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

Hand hygiene protocol

Answer

Gowning procedure

Answer

Garbing sequence

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

USP <797> sterility testing is waived

Answer

The preparation can only be compounded in a 503B outsourcing facility

Answer

The BUD is automatically extended to 180 days

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

To test the pH of compounded IV solutions before dispensing

Answer

To test the potency of active pharmaceutical ingredients

Answer

To simulate a hazardous drug spill response

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

503A pharmacies can compound large batch sizes for office stock without patient-specific prescriptions

Answer

503A pharmacies must comply with cGMP regulations

Answer

503B facilities are not required to register with the FDA

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

Shake the IV bag vigorously to mix contents

Answer

Warm the IV bag to 37°C in a water bath

Answer

Spike the bag with the primary IV tubing

Question 6

A non-sterile compounded cream contains a base of petrolatum and an active drug. Which type of record is the compounding pharmacy required to maintain for this preparation?

Accepted Answer

A compounding record (batch record) for each preparation made

Answer

A DEA Form 222 for each batch

Answer

An FDA pre-market approval application

Answer

A stability certificate from an independent laboratory for each batch