NAPLEX (North American Pharmacist Licensure Examination) Practice Exam

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What is defined as a medium risk CSP?

Using non-sterile ingredients or equipment
Using more than 3 sterile ingredients, including batch preparations
<=3 sterile ingredients, no more than 2 entries into any 1 sterile container
Opening SDC inside ISO 5 environment

The correct answer is: Using more than 3 sterile ingredients, including batch preparations

A medium risk CSP is defined as a compounded sterile preparation that uses more than 3 sterile ingredients, including batch preparations. Option A is incorrect because using non-sterile ingredients or equipment would make the CSP a high risk. Option C is incorrect because it limits the number of sterile ingredients to 3 and the number of entries into any one container to 2, making it a low risk CSP. Option D is incorrect because it refers to opening primary engineering control inside an ISO 5 environment, but it does not specify the number of sterile ingredients used in the preparation, which would still determine its risk level. Therefore, option B is the most accurate definition of a medium risk CSP.