Question

question 13

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

• a maximum of 1 year from the date compounded
• a maximum of 14 days from the date compounded
• a maximum of 6 months from the date compounded
• a maximum of 30 days from the date compounded

Explanation:

Identify the compounding type and guidelines

Using the USP 795 Regulations, Beyond-Use Dating, and Nonsterile Compounding knowledge points

• USP Chapter <795> governs nonsterile compounding standards.
• The preparation in question is a non-sterile, semisolid preparation containing water (such as a cream, gel, or ointment).

Determine the standard beyond-use date (BUD)

Using the Beyond-Use Dating and USP 795 Regulations knowledge points

• For nonsterile formulations, USP <795> establishes default maximum beyond-use dates (BUD) in the absence of specific stability data:
• Nonaqueous formulations: Not later than 6 months (or 180 days).
• 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.

Match with the correct option

Using the Beyond-Use Dating knowledge point

• A water-containing semisolid preparation (topical/dermal) has a maximum BUD of 30 days from the date compounded.
• This matches the fourth option: "A maximum of 30 days from the date compounded".

Answer:

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