503B Compliance
Comprehensive compliance framework for outsourcing facility operations, enabling interstate distribution of compounded medications to healthcare practitioners and facilities.
Effective Date: January 1, 2025
503B Outsourcing Facility Overview
Section 503B of the Federal Food, Drug, and Cosmetic Act establishes regulations for outsourcing facilities that manufacture compounded drugs for hospitals, clinics, pharmacies and providers and practitioners. Qualgen operates as a registered 503B outsourcing facility, enabling us to compound drugs without individual patient prescriptions.
Our 503B operations allow us to provide sterile and non-sterile compounded medications for office use by healthcare practitioners, supporting hospitals, clinics, and other hospitals, clinics, pharmacies and providers with ready-to-use formulations.
FDA Registration and Oversight
As a 503B outsourcing facility, Qualgen is registered with the FDA and subject to direct federal oversight, inspection, and regulation.
- FDA registration as outsourcing facility maintained annually
- Direct FDA inspection authority and compliance monitoring
- Quarterly reporting of compounded drug products to FDA
Current Good Manufacturing Practice (GMP)
503B facilities must comply with current Good Manufacturing Practice (GMP) standards applicable to pharmaceutical compounding, ensuring consistent quality and safety.
Manufacturing Controls
- Written procedures for all compounding operations
- Batch production and control records for each lot
- Raw material identity testing and qualification
- In-process controls and testing protocols
- Finished product testing and release criteria
- Stability testing and beyond-use dating validation
Quality Management System
- Quality unit independent of production operations
- Quality assurance and quality control procedures
- Change control and deviation management
- Corrective and Preventive Action (CAPA) system
- Management review and continuous improvement
- Vendor qualification and supply chain management
Bulk Drug Substances Compliance
503B facilities may only compound using bulk drug substances that appear on the FDA's published list of bulk drug substances for compounding, ensuring safety and regulatory compliance.
- Use of FDA-approved bulk drug substances only
- Compliance with FDA bulk drug substances list
- Certificate of Analysis verification for all substances
- Supplier qualification and audit programs
- Raw material storage and handling protocols
- Expiration dating and inventory management
- Nominated substances evaluation and approval process
Labeling and Distribution Requirements
503B compounded drugs must meet specific labeling requirements and may only be distributed to licensed healthcare practitioners and facilities for office use.
Labeling Requirements
- 'Compounded' statement prominently displayed
- Name and address of outsourcing facility
- Lot number and beyond-use date
- Active and inactive ingredients with quantities
- Dosage form and strength information
- Storage and handling instructions
Distribution Restrictions
- Sale only to licensed healthcare practitioners
- Distribution to hospitals and hospitals, clinics, pharmacies and providers
- Proper shipping and cold chain maintenance if required
- Distribution records and traceability
- Recall procedures and notification systems
Quality Control and Laboratory Testing
Comprehensive testing protocols ensure all 503B compounded products meet established specifications for identity, strength, quality, and purity.
- Raw material identity and purity testing
- Microbiological testing for sterile products
- Endotoxin testing for applicable preparations
- Potency and content uniformity analysis
- Physical and chemical stability testing
- Container closure integrity testing
- Environmental monitoring and trending
- Method validation and verification protocols
Facility Design and Operations
503B facilities must maintain appropriate design, environmental controls, and operational procedures to support GMP manufacturing operations.
- Segregated compounding areas by product type
- Cleanroom design and classification for sterile products
- HVAC systems with appropriate controls and monitoring
- Water system design, operation, and qualification
- Equipment qualification and preventive maintenance
- Cleaning and sanitization validation protocols
- Pest control and facility maintenance programs
- Material flow and contamination prevention
Personnel Qualifications and Training
All personnel involved in 503B operations receive comprehensive training appropriate to their roles and demonstrate ongoing competency.
Management and Supervisory Staff
- Advanced degrees in relevant scientific disciplines
- Experience in pharmaceutical compounding or compounding
- GMP training and certification programs
- Regulatory compliance and quality assurance training
Production and Quality Personnel
- Technical education and relevant experience
- GMP and aseptic technique training
- Job-specific competency demonstration
- Annual retraining and competency verification
User Fees and Regulatory Reporting
503B outsourcing facilities must pay annual user fees to the FDA and provide required periodic reporting to maintain registration status.
- Annual outsourcing facility user fee payment
- Quarterly reporting of compounded drug products
- Adverse event reporting within required timeframes
- Annual product and financial reporting to FDA
- State reporting requirements as applicable
- Inspection fee payments when applicable
Interstate Commerce and Market Access
503B registration enables interstate distribution of compounded drugs, providing hospitals, clinics, pharmacies and providers across the nation access to specialized medications.
- Interstate shipping and distribution capabilities
- Compliance with state pharmacy board requirements
- Multi-state licensing and registration maintenance
- Transportation and shipping validation protocols
- Cold chain management for temperature-sensitive products
- Emergency supply and disaster response capabilities
Safety Monitoring and Adverse Event Reporting
Robust pharmacovigilance systems ensure timely detection, evaluation, and reporting of adverse events associated with 503B compounded products.
- Adverse event monitoring and collection systems
- Serious adverse event reporting to FDA within 15 days
- Periodic safety update reports as required
- Risk evaluation and mitigation strategies (REMS)
- Product quality complaint investigation procedures
- Recall and market withdrawal procedures when necessary
Questions About 503B Compliance?
Our regulatory team is here to assist with any compliance-related inquiries.
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