title: Quality-control analytical methods: a guide to quality control testing for the compounding pharmacist.
abstract: Testing procedures must be in place for pharmacies that compound sterile and nonsterile preparations, and any such procedures must meet the standards set forth in United states Pharmacopeia Chapters 795 and 797, as well as other related chapters. Having written procedures that meet the standards of the United States Pharmacopeia not only aids in assuring the safety of the patients who use these preparations, but also provides some protection for the pharmacy should quality control/quality assurance issues be questioned by regulatory authorites. A pharmacy also must consider its state board of pharmacy regulations when setting up its procedures. To provide guidance in potency testing of sterile and nosterile preparations, a compounding pharmacy should consider having a standard operating procedure in place.
authors: Eagle Analytical Services, Ltd., Houston, Texas.
authors: William J
authors: WJ
authors: Zolner