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 operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations, and provides medications for office use by healthcare practitioners.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded medications. These preparations are dispensed to healthcare providers for office use, allowing physicians, surgeons, and other medical professionals at their practices to have essential medications readily available for patient administration. This model is crucial for supporting various medical treatments and procedures that require access to specific drug formulations that are not commercially available. Our operations are dedicated to serving the needs of practitioners who require these vital medications for their patients.
Our facility at 2160 W State Road 434 is equipped with state-of-the-art technology and staffed by a team of highly trained pharmacists and technicians. Every process, from ingredient sourcing to final product testing, is meticulously controlled to ensure the potency, purity, and sterility of every preparation that leaves our facility. We maintain a robust quality assurance program that meets and exceeds the requirements set forth by the FDA for 503B outsourcing facilities. This unwavering dedication to quality provides healthcare professionals with the confidence that the medications they use are safe, effective, and reliable.
503B Compounding Pharmacy provides an essential service to the local medical community by supplying medications that are often critical for patient care. Our location at 2160 W State Road 434, Longwood, FL 32779 is central to our mission of supporting healthcare delivery. For more information about our services or to speak with our team, please contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means our facility is registered with the FDA under Section 503B and adheres to strict federal regulations, including current Good Manufacturing Practices (cGMP). This ensures the medications we produce meet the highest standards of quality, purity, and sterility for office use by healthcare practitioners.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our medications are supplied for office use to licensed healthcare practitioners, including physicians, surgeons, and other medical professionals. We work directly with practices to provide the compounded preparations they need for patient care.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in the large-scale compounding of both sterile and non-sterile medications. This includes preparations like injectables, ophthalmics, and other formulations that are not commercially available but are necessary for medical treatments.
How does the quality assurance process work at your facility?
We have a comprehensive quality assurance program that oversees every aspect of production. This includes rigorous testing of ingredients, environmental monitoring of our cleanrooms, and validated processes to ensure the potency, sterility, and stability of every batch of medication we produce.
How can a healthcare practice at 2160 W State Road 434 get started with your services?
Healthcare practices interested in our services can initiate contact by calling our facility at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ to learn more and discuss their specific compounding needs.