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 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 the highest standards of quality and safety, including current Good Manufacturing Practices (cGMP), which differentiates our operations from traditional compounding pharmacies. We provide these medications for office use by healthcare practitioners and for specific patient prescriptions, ensuring a critical component of the local healthcare infrastructure at 2160 W State Road 434, Longwood, FL 32779.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are not commercially available. This includes creating formulations without certain allergens like dyes or preservatives, altering the strength or dosage form of a medication to meet specific patient needs, or compounding a medication that is currently on the FDA drug shortage list. Our work at the 2160 W State Road 434, Longwood, FL 32779 location is pivotal for physicians, veterinarians, and other healthcare providers who require reliable access to high-quality compounded preparations for their patients. The 503B designation ensures a level of federal oversight and quality control that provides confidence to the medical community.
Our services at 2160 W State Road 434, Longwood, FL 32779 are fundamentally oriented toward supporting healthcare professionals. We provide office-use medications that practitioners can keep on hand for immediate administration to patients during procedures or appointments. Furthermore, we compound patient-specific medications based on prescriptions received from licensed prescribers. The environment at our 2160 W State Road 434, Longwood, FL 32779 facility is designed for precision, utilizing advanced technology and rigorous testing protocols to ensure the potency, purity, and sterility of every preparation that leaves our facility.
503B Compounding Pharmacy is committed to upholding the integrity of the compounding profession. The team at 2160 W State Road 434, Longwood, FL 32779 consists of highly skilled pharmacists and technicians who are experts in the art and science of pharmaceutical compounding. We understand the critical importance of our role in the patient care continuum and are dedicated to being a dependable resource for the medical community located near our facility at 2160 W State Road 434, Longwood, FL 32779. For more information or to initiate a order, you can visit our website at or contact us directly by phone at (407)993-1381.
FAQ
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. This requires us to comply with stringent current Good Manufacturing Practices (cGMP) for higher-volume compounding and subjects us to federal oversight and routine FDA inspections, ensuring a consistent level of quality and safety in our compounded preparations.
Can I, as a patient, directly order medications from 503B Compounding Pharmacy?
No, 503B Compounding Pharmacy primarily provides medications for office use by healthcare practitioners. Patient-specific medications are compounded based on a prescription from your licensed healthcare provider. Your provider will work directly with our facility at 2160 W State Road 434, Longwood, FL 32779 to fulfill your prescription needs.
What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
Our 503B outsourcing facility specializes in compounding a wide range of sterile and non-sterile medications that are not otherwise commercially available. This includes preparations for hormone therapy, pain management, dermatology, ophthalmology, and medications that are on the FDA’s drug shortage list, all produced under cGMP standards.
How does a healthcare provider at 2160 W State Road 434 place an order with your facility?
Healthcare providers can place orders for office-use or patient-specific compounded medications by contacting 503B Compounding Pharmacy directly. Orders can be initiated by calling our facility at (407)993-1381. Our team will guide you through the required documentation and process.
Why would a healthcare provider choose a 503B outsourcing facility over a traditional compounding pharmacy?
Healthcare providers choose a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 for the added assurance of federal oversight and cGMP compliance. This is especially critical for sterile injections, ophthalmics, and other high-risk preparations, as it ensures a level of quality control, testing, and consistency that is mandated by federal law.