Question

Which guidelines does a Sterile Compounding Permit operate under?

a) USP 800.
b) FDA regulations.
c) State health department guidelines.
d) ACHA recommendations.

Answer 1

Option A. Sterile Compounding Permits largely follow USP standards, particularly USP 797 and USP 800, to ensure the safety and efficacy of compounded sterile medications.

Step-by-step explanation:

A Sterile Compounding Permit operates under guidelines set by USP 797 and USP 800 from the United States Pharmacopeia, which detail the standards for compounding sterile preparations and handling hazardous drugs in healthcare settings respectively. Sterile Compounding Permits largely follow USP standards, particularly USP 797 and USP 800, to ensure the safety and efficacy of compounded sterile medications.

While the FDA does oversee drug manufacturing, the specifics of sterile compounding are guided by USP standards, which are often adopted by state health boards and enforced by state health department guidelines. The ACHA (American College Health Association) may provide recommendations, but when it comes to permits and regulations for compounding pharmacies, USP standards are the primary ones followed.