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Chapter 10

Notes Review

QuestionAnswer
Parenteral products have special requirements for what? Their preparation, packaging, and administration.
Why must these formulations be sterile? They have rapid access to the circulatory system and can cause a patient great harm if an infection develops or if a mistake in dosage is made.
Compounding regulations, standards, and guidelines involve the work of many organizations, boards, and agencies at what levels? Federal and state.
Who are the two primary regulators in compounding? The FDA and individual state boards of pharmacy.
Since 2004, the USP-NF has been the predominant organization that does what? Set sterile compounding standards.
Chapter <797> contains requirements for what? The development and implementation of essential policies and procedures for the safe preparation of compounded sterile preparations (CSP).
Chapter <797> also requires that personnel who prepare CSPs be trained in what? The principles and practices of aseptic techniques before preparing CSPs.
Why does the administration set port have a plastic cover on it? To maintain the sterility of the bag.
The medication port is covered by what? A protective rubber tip.
What are ampules? Elongated, sealed glass containers with a neck that must be snapped off.
What part of the vial does the needle go through to withdraw or add to the contents? The rubber stopper.
Created by: Ms.little1
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