USP 825 TEST QUESTIONS AND
ANSWERS
Radiopharmaceutical - 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 - ANSWER Who
does control of radiopharmaceuticals fall under?
No, they are excluded - 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 - 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 radiopharmaceuticals which
make compliance with 797 difficult or impossible - 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 - 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) - ANSWER Who does 825 apply to?
ANSWERS
Radiopharmaceutical - 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 - ANSWER Who
does control of radiopharmaceuticals fall under?
No, they are excluded - 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 - 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 radiopharmaceuticals which
make compliance with 797 difficult or impossible - 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 - 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) - ANSWER Who does 825 apply to?
