NAPLEX Question of the Week: Sterile Preparation

This week's question is regarding sterile preparations.
NAPLEX Question of the Week: Sterile Preparation
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You are staffing the IV compounding room over the weekend and one of your newer pharmacy technicians has a question. He punctured a dexamethasone phosphate 4mg/mL multi-dose 30 ml vial (used 4 ml total) from the normal pharmacy stock a few minutes ago and wishes to know whether this vial should be discarded. You inspect the vial's label and read the following:

Today's date: February 4th, 2023

Manufacturer's expiration date: February 28th, 2023

What is the correct answer?

A. The vial should not be discarded. A beyond-use-date of February 28th should be used for the vial.

B. The vial should not be discarded. A beyond-use-date of no later than February 11th should be used for the vial.

C. The vial should not be discarded. A beyond-use-date of 28 days from today should be used for the vial.

D. The vial should be discarded.

Answer with rationale:

Sterile and non sterile products are an important component of the NAPLEX. Many students in day to day practice do not necessarily encounter the various regulatory issues related to these products. Two particular NAPLEX competency statements are of note here:

  • 5.2 – Techniques, procedures, or equipment for hazardous or non-hazardous sterile products
  • 5.3 – Techniques, procedures, or equipment for hazardous or non-hazardous non-sterile products

Therefore it is prudent to study these areas in preparation for the exam.

Because this is a multi dose vial, answer D is incorrect as it is perfectly allowable to use this vial again for further compounded doses as long as stored per manufacturer's instructions. There is no indication that this has been stored inappropriately as it came from normal pharmacy stock.

Answer B is incorrect as 7 days is not an appropriate beyond-use-date (BUD) when puncturing a multi dose vial. It normally should be within 28 days of puncturing the vial. 

Answer C is incorrect as the manufacturer's expiration date falls before this 28 day date and therefore would be the default latest day the vial should be used. The 28-day recommended BUD for most instances only applies if the manufacturer's date falls after this date. Therefore the correct answer is A. 

Hope everyone had a great January and has a study plan together. If not, definitely check out our first two articles from the new year to help you create a plan personalized for you!

Dr. B

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