Compounding Pharmacy Standard Operating Procedure

Description

A compounding pharmacy standard operating procedure (SOP) is a document that outlines the steps and processes involved in the preparation and handling of compounded medications. It is designed to ensure that all compounds are prepared consistently and safely, and that they meet the required standards of quality and purity. Here is an example of a compounding pharmacy SOP: Receiving and Storage of Raw Materials: All raw materials must be checked for expiration dates and proper storage conditions upon arrival. Any materials that do not meet the standards must be rejected and returned to the supplier. Raw materials must be stored in a designated area that is separate from finished products and is maintained at the appropriate temperature and humidity. Preparation of Compounded Medications: All compounds must be prepared in a clean and designated area that meets the requirements of the USP <797> standards for sterile compounding. Personal protective equipment (PPE) must be worn at all times during the preparation process. Aseptic technique must be used to minimize the risk of contamination. Compounded medications must be prepared according to the prescribed formula and checked for accuracy. Quality Control: Samples of each compound must be tested for potency, purity, and stability according to the USP <795> and <797> standards. Any compounds that do not meet the standards must be rejected and discarded. Labeling and Packaging: All compounded medications must be properly labeled with the name of the medication, the strength, the dosage form, the expiration date, and any special instructions. Medications must be packaged in a way that ensures their stability and protects them from contamination. Record Keeping: Detailed records must be kept for all compounded medications, including the formula, preparation process, testing results, and final product. These records must be readily accessible for review by the pharmacist and any regulatory agencies. Training and Certification: All staff involved in the compounding process must be trained and certified in the proper handling and preparation of compounded medications. Training must be regularly updated to ensure that all staff are knowledgeable and compliant with the SOP.