AND ANSWERS
USP 795 -
correct answer ✅Non-sterile compounding
USP 797 -
correct answer ✅sterile compounding
Compounded drugs -
correct answer ✅are NOT regulated by the FDA or are FDA
approved
Non-sterile compounding examples -
correct answer ✅lozenges, solutions, lollipops, creams, ointments,
lotions, emulsion, spray, gel, suspension
non-sterile compounding rules -
correct answer ✅must record everything in detail, date of prep, lot
numbers, qtys, mixing order, weights, expiration dates of each
ingredient
you can only make 1 product at a time
,PNN - CPJE STUFF EXAM QUESTIONS
AND ANSWERS
BEFORE entering a non-sterile compounding area -
correct answer ✅remove extra clothing (hats, jewelry, jackets)
Hand hygiene: wash hands/arms for 30 sec
Wear gloves (for ALL compounds)
ONLY GOWNS can be REUSED over multiple days
Non-disposable garg (goggles) should be cleaned w/*70% isopropyl
alc* before being reused
USP 795: Compounding Steps -
correct answer ✅1. Label the Rx containers (generic/chem name,
strength, amt)
- instructions for use and storage req
- initials of the compounder
2. BEYOND USE DATE (depends on):
- Aqueous oral = 14 days ref
- Aqueous topical PF: 14 days ref (emulsion, gel, cream, sol, spray,
suspension)
- aqueous topical w/preservative: 35 days
,PNN - CPJE STUFF EXAM QUESTIONS
AND ANSWERS
- non-aqueous topical (ointment, suppositories, troches) = 90 days
- SOLID forms (caps, tabs, granules, powder) = 180d
Non-sterile compounding CLEANING SCHEDULE -
correct answer ✅Work surfaces:
- Beginning and end of each shift
- After spills
- In between making compounds made w/diff ingredients
Floors: DAILY (and after spills)
Walls: every 3 MONTHS
Storage shelves: every 3 MONTHS
Master formulation record vs Compounding Record -
correct answer ✅Master Formulation Record = recipe
Compounding Record = record of what you did every time a
compound is made
, PNN - CPJE STUFF EXAM QUESTIONS
AND ANSWERS
-keep records for at least THREE YEARS
Ingredients must be: -
correct answer ✅USP recommends 2 different grades of
ingredients
NF and FCC
Storage Temp Definitions -
correct answer ✅Freezing = -25 to -10
To protect from freezing = > 0
Cold: <= 8
Ref = 2-8
Cool= 8-15