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
Universal Citation: NV Admin Code 639.67073
Current through September 16, 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.
2. If an immediate-use sterile compounded drug product is not immediately administered by direct injection into a patient by the person who compounded it, the compounded drug product must bear a label which includes, without limitation:
(a) The name and, if the patient has an
identification number, the identification number of the patient;
(b) The name and amount of each ingredient of
the compounded drug product;
(c)
The initials of the person who compounded the compounded drug product;
and
(d) The exact date and time of
expiration of the compounded drug product.
3. An immediate-use sterile compounded drug product must not be stored for later use.
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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