USP (795,797,800, 825) UPDATED ACTUAL
Exam Questions and CORRECT Answers
BUDs under USP 795 - CORRECT ANSWER - - nonpreserved aqueous dosage forms (aw
>/= 0.60) = 14 days (refrigerated)
- preserved aqueous dosage forms (aw>/= 0.60) =35 days (room temp or refrigerated)
- oral nonaqueous liquids (aw<0.60) = 90 days (room temp or refrigerated)
- other non-aqueous dosage forms (aw<0.60) = 180 days (room temp or refrigerated)
aw = activity of water
BUD for atenolol compounded oral suspension (aqueous, aw>/= 0.60) with preservatives added -
CORRECT ANSWER - 90 days
aqueous dosage forms - CORRECT ANSWER - emulsions, gels, creams,solutions, sprays
or suspensions
Nonaqueous dosage forms - CORRECT ANSWER - capsules, tablets, granules, powders,
nonaqueous topicals, suppositories, torches or lozenges
additional: elixirs, tinctures, solutions or suspensions (aw <0.60)
nonsterile compounding - CORRECT ANSWER - USP 795
sterile compounding - CORRECT ANSWER - USP 797
hazardous compounding - CORRECT ANSWER - USP 800
, radiopharmaceutical (nuclear) compounding - CORRECT ANSWER - USP 825
handling non-sterile hazardous drugs must be complaint with - CORRECT ANSWER -
USP 795 and USP 800
hazardous drugs - CORRECT ANSWER - any drug in atleast one of the following 6
criteria
1) teratogenicity or other development toxicity
2) reproductive toxicity
3) carcinogenicity
4) genotoxicty
5) organ toxicity
6)drug with safe-handling guidelines from the manufacturer
USP 795 personal training - CORRECT ANSWER - initially and at least every 12 months
USP 795 at minimum personnel must revmove - CORRECT ANSWER - personal out
garments
all hand, wrist, and other exposed jewelry
earbuds or headphones
minimum frequency for cleaning and sanitizing nonsterile compounding areas- surfaces -
CORRECT ANSWER - work surfaces
- at the beginning and end of each shift on days when compounding occurs, after spills and when
surface contamination (from splashes) is known or suspected
- between compounding CNSPs with different components
Exam Questions and CORRECT Answers
BUDs under USP 795 - CORRECT ANSWER - - nonpreserved aqueous dosage forms (aw
>/= 0.60) = 14 days (refrigerated)
- preserved aqueous dosage forms (aw>/= 0.60) =35 days (room temp or refrigerated)
- oral nonaqueous liquids (aw<0.60) = 90 days (room temp or refrigerated)
- other non-aqueous dosage forms (aw<0.60) = 180 days (room temp or refrigerated)
aw = activity of water
BUD for atenolol compounded oral suspension (aqueous, aw>/= 0.60) with preservatives added -
CORRECT ANSWER - 90 days
aqueous dosage forms - CORRECT ANSWER - emulsions, gels, creams,solutions, sprays
or suspensions
Nonaqueous dosage forms - CORRECT ANSWER - capsules, tablets, granules, powders,
nonaqueous topicals, suppositories, torches or lozenges
additional: elixirs, tinctures, solutions or suspensions (aw <0.60)
nonsterile compounding - CORRECT ANSWER - USP 795
sterile compounding - CORRECT ANSWER - USP 797
hazardous compounding - CORRECT ANSWER - USP 800
, radiopharmaceutical (nuclear) compounding - CORRECT ANSWER - USP 825
handling non-sterile hazardous drugs must be complaint with - CORRECT ANSWER -
USP 795 and USP 800
hazardous drugs - CORRECT ANSWER - any drug in atleast one of the following 6
criteria
1) teratogenicity or other development toxicity
2) reproductive toxicity
3) carcinogenicity
4) genotoxicty
5) organ toxicity
6)drug with safe-handling guidelines from the manufacturer
USP 795 personal training - CORRECT ANSWER - initially and at least every 12 months
USP 795 at minimum personnel must revmove - CORRECT ANSWER - personal out
garments
all hand, wrist, and other exposed jewelry
earbuds or headphones
minimum frequency for cleaning and sanitizing nonsterile compounding areas- surfaces -
CORRECT ANSWER - work surfaces
- at the beginning and end of each shift on days when compounding occurs, after spills and when
surface contamination (from splashes) is known or suspected
- between compounding CNSPs with different components
