MCC Beyond-Use Dating and Stability

Question 1

According to USP <795>, what is the maximum beyond-use date (BUD) for a nonaqueous compounded preparation when no stability data is available (Category 1)?

Accepted Answer

180 days

Answer

14 days

Answer

90 days

Answer

365 days

Question 2

What is the primary purpose of assigning a beyond-use date to a compounded preparation?

Accepted Answer

To ensure the preparation maintains acceptable potency, quality, and purity until use

Answer

To comply with state pharmacy board requirements only

Answer

To limit the pharmacist's liability for product failures

Answer

To synchronize with the expiration date of raw ingredients

Question 3

According to USP <797>, what is the maximum BUD for a Category 1 compounded sterile preparation (CSP) stored at controlled room temperature?

Accepted Answer

12 hours

Answer

24 hours

Answer

48 hours

Answer

72 hours

Question 4

Which of the following factors does NOT directly affect the stability of a compounded preparation?

Accepted Answer

Color of the compounding hood

Answer

pH of the formulation

Answer

Packaging and container type

Answer

Storage temperature

Question 5

What type of chemical degradation occurs when a drug molecule reacts with water molecules in the formulation?

Accepted Answer

Hydrolysis

Answer

Photolysis

Answer

Oxidation

Answer

Thermolysis

Question 6

Which storage condition is most commonly used to extend the BUD of water-containing compounded preparations?

Accepted Answer

Refrigeration (2–8°C)

Answer

Elevated temperature (40°C)

Answer

Freezing (−20°C or below)

Answer

Room temperature with desiccants

Question 7

When a compounded preparation is made from a commercially manufactured drug product, how does the source product's expiration date affect the BUD assignment?

Accepted Answer

The BUD cannot exceed the expiration date of the source manufactured product

Answer

The BUD defaults to 6 months regardless of the source product's date

Answer

The source product's expiration date is irrelevant to the BUD

Answer

The BUD must be at least 1 year from the date of compounding