CSPT - Compounded Sterile Preparation Technician Labeling and Documentation Questions and Answers 3

Question 1

When documenting a deviation from the Master Formulation Record, what is required?

Accepted Answer

The deviation must be documented with reason, approval by designated person, and impact assessment

Answer

No documentation if pharmacist approves verbally

Answer

Only a verbal notification to supervisor

Answer

Deviations are never permitted

Question 2

What is the role of Standard Operating Procedures (SOPs) in a sterile compounding program?

Accepted Answer

Mandatory written procedures that define how each process must be performed consistently

Answer

Optional guidelines with general recommendations

Answer

Marketing materials for accreditation purposes

Answer

Apply only to pharmacists

Question 3

What storage condition information is required on a CSP label?

Accepted Answer

Specific storage temperature range, light protection if applicable, and special handling requirements

Answer

Only refrigerate or room temperature

Answer

No storage information needed if dispensed immediately

Answer

The pharmacy general storage policy number

Question 4

What documentation is required for environmental monitoring results?

Accepted Answer

All results must be documented, reviewed, and trended regardless of pass or fail

Answer

Only results that exceed action levels

Answer

Environmental monitoring does not require documentation

Answer

Only viable sampling results need documentation

Question 5

What is the purpose of a recall procedure in a sterile compounding quality assurance program?

Accepted Answer

To establish a systematic process for retrieving all units of a potentially defective CSP

Answer

To return unused drugs to manufacturer for credit

Answer

To reduce pharmacy inventory levels

Answer

To notify the FDA of new formulations

Question 6

When a batch of CSPs is prepared, what batch-specific information must be recorded?

Accepted Answer

Batch number, quantity prepared, ingredient lot numbers, preparer identity, verifier identity, date/time, and yield

Answer

Only the total number of units

Answer

Only the pharmacist initials

Answer

Only needed for controlled substances