Compounding Pharmacy Inspections:
What You Must Know To Prepare for the FDA
A white paper by Steven G. Richter Ph.D., Microtest Labs
The U.S. Food and Drug Administration (FDA) requires all compounding pharmacies to comply with USP section <797>, which outlines the different standards and regulations for environmental control, testing, and personnel training. Currently, large-scale compounders’ operations do not fall under the scrutiny and regulation of the FDA. However, these facilities may now face inspections from both the state regulatory authorities and the federal government.
In anticipation of new FDA regulations, many companies are working toward correcting potential problems and attaining USP <797> compliance. This white paper addresses the issues that compounding pharmacies must address prior to undergoing an FDA or state inspection.