Pharmacy Law Practice Exam

What is category 2 for compounding pharmacy according to 797 standards?

1. Immediate use product

2. Typical intravenous compounding in a primary control setting

3. Higher risk compounding with products requiring lots of manipulation

4. More environmental control and testing

The correct answer is: More environmental control and testing

The definition of category 2 compounding pharmacy according to the USP <797> standards is focused on the requirements for more environmental control and testing. This category addresses the need for maintaining stricter control measures during compounding processes to ensure patient safety and minimize contamination risks. In category 2 compounding, the environment must be monitored closely, including the use of clean rooms and proper air filtration systems, to mitigate risks during the compounding of sterile preparations. This level of control aims to ensure that compounded products are safe for administration, given that they are often used for patients with compromised health conditions. Other options describe different aspects or levels of compounding pharmacy practices but do not accurately capture the essence of category 2. Immediate use products, for example, fall under a different category focusing on time-sensitive needs, whereas typical intravenous compounding aligns more with the general practices of compounding rather than the specific controls associated with category 2. Higher risk compounding indicates a more complex level of preparation but does not specifically relate to the environmental controls that are central to category 2 standards.