503B Outsourcing &
Compounding Excellence
FDA-registered 503B outsourcing facility providing sterile and non-sterile compounding services with full cGMP compliance.
503B Compounding Excellence
FDA Registered & Compliant
Full cGMP compliance across all facilities
Sterile Compounding
ISO Class 5 clean room environments
Nationwide Distribution
All 50 states shipping capabilities
503B Outsourcing Services Overview
Our state-of-the-art 503B outsourcing facility delivers comprehensive compounding solutions designed to meet the demanding needs of hospitals, health systems, and specialty practices. We combine advanced technology with rigorous quality standards to ensure consistent, reliable pharmaceutical products.
What Sets Us Apart
FDA-Registered Excellence
Our facility is fully registered with the FDA as a 503B outsourcing facility, ensuring compliance with all federal regulations and manufacturing standards.
Advanced Technology
State-of-the-art compounding equipment and automated systems ensure precision, consistency, and efficiency in every batch we produce.
Expert Team
Our highly trained pharmacists and technicians bring decades of experience in pharmaceutical compounding and quality assurance.
Comprehensive Compounding Capabilities
From sterile injectable production to specialty formulations, our 503B facility offers a complete range of compounding services to meet diverse healthcare needs.
Sterile Compounding Services
Sterile Injectable Production
High-volume production of sterile injectable medications in controlled ISO Class 5 environments. Our capabilities include single-dose vials, multi-dose vials, and pre-filled syringes.
- IV admixtures and infusions
- Chemotherapy and oncology preparations
- Critical care medications
- Pediatric formulations
- Emergency medicine compounds
Ophthalmic Formulations
Specialized sterile ophthalmic preparations including eye drops, ointments, and irrigation solutions manufactured in dedicated clean room environments.
- Preservative-free formulations
- Custom concentration eye drops
- Ophthalmic ointments
- Irrigation solutions
- Specialty surgical preparations
Non-Sterile Compounding Services
Oral Solid Dosage Forms
Custom capsules, tablets, and powders formulated to meet specific patient needs and dosing requirements.
- Custom strength capsules
- Combination formulations
- Pediatric dosage forms
- Modified release preparations
Topical Preparations
Creams, ointments, gels, and lotions compounded for dermatological and therapeutic applications.
- Dermatological formulations
- Pain management compounds
- Hormone replacement therapy
- Veterinary applications
Liquid Formulations
Oral liquids, suspensions, and solutions designed for patients who cannot take traditional dosage forms.
- Oral suspensions
- Flavored pediatric liquids
- Nasal sprays
- Ear drops
Custom Services & Solutions
Custom Batch Production
Flexible batch sizes from small specialty runs to large-scale production, tailored to meet your specific volume requirements and delivery timelines.
- Scalable production volumes
- Rush order capabilities
- Scheduled delivery programs
- Inventory management support
Private Label Options
Complete private labeling services allowing you to offer compounded medications under your own brand with custom packaging and labeling solutions.
- Custom label design
- Branded packaging options
- Regulatory compliance support
- Marketing material assistance
Regulatory Compliance & Quality Assurance
Our 503B facility operates under the highest regulatory standards, ensuring every product meets or exceeds FDA requirements for safety, quality, and efficacy.
FDA Registered
503B Outsourcing Facility
cGMP Compliant
Current Good Manufacturing Practices
USP Standards
USP <797 & <795 Compliance
ISO Certified
International Quality Standards
Quality Management Systems
Comprehensive Testing
Every batch undergoes rigorous testing including sterility, potency, purity, and stability testing using validated analytical methods.
Environmental Monitoring
Continuous monitoring of cleanroom environments with real-time particle counting and microbial testing to ensure optimal conditions.
Documentation & Traceability
Complete batch records and traceability from raw materials to finished products, ensuring full compliance and recall capabilities.
Personnel Qualification
All personnel undergo extensive training and qualification programs to ensure competency in aseptic techniques and quality standards.
Our 503B Compounding Process
From order receipt to final delivery, our systematic approach ensures consistent quality and regulatory compliance at every stage of the compounding process.
Order Processing
Order review, verification, and scheduling based on complexity and priority requirements
Material Preparation
Raw material verification, weighing, and preparation in controlled environments
Compounding
Precise formulation and compounding using validated procedures and equipment
Quality Control
Comprehensive testing, packaging, labeling, and final release for distribution
Sterile Compounding Workflow
Non-Sterile Compounding Workflow
Client Success Stories
Healthcare partners trust SGP Care for reliable, high-quality 503B outsourcing services
Dr. Michael Johnson
Director of Pharmacy, Metropolitan Health System
"SGP Care's 503B outsourcing services have been instrumental in ensuring our hospital has access to critical medications during shortages. Their quality standards and reliable delivery have made them an indispensable partner in our pharmacy operations."
Lisa Chen, PharmD
Chief Pharmacy Officer, Regional Cancer Center
"The sterile compounding expertise at SGP Care has allowed us to provide specialized oncology preparations that aren't commercially available. Their attention to detail and regulatory compliance gives us complete confidence in their products."
Frequently Asked Questions
Common questions about our 503B outsourcing services
Ready to Partner with SGP Care?
Experience the reliability and quality of our FDA-registered 503B outsourcing facility. Contact us today to discuss your compounding needs and discover how we can support your healthcare operations.
Contact Our 503B Team
Ready to discuss your outsourcing needs? Our experts are here to help.
Get in Touch
777 S. Flagler Dr.
Suite 800 - West Tower
Palm Beach, FL 33401
Facility Hours
Production: 24/7 Operations
Customer Service: Monday - Friday, 8:00 AM - 6:00 PM EST
Emergency Support: 24/7 Available