013 - Competency and proficiency of certain pharmaceutical personnel

Current through June 11, 2024
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 practice of
				compounding drug products:
(a) Is competent
				and proficient in compounding the drug products that the pharmacist or
				pharmaceutical technician will be authorized and expected to
				compound;
(b) Complies with the
				provisions of NAC 639.661 to 639.690, inclusive, concerning the drug products
				which the pharmacist or pharmaceutical technician compounds and the compounded
				drug products which the pharmacist or pharmaceutical technician dispenses at
				the pharmacy; and
(c) Receives, on
				an ongoing basis, sufficient training to maintain that competency and
				proficiency.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Generally › Section 639.67015 - Establishment of policies and procedures

Current through June 11, 2024
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 has the identity, strength,
				quality and purity which the compounded drug product is purported or
				represented to have. Such policies and procedures must include, without
				limitation:
(a) Policies and procedures for:
(1) The processes used by the pharmacy to
				compound drug products;
(2) The
				equipment used by the pharmacy to compound drug products;
(3) Ensuring that the actual weights and
				measures of each component are within plus or minus 5 percent of the
				theoretical weights and measures required for the drug products compounded by
				the pharmacy;
(4) Tracking,
				recalling and destroying the drug products compounded by the pharmacy, which
				must include a requirement that the pharmacy ensure that all drug products
				which could have been compounded with a particular component be located,
				recalled and destroyed; and
(5)
				Identifying the drug products or components of drug products that will be
				considered hazardous drugs.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Generally › Section 639.67017 - Use of automated compounding devices

Current through June 11, 2024
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.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Generally › Section 639.67019 - Retention of records

Current through June 11, 2024
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 date the record was made;
				and
(b) Available for inspection
				and copying by the Board or its representative.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Generally › Section 639.6702 - Records concerning drug products compounded in excess and in bulk quantities

Current through June 11, 2024
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 quantities, the pharmacist who compounded or
				  supervised the compounding of the compounded drug product shall prepare a
				  record, either on paper or in the pharmacy's computer system, that includes,
				  without limitation:
1. The name of the
				compounded drug product;
2. A list
				of the components and quantities of components used to compound the drug
				product, including, without limitation, the manufacturer or supplier of the
				components used, the lot number of the components used and the expiration dates
				of the components used;
3. The
				internal control number assigned to the compounded drug product by the
				pharmacist or the number of the prescription of the compounded drug
				product;
4. The beyond-use date of
				the compounded drug product;
5. The
				date of preparation of the compounded drug product;
6. The initials of the pharmacist or
				pharmaceutical technician who compounded the compounded drug product;
7. If the drug product was compounded by a
				pharmaceutical technician, the initials of the pharmacist who supervised the
				pharmaceutical technician; and
8.
				The quantity of the final compounded drug product.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Nonsterile Products › Section 639.6703 - Labeling

Current through June 11, 2024
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 that is in excess of the amount required by
				the prescription or chart order and any nonsterile compounded drug product that
				is compounded in bulk quantities. The label must include, without limitation:
(a) The name of the final compounded drug
				product or the name of each active ingredient present in the nonsterile
				compounded drug product and, as appropriate, the concentration of each active
				ingredient in the final compounded drug product;
(b) The internal control number assigned to
				the compounded drug product by the pharmacist; and
(c) The beyond-use date of the compounded
				drug product.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Nonsterile Products › Section 639.67033 - Environmental standards

Current through June 11, 2024
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 described in subsection 1 has adequate space in which to
				place, in an orderly manner, the equipment and materials that will be used in
				the compounding process;
3. Ensure
				that the area described in subsection 1 is cleaned using an antiseptic cleaning
				method before and after any compounding occurs in the area to prevent
				cross-contamination between the previously compounded drug products and any
				subsequently compounded drug products;
4. Ensure that any equipment used to compound
				a nonsterile compounded drug product is cleaned after the compounding of that
				drug product is completed to prevent cross-contamination from occurring when
				the equipment is used in the compounding process of any subsequently compounded
				drug products;
5. If the pharmacy
				compounds both nonsterile compounded drug products and sterile compounded drug
				products, ensure that none of the equipment which is used to compound
				nonsterile compounded drug products is used to compound sterile compounded drug
				products unless the equipment is cleaned and sanitized before the compounding
				of sterile compounded drug products begins; and
6. Ensure that any employee of the pharmacy
				who compounds nonsterile compounded drug products washes his or her hands with
				soap and water or with an antimicrobial agent before and after compounding
				nonsterile compounded drug products.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Nonsterile Products › Section 639.67035 - Establishment of policies and procedures

Current through June 11, 2024
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
				  compounding nonsterile compounded drug products to ensure that each final
				  compounded drug product has the identity, strength, quality and purity which
				  the compounded drug product is purported or represented to have. Such policies
				  and procedures must include, without limitation:
1. Policies and procedures for:
(a) Making and maintaining records concerning
				the components used to compound each nonsterile compounded drug
				product;
(b) The amount of each
				component used to compound each nonsterile compounded drug product;
(c) The order of each step in the process of
				compounding each nonsterile compounded drug product; and
(d) Including the information listed in
				paragraphs (a), (b) and (c) on the original hard copy of the prescription
				maintained in the written records of the pharmacy or in a computer system that
				may be accessed to provide information:
(1)
				For refilling the prescription; or
(2) Requested by the staff of the
				Board.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Nonsterile Products › Section 639.67037 - Safety procedures for storage, handling, compounding and disposal; training required

Current through June 11, 2024
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 inventory at the pharmacy and in such a
				manner and location as to minimize the contamination of other drugs in and
				employees of the pharmacy;
(b)
				Handle the components of the hazardous drugs with caution by using appropriate
				gloves while distributing, receiving, stocking, inventorying, and preparing for
				administering and disposing of the components of a hazardous drug or a final
				compounded drug product;
(c) Ensure
				that an employee of the pharmacy involved with compounding hazardous drugs
				wears personal protective equipment, including, without limitation, gowns, face
				masks, eye protection, double gloves or chemotherapy gloves;
(d) Dispose of all waste relating to
				compounding hazardous drugs in a manner that complies with any applicable
				state, federal and local laws and regulations; and
(e) Ensure that any employees of the pharmacy
				who are known to the pharmacy to be at special risk with regard to the
				properties of the hazardous drugs are limited from exposure to those
				drugs.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67051 - Air quality testing and certification

Current through June 11, 2024
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 environments attain the air quality
				required by the provisions of NAC 639.661 to 639.690, inclusive, for an ISO
				Class 5, ISO Class 7 or ISO Class 8 environment, as applicable.
2. The air quality testing required by
				subsection 1 must be performed randomly with regard to:
(a) The time of day the air samples are
				collected;
(b) The staff who is on
				duty when the samples are gathered; and
(c) The locations within the pharmacy from
				which the samples are collected.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67053 - Tests for competency and proficiency of certain pharmaceutical personnel

Current through June 11, 2024
1. Except as otherwise provided in
				subsections 4 and 5, 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
				pass a media fill test which must be conducted in the manner provided by
				chapter 797 of the
United States Pharmacopeia - National
				Formulary
, as adopted by reference in paragraph (c) of subsection 1 of
				NAC 639.670, and which must be commensurate to the highest level of risk of
				compounding sterile compounded drug products that the pharmacist or
				pharmaceutical technician will be authorized by the pharmacy to perform:
(a) Before the pharmacy authorizes the
				pharmacist or pharmaceutical technician to compound a sterile compounded drug
				product that will be administered or dispensed to a patient;
(b) At least once each year thereafter if the
				pharmacy authorizes the pharmacist or pharmaceutical technician to compound
				low-risk sterile compounded drug products or medium-risk sterile compounded
				drug products; and
(c) At least
				twice each year thereafter if the pharmacy authorizes the pharmacist or
				pharmaceutical technician to compound high-risk sterile compounded drug
				products.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67055 - Record verifying accuracy required to be made

Current through June 11, 2024
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 products compounded by an
				institutional pharmacy, a pharmacist shall make a record verifying the accuracy
				of each sterile compounded drug product that the pharmacist:
(a) Compounded;
(b) Verified the accuracy of after it was
				compounded by a pharmaceutical technician; or
(c) Dispensed for administration to a patient
				in a medical facility.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67057 - Procedures following breach of seal of single-dose and multi-dose containers

Current through June 11, 2024
1. If, in the
				course of compounding a drug product, the seal of a single-dose container,
				including, without limitation, a bag, bottle, syringe or vial of a sterile drug
				product, is breached, the time and date of the breach must be marked upon the
				container and the contents of the container may be used:
(a) Within 1 hour after the breach of the
				seal if:
(1) The breach occurred in an
				environment with an air quality that is worse than ISO Class 5; and
(2) The container is subsequently stored in
				an environment with an air quality that is worse than ISO Class 7;
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67059 - Exemptions for certain institutional pharmacies

Current through June 11, 2024
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 products if
				  the institutional pharmacy serves an institution that:
1. Has less than 100 beds licensed for
				providing acute care; and
2. Is
				located in a county:
(a) Whose population is
				less than 100,000; or
(b) Whose
				population is 100,000 or more if the hospital is designated as a rural hospital
				by the Nevada Office of Rural Health within the University of Nevada School of
				Medicine.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67061 - Low-risk sterile compounding: Process and storage

Current through June 11, 2024
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 drug product is at a low risk of contamination; and
(c) One or more of the following conditions
				are present:
(1) The compounding process
				involves aseptic manipulations that are performed entirely within an
				environment with an air quality of at least ISO Class 5 and uses only sterile
				ingredients, products, components and devices;
(2) The compounding process involves only
				transferring, measuring and mixing manipulations and uses not more than three
				commercially manufactured sterile drug products or other entries of a sterile
				drug product into one container, including, without limitation, a bag or vial,
				to make the final compounded drug product;
(3) The manipulations needed to compound the
				drug product are limited to aseptically opening ampules, penetrating sterile
				stoppers on vials with sterile needles and syringes, and transferring sterile
				liquids in sterile syringes to sterile administration devices, package
				containers or other sterile drug products and containers for storage and
				dispensing;
(4) The final
				compounded drug product contains a volume of 15 milliliters or less of a
				radiopharmaceutical and has an expiration time of 18 hours or less per dosage
				unit, including, without limitation, a dosage unit of a radiopharmaceutical
				prepared from an eluate by using a molybdenum-99technetiym-99m generator;
				or
(5) The final compounded drug
				product contains commercially manufactured cyclotron radiopharmaceuticals which
				contain preservatives and which have expiration times of 72 hours or
				less.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67063 - Low-risk sterile compounding: Radiopharmaceutical drug products

Current through June 11, 2024
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
				radiopharmaceutical compounded drug products are compounded in a vertical
				laminar airflow hood or Class II type B2 biological safety cabinet that is
				located in an environment with an air quality of ISO Class 8 or
				higher;
2. Only shielded vials,
				syringes and other devices and containers specifically manufactured for use
				with radiopharmaceutical components are used in the compounding
				process;
3. Each employee of the
				nuclear pharmacy who will compound radiopharmaceutical drug products is trained
				and knowledgeable with regard to compounding, handling, cleaning and any
				special techniques used with radiopharmaceutical drug products; and
4. Any special equipment or device that is
				used to compound radiopharmaceutical products, including, without limitation, a
				molybdenum-99technetiym-99m generator, is used, stored and maintained according
				to the directions of the manufacturer of the equipment or device.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67065 - Medium-risk sterile compounding: Process and storage

Current through June 11, 2024
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
				compounded drug product is compounded using aseptic techniques pursuant to one
				of the conditions listed in NAC 639.67061 as a condition for a low-risk sterile
				compounded drug product; and
(c)
				One or more of the following conditions are present:
(1) Individual or small doses of sterile drug
				products are combined or pooled to prepare the final compounded drug product
				that will be administered to multiple patients or to one patient multiple
				times;
(2) The compounding process
				includes complex aseptic manipulations other than a single-volume
				transfer;
(3) The compounding
				process uses more than three commercially manufactured sterile drug products or
				other entries of a sterile drug product into one container, including, without
				limitation, a bag or vial, to make the final compounded drug product;
(4) The final compounded drug product does
				not contain broad-spectrum bacteriostatic substances and will be administered
				over a period which exceeds 24 hours; or
(5) The compounding process requires an
				unusually long duration, as determined by the managing pharmacist, including,
				without limitation, the period required to complete dissolution or homogeneous
				mixing.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67067 - High-risk sterile compounding: Process and storage

Current through June 11, 2024
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 drug product is contaminated with or at a high risk of becoming
				contaminated with infectious microorganisms; and
(c) One or more of the following conditions
				are present:
(1) One or more of the
				ingredients or devices used in the compounding process are nonsterile;
				or
(2) One or more of the
				ingredients or devices used in the compounding process were sterile but were
				exposed or are suspected of having been exposed for more than 1 hour to an air
				quality inferior to an ISO Class 5 environment.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67069 - High-risk sterile compounding: Sterilization

Current through June 11, 2024
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 product is sterilized through filtration,
				by using steam in an autoclave or by dry heat. Except as otherwise provided in
				subsection 5, a pharmacist engaged in the practice of compounding high-risk
				sterile compounded drug products shall choose the method of sterilization that
				ensures the strength, purity, quality and packaging integrity of the final
				compounded drug product.
2. If a
				pharmacy sterilizes high-risk sterile compounded drug products using the
				filtration method, the pharmacy shall:
(a)
				Use commercially available sterile filters that are:
(1) Pyrogen-free and have a nominal porosity
				of 0.2 micron or 0.22 micron; and
(2) Certified by the manufacturer to retain
				at least 107 microorganisms of a strain of
Brevundimonas
(
Pseudomonas
)
diminuta
on each square centimeter of upstream filter surface
				area under conditions similar to the conditions of sterilization of the
				high-risk compounded drug products;
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67071 - High-risk sterile compounding: Testing of certain drug products

Current through June 11, 2024
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 a
				quantity of the high-risk sterile compounded drug product for:
(a) Sterility using a membrane filtration
				method or an equivalent method, as determined by the Board, before any of the
				compounded drug product may be administered or dispensed to a patient;
				and
(b) Excessive bacterial
				endotoxins using an appropriate test, as determined by the Board, for the
				particular product at issue before any of the compounded drug product may be
				administered or dispensed to a patient.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67073 - Immediate-use sterile compounding: Preparation and labeling

Current through June 11, 2024
1. A sterile compounded drug product is an
				immediate-use sterile compounded drug product if:
(a) The compounded drug product is intended
				only for the purpose of emergency care or immediate care of a
				patient;
(b) The compounding of the
				drug product occurs in an environment other than an ISO Class 5 environment and
				the compounding process consists of simple aseptic measuring and transfer
				manipulations performed with not more than six sterile nonhazardous commercial
				drug products and diagnostic radiopharmaceutical drug products, excluding
				infusion solutions or diluents;
(c)
				The preparation procedure occurs continuously without delays or interruptions
				and does not exceed 1 hour unless a period longer than 1 hour is required for
				the reconstitution of the compounded drug product;
(d) During compounding and before the
				administration of the compounded drug product, no part of the drug product or
				critical surfaces and ingredients of the drug product is directly exposed to
				contact contamination, including, without limitation, human touch, cosmetic
				flakes or particulates, blood or other bodily substances of a person or
				nonsterile inanimate sources; and
(e) Except as otherwise provided in paragraph
				(c), the administration of the compounded drug product begins not later than 1
				hour after the start of the preparation of the compounded drug product and the
				compounded drug product is fully administered as soon as practicable but not
				longer than 24 hours after the administration of the compounded drug product
				began or the compounded drug product is disposed of promptly and
				safely.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67075 - Immediate-use sterile compounding: Compounding standards

Current through June 11, 2024
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 with all
				compounding standards applicable to low-risk sterile compounded drug
				products.
2. An immediate-use
				sterile compounded drug product which contains more than three commercial
				sterile drug products or which requires complex manipulations or complex
				preparation must comply with all compounding standards applicable to
				medium-risk sterile compounded drug products.
3. An immediate-use sterile compounded drug
				product that contains one or more nonsterile ingredients or components must
				comply with all compounding standards applicable to high-risk sterile
				compounded drug products.
Added to NAC by Bd. of
				  Pharmacy by R035-06, eff. 9-18-2008
NRS
					 639.070
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67077 - Sterile hazardous drugs: Safety procedures for storage, handling, compounding and disposal

Current through June 11, 2024
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 other inventory at the pharmacy and in such a
				manner and location as to minimize the contamination of other drugs in and
				employees of the pharmacy;
(b)
				Handle the components of the hazardous drugs with caution by using appropriate
				gloves during preparation, handling and disposal of the components of the
				hazardous drug or final compounded drug product;
(c) Compound the hazardous drugs pursuant to
				the requirements set forth in NAC 639.661 to 639.690, inclusive, and applicable
				to the risk level of the compounded hazardous drugs;
(d) Ensure that an employee of the pharmacy
				involved with compounding hazardous drugs wears personal protective equipment,
				including, without limitation, gowns, gloves, face masks, hair covers, shoe
				covers or dedicated shoes, and, if the hazardous drugs contain one or more
				antineoplastic agents or it is recommended by the drug manufacturer, double
				gloves or chemotherapy gloves;
(e)
				Dispose of all waste relating to the compounding of the hazardous drugs in a
				manner that complies with any applicable state, federal and local laws and
				regulations; and
(f) Ensure that
				any employees of the pharmacy who are known to the pharmacy to be at special
				risk with regard to the properties of the hazardous drugs are limited from
				exposure to those drugs.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Sterile Products › Section 639.67079 - Sterile hazardous drugs: Required training for certain pharmaceutical personnel

Current through June 11, 2024
1. A pharmacy
				engaged in the practice of compounding sterile hazardous drugs and dispensing
				sterile compounded hazardous drugs shall require each pharmacist and
				pharmaceutical technician who compounds sterile hazardous drugs to be trained
				in the storage, handling, compounding, safety procedures and disposal of such
				compounded drugs:
(a) Before the pharmacy
				authorizes the pharmacist or pharmaceutical technician to compound a sterile
				hazardous drug that will be administered or dispensed to a patient;
				and
(b) At least once each year
				thereafter.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Parenteral Solutions › Section 639.672 - Reference materials required to be located in or immediately available to pharmacy

Current through June 11, 2024
Any pharmacy engaged in the practice of compounding and
				  dispensing parenteral solutions shall have current reference materials located
				  in or immediately available to the pharmacy. The reference materials must
				  include information on:
1. All drugs
				and chemicals used in services related to parenteral therapy; and
2. The activities involved in parenteral
				therapy, including manufacturing, dispensing, distribution and
				counseling.
Added to NAC by Bd. of
				  Pharmacy, eff. 8-14-87
NRS
					 639.070,
					 639.2807
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Parenteral Solutions › Section 639.680 - Labeling

Current through June 11, 2024
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) Instructions for
				storage and handling.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Parenteral Solutions › Section 639.682 - Record for each patient

Current through June 11, 2024
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
				summary of the most recent hospitalization of the patient or the patient's
				medical history; and
(c) Any notes
				taken by the pharmacist concerning the progress of the patient which document
				any contact with the patient or the practitioner concerning the parenteral
				therapy.
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Parenteral Solutions › Section 639.683 - Delivery, storage and recordation of delivery

Current through June 11, 2024
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 sterile parenteral solution;
2. A patient is advised of the appropriate
				conditions for the storage and disposal of the sterile parenteral solution;
				and
3. The delivery of a controlled
				substance listed in schedule II, as set forth in NAC 453.520, is documented and
				a receipt which indicates that the patient received that controlled substance
				is included with the records maintained at the pharmacy.
Added to NAC by Bd. of
				  Pharmacy, eff. 7-7-94
NRS
					 639.070,
					 639.2807
Nevada Administrative Code › Chapter 639 - Pharmacists and Pharmacy › COMPOUNDING AND DISPENSING DRUG PRODUCTS › Standards for Compounding and Dispensing Parenteral Solutions › Section 639.686 - Written policies and procedures for disposal of infectious materials and materials containing cytotoxic residues

Current through June 11, 2024
In addition to the requirements of NAC 639.67015 and
				  639.67017, any pharmacy providing parenteral solutions shall have written
				  policies and procedures for the disposal of infectious materials and materials
				  containing cytotoxic residues. The procedures must contain methods for the
				  cleanup of spills and must be in conformance with the regulations of the local
				  health authority. The pharmacy shall ensure the return of infectious materials
				  and materials containing cytotoxic residues to the pharmacy or shall inform the
				  provider of care of the procedures for the proper destruction of such
				  materials.
Added to NAC by Bd. of
				  Pharmacy, eff. 8-14-87; A by R035-06, 9-18-2008
NRS
					 639.070,
					 639.2807