ExCPT Test Sterile and Non-Sterile Compounding 3

Question 1

Which component of aseptic technique involves maintaining a direct, unobstructed pathway of ISO 5 air from the HEPA filter to the critical site?

Accepted Answer

Critical site protection / first air principle

Answer

The 'first air principle' means the first air to contact a critical site (needle tip, vial septum, syringe tip) must be uncontaminated ISO 5 air directly from the HEPA filter — no objects should block this airflow.

Question 2

A compounded preparation contains a controlled substance. Which additional regulatory requirement applies?

Accepted Answer

DEA regulations for controlled substance handling, storage, and record-keeping apply

Answer

When compounding involves controlled substances, DEA regulations overlay all other compounding requirements — including proper DEA registration, storage in appropriate vaults/safes, and mandatory record-keeping.

Question 3

What is the purpose of media-fill testing in sterile compounding?

Accepted Answer

To verify that a compounder's aseptic technique does not introduce microbial contamination

Answer

Media-fill tests use a sterile microbiological growth medium in place of actual drug solution. If technique is proper, the medium should remain sterile (no growth); turbidity indicates a breach in aseptic technique.

Question 4

Which of the following is a key difference between a 503A compounding pharmacy and a 503B outsourcing facility?

Accepted Answer

503B outsourcing facilities can compound large batches without patient-specific prescriptions under FDA oversight

Answer

503B outsourcing facilities are FDA-registered entities that can compound large batches for office stock/hospital use without individual patient prescriptions but must comply with cGMP standards and FDA oversight.

Question 5

When preparing an IV admixture, what should the technician do BEFORE adding a drug to an IV bag?

Accepted Answer

Visually inspect the IV bag for particulate matter, leaks, and clarity

Answer

Before adding any drug to an IV bag, the bag must be visually inspected for particulate matter, discoloration, cloudiness, leaks, cracks, or any abnormality that would render it unsuitable for use.

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ExCPT Test Sterile and Non-Sterile Compounding 3