USP (795,797,800, 825) Exam 2025
Questions and Answers
BUDs under USP 795 - 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 - ANSWER✔✔-90 days
aqueous dosage forms - ANSWER✔✔-emulsions, gels, creams,solutions, sprays or
suspensions
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, Nonaqueous dosage forms - ANSWER✔✔-capsules, tablets, granules, powders,
nonaqueous topicals, suppositories, torches or lozenges
additional: elixirs, tinctures, solutions or suspensions (aw <0.60)
nonsterile compounding - ANSWER✔✔-USP 795
sterile compounding - ANSWER✔✔-USP 797
hazardous compounding - ANSWER✔✔-USP 800
radiopharmaceutical (nuclear) compounding - ANSWER✔✔-USP 825
handling non-sterile hazardous drugs must be complaint with - ANSWER✔✔-USP 795
and USP 800
hazardous drugs - 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
COPYRIGHT © 2025 ALL RIGHTS RESERVED
Questions and Answers
BUDs under USP 795 - 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 - ANSWER✔✔-90 days
aqueous dosage forms - ANSWER✔✔-emulsions, gels, creams,solutions, sprays or
suspensions
COPYRIGHT © 2025 ALL RIGHTS RESERVED
, Nonaqueous dosage forms - ANSWER✔✔-capsules, tablets, granules, powders,
nonaqueous topicals, suppositories, torches or lozenges
additional: elixirs, tinctures, solutions or suspensions (aw <0.60)
nonsterile compounding - ANSWER✔✔-USP 795
sterile compounding - ANSWER✔✔-USP 797
hazardous compounding - ANSWER✔✔-USP 800
radiopharmaceutical (nuclear) compounding - ANSWER✔✔-USP 825
handling non-sterile hazardous drugs must be complaint with - ANSWER✔✔-USP 795
and USP 800
hazardous drugs - 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
COPYRIGHT © 2025 ALL RIGHTS RESERVED
