Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of pharmaceutical quality, producing medications in bulk for healthcare providers to administer to their patients within their practice settings. Our core mission is to provide healthcare practitioners with access to reliable, high-quality compounded medications that are essential for patient care.
The operations at our Longwood facility are distinct from traditional compounding pharmacies. We operate under current Good Manufacturing Practices (cGMP), which are the strict quality standards enforced by the FDA for all drug manufacturers. This commitment to cGMP ensures that every batch of medication we produce at our location on W State Road 434 undergoes rigorous testing, quality control, and environmental monitoring. This level of oversight provides physicians, surgeons, hospitals, and clinics with the assurance that the medications they use are of consistent potency, purity, and quality, batch after batch.
Our 503B compounding pharmacy provides healthcare professionals with a critical alternative to commercially available drugs, particularly during times of shortage. When a manufacturer’s drug is on backorder or discontinued, our facility can step in to compound that essential medication, helping to prevent interruptions in patient treatment plans. The services provided from 2160 W State Road 434 are vital for maintaining continuity of care and ensuring that medical providers have the necessary tools to treat their patients effectively and safely.
We invite medical practices and healthcare facilities to partner with us. For more information about our services or to discuss your specific needs, please contact our facility directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our capabilities and compliance: https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that this facility is a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434 is an FDA-registered outsourcing facility. We compound large batches of medications without patient-specific prescriptions and are required to comply with stringent federal current Good Manufacturing Practices (cGMP) for quality and safety.
Who can order medications from the 503B Compounding Pharmacy in Longwood?
Our medications are distributed to healthcare professionals and facilities. This includes physicians, clinics, hospitals, and surgery centers that administer medications in-office or use them within their institutional practice. We do not dispense medications directly to individual patients.
What types of medications does the 503B facility on W State Road 434 compound?
Our FDA-registered outsourcing facility compounds both sterile and non-sterile medications in bulk. This includes injectables, ophthalmics, and other preparations that are often used in clinical settings to address patient needs and drug shortages.
How does the 503B Compounding Pharmacy ensure medication quality?
Operating under cGMP guidelines, our facility implements robust quality control processes. This includes testing raw materials, validating compounding processes, conducting sterility testing, and performing rigorous environmental monitoring within our cleanrooms at the Longwood location.
How can a healthcare provider place an order with your facility?
Healthcare providers can contact our facility directly to establish an account and place orders. Please call us at (407)993-1381 to speak with a representative. More information is also available on our website at https://503bcompoundingpharmacy.com/.