Question 32

The labeling of a compounded nonsterile preparation shall include the active component(s).

Labeling for compounded nonsterile preparations must clearly indicate the active component(s) to ensure proper identification and use of the preparation.

A) the compound's indication

While including the indication may be beneficial for patient understanding, USP Chapter 795 does not mandate the indication as a required element of labeling for compounded nonsterile preparations, making this option incorrect.

B) any anticipated side effect(s)

Although informing about potential side effects is important in medication safety, USP Chapter 795 does not specify that anticipated side effects must be included in the labeling of compounded nonsterile preparations, rendering this option incorrect.

C) an NDC number

An NDC (National Drug Code) number is typically associated with commercially manufactured drugs and is not required for compounded preparations according to USP Chapter 795, thus making this option incorrect.

D) the active component(s)

This option is correct as USP Chapter 795 explicitly states that the labeling of compounded nonsterile preparations must include the active component(s) to provide essential information for safe and effective use.

Conclusion

The labeling requirement for active component(s) ensures that healthcare providers and patients have critical information necessary for the safe administration of the preparation. Other options, while relevant to medication safety, do not align with the specific requirements set forth in USP Chapter 795, confirming that D is the definitive correct answer.