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 specifically designed and regulated to produce large volumes of compounded sterile and non-sterile medications for healthcare providers. As a 503B outsourcing facility, we adhere to rigorous federal standards for current good manufacturing practices (cGMP), which provides a significant level of quality and safety assurance for the medications we compound. Our primary mission is to support the medical community by providing bulk quantities of high-quality, compounded medications that are not commercially available.
The operations at our Longwood facility are distinct from traditional compounding pharmacies. We serve healthcare facilities and practitioners by providing medications for office use, meaning the medications we produce are administered to patients within a clinical setting rather than being dispensed directly to an individual for home use. This model allows physicians, surgeons, hospitals, and clinics in the area to have reliable access to essential medications that are critical for their practice, including anesthetic preparations, ophthalmic solutions, and other injectable medications. Our role is to be a dependable manufacturing partner for the local medical community.
Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art cleanrooms and environmental monitoring systems to ensure every product meets strict sterility and potency specifications. The team at 503B Compounding Pharmacy includes highly trained pharmacists, pharmacy technicians, and quality assurance professionals who are dedicated to the science of compounding. Every batch of medication is subjected to extensive testing and quality control checks before it is released for distribution. This commitment to quality and compliance is the foundation of our service at this facility.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with our 503B outsourcing facility offers numerous advantages. It ensures a consistent supply of critical medications, reduces the compounding burden on in-house pharmacy staff, and mitigates risk through our adherence to federal cGMP standards. We provide a streamlined process for ordering and delivery, designed to integrate seamlessly with the operations of local medical practices. For more information about our services or to discuss your facility's specific needs, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
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 complies with strict federal current good manufacturing practices (cGMP). This regulatory status differentiates us from traditional 503A pharmacies and signifies we are authorized to compound large quantities of medications for office use by healthcare practitioners without patient-specific prescriptions.
2. Can I, as an individual patient, get a prescription filled at your location?
No. Our facility at 2160 W State Road 434, Longwood, FL 32779 operates under a specific regulatory framework that focuses on supplying compounded medications in bulk for office use to healthcare facilities and practitioners. We do not dispense medications directly to individual patients. You would need to receive any medications we compound through your healthcare provider 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 sterile injectable medications, including IV bags, syringes, and ophthalmic solutions. These are often used for anesthesia, pain management, antibiotics, and other treatments administered in clinics, surgical centers, and other healthcare settings. All our compounding activities are conducted under cGMP standards.
4. How do healthcare providers at this location order from you?
Healthcare providers and facilities can place orders by contacting our facility directly. Our team will guide you through the process, which typically involves setting up an account and discussing your specific medication needs. You can initiate this process by visiting our website at or calling us at (407)993-1381.
5. Why should a clinic at 2160 W State Road 434 use a 503B outsourcing facility?
Utilizing our 503B outsourcing facility provides clinics and hospitals with a reliable source of high-quality, compounded medications that have been produced under the most rigorous FDA standards. This partnership ensures patient safety, reduces the regulatory and operational burden on the clinic's own staff, and guarantees consistency and reliability in the medications used for patient procedures.