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What is the first enforceable national published standards regarding sterile products?
USP 797
What precautions should be taken when receiving and storing hazardous agents?
Wear gloves
What are your primary engineering controls?
Hoods
Should your direct compounding area be in the anteroom?
No
Which would be a required auxiliary label for C-II through C-V drugs?
Federal law prohibits the transfer of this drug to any other person
Take until completely gone
For topical use only
Refrigerate
Federal law prohibits the transfer of this drug to any other person
What document/guidelines should you use to make sure you are following the most current standards for compounding sterile products?
USP 797
What is the definition of sterile?
absent of microorganisms
What is the definition of pyrogen?
fever producing organisms
When do you take off used personal protective equipment?
before leaving the compounding area
What would happen if we did not follow P & P for Sterile Compounding?
product contamination
What reference will a pharmacist use to determine the chemical drug compatibility or incompatibility of three medications added to an IV solution?
Trissel's Stability of Compounded Formulations
Define Compounding
when a RPH or CPhT uses bulk ingredients to prepare a speciality prescribed medication that is not commercially available
Define Investigational Drug
medications not yet approved by the FDA, but are in testing phases
USP <800> addresses which area of compounding?
Hazardous
How often must pre-filters in all PECs be replaced?
every 30 days
What is a Master Formulation Record?
the set recipe we use in compounding facilities, to make certain products with specific amounts and directions for mixing
What is the weakened or scored area on the glass neck of an ampule?
break ring
How often must the HEPA filter be recertified in a PEC?
every 6 months
What is "coring"
when a tech inadvertently introduces a small piece of rubber into an IV bag by entering the rubber stopper incorrectly
What is required information to be on a unit-dose product label?
barcode of the product
Why do we clean the counting tray and spatula with 70% IPA after counting antibiotics?
to prevent cross contamination for patient's allergies to certain antibiotics
What is the only container technicians may use to dispose of any needle, lancet, broken ampules, or any other equipment?
Sharps container
What is the reason for using glass syringes, instead of plastic syringes, in sterile compounding?
Glass syringes are used when certain chemotherapy products are prepared
What does the abbreviation D5NS indicate?
5% dextrose in 0.9% normal saline
What items might you find in the anteroom of the sterile compounding area?
PPE and hand hygiene equipment
When working in a BSC, what is the term used when the hands go over objects causing an airflow block?
shadowing
What is the purpose of the chemotherapy compounding mat?
absorb spills during the preparation of hazardous drugs
What contains: gloves, shoe covers, waste disposal bags, goggles, incident reports, & disposal scoops, amongst other supplies?
Chemo Spill Kit
If a med is to be admin "PR", which of the following forms is most likely to be used?
Suppository, per rectum
Where would IV chemotherapy products be compounded at?
Biological Safety Cabinet
What do you need in the HD compounding area for removal of hazardous substances from the face & skin?
Eye wash station
What agency has the authority to enforce GMPs?
FDA
What is the term used to describe the leaking of IV fluids into the tissue surrounding the injection site?
extravasation
What information has to be on the label that a patient would receive on an RX bottle?
pharmacy name/address, serial (RX) number, date filled, patient and prescriber name, and instructions
What is the piece of equipment that uses heat & pressure to sterilize medical instruments & supplies?
autoclave
What AUX label is required on liquid suspensions?
shake well
How are the compounding aseptic isolator & horizontal laminar airflow workbench alike?
CAI and LAWF are ISO 5
What should HD workers do when cleaning up a hazardous agent spill?
start at edges then work inwards
In what PEC would non-hazardous aseptic compounding be performed?
horizontal fume hood
What is the life-threatening reaction that happens when a pt has a healthcare-associated infection that is so threatening that the body's immune system goes into overdrive?
sepsis
Define pathogen
disease-causing organism
What is another name for repackaging bulk meds, such as tablets or capsules, into cards or individual doses?
unit dosing
What is the term used to describe the tweezers like instrument that CPhT could use for picking up pharmaceutical weights used with balances?
forceps
In what situation do you need to use a master formulation record per the guidelines in USP <797>?
compounding many sterile products
If a med is injected into the skin, that is often referred to as what ROA?
intradermal parenteral (injection) route
A sealed glass or plastic container with a rubber seal with hard plastic cap is known as what?
vial
Compromising a quality control measure may result in what devastating effect?
CSP contamination, pt death/injury
Creams, gels & ointments are given via what ROA?
topically
What would need pharmaceutical weights to calibrate, so that the equipment is measured correctly?
class III prescription balance
When an object, such as a medical instrument, is sterilized, the microbial life forms on it are?
absent
How often do the sterile compounding techniques of the IV CPhT need to be re-evaluated?
annually or semi-annually