Among USP 795 compound BUDs, which dosage form generally has the longest beyond-use date?

• A. Non-preserved aqueous
• B. Preserved aqueous
• C. Nonaqueous dosage forms
• D. Solid dosage forms

Answer: (D)

In USP 795, how long you can keep a compounded product (beyond-use date) hinges on water content and microbial risk. Water-containing preparations are more prone to microbial growth and hydrolysis, so their BUDs are shorter. Non-aqueous formulations, which have little to no water, are limited mainly by the stability of the ingredients and often permit a longer BUD. Solid dosage forms are essentially dry and very stable, with minimal moisture, so they tend to have the longest BUD among common compounded dosage forms. That’s why solid dosage forms are associated with the longest beyond-use date.