Compounding Procedures SOPs

SOP's listed as links are currently available. Others will be coming soon.
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Number Title
8.001 Prescription Order Intake
8.001.1 Anticipatory Compounding
8.002 Handling of Vials
8.002.1 General Compounding-Vials
8.003 Assignment of Prescription / Invoice Number
8.004 Assignment of Batch Number
8.005 Packaging of Compounded Sterile and Non-Sterile Preparations
8.005.02 Packing Material for Transport
8.005.03 Delivery Containers
8.006 Labeling of Completed Preparations
8.007 Shipping of a Compounded Preparation
8.008 Compounding Record - Electronic or Paper Trail Documentation for Compounded Preparations
8.008.01 Basic Compounding Documentation - The Master Formula Form
8.008.02 Basic Compounding Documentation - The Compounding Record or Batch Control Sheet
8.008.03 Master Formulation Record - Example
8.008.04 Documentation—Ingredients with NDC or API Codes
8.008.05 Clinical Studies Supporting Preparations
8.008.06 Documenting Stability, Safety and Efficacy of Ingredients
8.009 Compliance with USP <795> Pharmaceutical Compounding-Nonsterile Preparations
8.009.1 Compliance with USP <795> Pharmaceutical Compounding-Nonsterile Preparations with Beyond-Use Dates
8.01 Patient Counseling for Compounded Prescriptions
8.011 Assignment of Beyond-Use Date for Non-Sterile Compounded Preparations
8.012 Compounding Sterile Solutions
8.013 Compounding Sterile Suspensions
8.014 Extemporaneous Compounding (No Master Formula Record)
8.018 Handling Drugs in the Dry State
8.019 Handling Drugs in the Liquid State
8.02 Handling Drugs in the Semisolid State
8.021 Assignment of Beyond-Use Date for Sterile Compounded Preparations
8.021.1 Beyond Use Dating
8.021.2 Multi-Component BUD
8.022 Filling a Syringe with a Sterile Compounded Preparation
8.023 Cleaning, Sterilizing and Depyrogenating Vials
8.024 Cleaning, Sterilizing and Depyrogenating Septa
8.025 Capping Filled Vials
8.026 Washing Glassware and Equipment To Be Used in Compounding Nonsterile Preparations
8.027 Washing and Sterilizing Glassware and Equipment Used in Compounding Sterile Preparations
8.028 Establishing and Maintenance of Standard Formulas and Dilutions for Medications in Ambulatory Infusion Pumps
8.029 Use of Autoclave Indicating Paper and Tape
8.031 Hazardous Drug Spills
8.032 Transporting Cytotoxic Agents
8.033 Developing a Capsule Formulation
8.033.1 Capsule Preparation
8.034 General Aseptic Procedures Used at a Laminar Airflow Workbench
8.035 Using the Pass-Thru (Either from Anteroom to Cleanroom or with Glovebox)
8.036 Using a Vented Needle
8.037 Filtering of Ampules
8.038 Filling of Ambulatory Pumps
8.038.01 Homepump Filling
8.038.02 Intermate Infuser Filling
8.038.05 CADD - Pharmacia Deltec Medication Cassette Filling
8.039 Filling a Syringe with a Non-Sterile Compounded Preparation
8.039.1 Non-Sterile to Sterile Sterilization and Syringe Mixing
8.04 Compounding All-In-One or 3-In-One TPN
8.041 Sterile Vacuum Filtration
8.042 Steam Sterilization by Autoclave
8.044 Particle Size Reduction - Pill Tile & Spatula
8.044.1 Pulverization by Intervention
8.045 Geometric Dilution Pulverization by Intervention with Manual Mortar and Pestle
8.046 Dry Heat Sterilization
8.046.1 Dry Heat Sterilization (Depyrogenation)
8.047 Reconstitution of a Sterile Powder
8.048 Reconstitution of a Nonsterile Powder
8.049 Compounding Sterile Preparations
8.052 Geometric Dilution Pulverization by Intervention with Electric Mortar and Pestle
8.053 Pulverization of Tablets or Crystals Using an Electric Mortar and Pestle
8.054 Compounding Nonsterile Cytotoxic Drugs
8.055 List of Potentially Hazardous Chemicals - Drugs
8.056 Syringe-to-Syringe Mixing
8.058 Dry Heat Depyrogenation of Glassware and Metalware
8.059 General Compounding-Ampoules
8.060 Compounding a Formulation Using Software Documentation
8.061 Critical Site Contamination
8.062 Compounding with Concentrated Acids
8.063 Compounding Sterile Doasage Forms
8.064 Use of Single Dose and Multiple Dose Containers
8.065 Donning Procedure Order
8.066 Preparation of Intrathecal Injectables for Administration
8.067 Use of the Cleanroom Pass-Thru
8.068 Compounding Nonsterile Dosage Forms-General
8.069 Preparing Fortified Ophthalmic Drops
8.070 Equipment and Safety Precautions for Sterilization of Empty Ointment Tubes
8.079 Aseptic Filtration
8.080 Aseptic Filling and Packaging of Sterile Preparations
8.081 Filling and Packaging of Parenterals (Terminally Sterilized Preparations)
8.082 Compressed Gas Handling
8.083 Dry Heat Sterilization Requirements
8.084 Dry Heat Sterilization
8.085 Cleaning the Visual Inspection Hood
8.086 Cross-Contamination Prevention
8.090 Compounding Ointments, Creams and Pastes
8.091 Compounding Gels
8.092 Compounding Suppositories/Inserts, Troches/Lozenges and Lollipops
8.10 Compounding with 3 or More Ingredients