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 pharmaceutical quality, producing medications for office use by healthcare practitioners and for specific patient prescriptions when a commercially available drug is not suitable.
The operations at our Longwood location are distinct from traditional compounding pharmacies. Our 503B status signifies that our facility is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent standards for potency, purity, and sterility. We provide healthcare providers in the local community with access to a reliable source of high-quality compounded medications for their practice needs.
Our core service is the compounding of medications in anticipation of receiving a prescription, or for office use, which is a key differentiator of a 503B outsourcing facility. This allows physicians, surgeons, and other healthcare professionals practicing near 2160 W State Road 434, Longwood, FL 32779 to have essential medications readily available for procedures and treatments. We compound a significant volume of injectable medications, including IV bags, epidurals, and other sterile preparations that are critical for hospital and clinic settings.
The team at our Longwood facility comprises skilled pharmacists and technicians who are experts in the science of pharmaceutical compounding. We utilize state-of-the-art equipment and technology within our controlled environment at 2160 W State Road 434, Longwood, FL 32779 to ensure accuracy and consistency in every batch. Our commitment to compliance and patient safety is paramount, and we maintain comprehensive documentation for every product we compound.
For healthcare providers seeking a trusted 503B outsourcing facility partner, we invite you to connect with us. You can learn more about our services and how we can support your practice by visiting our website at or by calling us directly at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with strict federal standards, including current Good Manufacturing Practices (cGMP). This regulatory framework ensures the medications we compound for office use meet the highest levels of quality, sterility, and safety.
2. Can I, as an individual patient, get my prescriptions filled at your location?
Our primary function is to supply compounded medications for office use by healthcare practitioners. While we compound based on specific prescriptions, these are typically initiated and ordered by a healthcare provider for use within their practice at 2160 W State Road 434, Longwood, FL 32779, not dispensed directly to individual patients walking in.
3. What types of medications do you compound at your Longwood facility?
As a 503B outsourcing facility, we specialize in compounding a wide range of sterile preparations, including IV solutions, injectables, and irrigation solutions. These are produced in larger batches for healthcare providers who require them for procedures and treatments.
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. You can reach our team at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 to discuss your specific needs and establish an account.
5. Why should a practice source medications from a 503B outsourcing facility like yours?
Sourcing from our FDA-registered 503B facility at 2160 W State Road 434, Longwood, FL 32779 provides assurance of cGMP compliance, which mitigates risk for your practice. It ensures the medications you use are produced under the most rigorous quality controls, providing a higher level of patient safety and product consistency.