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 at 2160 W State Road 434, Longwood, FL 32779
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 quality and safety, which are rigorously enforced by the FDA. This designation distinguishes us from traditional compounding pharmacies and ensures that healthcare providers at our location receive medications that are produced under a framework of current Good Manufacturing Practices (cGMP).
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. Our services are specifically designed for the medical community operating in and around our facility at 2160 W State Road 434, Longwood, FL 32779. We compound medications that are often in short supply or are not available from commercial manufacturers, ensuring that local practitioners have reliable access to the essential drugs their patients need. Our operations are strictly for office-use dispensing and we do not engage in direct patient dispensing from this location.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced environmental controls and technology to ensure the sterility, potency, and purity of every preparation. Our team of highly trained pharmacists and technicians follows stringent protocols for every step of the compounding process, from sourcing high-quality active pharmaceutical ingredients (APIs) to final product testing and packaging. This meticulous approach guarantees that every medication leaving our facility meets precise specifications and is safe for administration.
503B Compounding Pharmacy provides an essential service to hospitals, clinics, and healthcare providers by compounding critical medications such as sterile injectables, ophthalmics, and other preparations. By operating as a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we help mitigate drug shortages and provide a trusted source for high-quality compounded preparations. Our commitment is to support the local healthcare infrastructure with dependable, compliant, and essential pharmaceutical services.
For more information about our services for healthcare providers, please visit our website at or contact us directly at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that you are a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under strict federal regulations, specifically Section 503B of the FD&C Act. We comply with Current Good Manufacturing Practices (cGMP), which are the same standards required of large pharmaceutical manufacturers. This ensures the medications we compound for office use meet the highest levels of quality, sterility, and safety.
2. Can I, as a patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 compounds medications exclusively for office use by healthcare providers. We do not dispense medications directly to patients. Your healthcare provider will administer or dispense the medication to you from their own inventory, which they have sourced from our facility.
3. What types of medications do you compound at your Longwood facility?
At our location on 2160 W State Road 434, Longwood, FL 32779, we specialize in compounding sterile preparations, including injectables, ophthalmics, and other formulations that are often on drug shortage lists or are not commercially available. We produce these in larger batches for healthcare providers to have on hand for their patients.
4. How do I, as a healthcare provider, order from your facility?
Healthcare providers can place orders for compounded medications by contacting our facility directly at (407)993-1381. Our team will provide you with ordering information, available formulations, and discuss your specific needs for office-use medications at your practice.
5. Why should a provider choose a 503B outsourcing facility over a traditional compounding pharmacy?
Choosing a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 provides an added layer of safety and quality assurance. Our adherence to cGMP standards and FDA oversight means every batch of medication is rigorously tested for sterility, potency, and purity. This reduces risk for providers and ensures their patients receive the highest quality compounded preparations available.