INTRODUCTION

The need for a quality assurance system is well documented in United States Pharmacopeia (USP) chapters for compounded preparations (see Quality Control under Pharmaceutical Compounding—Nonsterile Preparations 〈795〉 and Quality Assurance (QA) Program under Pharmaceutical Compounding—Sterile Preparations 〈797〉). A quality assurance program is guided by written procedures that define responsibilities and practices that ensure compounded preparations are produced with quality attributes appropriate to meet the needs of patients and health care professionals. The authority and responsibility for the Quality Assurance program should be clearly defined and implemented and should include at least the following nine separate but integrated components: (1) training; (2) standard operating procedures (SOPs); (3) documentation; (4) verification; (5) testing; (6) cleaning, disinfecting, and safety; (7) containers, packaging, repackaging, labeling, and storage; (8) outsourcing, if used; and (9) responsible personnel.