USP 825 QUESTIONS WITH ANSWERS RATED A+
Requirements are conveyed by use of the term "must"
Recommendations are conveyed by use of the terms "should" or "may" - How do you know what
are requirements versus recommendations in 825?
regulators such as the FDA, states, other government authorities, and accreditation/credentialing
organizations (Not USPs) - Who is responsible for ensuring compliance with the requirements of
USP standards?
Celsius (centigrade) - Are the temperatures in 825 expressed in degrees Fahrenheit or Celsius?
No, 825 explicitly states that it does not cover the "administration of radiopharmaceuticals to
patients" - Is administration to the patients in the scope of 825?
kit-splitting (fractionation) - the act of dividing the contents of kit vial and transferring aliquots
into other containers for storage and subsequent radiolabeling
825 defines standards that must be met if kit splitting is performed
- it may be used to meet the patient need - Is kit-splitting (fractionation) allowed per 825?
It describes appropriate standards that provide reasonable assurance of maintaining patient safety
while also providing reasonable assurance for the safety of individuals performing these
activities - Why is 825 needed?
Yes - Do students and trainees need to perform gloved fingertip testing and media fill testing
prior to preparing sterile radiopharmaceuticals beyond immediate use?
Yes, a worker can prepare radiopharmaceuticals for immediate use regardless of the results of
their media fill challenge
- some regulatory authorities and accreditors expect documented competency for performance of
critical activities, so documentation of training and performance assessment for
radiopharmaceutical preparation for immediate use is recommended - Can radiopharmaceuticals
be prepared for immediate use if the worker fails the media fill challenge?
desginated person - one or more individuals assigned to be responsible and accountable for the
performance and operation of the radiopharmaceutical processing facility and for personnel who
prepare, compound, dispense, and repackage radiopharmaceuitcals
Media fill challenge will be observed by a "designated person" who must be appropriately
trained in their area of supervision - Does the media fill proctor need to have specialized or
additional training?
Requirements are conveyed by use of the term "must"
Recommendations are conveyed by use of the terms "should" or "may" - How do you know what
are requirements versus recommendations in 825?
regulators such as the FDA, states, other government authorities, and accreditation/credentialing
organizations (Not USPs) - Who is responsible for ensuring compliance with the requirements of
USP standards?
Celsius (centigrade) - Are the temperatures in 825 expressed in degrees Fahrenheit or Celsius?
No, 825 explicitly states that it does not cover the "administration of radiopharmaceuticals to
patients" - Is administration to the patients in the scope of 825?
kit-splitting (fractionation) - the act of dividing the contents of kit vial and transferring aliquots
into other containers for storage and subsequent radiolabeling
825 defines standards that must be met if kit splitting is performed
- it may be used to meet the patient need - Is kit-splitting (fractionation) allowed per 825?
It describes appropriate standards that provide reasonable assurance of maintaining patient safety
while also providing reasonable assurance for the safety of individuals performing these
activities - Why is 825 needed?
Yes - Do students and trainees need to perform gloved fingertip testing and media fill testing
prior to preparing sterile radiopharmaceuticals beyond immediate use?
Yes, a worker can prepare radiopharmaceuticals for immediate use regardless of the results of
their media fill challenge
- some regulatory authorities and accreditors expect documented competency for performance of
critical activities, so documentation of training and performance assessment for
radiopharmaceutical preparation for immediate use is recommended - Can radiopharmaceuticals
be prepared for immediate use if the worker fails the media fill challenge?
desginated person - one or more individuals assigned to be responsible and accountable for the
performance and operation of the radiopharmaceutical processing facility and for personnel who
prepare, compound, dispense, and repackage radiopharmaceuitcals
Media fill challenge will be observed by a "designated person" who must be appropriately
trained in their area of supervision - Does the media fill proctor need to have specialized or
additional training?
