CPJE CPJE Sterile Products and IV Admixtures 2 — Questions and Answers
Question 1: Under California law, a pharmacy compounding sterile preparations for office use must:
- Hold a sterile compounding pharmacy license from the Board of Pharmacy (Correct answer)
- Only have a standard retail pharmacy permit
- Register with the DEA for sterile products
- Obtain a hospital pharmacy permit
Correct answer: Hold a sterile compounding pharmacy license from the Board of Pharmacy
California requires pharmacies engaged in sterile compounding, including office-use preparations, to obtain a separate sterile compounding pharmacy license.
Question 2: Which solution is an appropriate diluent for intravenous vancomycin administration?
- 0.9% sodium chloride (NS) or 5% dextrose in water (D5W) (Correct answer)
- Sterile water for injection only
- Lactated Ringer's solution only
- Bacteriostatic normal saline
Correct answer: 0.9% sodium chloride (NS) or 5% dextrose in water (D5W)
Vancomycin is compatible with NS and D5W for IV infusion; bacteriostatic solutions are avoided for large-volume IV preparations.
Question 3: What is the recommended minimum infusion time for vancomycin 1g IV to prevent Red Man Syndrome?
- At least 60 minutes (Correct answer)
- At least 15 minutes
- At least 30 minutes
- No minimum time required
Correct answer: At least 60 minutes
Vancomycin must be infused over at least 60 minutes per gram to prevent Red Man Syndrome, an infusion-related reaction.
Question 4: A pharmacist identifies a physical incompatibility between two IV medications. What should be done?
- Administer the drugs through separate IV lines or at separate times (Correct answer)
- Mix them rapidly and administer immediately
- Use a filter needle to remove precipitate
- Consult the physician and proceed with mixture
Correct answer: Administer the drugs through separate IV lines or at separate times
Physical incompatibilities such as precipitation or color change indicate the drugs must be separated to ensure safety and therapeutic integrity.
Question 5: Which type of container is required for light-sensitive IV preparations such as nitroglycerin infusions?
- Amber or opaque IV bags and tubing (Correct answer)
- Standard clear polyvinyl chloride (PVC) bags
- Glass vials only
- Any container is acceptable
Correct answer: Amber or opaque IV bags and tubing
Light-sensitive drugs like nitroglycerin must be protected using amber or opaque containers throughout preparation and administration.
Question 6: Environmental monitoring in a sterile compounding facility includes surface sampling using what primary method?
- Contact plates or swabs with growth media incubated for colony-forming unit counts (Correct answer)
- Visual inspection only
- pH testing of surfaces
- Air particulate counting only
Correct answer: Contact plates or swabs with growth media incubated for colony-forming unit counts
USP <797> requires regular surface sampling with contact plates or swabs incubated for microbial growth to detect contamination in the cleanroom.
CPJE CPJE Sterile Products and IV Admixtures 2
Under California law, a pharmacy compounding sterile preparations for office use must: