USP 825 UPDATED Exam Questions and
CORRECT Answers
what is USP 825 - CORRECT ANSWER - United states Pharmacopeia
- chapter about minimum standads to prepping sterile and non sterile radiopharms
what USP chapters cover sterile and nonsterile non radioacive - CORRECT ANSWER -
797- sterile
795- nonsterile
who can inspect nuc med departments under USP 825 - CORRECT ANSWER - -NRC
-US FDA
-State board of pharmacy
-DOT
-TJC
_Centers fpr medicare services
when did USP 825 go live - CORRECT ANSWER - -november 2022
Beyond-use date (BUD) - CORRECT ANSWER - - the date or time a drug or material can
no longer be used; drug is ineffective after this date
ISO Class 5 - CORRECT ANSWER - International Organization for Standardization Class
5 environment
- ante room
-buffer room
air hood
- this is what a radiopharmacy is (a hot lab does not have these)
, BUD of any radiopharm prepared outside ISO 5 - CORRECT ANSWER - 1 hour
-falls under immediate use criteria
12 hour BUD requires - CORRECT ANSWER - ISO class 5 hood
- bi annual glove testing
- media filling test
-etc
what are sterile radiopharms - CORRECT ANSWER - • Intravenous
• Intrathecal
• Intraperitoneal
• Subcutaneous and Intradermal
• Inhalations
• Ophthalmics.
non sterile radiopharms - CORRECT ANSWER - • Oral capsules
• Oral solutions.
when does BUD begin - CORRECT ANSWER - after first needle puncture of vial septum
aseptic technique for immediate use includes - CORRECT ANSWER - • Avoidance of
touch contamination
• Disinfection of the vial septum with 70% IPA
• Disinfection of non sterile gloves with 70% IPA
• When changing a syringe needle you are exposing the critical sites to non sterile air,
replacing the needle cap must be immediate with avoiding touch contamination.
CORRECT Answers
what is USP 825 - CORRECT ANSWER - United states Pharmacopeia
- chapter about minimum standads to prepping sterile and non sterile radiopharms
what USP chapters cover sterile and nonsterile non radioacive - CORRECT ANSWER -
797- sterile
795- nonsterile
who can inspect nuc med departments under USP 825 - CORRECT ANSWER - -NRC
-US FDA
-State board of pharmacy
-DOT
-TJC
_Centers fpr medicare services
when did USP 825 go live - CORRECT ANSWER - -november 2022
Beyond-use date (BUD) - CORRECT ANSWER - - the date or time a drug or material can
no longer be used; drug is ineffective after this date
ISO Class 5 - CORRECT ANSWER - International Organization for Standardization Class
5 environment
- ante room
-buffer room
air hood
- this is what a radiopharmacy is (a hot lab does not have these)
, BUD of any radiopharm prepared outside ISO 5 - CORRECT ANSWER - 1 hour
-falls under immediate use criteria
12 hour BUD requires - CORRECT ANSWER - ISO class 5 hood
- bi annual glove testing
- media filling test
-etc
what are sterile radiopharms - CORRECT ANSWER - • Intravenous
• Intrathecal
• Intraperitoneal
• Subcutaneous and Intradermal
• Inhalations
• Ophthalmics.
non sterile radiopharms - CORRECT ANSWER - • Oral capsules
• Oral solutions.
when does BUD begin - CORRECT ANSWER - after first needle puncture of vial septum
aseptic technique for immediate use includes - CORRECT ANSWER - • Avoidance of
touch contamination
• Disinfection of the vial septum with 70% IPA
• Disinfection of non sterile gloves with 70% IPA
• When changing a syringe needle you are exposing the critical sites to non sterile air,
replacing the needle cap must be immediate with avoiding touch contamination.
