CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 2 — Questions and Answers
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?
- 30 days
- 45 days
- 60 days
- 180 days (Correct answer)
Correct answer: 180 days
USP <797> permits a BUD of up to 180 days for Category 2 CSPs stored frozen when no product-specific stability data exists.
Question 2: Which of the following is the BEST source to verify the chemical stability of a CSP ingredient before assigning a BUD?
- Package insert only
- Trissel's Handbook on Injectable Drugs (Correct answer)
- Pharmacist judgment alone
- Manufacturer verbal confirmation
Correct answer: Trissel's Handbook on Injectable Drugs
Trissel's Handbook on Injectable Drugs is a primary peer-reviewed reference for parenteral compatibility and stability data.
Question 3: A compounded IV admixture shows a visible color change after 24 hours of storage. This observation most likely indicates:
- Normal reconstitution effect
- Chemical degradation or incompatibility (Correct answer)
- Proper mixing of electrolytes
- Successful sterilization
Correct answer: Chemical degradation or incompatibility
A color change in a CSP is a physical sign of chemical degradation or drug incompatibility, warranting rejection.
Question 4: Which pH range is generally considered most favorable for the stability of most aqueous injectable CSPs?
- 2.0–3.0
- 4.5–8.5 (Correct answer)
- 9.0–10.0
- 10.5–12.0
Correct answer: 4.5–8.5
Most parenteral drugs exhibit optimal stability in the pH range of 4.5–8.5, which also aligns with physiologic tolerability.
Question 5: Under USP <797>, which of the following actions is required when a CSP's BUD has been exceeded?
- Relabel with a new BUD
- Return to the pharmacist for re-evaluation
- Discard the preparation immediately (Correct answer)
- Extend BUD if stored refrigerated
Correct answer: Discard the preparation immediately
Once a BUD has passed, the CSP must be discarded because its sterility and potency can no longer be assured.
Question 6: Which type of container is preferred to minimize oxidative degradation when assigning a BUD to a light-sensitive CSP?
- Clear glass vial
- Amber vial or foil overwrap (Correct answer)
- Polypropylene bag
- Stainless steel container
Correct answer: Amber vial or foil overwrap
Amber vials or foil overwraps block UV and visible light, reducing photodegradation and supporting a longer BUD.
CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 2
What is the maximum BUD for a Category 2 CSP stored frozen (-25°C to -10°C) when no stability data is available?