Records and record-keeping for the hospital compounding pharmacist

The United States Pharmacopeial Convention, Inc., is recognized by federal law and by most state boards of pharmacy as the official group for setting the standards for pharmaceuticals and pharmacy practice, including compounding. The standards of United States Pharmacopeia Chapter 795 require that a pharmacy maintain records on a compounded preparation, including the formulation record, and a Material Safety Data Sheets file. The American Society of Health-Systems Pharmacists' guidelines require that hospital pharmacy departments maintain at least four sets of records in the compounding area: (1) compounding formulas and procedures, (2) compounding logs of all compounded preparations, including batch records and sample batch labels, (3) equipment maintenance records, and (4) a record of ingredients purchased, including cerificates of analysis and Material Saftey Data Sheets. Hospital compounding records may be inspected by any of several outside organizations, including state boards of pharmacy, third-party payers, the Joint Commission on Accreditaion of Healthcare Organizations, the Drug Enforcement Agency, and attorneys. With the existing standards and guidelines in place and the importance of documentation unquestionable, a record of pharmacy activites should be maintained in a compounding pharmacy so that preparations can be replicated consistently, the history of each ingredient traced, equipment maintenance and calibration verified, and compounding procedures evaluated easily.