MCC Beyond-Use Dating and Stability 1

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

USP <795> allows up to 180 days for Category 1 nonaqueous formulations when no supporting stability data is available, as these formulations are inherently more stable without water.

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

BUDs are assigned to ensure compounded preparations remain safe and effective with acceptable potency, quality, and purity throughout their intended use period.

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

Category 1 CSPs have the most conservative BUD of 12 hours at controlled room temperature per USP <797>, due to minimal sterility assurance requirements.

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

The color of the compounding hood has no effect on product stability; pH, container type, and storage temperature are all critical determinants of preparation stability.

Question 5

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

Accepted Answer

Hydrolysis

Answer

Hydrolysis is the cleavage of a chemical bond by reaction with water and is one of the most common degradation pathways for drugs in aqueous formulations.

MCC - Medication Compounding Certification Practice Test

MCC - Medication Compounding Certification Practice Test

MCC Beyond-Use Dating and Stability 1