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Advisor
Posts: 46
Registered: ‎05-17-2016
0

CSP or reconstitution?

Questions regarding the difference between reconstitution and a CSP specific to nursing function on the floor. If a nurse reconstitutes and draws up a medication (famotidine diluted with saline, protonix diluted with saline, hydrocortisone diluted with saline, etc ) for IV push and immediately administers, is this considered compounding? I do know that this practice would not be covered by the immediate use provision. At the beginning of current chapter <797> its states : NOTE—The FDA states that “Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling” [21 USC 321 (k) and (m)]. Is USP just making a reference to the FDA's statement, or is this stating that this is also USP 797 stance on this. Trying to make sure that we are doing the correct thing as this could be highly impactful.
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Occasional Visitor
Posts: 3
Registered: ‎02-07-2018
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Re: CSP or reconstitution?

my undesrtanding of nursing admixture, if recontituting and adminstering the entire contents of drug without leaving the patient, nurse would not have to sign label and date all of the IV admixture info for immediate use. If nurse mixes and IVPB for 15-30 min infusion and is taking care of other patients then the prep is a CSP. If nurse acitivates a duplex or add ease IVPB not compounding , its reconstituting a med. hope this  helps.