CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 2

Question 1

What is the maximum BUD for a Category 2 CSP stored frozen (-25°C to -10°C) when no stability data is available?

Accepted Answer

180 days

Answer

30 days

Answer

45 days

Answer

60 days

Question 2

Which of the following is the BEST source to verify the chemical stability of a CSP ingredient before assigning a BUD?

Accepted Answer

Trissel's Handbook on Injectable Drugs

Answer

Package insert only

Answer

Pharmacist judgment alone

Answer

Manufacturer verbal confirmation

Question 3

A compounded IV admixture shows a visible color change after 24 hours of storage. This observation most likely indicates:

Accepted Answer

Chemical degradation or incompatibility

Answer

Normal reconstitution effect

Answer

Proper mixing of electrolytes

Answer

Successful sterilization

Question 4

Which pH range is generally considered most favorable for the stability of most aqueous injectable CSPs?

Accepted Answer

4.5–8.5

Answer

2.0–3.0

Answer

9.0–10.0

Answer

10.5–12.0

Question 5

Under USP <797>, which of the following actions is required when a CSP's BUD has been exceeded?

Accepted Answer

Discard the preparation immediately

Answer

Relabel with a new BUD

Answer

Return to the pharmacist for re-evaluation

Answer

Extend BUD if stored refrigerated

Question 6

Which type of container is preferred to minimize oxidative degradation when assigning a BUD to a light-sensitive CSP?

Accepted Answer

Amber vial or foil overwrap

Answer

Clear glass vial

Answer

Polypropylene bag

Answer

Stainless steel container