beyond use dating (kirk)
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51 Terms
beyond-use-dating
the date, or hour and the date after which a CSP must not be used, stored, or transported. the date is determined from the date and time the preparation is compounded
-USP 797
pharmacy
who assigns beyond use date? (BUD)
expiration date
time during which a product maintains expected quality
manufacturer
who assigns the expiration date?
In-Use Time
maximum amount of time a vial can be used after intial manipulation
manufacturer
who assigns in-use time?
Hang-Time or Infusion-Time
allowable length of time for an infusion to be used before it must be taken down
nursing
who assigns the Hang-Time/Infusion-Time?
stability
the extent to which a product reatins physiochemical properties through its expiration date
-chemical, physical, microbiological, therapeutic effect, and toxicity
-FDA approved package insert
sterility
complete absense of viable microorganisms
-depends on ingredients and equipment used, preparation environment, and storage conditions
freezing
refrigeration
light (natural and room)
plastic containers, lines
plasticizer from PVC containers
what factors affect stability?
inactivation, cracking
how does freezing affect stability?
crystallization or precipitation
how does refrigeration affect stability?
degradation
how does light affect stability?
absorption of lipophilic agents
how does plastic containers affect stability?
leaching carcinogenic plastic (DEHP) from PVC
how does plasticisers affect stability?
least sterile- nonsterile ingredients or equipment
sterile- nonsterile ingredient/equipment + sterile ingredient/equipment
most sterile- all ingredients/ equipment sterile
based on ingredients and sterility, what are least and most sterile?
least sterile- immediate use (prepped anywhere, no PEC hood or SEC cleanroom)
sterile- category 1 (ISO class 5 PEC hood, SEC segregated compounding area)
most sterile- categories 2 & 3 (ISO class 5 PEC hood, SEC class 7 cleanroom/cleanroom suite
based on preparation environment, what are least and most sterile?
least sterile- controlled room temp (CRT) 20-25°C
sterile- refrigeration (REF) 2-8°C
most sterile- frozen (FRO) -25 - -10°C
based on storage conditions, what are least and most sterile?
sterile ingredients and equipment
what is involved in aseptic technique?
sterile OR nonsterile ingredients
what is involved in aseptic filtration?
sterile OR nonsterile ingredients
what is involved in terminal sterilization?
USP 797
what USP guideline refers to sterility testing?
4 hours
what is the beyond use date for immediate use?
-RN prepares a med for a patient at bedside
-pharmer draws up a med for a code on the unit
-doses drawn up in ambulances
what are examples of immediate use?
CRT: less than or equal to 12 hours
REF: less than or equal to 24 hours
what is beyond use date for category 1 CSPs sterile or nonsterile components?
-sterile eye drops made in an isolator in the corner of a compounding pharmacy
-IVs made in a satellite pharmacy with a PEC
-vet chemotherapy made in a containment PEC in their clinic
what are examples of category 1 CSPs sterile or nonsterile components?
1 day
what is beyond use date for category 2 CSPs sterile or nonsterile components-no sterility testing?
-has at least 1 nonsterile product and is in CRT
4 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-no sterility testing?
-has at least 1 nonsterile product and is in REF
45 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-no sterility testing?
-has at least 1 nonsterile product and is in freezer
4 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-no sterility testing?
-has all sterile products and is in CRT
10 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-no sterility testing?
-has all sterile products and is in REF
45 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-no sterility testing?
-has all sterile products and is in freezer
-hospital pharmacies
-larger compounding pharmacies
-specialty pharmacies (disease specific)
what are examples of category 2 CSPs?
14 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-sterility testing ad/or terminal sterilization?
-has no sterility testing but does have terminal sterilization and is in CRT
28 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-sterility testing ad/or terminal sterilization?
-has no sterility testing but does have terminal sterilization and is in REF
45 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-sterility testing and/or terminal sterilization?
-has no sterility testing but does have terminal sterilization and is in freezer
14 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-sterility testing and/or terminal sterilization?
-has sterility testing and has no terminal sterilization and is in CRT
28 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-sterility testing and/or terminal sterilization?
-has sterility testing and has no terminal sterilization and is in REF
60 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-sterility testing and/or terminal sterilization?
-has sterility testing and has no terminal sterilization and is in freezer
45 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-sterility testing and/or terminal sterilization?
-has sterility testing and terminal sterilization and is in CRT
60 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-sterility testing and/or terminal sterilization?
-has sterility testing and terminal sterilization and is in REF
90 days
what is beyond use date for category 2 CSPs sterile or nonsterile components-sterility testing and/or terminal sterilization?
-has sterility testing and terminal sterilization and is in freezer
-larger pharmacies/systems
-larger compounding pharmacies
-outsourcing pharmacies (503B)
what are examples of category 2 CSPS sterile or nonsterile components-sterility testing and/or terminal sterilization?
30 days
what is the beyond use date for category 3 CSPs sterile or nonsterile components that must pass sterility testing?
-no terminal sterilization and in CRT
45 days
what is the beyond use date for category 3 CSPs sterile or nonsterile components that must pass sterility testing?
-no terminal sterilization and in REF
60 days
what is the beyond use date for category 3 CSPs sterile or nonsterile components that must pass sterility testing?
-no terminal sterilization and in freezer
45 days
what is the beyond use date for category 3 CSPs sterile or nonsterile components that must pass sterility testing?
-has terminal sterilization and in CRT
60 days
what is the beyond use date for category 3 CSPs sterile or nonsterile components that must pass sterility testing?
-has terminal sterilization and in REF
90 days
what is the beyond use date for category 3 CSPs sterile or nonsterile components that must pass sterility testing?
-has terminal sterilization and in freezer
-larger hospital pharmacies/systems
-larger compounding pharmacies
-outsourcing pharmacies (503B)
what are examples of category 3 CSPs sterile or nonsterile components that must pass sterility testing?