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, our 503B outsourcing facility undergoes rigorous FDA inspections and adheres to Current Good Manufacturing Practices (cGMP), ensuring that every preparation meets stringent federal quality standards.
At our Longwood location, we specialize in the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. Our core mission is to provide physicians, surgeons, hospitals, and clinics with access to bulk quantities of high-quality, reliable compounded preparations. This allows healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to focus on patient care with the confidence that their necessary medications are prepared under the most controlled and quality-assured conditions.
The services provided by 503B Compounding Pharmacy are distinct. We produce medications that are often in short supply or unavailable from conventional pharmaceutical manufacturers. Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced environmental controls and testing laboratories to ensure sterility, potency, and stability. Every batch is meticulously prepared and undergoes a series of quality control tests before it is released, providing an unparalleled level of assurance for the medical community we serve directly from this location.
Healthcare professionals seeking a dependable source for compounded pharmaceutical needs can rely on 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. We encourage you to contact us to discuss how our services can support your practice. You can reach us by phone at (407)993-1381 or visit our website for more detailed information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. We comply with Current Good Manufacturing Practices (cGMP) and are subject to regular FDA inspections, ensuring the medications we compound meet the highest federal standards for safety, quality, and purity.
2. Can I, as a patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy primarily distributes compounded medications for office use by healthcare practitioners. Patients should receive their medications directly from their prescribing doctor or clinic. Our services are designed to supply healthcare providers at our location, 2160 W State Road 434, Longwood, FL 32779, with the medications they need to administer to patients in a clinical setting.
3. What types of medications do you compound at your Longwood facility?
At our facility on W State Road 434, we compound a wide range of sterile preparations, including injectables, ophthalmics, and irrigations, as well as non-sterile medications. These are produced in larger batches for healthcare providers and are often medications that are on drug shortage lists or are not commercially available from standard pharmaceutical manufacturers.
4. How does a healthcare provider at 2160 W State Road 434 place an order with you?
Healthcare providers and their authorized staff can place orders by contacting our facility directly at (407)993-1381. Our team will guide you through the ordering process, answer any questions about specific preparations, and arrange for delivery or pickup as required.
5. Why should a healthcare provider choose 503B Compounding Pharmacy?
Choosing our facility at 2160 W State Road 434, Longwood, FL 32779 provides assurance. You are sourcing medications from an FDA-registered outsourcing facility that adheres to the most rigorous compounding standards. This mitigates risk, ensures consistency and reliability in the medications you use, and allows you to offer treatments that may otherwise be inaccessible to your patients.