Question 42

Equipment and utensils used for nonsterile compounding should not be reactive, additive, or sorptive.

Nonsterile compounding requires that equipment and utensils do not interact with the ingredients in a way that could alter the product. This ensures the integrity and safety of the compounded formulation.

A) affect the purity of the product

This option is incorrect because the equipment and utensils should not affect the purity of the product. In fact, they must be designed to prevent any contamination or alteration of the compounded substance.

B) not be reactive, additive, or sorptive

This option is correct as it aligns with USP Chapter 795 requirements. Equipment and utensils must be constructed from materials that do not react with, add to, or absorb the active ingredients or excipients, thereby ensuring the quality and safety of the compounded products.

C) adhere to USP Chapter 797 guidelines as well

This option is incorrect in the context of nonsterile compounding as USP Chapter 797 specifically pertains to sterile compounding. While both chapters emphasize quality, the standards and requirements differ based on the nature of compounding.

D) not be made of glass or porcelain

This option is misleading as glass and porcelain can be suitable materials for certain types of nonsterile compounding, provided they are not reactive or sorptive. Therefore, this statement does not accurately reflect the requirements set forth in USP Chapter 795.

Conclusion

The correct answer, B, emphasizes the critical requirement for equipment and utensils in nonsterile compounding to avoid any reactivity or interference with the compounded product. Other options either misinterpret the guidelines or do not apply appropriately to the context of nonsterile compounding, thus supporting the necessity of option B.