Pharmacy Quality Management System

A comprehensive QMS template designed for pharmacy operations including retail, hospital, compounding, and specialty pharmacies.

💊 Designed For

• Retail Pharmacies - Community and chain pharmacies
• Hospital Pharmacies - Inpatient and outpatient pharmacy services
• Compounding Pharmacies - Sterile and non-sterile compounding
• Specialty Pharmacies - High-cost and complex medication management
• Long-Term Care Pharmacies - Nursing home and assisted living facilities
• Mail Order Pharmacies - Central fill and mail-order operations
• Nuclear Pharmacies - Radiopharmaceutical preparation

📋 Regulatory Framework

This template supports compliance with:

• State Board of Pharmacy regulations
• DEA (Drug Enforcement Administration) requirements
• FDA regulations for drug handling
• USP <795> - Non-Sterile Compounding
• USP <797> - Sterile Compounding
• USP <800> - Hazardous Drug Handling
• USP <825> - Radiopharmaceuticals
• HIPAA - Patient privacy and data protection
• Joint Commission - Hospital pharmacy standards
• ACHC/URAC - Specialty pharmacy accreditation

Repository Structure

├── SOPs/
│   ├── Dispensing/           # Prescription processing & dispensing
│   ├── Compounding/          # Sterile & non-sterile compounding
│   ├── Controlled-Substances/# DEA compliance & C-II handling
│   ├── Inventory/            # Drug procurement & management
│   ├── Patient-Safety/       # Error prevention & reporting
│   └── General/              # General pharmacy operations
├── Forms/
│   ├── Compounding-Logs/     # Master formulation & batch records
│   ├── Temperature-Logs/     # Refrigerator & freezer monitoring
│   ├── Controlled-Substance/ # DEA forms & perpetual inventory
│   └── Training/             # Competency assessments
├── Policies/                 # Pharmacy policies
├── Work-Instructions/        # Step-by-step procedures
└── Templates/                # Document templates

🤖 AI-Powered Assistance

This repository includes AtomicAI, your pharmacy QMS assistant. Mention @atomicai in any issue or pull request to:

• Draft pharmacy SOPs following USP guidelines
• Create compounding formulation records
• Generate controlled substance procedures
• Develop patient counseling protocols
• Review documents for regulatory compliance

Example Prompts

• "@atomicai create an SOP for sterile compounding garbing procedures per USP 797"
• "@atomicai draft a controlled substance discrepancy investigation form"
• "@atomicai write a policy for medication error reporting"
• "@atomicai create a temperature excursion response procedure"

Getting Started

1. Customize Policies - Update policies in /Policies for your pharmacy type
2. Adapt SOPs - Modify SOPs to match your workflow and state requirements
3. Set Up Logs - Configure forms for your compounding and inventory needs
4. Train Staff - Use training forms to document competencies

Key Documents to Create First

1. Dispensing SOP - Core prescription processing workflow
2. Error Reporting Policy - Patient safety foundation
3. Controlled Substance Policy - DEA compliance essential
4. Compounding SOPs - If applicable to your practice
5. HIPAA Policy - Patient privacy requirements

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This template is maintained by AtomicQMS. For questions, open an issue in this repository.