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
Universal Citation: NV Admin Code 639.67067
Current through September 16, 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.
2. Unless sterility testing or potency limitations allow for a different period, the period of storage before administration of a high-risk sterile compounded product must not exceed:
(a) Twenty-four hours at a controlled room
temperature that is at least 20 degrees Celsius (68 degrees Fahrenheit) but not
more than 25 degrees Celsius (77 degrees Fahrenheit);
(b) Three days at a temperature that is at
least 2 degrees Celsius (36 degrees Fahrenheit) but not more than 8 degrees
Celsius (46 degrees Fahrenheit); or
(c) Forty-five days in a solid frozen state
that is -10 degrees Celsius (14 degrees Fahrenheit) or colder.
Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008
NRS 639.070
Disclaimer: These regulations may not be the most recent version. Nevada may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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