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Compounding Procedures SOPs

SOP's listed as links are currently available. Others will be coming soon.
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Number Updated Reviewed  Title
8.001 10/18/23 Prescription Order Intake
8.001.1 12/7/17 10/18/23 Anticipatory Compounding
8.002 10/18/23 Handling of Vials
8.002.1 7/21/08 10/18/23 General Compounding-Vials
8.003 10/18/23 Assignment of Prescription / Invoice Number
8.004 10/18/23 Assignment of Batch Number
8.005 10/18/23 Packaging of Compounded Sterile and Non-Sterile Preparations
8.005 u 8/21/19 10/18/23 Packaging of Compounded Sterile and Non-Sterile Preparations (USP 2019)
8.005.02 10/18/23 Packing Material for Transport
8.005.03 7/21/08 10/18/23 Delivery Containers
8.005.2 u 8/21/19 10/18/23 Packing Material for Transport (USP 2019)
8.006 9/5/08 10/18/23 Labeling of Completed Preparations
8.006 u 8/21/19 10/18/23 Labeling of Completed Preparations (USP 2019)
8.007 10/18/23 Shipping of a Compounded Preparation
8.008 10/18/23 Compounding Record - Electronic or Paper Trail Documentation for Compounded Preparations
8.008.01 10/18/23 Basic Compounding Documentation - The Master Formula Form
8.008.02 10/18/23 Basic Compounding Documentation - The Compounding Record or Batch Control Sheet
8.008.03 7/21/08 10/18/23 Master Formulation Record - Example
8.008.04 2/19/15 10/18/23 Documentation—Ingredients with NDC or API Codes
8.008.05 4/28/15 10/18/23 Clinical Studies Supporting Preparations
8.008.06 4/28/15 10/18/23 Documenting Stability, Safety and Efficacy of Ingredients
8.008.1 u 8/21/19 10/18/23 Basic Compounding Documentation - The Master Formula Form (USP 2019)
8.008.2 u 8/21/19 10/18/23 Basic Compounding Documentation - The Compounding Record (USP 2019)
8.009 4/5/17 10/18/23 Compliance with USP <795> Pharmaceutical Compounding-Nonsterile Preparations
8.009.1 8/14/17 10/18/23 Compliance with USP <795> Pharmaceutical Compounding-Nonsterile Preparations with Beyond-Use Dates
8.01 10/18/23 Patient Counseling for Compounded Prescriptions
8.011 10/18/23 10/18/23 Assignment of Beyond-Use Date for Non-Sterile Compounded Preparations
8.011 u 8/21/19 10/18/23 Assignment of Beyond-Use Date Non-Sterile Compounded Preparations (USP 2019)
8.012 10/18/23 Compounding Sterile Solutions
8.013 10/18/23 Compounding Sterile Suspensions
8.014 10/18/23 Extemporaneous Compounding (No Master Formula Record)
8.018 10/18/23 Handling Drugs in the Dry State
8.019 10/18/23 Handling Drugs in the Liquid State
8.02 10/18/23 Handling Drugs in the Semisolid State
8.021 10/18/23 10/18/23 Assignment of Beyond-Use Date for Sterile Compounded Preparations
8.021.1 7/21/08 10/18/23 Beyond Use Dating
8.021.2 4/28/15 10/18/23 Multi-Component BUD
8.021.7 u 8/21/19 10/18/23 Assignment of Beyond-Use Date for Sterile Compounded Preparations (USP 2019)
8.022 10/18/23 Filling a Syringe with a Sterile Compounded Preparation
8.023 10/18/23 Cleaning, Sterilizing and Depyrogenating Vials
8.024 10/18/23 Cleaning, Sterilizing and Depyrogenating Septa
8.025 10/18/23 Capping Filled Vials
8.026 10/18/23 Washing Glassware and Equipment To Be Used in Compounding Nonsterile Preparations
8.027 4/20/05 10/18/23 Washing and Sterilizing Glassware and Equipment Used in Compounding Sterile Preparations
8.028 10/18/23 Establishing and Maintenance of Standard Formulas and Dilutions for Medications in Ambulatory Infusion Pumps
8.029 10/18/23 Use of Autoclave Indicating Paper and Tape
8.031 4/1/16 10/18/23 Hazardous Drug Spills
8.032 10/18/23 Transporting Cytotoxic Agents
8.033 10/18/23 Developing a Capsule Formulation
8.033.1 6/4/18 10/18/23 Capsule Preparation
8.034 10/18/23 General Aseptic Procedures Used at a Laminar Airflow Workbench
8.034 u 8/21/19 10/18/23 General Aseptic Procedures Used at a Laminar Airflow Workbench (USP 2019)
8.035 10/18/23 Using the Pass-Thru (Either from Anteroom to Cleanroom or with Glovebox)
8.036 10/18/23 Using a Vented Needle
8.037 10/18/23 Filtering of Ampules
8.038 10/18/23 Filling of Ambulatory Pumps
8.038.01 10/18/23 Homepump Filling
8.038.02 6/2/05 10/18/23 Intermate Infuser Filling
8.038.05 10/18/23 CADD - Pharmacia Deltec Medication Cassette Filling
8.039 10/18/23 Filling a Syringe with a Non-Sterile Compounded Preparation
8.039.1 5/14/12 10/18/23 Non-Sterile to Sterile Sterilization and Syringe Mixing
8.04 10/18/23 Compounding All-In-One or 3-In-One TPN
8.041 10/18/23 Sterile Vacuum Filtration
8.042 10/18/23 Steam Sterilization by Autoclave
8.044 10/18/23 Particle Size Reduction - Pill Tile & Spatula
8.044.1 9/16/08 10/18/23 Pulverization by Intervention
8.045 10/18/23 Geometric Dilution Pulverization by Intervention with Manual Mortar and Pestle
8.046 10/18/23 Dry Heat Sterilization
8.046.1 8/27/08 10/18/23 Dry Heat Sterilization (Depyrogenation)
8.047 6/2/05 10/18/23 Reconstitution of a Sterile Powder
8.048 6/2/05 10/18/23 Reconstitution of a Nonsterile Powder
8.049 6/2/05 10/18/23 Compounding Sterile Preparations
8.052 10/18/23 Geometric Dilution Pulverization by Intervention with Electric Mortar and Pestle
8.053 6/2/05 10/18/23 Pulverization of Tablets or Crystals Using an Electric Mortar and Pestle
8.054 6/2/05 10/18/23 Compounding Nonsterile Cytotoxic Drugs
8.055 3/30/15 10/18/23 List of Potentially Hazardous Chemicals - Drugs
8.056 3/30/15 10/18/23 Syringe-to-Syringe Mixing
8.058 2/1/06 10/18/23 Dry Heat Depyrogenation of Glassware and Metalware
8.059 7/21/08 10/18/23 General Compounding-Ampoules
8.060 7/21/08 10/18/23 Compounding a Formulation Using Software Documentation
8.061 7/31/08 10/18/23 Critical Site Contamination
8.062 9/5/08 10/18/23 Compounding with Concentrated Acids
8.063 8/15/08 10/18/23 Compounding Sterile Doasage Forms
8.064 8/15/08 10/18/23 Use of Single Dose and Multiple Dose Containers
8.064 u 8/21/19 10/18/23 Use of Single Dose and Multiple Dose Containers (USP 2019)
8.064.1 u 8/21/19 10/18/23 Use of Compounded Multiple Dose CSPs as Components in Compounding CSPs (USP 2019)
8.064.2 u 8/21/19 10/18/23 Use of Compounded Single-Dose CSPs as Components in Compounding CSPs (USP 2019)
8.065 8/15/08 10/18/23 Donning Procedure Order
8.066 8/27/08 10/18/23 Preparation of Intrathecal Injectables for Administration
8.067 9/5/08 10/18/23 Use of the Cleanroom Pass-Thru
8.068 9/16/08 10/18/23 Compounding Nonsterile Dosage Forms-General
8.069 9/16/08 10/18/23 Preparing Fortified Ophthalmic Drops
8.070 5/30/12 10/18/23 Equipment and Safety Precautions for Sterilization of Empty Ointment Tubes
8.079 5/30/12 10/18/23 Aseptic Filtration
8.080 5/30/12 10/18/23 Aseptic Filling and Packaging of Sterile Preparations
8.081 5/30/12 10/18/23 Filling and Packaging of Parenterals (Terminally Sterilized Preparations)
8.082 5/30/12 10/18/23 Compressed Gas Handling
8.083 5/30/12 10/18/23 Dry Heat Sterilization Requirements
8.084 5/30/12 10/18/23 Dry Heat Sterilization
8.085 5/30/12 10/18/23 Cleaning the Visual Inspection Hood
8.086 7/17/14 10/18/23 Cross-Contamination Prevention
8.090 1/8/15 10/18/23 Compounding Ointments, Creams and Pastes
8.091 1/8/15 10/18/23 Compounding Gels
8.091.1 6/4/20 10/18/23 Preparation of Sterile Gels
8.092 2/7/17 10/18/23 Compounding Suppositories/Inserts, Troches/Lozenges and Lollipops
8.093 6/12/20 10/18/23 Compounding Nonsterile Suspensions
8.094 6/12/20 10/18/23 Compounding Nonsterile Solutions
8.10 10/26/18 10/18/23 Compounding with 3 or More Ingredients
8.20 u 8/21/19 10/18/23 Introducing Items Into the Cleanroom and PEC (USP 2019)