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 operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is specifically designed and regulated to compound large volumes of sterile and non-sterile medications without receiving patient-specific prescriptions. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. We serve healthcare providers and facilities by providing them with access to essential medications that are often on shortage or are not commercially available, ensuring continuity of care for their patients.
The operations at our Longwood location are governed by rigorous Current Good Manufacturing Practices (cGMP). This means every process, from ingredient sourcing to final product testing, is meticulously controlled and documented. Our sterile compounding suites are environmentally monitored to ensure aseptic conditions, and our non-sterile compounding areas adhere to strict protocols to prevent contamination. By operating under 503B regulations, we provide healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with the assurance that the medications they utilize meet stringent federal quality standards beyond those of traditional compounding.
The core service of 503B Compounding Pharmacy is the large-scale production of compounded medications for office use. This allows physicians, surgeons, hospitals, and clinics in the area to maintain an inventory of critical medications for immediate administration to patients. Our portfolio includes a wide array of preparations, such as sterile injectables, ophthalmics, and other dosage forms that are essential for various medical procedures and treatments. The ability to provide these medications from an FDA-registered 503B outsourcing facility offers practitioners a reliable and compliant source for their patient care needs.
Our team at 2160 W State Road 434, Longwood, FL 32779 comprises skilled pharmacists, pharmacy technicians, and quality assurance professionals dedicated to the science of compounding. We leverage advanced technology and evidence-based practices to ensure every formulation is accurate, potent, and pure. The focus of 503B Compounding Pharmacy is solely on supplying other healthcare entities; we do not dispense medications directly to individual patients based on a prescription. Our role is to be a vital link in the healthcare chain, supporting local medical practices with high-quality, compounded pharmaceutical products.
For healthcare providers seeking a trusted partner for their compounding needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a resource. We encourage you to contact us to discuss how our services can support your practice. You can reach us via our website at or by phone at (407)993-1381 for more information.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B of the FD&C Act. We compound large batches of medications for office use by healthcare professionals and are required to comply with stringent federal manufacturing standards, including Current Good Manufacturing Practices (cGMP).
2. Can I, as an individual patient, get a prescription filled at your location?
No. 503B Compounding Pharmacy does not accept or process individual patient prescriptions. Our services are exclusively for healthcare providers and facilities. We compound medications in larger quantities for them to keep in stock and administer to their patients within their practice at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does your 503B facility compound?
We compound a range of sterile and non-sterile medications that are often on drug shortage lists or are not available from commercial manufacturers. This includes sterile injectables, ophthalmics, and other preparations needed by healthcare providers for procedures and treatments at their practices.
4. How does the quality control at a 503B outsourcing facility differ from a traditional pharmacy?
As a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we operate under cGMP regulations. This requires rigorous testing of ingredients (APIs), finished product potency and sterility testing, extensive environmental monitoring, and comprehensive documentation for every batch produced, which goes beyond the standards applied to traditional compounding pharmacies.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from your 503B facility?
Healthcare providers and facilities can place orders by contacting 503B Compounding Pharmacy directly. You can inquire about our available products and ordering process by calling us at (407)993-1381 or by visiting our website at .