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STANDARD OPERATING PROCEDURES – NON-STERILE & STERILE SET (USP <795>, USP <797> & USP <800>)

Facilitate your day-to-day compliance with our comprehensive set of 70+ non-sterile, customizable, user-friendly SOPs


Product No: SP001


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Description


- Over 150 non-sterile and sterile (non-hazardous and hazardous) SOP templates organized in a logical, user-friendly infrastructure that will save you time, improve the quality of your compounding practice, and facilitate your day-to-day compliance.


- Each SOP Is customizable allowing you to adapt them to your specific pharmacy's needs.


- Our SOPs will assist your pharmacy in achieving compliance with regulatory guidelines and standards of practice:

  • USP <795> (currently official as of Nov. 1, 2023), USP <797> (currently official as of Nov. 1, 2023), USP <800> (2020), and related chapters
  • National institute for Occupational Safety and Health (NIOSH)
  • Occupational Safety and Health Administration (OSHA)
  • Controlled Environmental Testing Association (CETA)
  • Environmental Protection Agency (EPA)
  • Drug Enforcement Administration (DEA)
  • ACHC/PCAB accreditation requirements

- Our SOPs will also facilitate accreditation with ACHC/PCAB and NABP Compounding Pharmacy accreditation.


All SOPs must be downloaded within one (1) year from date of purchase, with a limit of one (1) download per SOP package




Non-Sterile SOP Master Index






Preamble SOPs

- Preamble - Implementing - Standard Operating Procedures - Compounding Practices

- Preamble - Customizing - Standard Operating Procedures - Compounding Practices

- Preamble - Recording - Good Documenting Practices - Compounding Practices

- Preamble - Credentialing - Compounding Facilities - Compounding Practices

- Preamble - Managing - QA & QC Programs - Compounding Practices

- Preamble - Managing - Hazard Communication Program - Compounding Practices (HD)

- Preamble - Managing - Risk Determination Program - Compounding Practices (HD)

- Preamble - Managing - Vendor Qualification - Compounding Practices

Procedure SOPs

- Procedure - Reviewing - Quarterly and Annual Assessments - Compounding Practices

- Procedure - Cleaning & Sanitizing - Compounding Facility - Compounding Practices

- Procedure - Deactivating & Decontaminating - Compounding Facility - Compounding Practices (HD)

- Procedure - Cleaning - Chemical Spills - Compounding Practices

- Procedure - Receiving - Chemicals - Compounding Practices

- Procedure - Storing - Chemicals - Compounding Practices

- Procedure - Storing - Chemicals - Compounding Practices (HD)

- Procedure - Managing – Mapping Strategies - Compounding Practices (HD)

- Procedure - Managing - Environment - Compounding Practices

- Procedure - Managing - Environment - Compounding Practices (HD)

- Procedure - Managing - Incidents and Accidents - Compounding Practices

- Procedure - Managing - Inventory Discrepancies - Compounding Practices

- Procedure - Managing - Emergency Equipment and Supplies - Compounding Practices

- Procedure - Managing - Waste Disposal - Compounding Practices

- Procedure - Managing - Power Outages - Compounding Practices

- Procedure - Operating - Capsule Machine - Compounding Practices

- Procedure - Operating - Electronic Balance - Compounding Practices

- Procedure - Operating - Hot Plate Stirrer - Compounding Practices

- Procedure - Operating - Measuring Devices - Compounding Practices

- Procedure - Operating - Mill - Compounding Practices

- Procedure - Operating - Mixing Technology - Compounding Practices

- Procedure - Operating - pH Meter - Compounding Practices

- Procedure - Operating - Refrigerator and Freezer - Compounding Practices

- Procedure - Operating - Thermometer - Compounding Practices

- Procedure - Operating - Manual Tumbler Mixer - Compounding Practices

- Procedure - Operating - Planetary Mixer - Compounding Practices

- Procedure - Operating - Analytical Balance - Compounding Practices

- Procedure - Performing - Mock Recall (Inventory & Preparations) - Compounding Practices

- Procedure - Performing - Recall (Inventory & Preparations) - Compounding Practices

Patient SOPs

- Patient - Processing - Compounding Records - Compounding Practices

- Patient - Processing - Return of Prescriptions - Compounding Practices

- Patient - Performing - Counseling and Monitoring - Compounding Practices

- Patient - Managing - Medication Therapy - Compounding Practices

- Patient - Reporting - Medication Errors - Compounding Practices

- Patient - Reporting - Complaints - Compounding Practices

- Patient -Reporting - Adverse Events - Compounding Practices

Personnel SOPs

- Personnel - Managing - Employment - Compounding Practices

- Personnel - Managing - Professional Development - Compounding Practices

- Personnel - Managing - Professional Development - Compounding Practices (HD)

- Personnel - Monitoring - Infection Control - Compounding Practices

- Personnel - Monitoring - Medical Surveillance - Compounding Practices (HD)

- Personnel - Gowning - Personal Protective Equipment - Compounding Practices

- Personnel - Gowning - Personal Protective Equipment - Compounding Practices (HD)

Process SOPs

- Process - Developing - Process Development Records - Compounding Practices

- Process - Developing - Non-Sterile Dosage Forms - Compounding Practices

- Process - Performing - Visual Inspections - Compounding Practices

- Process - Performing - Independent Batch Testing - Compounding Practices

- Process - Assigning - Beyond-Use Dates - Compounding Practices

- Process - Labeling - Finished Preparations - Compounding Practices

- Process - Testing - Weight Variance - Compounding Practices

- Process - Packaging - Compounded Non-Sterile Preparations - Compounding Practices

- Process - Shipping - Compounded Non-Sterile Preparations - Compounding Practices

Controlled Substance SOPs

- Property - Purchasing - Inventory - Controlled Substances

- Property - Processing - Inventory - Controlled Substances

- Property - Processing - Return of Goods Authorization - Controlled Substances

- Procedure - Storing - Inventory - Controlled Substances

- Procedure - Reporting - Discrepancies - Controlled Substances

- Procedure - Disposing - Chemicals - Controlled Substances

- Procedure - Performing - Mock Recall - Controlled Substances

- Procedure - Performing - Recall - Controlled Substances

- Preparation - Assessing - Order to Compound - Controlled Substances

- Preparation - Labeling - Requirements - Controlled Substances

- Preparation - Dispensing - Verification - Controlled Substances

Property SOPs

- Property - Purchasing - Technology - Compounding Practices

- Property - Purchasing - Chemicals - Compounding Practices

- Property - Excluding - Banned Substances - Compounding Practices

Preparation SOPs

- Preparation - Managing - Formulation Record Database - Compounding Practices





Sterile SOP Master Index






Preamble SOPs

- Preamble - Implementing - Standard Operating Procedures - Compounding Practices

- Preamble - Customizing - Standard Operating Procedures - Compounding Practices

- Preamble - Recording - Good Documenting Practices - Compounding Practices

- Preamble - Credentialing - Compounding Facilities - Compounding Practices

- Preamble - Managing - QA & QC Programs - Compounding Practices

- Preamble - Managing - Hazard Communication Program - Compounding Practices (HD)

- Preamble - Managing – CSP Categories – Compounding Practices

- Preamble - Managing - Risk Determination Program - Compounding Practices (HD)

- Preamble - Managing - Vendor Qualification - Compounding Practices

Procedure SOPs

- Procedure - Reviewing - Quarterly and Annual Assessments - Compounding Practices

- Procedure - Cleaning & Disinfecting - Compounding Facility - Compounding Practices

- Procedure - Deactivating & Decontaminating - Compounding Facility - Compounding Practices (HD)

- Procedure - Cleaning - Chemical Spills - Compounding Practices

- Procedure - Receiving - Chemicals - Compounding Practices

- Procedure - Storing - Chemicals - Compounding Practices

- Procedure - Storing - Chemicals - Compounding Practices (HD)

- Procedure - Managing - Environment - Compounding Practices

- Procedure - Managing - Environment - Compounding Practices (HD)

- Procedure - Managing - Incidents and Accidents - Compounding Practices

- Procedure - Managing - Inventory Discrepancies - Compounding Practices

- Procedure - Managing - Emergency Equipment and Supplies - Compounding Practices

- Procedure - Managing - Waste Disposal - Compounding Practices

- Procedure - Managing - Power Outages - Compounding Practices

- Procedure - Managing - Mapping Strategies - Compounding Practices

- Procedure - Maintaining - Sanitary Conditions - Compounding Practices

- Procedure - Sampling - Airborne Particle Count - Compounding Practices

- Procedure - Sampling - Air and Surface CFU Count, and Chemical Residue - Compounding Practices

- Procedure - Operating - Electronic Balance - Compounding Practices

- Procedure - Operating - Hot Plate Stirrer - Compounding Practices

- Procedure - Operating - Measuring Devices - Compounding Practices

- Procedure - Operating - Depyrogenation Oven - Compounding Practices

- Procedure - Operating - Dry Heat Sterilizer - Compounding Practices

- Procedure - Operating - Steam Heat Sterilizer - Compounding Practices

- Procedure - Operating - Incubator - Compounding Practices

- Procedure - Operating - pH Meter - Compounding Practices

- Procedure - Operating - Refrigerator and Freezer - Compounding Practices

- Procedure - Operating - Thermometer - Compounding Practices

- Procedure - Operating - Closed System Transfer Device - Compounding Practices (HD)

- Procedure - Operating - Automated Compounding Devices - Compounding Practices

- Procedure - Operating - Nitrogen Gas Dispenser - Compounding Practices

- Procedure - Operating - Filters - Compounding Practices

- Procedure - Operating – CAI or CACI - Compounding Practices

- Procedure - Operating - Analytical Balance - Compounding Practices

- Procedure - Performing - Mock Recall (Inventory & Preparations) - Compounding Practices

- Procedure - Performing - Recall (Inventory & Preparations) - Compounding Practices

Patient SOPs

- Patient - Processing - Compounding Records - Compounding Practices

- Patient - Processing - Return of Prescriptions - Compounding Practices

- Patient - Performing - Counseling and Monitoring - Compounding Practices

- Patient - Managing - Medication Therapy - Compounding Practices

- Patient - Managing - Medication Errors - Compounding Practices

- Patient - Reporting - Complaints - Compounding Practices

- Patient - Reporting - Adverse Events - Compounding Practices

Personnel SOPs

- Personnel - Managing - Employment - Compounding Practices

- Personnel - Managing - Professional Development - Compounding Practices

- Personnel - Managing - Professional Development - Compounding Practices (HD)

- Personnel - Performing – Garbing and Hand Hygiene - Compounding Practices

- Personnel - Personnel – Performing – Aseptic Manipulations - Compounding Practices

- Personnel - Monitoring - Infections - Compounding Practices

- Personnel - Monitoring - Medical Surveillance - Compounding Practices (HD)

- Personnel - Garbing - Hand Hygiene and PPE - Compounding Practices

- Personnel - Garbing - Hand Hygiene and PPE - Compounding Practices (HD)

- Personnel - Preventing - Needle Sticks - Compounding Practices

Process SOPs

- Process - Developing - Process Development Records - Compounding Practices

- Process - Performing - Visual Inspections - Compounding Practices

- Process - Assigning - Beyond-Use Dates - Compounding Practices

- Process - Labeling - Finished Preparations - Compounding Practices

- Process - Testing - Sterility - Compounding Practices

- Process - Testing - Endotoxins - Compounding Practices

- Process - Testing - Stability - Compounding Practices

- Process - Testing - Antimicrobial Effectiveness - Compounding Practices

- Process - Packaging - Compounded Sterile Preparations - Compounding Practices

- Process - Shipping - Compounded Sterile Preparations - Compounding Practices

- Process - Performing – Aseptic Technique - Compounding Practices

Controlled Substance SOPs

- Property - Purchasing - Inventory - Controlled Substances

- Property - Processing - Inventory - Controlled Substances

- Property - Processing - Return of Goods Authorization - Controlled Substances

- Procedure - Storing - Inventory - Controlled Substances

- Procedure - Reporting - Discrepancies - Controlled Substances

- Procedure - Disposing - Chemicals - Controlled Substances

- Procedure - Performing - Mock Recall - Controlled Substances

- Procedure - Performing - Recall - Controlled Substances

- Preparation - Assessing - Order to Compound - Controlled Substances

- Preparation - Labeling - Requirements - Controlled Substances

- Preparation - Dispensing - Verification - Controlled Substances

Property SOPs

- Property - Selecting - Technology - Compounding Practices

- Property - Selecting - Chemicals - Compounding Practices

- Property - Excluding – Banned Substances - Compounding Practices

Preparation SOPs

- Preparation - Managing - Formulation Record Database - Compounding Practices



Consultant travel and accommodations not included.

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