Question

question 21

according to the united states pharmacopeia (usp), which the following is the beyond-use date for a nonsterile, semisolid preparation containing water?

a maximum of 30 days from the date compounded

a maximum of 1 year from the date compounded

a maximum of 6 months from the date compounded

a maximum of 14 days from the date compounded

Explanation:

Identify the compounding type

The question asks for the beyond-use date (BUD) of a nonsterile, semisolid preparation containing water. This falls under the guidelines of USP Standards, specifically USP Chapter <795> for pharmaceutical nonsterile compounding.

Recall USP <795> BUD limits

Under USP <795>, default beyond-use dates for nonsterile compounded preparations packaged in tight, light-resistant containers are determined by the formulation type:

• Nonaqueous formulations: Not later than 6 months (or the earliest expiration date of any active pharmaceutical ingredient).
• Water-containing oral formulations: Not later than 14 days when stored at controlled cold temperatures.
• Water-containing topical/dermal and mucosal liquid and semisolid formulations: Not later than 30 days.

Apply to the given preparation

The preparation in question is a "semisolid preparation containing water" (which is a water-containing topical/dermal or mucosal semisolid formulation, such as a cream or gel). According to USP Standards, the maximum BUD for this category is 30 days from the date compounded.

Evaluate the options

• Option 1: A maximum of 30 days from the date compounded (Correct).
• Option 2: A maximum of 1 year from the date compounded (Incorrect).
• Option 3: A maximum of 6 months from the date compounded (Incorrect, this is for nonaqueous formulations).
• Option 4: A maximum of 14 days from the date compounded (Incorrect, this is for water-containing oral formulations).

Answer:

• (A) A maximum of 30 days from the date compounded (Correct answer)
• (B) A maximum of 1 year from the date compounded
• (C) A maximum of 6 months from the date compounded
• (D) A maximum of 14 days from the date compounded