TQIP
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We’re Ready When You Are
Have a quote request, licensing question, or custom need? Reach out anytime — our team responds within 24 hours.
📧 info@503Boutsourcingone.com
📞 (754) 265-4280
📅 Or book a free consultation.
cGMP-Certified. TQIP-Driven.
Our operations follow FDA current Good Manufacturing Practices (cGMP), ensuring every product is compounded, tested, and released under strict quality controls. From ISO-8 cleanrooms to validated sterility and potency testing — compliance is built into every dose.
Across the U.S., hospitals and healthcare providers are facing unprecedented shortages of critical medications — from injectables to anesthetics. These disruptions are driven by supply chain breakdowns, manufacturing delays, and increased demand. At 503Boutsourcingone, we’re stepping up to fill the gap. As an FDA-registered 503B outsourcing facility, we offer reliable, ready-to-ship sterile medications with verified potency, sterility, and COAs — all backed by rapid 24–72 hour fulfillment. When availability is uncertain, Top Quality is Priority (TQIP) means your patients and providers aren’t left waiting.
🚨 Navigating the National Medication Shortage
TQIP-Powered. TQIP-Driven. Built to Fill the Gaps Others Can’t.
Why Providers Choose 503BoutsourcingOne
At 503B-outsourcing-One, we know what matters
most to healthcare professionals: safety, speed,
and service you can rely on. That’s why we built
our operation to deliver:
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24–72 hour fulfillment with priority shipping
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COA-tested batches for every product
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Private-label packaging for GPOs and health systems
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ISO-8 cleanrooms monitored under strict cGMP
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Responsive support — every client gets a dedicated contact
You're not just ordering sterile meds — you're gaining a reliable compounding partner who treats compliance as a floor, not a ceiling.
📞 Ready to get started? [Request a Custom Quote] or [Schedule a Consultation]
Download Our Catalog, COA Guide, and More
We believe in transparency. That’s why we provide every document you need to evaluate our products and practices — from our full PDF catalog to our 2025 business plan and COA explainer. Start here to get everything you need in one place.
TQIP-Powered. TQIP-Driven
Let’s Build Something Together
We support GPOs, reps, health systems, and distributors with co-branded and private-label medication programs. Whether you need formulary alignment or fulfillment support, our team is ready. Let’s connect and explore what sterile success looks like — together.
503B-outsourcing-One is your dedicated partner for FDA-registered sterile compounding. We deliver high-quality medications with COA, rapid turnaround, and unmatched compliance. Whether you're a hospital, clinic, or GPO — we compound with precision because Top Quality is Priority (TQIP).
Sterile Outsourcing Built for Speed, Safety, and Scale
Founded to raise the bar in sterile outsourcing, 503B-outsourcing-One operates 4 ISO-8 cleanrooms under strict cGMP. Our facility is DEA-registered, USP <797>/<800> compliant, and built to scale. TQIP isn’t just a slogan — it’s our system-wide protocol for safety, service, and sterile excellence.
Who We Are and Why It Matters
Explore our full line of TQIP-approved compounded medications — from ophthalmics to OR syringes and PCA pain management solutions. All products are supported with Certificates of Analysis and available for delivery within 24–72 hours. Custom formulations and white-labeling available on request.
Sterile Medications, Ready When You Are
Our operation is FDA-registered, DEA-certified, and ISO-validated — with every batch tested for sterility, potency, and endotoxins. We follow USP <797>, <800>, and <825> standards to the letter. Because for us, compliance is the floor. TQIP is the standard.
Built on Compliance. Driven by Quality.
