MCC Beyond-Use Dating and Stability 2

Question 1

Which analytical method is considered the gold standard for assessing drug concentration and confirming potency during stability testing of compounded preparations?

Accepted Answer

High-performance liquid chromatography (HPLC)

Answer

Visual inspection only

Answer

pH measurement

Answer

Osmolarity testing

Question 2

According to USP <797> (2023), what is the maximum BUD for a Category 2 CSP stored at controlled room temperature WITHOUT extended stability studies?

Accepted Answer

4 days

Answer

12 hours

Answer

24 hours

Answer

14 days

Question 3

What does the term 'potency' refer to in the context of beyond-use dating for compounded preparations?

Accepted Answer

The amount of active drug per unit that produces a given pharmacological effect

Answer

The color and clarity of the preparation

Answer

The microbial bioburden of the preparation

Answer

The viscosity of the compounded product

Question 4

Which organization provides the primary national standards for beyond-use dating in both sterile and non-sterile compounded preparations in the United States?

Accepted Answer

United States Pharmacopeia (USP)

Answer

FDA only

Answer

DEA only

Answer

Centers for Disease Control and Prevention (CDC)

Question 5

A pharmacist compounds a water-containing oral suspension from bulk chemicals. Under USP <795> Category 1 guidelines, what is the maximum BUD?

Accepted Answer

35 days under refrigeration

Answer

14 days at room temperature

Answer

90 days at room temperature

Answer

180 days under refrigeration

Question 6

Which of the following best describes 'accelerated stability testing' for compounded preparations?

Accepted Answer

Testing performed by exposing preparations to extreme conditions (e.g., elevated temperature/humidity) to predict long-term stability

Answer

Immediate post-compounding potency verification only

Answer

Stability testing conducted exclusively at room temperature for 30 days

Answer

Visual inspection of the preparation for color changes over 24 hours

Question 7

When peer-reviewed literature documents stability data for a specific compounded formulation, how should this data influence BUD assignment?

Accepted Answer

The BUD may be extended based on valid stability data, provided compounding conditions match those studied

Answer

Use the manufacturer's expiration date from any ingredient in place of literature data

Answer

Apply only the standard USP default BUD and ignore literature data

Answer

Assign a BUD of 1 year for any preparation with any documented stability reference