Let's solve **step-by-step** for the **actual BUD (Beyond-Use Date)** for your compounded MBK Base Suppository. --- ## 1. Gather Information **Ingredients and Expiration Dates:** - **Acetaminophen Powder (API):** 10/30/2027 - **Silica Gel:** 6/25/2026 - **MBK (Fatty Acid) Base:** 1/25/2026 --- ## 2. Determine the Earliest Expiration Date The **earliest expiration date** among your ingredients is: - **MBK Base:** 1/25/2026 --- ## 3. Apply USP <795> BUD Guidelines **Suppositories** are **non-aqueous formulations**. According to **USP <795>** (updated 2023), the default BUD for a **non-aqueous dosage form** (e.g., suppositories) is: > **"The earliest of:** > - **6 months from compounding date** > - **Expiration date of any ingredient" > **(whichever comes first)"** --- ## 4. Calculate BUD Assuming you compound **today** (let's say today is **June 15, 2024**): - **Six months from today:** December 15, 2024 - **Earliest ingredient expiration:** January 25, 2026 **Compare:** - 6 months from compounding date (**December 15, 2024**) - Earliest ingredient expiration (**January 25, 2026**) **The BUD is the earlier of the two.** --- ## 5. **Final BUD** **Final BUD:** **December 15, 2024** (6 months from compounding date, since it is earlier than any ingredient expiration) --- ## **Summary Table** | Ingredient | Expiration Date | |--------------------|-------------------| | Acetaminophen | 10/30/2027 | | Silica Gel | 6/25/2026 | | MBK Base | 1/25/2026 | - **6 months from today:** **12/15/2024** - **Earliest ingredient expiration:** **1/25/2026** **Answer:** > **The actual BUD for your compounded MBK Base Suppository is December 15, 2024.** --- **Explanation:** For non-aqueous compounds, BUD is no later than 6 months from compounding or the earliest ingredient expiration, whichever is sooner. In this case, 6 months is sooner. If you compound on a different date, add 6 months to that date and ensure it does not exceed the earliest ingredient expiration.

- Acetaminophen Powder expiration date: 10/30/2027 - Silica Gel expiration date: 6/25/2026 - MBK (Fatty Acid) Base expiration date: 1/25/2026 - The earliest ingredient expiration date is 1/25/2026. - BUD guidelines for non-aqueous formulations (like suppositories) state the BUD is the earlier of: - 6 months from the compounding date - The earliest ingredient expiration date - Assuming compounding occurs on June 15, 2024: - 6 months from that date is December 15, 2024 - The earliest ingredient expiration is January 25, 2026 - Since December 15, 2024, is earlier than January 25, 2026, the **final BUD is December 15, 2024**.