503B Pharmacy Compounding Facility
Built for Precision. Operated for Compliance. Trusted for Care.
OutSourceWoRx built its 503B pharmacy compounding facility to meet the evolving needs of modern healthcare. We deliver sterile compounded medications with unmatched precision, consistency, and reliability serving hospital systems, infusion centers, surgical clinics, and specialty practices nationwide.
We don’t just meet minimum requirements; we exceed them. We do this by strictly following cGMP, using validated sterile processes, and promoting a culture of clinical excellence.
Why 503B Matters
A 503B outsourcing facility compounds medications in bulk for healthcare providers to use within their clinical settings. This model allows us to supply ready-to-use sterile products without requiring patient-specific prescriptions helping address drug shortages, variability in compounding, and complex regulatory demands.
As your 503B partner, we help you:
- Maintain permanent patient care
- Reduce the burden on in-house sterile compounding
- Strengthen compliance with federal and state regulations
- Improve operational efficiency and pharmacy workflows
We deliver consistency, compliance, and care in every product we create.
Built for Excellence in 503B Pharmacy Compounding
Our 503B pharmacy compounding facility has one goal: to deliver sterile, customized medications with integrity and reliability. Our infrastructure and processes protect product quality, patient safety, and regulatory compliance. This is true for every step, from our air filtration systems to our final packaging.
We combine advanced compounding equipment with rigorous quality control systems to ensure every batch meets or exceeds industry requirements. Our cleanrooms surpass both USP <797> and <800> guidelines. This creates an aseptic environment where precision and sterility are the standard, not the exception.
Our Facility Includes:
ISO-Classified Cleanrooms with Real-Time Environmental Monitoring
Continuous oversight of air quality, particle counts, temperature, and humidity ensures optimal sterile conditions.
Aseptic Processing Using Automated Sterile Filling Equipment
Reducing human contact and variability for increased accuracy, reproducibility, and contamination prevention.
Secure Hazardous and Non-Hazardous Drug Preparation Zones
Dedicated, segregated areas for handling different drug classes to maintain safety and compliance with USP .
Redundant Safety Systems and HEPA Filtration
Multiple fail-safes and high-efficiency particulate filters to maintain cleanroom integrity even during power or system interruptions.
Cold-Chain Storage and Temperature-Controlled Logistics
Protecting the stability and potency of temperature-sensitive medications from compounding to delivery.
Full Traceability of Raw Materials and Batch Records
End-to-end documentation for every ingredient, process, and batch—ensuring transparency, accountability, and regulatory readiness.
We can meet your institution’s demands for any medication, from standard to complex. We deliver at scale, on time, and always with compliance.
Quality & Compliance at Every Step
At OutSourceWoRx , we build quality into every stage of our 503B pharmacy compounding process. We go beyond regulatory expectations not just meeting them, but consistently exceeding them. Our commitment to continuous improvement and meticulous attention to detail drives every aspect of our operations.
Our facility is fully cGMP-compliant, and our trained professionals and pharmacists follow strict protocols to protect sterility, potency, and patient safety. Using advanced compounding technology and a multi-layered quality assurance system, we ensure every product is safe, consistent, and ready for clinical use.
With OutSourceWoRx you can be confident in the integrity of every dose.
Backed by Clinical Pharmacists
Our team of experienced clinical pharmacists brings decades of sterile compounding expertise across hospital, infusion, and specialty care. With deep knowledge of dosing accuracy, therapeutic compatibility, and workflow integration, they ensure every product is both compliant and clinically effective.
We work closely with your team to develop custom formulations, recommend substitutions during shortages, and optimize formularies. Our single focus is to improve patient safety and outcomes.
Every product is designed with a singular focus: enhancing patient safety and outcomes.
Efficient Fulfillment & Delivery
We’ve engineered our 503B pharmacy compounding workflows to ensure seamless fulfillment from order to delivery. We offer dedicated account support and same-day processing to help our B2B clients thrive in high-demand environments.
Fulfillment Includes:
- Online or direct-order placement
- License and DEA verification
- Batch compounding with full testing
- Packaging with usage, storage, and compliance labeling
- Cold-chain shipping with tracking and confirmation
Our turnaround times match your urgency. Expect some items in just 24–48 hours and custom compounds in 5–10 business days.
Ensure Continuity of Care
Serving the Full Continuum of Care
At OutSourceWoRx , we partner with healthcare organizations across the United States. We deliver 503B pharmacy compounding solutions that meet the demands of diverse clinical environments. We have one goal: to provide sterile, compliant, and ready-to-use medications that fit seamlessly into your workflow. We do this for large hospitals and small clinics alike.
We are your trusted partner for 503B pharmacy compounding, delivering high-quality medications tailored to your needs. We’re here to help whether you’re managing high patient volumes, specialty care, or drug shortages.
We are your trusted partner for 503B pharmacy compounding, delivering high-quality medications tailored to your needs. We’re here to help whether you’re managing high patient volumes, specialty care, or drug shortages.