Under Category 2 BUDs for USP 797, which statement is accurate?

Under Category 2 BUDs for USP 797, which statement is accurate?

• A. Category 2 does not involve terminal sterilization
• B. Category 2 BUD is always exactly 14 days
• C. The BUD includes 14 days at RT, 28 days refrigerator, and 45 days freezer
• D. Refrigeration is prohibited for Category 2

Answer: (C)

BUD for Category 2 USP 797 compounds depends on how the product is stored, with longer time windows allowed when you refrigerate or freeze. For Category 2, the dates reflect stability data that support use for a while under proper storage: 14 days at room temperature, 28 days in the refrigerator, and 45 days in the freezer. Refrigeration slows both chemical degradation and microbial growth, and freezing can extend the usable window further, provided the drug and vehicle remain stable and the product remains protected from contamination. This is why that option is the best: it aligns with the established Category 2 BUD schedule. The other statements are not correct because BUD is not fixed at 14 days regardless of temperature, refrigeration is not prohibited (it’s permitted under Category 2), and terminal sterilization is not the determinant described by the BUD durations themselves.

BUD for Category 2 USP 797 compounds depends on how the product is stored, with longer time windows allowed when you refrigerate or freeze. For Category 2, the dates reflect stability data that support use for a while under proper storage: 14 days at room temperature, 28 days in the refrigerator, and 45 days in the freezer. Refrigeration slows both chemical degradation and microbial growth, and freezing can extend the usable window further, provided the drug and vehicle remain stable and the product remains protected from contamination.

This is why that option is the best: it aligns with the established Category 2 BUD schedule. The other statements are not correct because BUD is not fixed at 14 days regardless of temperature, refrigeration is not prohibited (it’s permitted under Category 2), and terminal sterilization is not the determinant described by the BUD durations themselves.