Compounding Pharmacy Software: USP 800 Compliance and Batch Management 2026

Compounding pharmacies face unprecedented regulatory complexity in 2026, with full enforcement of USP 795, 797, and 800 standards by state boards of pharmacy and FDA oversight. Specialized compounding pharmacy software has evolved from basic label printing to comprehensive quality management systems ensuring compliance, patient safety, and operational efficiency. This guide covers compounding software platforms, USP compliance features, batch management automation, and strategies for building profitable, compliant compounding operations.

Understanding Compounding Pharmacy Regulations 2026

USP Standards Overview

USP <795>: Pharmaceutical Compounding—Nonsterile Preparations

• Standards for compounding nonsterile medications
• Beyond-use dating (BUD) requirements
• Quality control and testing
• Facility and equipment standards
• Personnel training and competency
• Status: Current version enforceable

USP <797>: Pharmaceutical Compounding—Sterile Preparations

• Standards for sterile compounding (IV admixtures, injections, ophthalmics)
• Cleanroom classification requirements (ISO Class 5, 7, 8)
• Environmental monitoring and testing
• Personnel gowning and aseptic technique
• Media fill testing and competency assessment
• Status: Revised version effective, with continued updates

USP <800>: Hazardous Drugs—Handling in Healthcare Settings

• Standards for handling antineoplastics and other hazardous drugs
• Receipt, storage, compounding, dispensing, administration, disposal
• Containment primary and secondary engineering controls
• Personal protective equipment (PPE) requirements
• Environmental monitoring and wipe sampling
• Status: Enforceable by FDA as of November 1, 2023; state boards enforcing

FDA Oversight and Enforcement

Current Regulatory Framework:

• 503A Pharmacies: Traditional compounding under state pharmacy board oversight
• 503B Outsourcing Facilities: Register with FDA, subject to cGMP requirements
• FDA Inspections: Increasing frequency for both 503A and 503B
• Adverse Event Reporting: Mandatory for serious complications
• Product Recall Authority: FDA can mandate recalls for non-compliant products

State Board Requirements

Licensure and Inspections:

• Specialized compounding pharmacy licenses (many states)
• Annual or biennial inspections
• USP 795, 797, 800 compliance verification
• Personnel competency documentation
• Facility design and environmental control validation

Compounding Pharmacy Software Market 2026

Market Drivers

Regulatory Compliance:

• USP 800 enforcement driving software adoption
• Automated documentation reducing compliance burden
• Electronic batch records for FDA inspections
• Quality assurance automation

Patient Safety:

• Medication error prevention through automation
• Ingredient verification and checking
• Barcode scanning for accuracy
• Allergen flagging and contraindication alerts

Operational Efficiency:

• Batch compounding workflow optimization
• Inventory management for active pharmaceutical ingredients (APIs)
• Automated beyond-use dating calculations
• Electronic prescribing and order management

Leading Compounding Software Platforms 2026

1. Simplifi+ IV Workflow Management (Wolters Kluwer)

Overview: Comprehensive IV compounding workflow management with USP compliance automation.

Key Features:

• Guided patient-specific and batch compounding workflows
• Configurable safety checks and decision support
• USP 797 and 800 compliance documentation
• Environmental monitoring tracking
• Media fill test scheduling and documentation
• Competency assessment management
• Surface wipe sampling tracking
• Gravimetric analysis integration
• Barcode verification throughout workflow
• Assure-Trak closed-loop verification

Advanced Modules:

• Batch Compounding Module: Design facilities to batch doses ahead of time
• Advanced Compounding Module: Track newly required batch data for longer shelf-life medications, maintain compliance, access detailed reports for audits

Integration:

• EHR/CPOE integration for order receipt
• Pharmacy information systems
• Automated compounding devices (ACDs)
• Environmental monitoring systems

Ideal For: Hospital sterile compounding pharmacies, 503B outsourcing facilities

Pricing: Enterprise pricing, contact vendor

2. PK Software CompoundingRx

Overview: Specialized software for retail and hospital compounding pharmacies.

Key Features:

• Master formula library with thousands of compounds
• Ingredient inventory management
• Batch compounding with automated scaling
• Beyond-use date calculation (USP 795, 797)
• Label generation with required elements
• Quality control documentation
• Pricing and profitability analysis
• Prescription compounding workflow
• PCAB (Pharmacy Compounding Accreditation Board) compliance tools

Formula Database:

• 10,000+ formulas included
• Customizable formula creation
• Version control for formula changes
• Allergen and incompatibility flagging

Ideal For: Independent compounding pharmacies, hospital compounding operations

Pricing: Subscription-based, approximately $200-$500/month

3. LogiCoy CompoundingRx

Overview: Cloud-based compounding pharmacy management system.

Key Features:

• Cloud accessibility from any device
• Master formulation database
• Batch and individual compounding
• Inventory management for APIs and supplies
• Beyond-use dating automation
• Electronic batch records
• Quality assurance workflows
• Label printing with barcode generation
• Financial tracking and profitability analysis

Compliance Features:

• USP 795 and 797 documentation
• PCAB accreditation support
• State board inspection preparation
• Standard operating procedure (SOP) templates

Ideal For: Small to medium compounding pharmacies seeking cloud-based solution

Pricing: Tiered subscription, starting ~$150/month

4. ScriptPro Compounding Integration

Overview: Compounding module within ScriptPro pharmacy management platform.

Key Features:

• Integration with robotic dispensing systems
• Compounding workflow management
• Ingredient inventory tracking
• Formula library
• Label generation
• Quality control documentation
• Integrated with general pharmacy operations

Ideal For: Pharmacies using ScriptPro already and adding compounding services

5. Micro Merchant Systems (MMS) Compounding

Overview: Pharmacy management system with robust compounding functionality.

Key Features:

• Master formula database
• Batch compounding capabilities
• Inventory management
• Beyond-use dating calculations
• Compliance reporting
• Integration with general pharmacy dispensing workflow
• Pricing and profit margin analysis

Ideal For: Full-service pharmacies offering compounding alongside traditional dispensing

Specialized USP 800 Compliance Software

Wolters Kluwer Simplifi 797 (USP 800 Module)

Dedicated USP 800 Features:

• Hazardous drug inventory tracking
• Containment equipment monitoring
• PPE compliance documentation
• Environmental wipe sampling scheduling
• Surface sampling tracking and trending
• Hazardous waste disposal documentation
• Employee training and competency for HD handling
• Incident reporting and investigation

Surface Sampling Management:

• Sampling location mapping
• Scheduled and ad hoc sampling
• Lab result tracking
• Trending and analytics
• Corrective action documentation
• Regulatory reporting

Audit Readiness:

• Centralized documentation repository
• Automated audit trail generation
• Inspection preparation checklists
• Regulatory reporting tools

Essential Compounding Software Features

1. Master Formula Management

Formula Database:

• Searchable library of compounding formulas
• Categorization by therapeutic class, dosage form
• Active pharmaceutical ingredient (API) specifications
• Excipient and vehicle listings
• Step-by-step compounding instructions
• Beyond-use date calculations
• Literature references and stability data

Custom Formula Creation:

• Formula builder with drag-and-drop ingredient selection
• Automatic calculation of quantities for batch sizes
• Scaling functionality (e.g., adjust for 100 capsules vs. 30)
• Version control tracking formula changes over time
• Approval workflow for new formulas
• Allergen and incompatibility flagging

2. Batch Compounding Automation

Batch Management:

• Batch order creation from multiple prescriptions
• Automated ingredient quantity calculation for entire batch
• Batch record generation with all required elements:
  • Batch number
  • Date and time of compounding
  • Compounder identity
  • Formula reference
  • Ingredient lot numbers and expiration dates
  • Equipment used
  • Calculations performed
  • Quality control testing results
  • Beyond-use date assigned

Workflow Guidance:

• Step-by-step compounding instructions
• Visual aids (images, videos) for complex procedures
• Safety alerts and precautions
• Quality check prompts at critical steps
• Electronic signature capture for verification

3. Ingredient Inventory Management

Active Pharmaceutical Ingredients (APIs):

• Real-time inventory tracking by lot number
• Expiration date monitoring with automated alerts
• Automatic deduction upon compounding
• Reorder point and quantity suggestions
• Supplier management and ordering
• Receiving and lot verification
• Certificates of analysis (CoA) storage

Excipients and Supplies:

• Comprehensive inventory for all compounding supplies
• Usage tracking and trending
• Cost allocation to compounds
• Waste and spillage documentation

4. Beyond-Use Dating (BUD) Calculation

USP Compliance:

• Automated BUD calculation based on USP 795 or 797 criteria
• Consideration of API stability data
• Container type impact on BUD
• Storage condition requirements
• References to supporting literature
• Override capability with justification documentation

Categories:

• Aqueous solutions vs. non-aqueous
• Solid dosage forms
• Semisolid preparations
• Sterile products by risk level (low, medium, high)
• Temperature storage impact (room temp, refrigerated, frozen)

5. Quality Control and Testing

Testing Documentation:

• Sterility testing results (for sterile products)
• Endotoxin testing (for high-risk sterile products)
• Potency testing
• pH testing (for certain formulations)
• Visual inspection checklists
• Physical testing (weight variation, content uniformity)

Environmental Monitoring:

• Cleanroom viable and non-viable particle counts
• Surface wipe sampling for hazardous drugs
• Temperature and humidity logging
• Differential pressure monitoring
• Air changes per hour (ACPH) documentation

Personnel Competency:

• Initial and ongoing competency assessment scheduling
• Media fill test (gloved fingertip, sterile product) documentation
• Aseptic technique observation
• Training completion tracking
• Continuing education credits

6. Labeling and Packaging

Automated Label Generation:

• Patient-specific labels with all required elements
• Auxiliary labels (shake well, refrigerate, hazardous, etc.)
• Barcode generation for tracking
• Beyond-use date prominently displayed
• Compounding date and pharmacist verification
• Prescription number linkage

Batch Labels:

• Batch number and compounding date
• Beyond-use date
• Storage requirements
• Formula reference
• Ingredient lot numbers

7. Compliance Reporting and Audit Trail

Documentation:

• Complete electronic batch records
• Change history and version control
• Personnel actions logged with timestamps
• Ingredient lot traceability
• Equipment usage logs
• Maintenance and calibration records

Reports:

• Compounding volume by formula, compounder, time period
• Inventory usage and trends
• Quality control test results summary
• Environmental monitoring trending
• Competency assessment status
• Beyond-use date adherence

USP 800 Hazardous Drug Compliance

Defining Hazardous Drugs

NIOSH List Drugs:

• Group 1: Antineoplastic drugs
• Group 2: Non-antineoplastic hazardous drugs (hormones, antivirals, immunosuppressants)
• Group 3: Drugs with reproductive risk

Assessment Tools:

• NIOSH hazardous drug list integration into software
• Facility-specific assessment for additional drugs
• Automatic flagging of hazardous drugs in orders

Containment Requirements

Primary Engineering Controls (PECs):

• Biological safety cabinets (BSCs)
• Compounding aseptic containment isolators (CACIs)
• Software tracking which PEC used for each compound

Secondary Engineering Controls (SECs):

• Buffer rooms (ISO Class 7 or 8 depending on garb)
• Negative pressure relative to surrounding areas
• Dedicated hazardous drug compounding areas

Software Tracking:

• Assignment of compounds to specific PECs/SECs
• Equipment certification expiration alerts
• Maintenance scheduling
• Cleaning and decontamination documentation

Personal Protective Equipment (PPE)

Required PPE Documentation:

• Chemotherapy gloves (double gloving for high-risk)
• Gowns (disposable, impervious)
• Shoe covers
• Hair covers
• Eye/face protection
• Respiratory protection for certain scenarios

Software Features:

• PPE compliance checklists
• Training documentation for proper donning/doffing
• Inventory management for PPE supplies

Surface Wipe Sampling

USP 800 Requirement:

• Routine sampling of surfaces in hazardous drug compounding areas
• At least twice per year (monthly for new compounders or after facility changes)
• Lab analysis for drug residue
• Action levels established

Software Management:

• Sampling location maps
• Scheduled sampling reminders
• Lab order and result tracking
• Trending and analytics
• Action level exceedance alerts
• Corrective action planning and documentation

Implementing Compounding Pharmacy Software

Phase 1: Needs Assessment (Month 1)

Evaluate:

• Current compounding volume (prescriptions/day, batches/week)
• Types of compounding (sterile vs. non-sterile, hazardous vs. non-hazardous)
• Regulatory requirements (503A vs. 503B, state-specific)
• Existing technology (pharmacy management system, automated compounding devices)
• Pain points (compliance burden, documentation time, errors, efficiency)

Define Requirements:

• Must-have features vs. nice-to-have
• Integration needs with existing systems
• User count (compounders, pharmacists, technicians)
• Budget constraints
• Implementation timeline

Phase 2: Vendor Selection (Months 1-2)

Evaluate Platforms:

• Request demos from Simplifi+, PK Software, LogiCoy, and others
• Assess ease of use and learning curve
• Verify USP 795/797/800 compliance capabilities
• Check integration with your pharmacy system
• Review customer references from similar pharmacies
• Compare pricing (subscription vs. perpetual, per-user fees)

Selection Criteria:

• Feature completeness
• User experience
• Vendor support and training quality
• Track record and customer satisfaction
• Total cost of ownership

Phase 3: Implementation and Configuration (Months 2-4)

Technical Setup:

• Install software (cloud vs. on-premise)
• Configure system settings and user accounts
• Integrate with pharmacy management system
• Connect barcode scanners, label printers, scales

Data Migration:

• Import master formula library
• Transfer ingredient inventory
• Load historical batch records (if converting from another system)
• Upload SOPs and documentation templates

Customization:

• Configure formulas specific to your pharmacy
• Set up beyond-use dating rules
• Customize labels and batch records
• Define quality control workflows
• Establish user roles and permissions

Phase 4: Training (Months 3-4)

Staff Training:

• Compounders: Formula selection, batch record completion, ingredient verification
• Pharmacists: Formula approval, final verification, quality assurance
• Technicians: Inventory management, label printing, order entry
• Quality assurance: Environmental monitoring, competency tracking, reporting

Training Methods:

• Vendor-provided training sessions (onsite or virtual)
• Hands-on practice with test compounds
• Competency assessment before go-live
• Quick reference guides and job aids
• Ongoing training for new features

Phase 5: Go-Live and Optimization (Months 4-6)

Soft Launch:

• Start with non-sterile compounding or low-risk sterile products
• Parallel run with manual processes initially (if feasible)
• Monitor closely for issues
• Gather user feedback daily

Full Launch:

• Expand to all compounding operations
• Transition fully to electronic batch records
• Discontinue paper-based processes
• Establish regular quality audits of software data

Continuous Improvement:

• Regular review of formulas and updates
• Software version upgrades
• Feature adoption (use advanced capabilities as staff becomes proficient)
• Workflow refinement based on user feedback

ROI of Compounding Pharmacy Software

Cost Savings

Labor Efficiency:

• 40-60% reduction in batch record documentation time
• 30-50% reduction in inventory management time
• 80% reduction in compliance report generation time
• Automated calculations eliminating manual errors

Reduced Errors:

• Prevention of incorrect ingredient selection
• Elimination of calculation errors
• Barcode verification catching mistakes before they reach patients
• Potential savings from avoided errors: $10,000 - $100,000+ annually

Inventory Optimization:

• Reduced waste from expired APIs (10-20% reduction)
• Better forecasting of ingredient needs
• Optimal reorder quantities reducing carrying costs

Revenue Protection and Growth

Compliance Assurance:

• Avoidance of regulatory penalties and warning letters
• Protection of pharmacy license and accreditation
• Reduced risk of costly recalls

Quality Improvement:

• Improved patient outcomes and satisfaction
• Enhanced reputation enabling growth
• Accreditation achievement (PCAB) enabling insurance contracts

Operational Scalability:

• Ability to handle increased compounding volume without proportional staffing increase
• Faster turnaround time for compounded prescriptions
• Support for expansion into new compound types or hazardous drugs

Typical ROI Timeline

Investment:

• Software: $150-$500/month (or $25,000-$150,000 perpetual license)
• Implementation: $5,000-$25,000
• Training: $2,000-$10,000
• Hardware (barcode scanners, printers, etc.): $2,000-$10,000
• Total First-Year Cost: $20,000-$80,000

Payback:

• Small compounding pharmacy (10-30 compounds/day): 18-24 months
• Medium compounding operation (30-100 compounds/day): 12-18 months
• Large-scale or 503B outsourcing facility: 6-12 months

3-Year ROI: 200-400% for most compounding pharmacies

Compounding Software for Different Settings

Retail Compounding Pharmacies

Needs:

• Prescription compounding workflow
• Customer-facing education materials
• Pricing and profitability tracking
• Integration with general pharmacy dispensing
• Marketing tools for compounding services

Recommended Platforms: PK Software, LogiCoy, MMS Compounding

Hospital Sterile Compounding Pharmacies

Needs:

• IV admixture workflow
• Integration with CPOE/EHR
• Cleanroom environmental monitoring
• High-volume batch compounding
• Automated compounding device integration
• USP 797 and 800 compliance

Recommended Platforms: Simplifi+ IV Workflow Management, ScriptPro

503B Outsourcing Facilities

Needs:

• cGMP-compliant electronic batch records
• Full traceability and lot management
• Advanced quality control testing documentation
• FDA inspection readiness
• High-volume batch manufacturing
• Customer order management

Recommended Platforms: Simplifi+ Advanced Compounding, enterprise MES (manufacturing execution systems)

Specialty Compounding (Veterinary, Bioidentical Hormones, Pediatrics)

Needs:

• Specialized formula libraries
• Flavoring and palatability options
• Dose calculators for pediatric or weight-based dosing
• Client education materials
• Niche regulatory compliance (FDA Center for Veterinary Medicine for vet compounds)

Recommended Platforms: PK Software (strong formula library), custom solutions

Future Trends in Compounding Pharmacy Software

AI and Machine Learning

Emerging Capabilities:

• Predictive analytics for compounding demand forecasting
• AI-powered formula optimization for stability and efficacy
• Automated quality control trending and anomaly detection
• Machine learning for beyond-use dating refinement based on real-world stability data

Robotic Automation Integration

Automated Compounding Devices (ACDs):

• Software-controlled robotic compounding of IV admixtures
• Gravimetric verification of ingredient volumes
• Integration with compounding pharmacy software for order receipt and batch record generation
• Examples: ARxIUM, RIVA, IV-Soft, Omnicell IVX

Telepharmacy for Compounding Oversight

Remote Verification:

• Video monitoring of compounding process by remote pharmacist
• Real-time guidance for complex compounds
• Expanded access to specialized compounding expertise

Blockchain for Supply Chain Integrity

API Traceability:

• Blockchain-based certificates of analysis verification
• Supply chain transparency from manufacturer to compounder to patient
• Counterfeit ingredient prevention

Advanced Quality Analytics

Big Data and Analytics:

• Aggregated compounding data for industry benchmarking
• Predictive models for stability and beyond-use dating
• Quality trend analysis across facilities
• Proactive identification of quality risks

Regulatory Compliance Checklist

USP <795> (Nonsterile Compounding)

• [ ] Master formula records with all required elements
• [ ] Beyond-use dating based on USP criteria or stability data
• [ ] Ingredient identity verification before compounding
• [ ] Compounding record (batch record) for each preparation
• [ ] Quality control procedures and documentation
• [ ] Equipment calibration and maintenance logs
• [ ] Facility cleaning and maintenance documentation
• [ ] Personnel training and competency assessment
• [ ] Standard operating procedures (SOPs) for all processes

USP <797> (Sterile Compounding)

• [ ] Compounding area classification and certification (ISO Class 5, 7, 8)
• [ ] Environmental monitoring (viable and non-viable particles)
• [ ] Personnel gowning and aseptic technique competency
• [ ] Media fill testing (initial and periodic)
• [ ] Gloved fingertip sampling
• [ ] Surface sampling
• [ ] Beyond-use dating by risk level (low, medium, high)
• [ ] Master formulation and compounding records
• [ ] Quality assurance program
• [ ] Standard operating procedures

USP <800> (Hazardous Drugs)

• [ ] List of hazardous drugs handled
• [ ] Assessment for additional hazardous drugs
• [ ] Containment segregated compounding areas (if applicable)
• [ ] Negative pressure relative to adjacent areas
• [ ] Containment primary and secondary engineering controls
• [ ] Environmental wipe sampling program
• [ ] PPE requirements and training
• [ ] Spill kit and emergency procedures
• [ ] Hazardous waste disposal documentation
• [ ] Medical surveillance for personnel
• [ ] Standard operating procedures

Getting Started with Compounding Software

Step 1: Assess Readiness

Evaluate:

• Current compounding volume and growth projections
• Regulatory compliance gaps
• Staff technical proficiency
• Available budget for software and implementation
• Integration requirements with existing systems

Step 2: Research and Demo

Compare Platforms:

• Request demos from at least 3 vendors
• Test with realistic compounding scenarios from your pharmacy
• Involve compounders and pharmacists in evaluation
• Assess vendor support quality and responsiveness

Step 3: Plan Implementation

Develop Timeline:

• Typical implementation: 3-6 months
• Budget for software, implementation services, training, hardware
• Identify internal project champion
• Plan for workflow changes and staff adjustment period
• Set go-live date with buffer time

Step 4: Train and Launch

Execute Training Plan:

• Comprehensive training for all users before go-live
• Hands-on practice with real formulas (test mode)
• Competency verification
• Quick reference materials
• Ongoing support plan

Step 5: Monitor and Optimize

Track Success:

• Compounding accuracy rate
• Documentation time per compound
• Compliance with USP standards (internal audits)
• Staff satisfaction and adoption
• Return on investment metrics

Conclusion: Compounding Software as Quality Foundation

Compounding pharmacy software has evolved from optional documentation aid to essential quality management system in 2026. With full enforcement of USP 795, 797, and 800 standards, manual compounding documentation is no longer sustainable for compliant, efficient operations.

Leading compounding pharmacies using advanced software platforms achieve:

• USP Compliance: Automated documentation meeting all regulatory requirements
• Patient Safety: Barcode verification, allergy alerts, and calculation validation preventing errors
• Operational Efficiency: 40-60% reduction in documentation time
• Quality Assurance: Environmental monitoring, competency tracking, and trending for continuous improvement
• Audit Readiness: Complete electronic records ready for state board, FDA, or accreditation inspections

Whether you operate a retail compounding pharmacy, hospital sterile compounding operation, or 503B outsourcing facility, investing in purpose-built compounding software protects patients, ensures compliance, and enables scalable growth.

Contact MedSoftwares to discuss comprehensive pharmacy management solutions supporting compounding alongside traditional dispensing operations.

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