USP 825 UPDATED ACTUAL Exam
Questions and CORRECT Answers
Radiopharmaceutical - CORRECT ANSWER - a finished dosage form that contains a
radioactive substance in association with one or more ingredients and that is intended to
diagnose, stage a disease, monitor treatment, or provide therapy
US Nuclear Regulatory Commission (NRC) and the FDA - CORRECT ANSWER - Who
does control of radiopharmaceuticals fall under?
No, they are excluded - CORRECT ANSWER - Are radiopharmaceuticals classified as
NIOSH hazardous drugs because of the radiation hazard?
Provide uniform minimum standards for the preparation, compounding, dispensing, and
repackaging of sterile and non-sterile radiopharmaceuticals for humans and animals that occur as
part of state-licensed activities - CORRECT ANSWER - What is the purpose of 825?
in response to public comments associated with the 2015 proposed revision of 797 which
emphasized unique characteristics of radiopharmacetuticals which make compliance with 797
difficult or impossible - CORRECT ANSWER - Why was 825 developed?
by an Expert Panel composed of members from the USP Chemical Medicines 4 Expert
Committee (which oversees radioactive drugs), the USP Compounding Expert Committee, FDA,
Health Canada, nuclear pharmacists and a nuclear medicine technologist - CORRECT
ANSWER - How was USP 825 developed?
all individuals who prepare, compound, dispense or repackage radiopharmaceuticals
- authorized nuclear pharmacists (ANPs), authorized user (AU) physicians and individuals
working under their supervision (student pharmacists, nuclear pharmacy technicians, nuclear
medicine technologists, and students and physician residents and trainees) - CORRECT
ANSWER - Who does 825 apply to?
Questions and CORRECT Answers
Radiopharmaceutical - CORRECT ANSWER - a finished dosage form that contains a
radioactive substance in association with one or more ingredients and that is intended to
diagnose, stage a disease, monitor treatment, or provide therapy
US Nuclear Regulatory Commission (NRC) and the FDA - CORRECT ANSWER - Who
does control of radiopharmaceuticals fall under?
No, they are excluded - CORRECT ANSWER - Are radiopharmaceuticals classified as
NIOSH hazardous drugs because of the radiation hazard?
Provide uniform minimum standards for the preparation, compounding, dispensing, and
repackaging of sterile and non-sterile radiopharmaceuticals for humans and animals that occur as
part of state-licensed activities - CORRECT ANSWER - What is the purpose of 825?
in response to public comments associated with the 2015 proposed revision of 797 which
emphasized unique characteristics of radiopharmacetuticals which make compliance with 797
difficult or impossible - CORRECT ANSWER - Why was 825 developed?
by an Expert Panel composed of members from the USP Chemical Medicines 4 Expert
Committee (which oversees radioactive drugs), the USP Compounding Expert Committee, FDA,
Health Canada, nuclear pharmacists and a nuclear medicine technologist - CORRECT
ANSWER - How was USP 825 developed?
all individuals who prepare, compound, dispense or repackage radiopharmaceuticals
- authorized nuclear pharmacists (ANPs), authorized user (AU) physicians and individuals
working under their supervision (student pharmacists, nuclear pharmacy technicians, nuclear
medicine technologists, and students and physician residents and trainees) - CORRECT
ANSWER - Who does 825 apply to?
