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 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 pharmaceutical compounding. We produce large quantities of compounded sterile and non-sterile medications for healthcare providers, which are then administered to patients under their direct care and supervision.
As a 503B outsourcing facility, our operations are distinct from traditional compounding pharmacies. We are subject to rigorous current Good Manufacturing Practice (cGMP) regulations and undergo regular FDA inspections to ensure the integrity of every preparation that leaves our facility. The medications we compound at our Longwood location are intended for office use by physicians, surgeons, veterinarians, and other healthcare practitioners, providing them with a reliable and compliant source for their patients' specific medication needs.
The core of our service is providing bulk compounded medications that are not commercially available or are in shortage. Our team of highly skilled pharmacists and technicians utilizes state-of-the-art equipment and validated processes to ensure potency, purity, and sterility. We serve a critical role in the local healthcare ecosystem by ensuring that practitioners at 2160 W State Road 434, Longwood, FL 32779 have access to essential medications, including hormone replacement therapies, ophthalmologic solutions, injectable pain management formulations, and other vital sterile preparations.
Our facility at 2160 W State Road 434 is designed to meet the complex demands of modern medicine. We understand that healthcare providers require absolute confidence in their medication supply, and we build that confidence through transparency, quality, and consistent service. For more information or to discuss your specific needs, please contact us directly. We are your trusted partner in pharmaceutical compounding.
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 complies with stricter federal standards, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and safety for the compounded medications we produce in bulk for healthcare providers.
2. Can I, as an individual patient, pick up a prescription directly from your location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Patients receive their medications directly from their doctor, surgeon, or veterinarian, who orders our compounded preparations from our facility at 2160 W State Road 434, Longwood, FL 32779 for administration in a clinical setting.
3. What types of medications do you compound at your Longwood facility?
At our location on W State Road 434, we specialize in compounding a wide range of sterile preparations, including but not limited to injectables, ophthalmologic drops, and hormone therapy formulations. These are produced in larger quantities for healthcare providers to use within their practice.
4. How do I, as a healthcare provider, place an order with your pharmacy?
Healthcare providers can place orders by contacting our facility directly at (407)993-1381. Our team will work with you to understand your specific requirements and provide information on our available formulations and ordering process from our location at 2160 W State Road 434.
5. Why would a healthcare provider choose a 503B outsourcing facility like yours?
Healthcare providers choose our 503B outsourcing facility for the assurance of FDA-registered, cGMP-compliant quality. This is especially critical for medications administered in-office, as it guarantees the sterility, potency, and safety of the preparations used on their patients at 2160 W State Road 434, Longwood, FL 32779.