Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What is the BUD for USP 795 non-sterile oral compounds?

1. 14 days

2. 30 days

3. 6 months

4. 48 hours

The correct answer is: 14 days

The beyond-use date (BUD) for non-sterile oral compounded preparations, as per USP 795 guidelines, is determined to be 14 days when stored at controlled room temperature (20-25°C or 68-77°F). This time frame is established to ensure that the compounded medication maintains its potency and safety for patient use. Compounding non-sterile preparations requires careful consideration of the stability of the ingredients, the formulation process, and the conditions under which the product will be stored. A BUD of 14 days acknowledges that many non-sterile oral compounds may not retain their effectiveness beyond this period if not refrigerated, ensuring that patients receive a product that is both effective and safe to use. It’s important to note that different types of compounded preparations can have varying BUDs based on their formulation and storage requirements. For example, a BUD of 30 days may apply to other types of non-sterile compounds but is not applicable for oral dosages in the typical conditions outlined in USP 795. This distinction emphasizes the need to adhere strictly to the recommended guidelines for specific types of compounds to ensure patient safety and therapeutic effectiveness.