Question 1

What is the primary purpose of USP <795> in pharmacy practice?

Accepted Answer

USP <795> establishes standards for the preparation, labeling, quality criteria, and beyond-use dating of non-sterile compounded preparations to ensure patient safety and product quality.

Question 2

What is the purpose of a Wedgwood mortar compared to a glass mortar in non-sterile compounding?

Accepted Answer

A Wedgwood mortar's rough, porous surface makes it ideal for grinding and reducing hard, crystalline substances, while a glass mortar's smooth, non-porous surface is preferred for mixing liquids and for preparations where staining must be avoided.

Question 3

What is geometric dilution and why is it used in non-sterile compounding?

Accepted Answer

Geometric dilution is a technique for combining ingredients in which a small amount of drug is mixed with an equal part of diluent, then progressively larger portions of diluent are added, ensuring uniform distribution of a potent ingredient throughout the final preparation.

Question 4

What is the difference between an oil-in-water (O/W) cream and a water-in-oil (W/O) cream?

Accepted Answer

In an O/W cream, oil droplets are dispersed in a water continuous phase, making it lighter and washable; in a W/O cream, water droplets are dispersed in an oil continuous phase, making it greasier, more occlusive, and better for dry skin.

Question 5

What information must be included in a compounding log (batch record) according to USP <795>?

Accepted Answer

A compounding log must include the preparation name, formula, lot numbers of ingredients, quantities used, beyond-use date, initials of the compounder and verifying pharmacist, date prepared, and any notable observations or deviations.

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