CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 5 — Questions and Answers
Question 1: Which analytical method is considered the gold standard for confirming chemical stability and potency retention in a CSP for BUD validation purposes?
- Visual inspection for particulates
- pH testing with litmus paper
- Stability-indicating assay method (SIAM) (Correct answer)
- Osmolality measurement
Correct answer: Stability-indicating assay method (SIAM)
A stability-indicating assay method (SIAM) can differentiate the intact drug from its degradation products, making it the gold standard for potency confirmation.
Question 2: USP <797> requires that BUD labels on CSPs include which of the following elements?
- Date and time of preparation, storage conditions, and BUD (Correct answer)
- Patient name only
- Compounder's initials and batch number only
- Only the expiration date without storage instructions
Correct answer: Date and time of preparation, storage conditions, and BUD
BUD labels must include the preparation date and time, required storage conditions, and the beyond-use date/time to ensure safe patient use.
Question 3: A CSP is inadvertently stored at room temperature for 4 hours before being transferred to refrigeration. The assigned refrigerated BUD should be:
- Maintained unchanged because refrigeration resets stability
- Recalculated to account for the time already elapsed at room temperature (Correct answer)
- Extended because cold storage compensates for warm storage
- Reassigned as the maximum default BUD
Correct answer: Recalculated to account for the time already elapsed at room temperature
Time stored at room temperature consumes stability, so the BUD must be recalculated to subtract the equivalent degradation already incurred.
Question 4: Which USP chapter establishes standards for particulate matter in injections and is relevant to the physical stability assessment of CSPs?
- USP <71>
- USP <788> (Correct answer)
- USP <1116>
- USP <85>
Correct answer: USP <788>
USP <788> specifies limits for particulate matter in injections, making it directly relevant to the physical stability evaluation of CSPs.
Question 5: An ophthalmology clinic requests a CSP eye drop with a 30-day BUD. The preparation uses only sterile commercial products as starting ingredients, and no sterility testing is performed. Under USP <797>, this request is:
- Acceptable if the preparation is made in an ISO 5 environment
- Not achievable without sterility testing data supporting the extended BUD (Correct answer)
- Acceptable under Category 1 defaults
- Permissible if a preservative is added
Correct answer: Not achievable without sterility testing data supporting the extended BUD
Without sterility testing or peer-reviewed stability data, a 30-day BUD exceeds Category 2 defaults and cannot be assigned regardless of ISO classification.
Question 6: What is the primary reason why multi-dose vials (MDVs) have a 28-day in-use BUD after initial puncture, according to USP <797>?
- The preservative system becomes less effective over time after repeated punctures (Correct answer)
- The drug undergoes photodegradation after the seal is broken
- Evaporation of the solvent concentrates the active ingredient
- The rubber stopper degrades and leaches into the solution
Correct answer: The preservative system becomes less effective over time after repeated punctures
Repeated needle punctures can introduce contaminants that overwhelm preservatives over time, so the 28-day limit reflects the window during which the antimicrobial preservative system remains reliably effective.
Question 7: A hospital pharmacy receives a sterility test failure for a batch of CSPs. Regarding BUD, what is the immediate required action?
- Extend the BUD and repeat testing
- Quarantine and recall all affected CSPs from that batch (Correct answer)
- Issue new labels with a shorter BUD
- Continue dispensing while investigating the cause
Correct answer: Quarantine and recall all affected CSPs from that batch
A sterility test failure requires immediate quarantine and recall of all affected CSPs because continued use poses a direct patient safety risk.
CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 5
Which analytical method is considered the gold standard for confirming chemical stability and potency retention in a CSP for BUD validation purposes?