Aqueous Preserved Formulation BUD refrigerated or controlled room temperature?

Aqueous Preserved Formulation BUD refrigerated or controlled room temperature?

• A. 14 days
• B. 35 days
• C. 90 days
• D. 180 days

Answer: (B)

The key idea is that the beyond-use date for compounded products depends on whether the formulation is aqueous and preserved. Preservatives help prevent microbial growth, which allows a longer shelf life than unpreserved aqueous products. For an aqueous formulation that contains a preservative, the established beyond-use date is 35 days, and this applies whether the product is stored in the refrigerator or at controlled room temperature. So 35 days is the correct BUD for preserved aqueous formulations under either storage condition. (If the formulation were unpreserved, the BUD would be shorter, such as 14 days when refrigerated.)

The key idea is that the beyond-use date for compounded products depends on whether the formulation is aqueous and preserved. Preservatives help prevent microbial growth, which allows a longer shelf life than unpreserved aqueous products. For an aqueous formulation that contains a preservative, the established beyond-use date is 35 days, and this applies whether the product is stored in the refrigerator or at controlled room temperature. So 35 days is the correct BUD for preserved aqueous formulations under either storage condition. (If the formulation were unpreserved, the BUD would be shorter, such as 14 days when refrigerated.)