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.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility 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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to rigorous federal standards for quality control, testing, and production, which are distinct from traditional compounding pharmacies. This ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 receive the highest quality medications for their patients.
The primary function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. Our services are designed for physicians, surgeons, dermatologists, and other medical professionals who require ready-to-use medications for procedures, treatments, and immediate patient needs within their practice at 2160 W State Road 434, Longwood, FL 32779. We compound a wide array of preparations, including sterile injectables, ophthalmics, topicals, and other dosage forms that are not commercially available or are in shortage.
By operating under Section 503B, our facility is subject to Current Good Manufacturing Practice (cGMP) regulations. This means every batch of medication produced at our location on W State Road 434 is rigorously tested for potency, sterility, and endotoxins to guarantee patient safety and therapeutic efficacy. Healthcare providers can confidently utilize our products, knowing they meet the strictest quality benchmarks set forth by the FDA.
Our commitment is to support the local medical community by providing reliable access to essential medications. The team at 503B Compounding Pharmacy works diligently to fulfill orders with precision and efficiency, ensuring practitioners have what they need for their patients. For more information or to discuss your office use compounding needs, please contact us directly.
Website: | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. We comply with stringent cGMP regulations and undergo regular FDA inspections, which includes testing every batch of medication for sterility, potency, and purity before it is released.
2. Can I, as a patient, order medications directly from your facility?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Patients must receive their compounded medications through their prescribing physician or healthcare provider who orders from us for use within their practice.
3. What types of medications do you compound at your Longwood location?
At our facility at 2160 W State Road 434, we compound a range of sterile and non-sterile medications. This includes injectables, IV bags, ophthalmics, and topical formulations that are often used by healthcare providers for procedures, injections, and treatments in their offices.
4. How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can place orders for office use medications by contacting our facility directly via phone at (407)993-1381. Our team will work with you to process your order and coordinate delivery or pickup.
5. Why would a healthcare provider use a 503B outsourcing facility instead of a traditional pharmacy?
Healthcare providers choose a 503B outsourcing facility like ours for the assurance of FDA oversight and batch-level testing. This is crucial for office-use medications, particularly sterile injectables, where guaranteed sterility and potency are non-negotiable for patient safety and effective treatment outcomes.