Compounding Documentation
Introduction Good Compounding Practice, 2018 stipulates that compounding documents should include Master formulas Compounding records Standard operating procedures (SOPs) and related records Records such as the Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) for all ingredients According to Good Compounding Practice, 2018 , all records and reports should be retained for 1 year after the beyond-use date, in accordance with relevant laws. Prescription for compounded poisons intended for individual patients must be retained for at least 2 years. During the retention period, all records and reports must be readily available for authorized inspection. NOTE: Pharmaceutical Compounding and Dispensing, 2010 suggests that extemporaneous record sheets should be kept for a minimum of two years, although ideally five years would be advisable. Master Formula The master formulation record (or master formula) serves as the recipe for compounding a preparation , outlining the r...