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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. We are located at 2160 W State Road 434, Longwood, FL 32779, providing essential pharmaceutical compounding services from this specific facility. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing large-scale batches of compounded medications for office use by healthcare practitioners. Our operations are distinct from traditional compounding pharmacies, focusing on non-patient-specific, sterile and non-sterile preparations that are distributed to hospitals, clinics, and physician offices for immediate administration to patients.
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is dedicated to rigorous quality control. Our state-of-the-art facility features advanced environmental monitoring, stringent testing protocols, and compliance with Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility meets precise specifications for potency, purity, and sterility. We provide healthcare professionals with a reliable source for critical medications, including those that may be in short supply or discontinued by commercial manufacturers. Our team of highly skilled pharmacists and technicians is committed to supporting the local medical community by delivering consistent, high-quality compounded preparations.
Our service at 2160 W State Road 434, Longwood, FL 32779 is focused on supplying healthcare providers. We compound a range of preparations, including sterile injectables, ophthalmics, and other dosage forms necessary for patient care. By operating as a 503B outsourcing facility, we provide an added layer of safety and regulatory oversight, giving practitioners confidence in the medications they use. For more information or to discuss your facility's needs, please contact us at our website, , or by phone at (407)993-1381.
Frequently Asked Questions
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. This registration requires us to comply with more rigorous standards, including Current Good Manufacturing Practices (cGMP), for the large-scale compounding of medications intended for office use by healthcare providers.
2. Can I, as a patient, pick up my prescription directly from your location?
No. Our 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 does not dispense medications directly to patients. We supply compounded preparations exclusively to healthcare practitioners and facilities for administration to their patients within a clinical setting.
3. What types of medications do you compound at your Longwood facility?
From our location at 2160 W State Road 434, we compound a variety of sterile and non-sterile preparations, including injectables, ophthalmics, and other formulations. These are produced for office use to support healthcare providers in their practice, particularly for medications that are on shortage or not commercially available.
4. How does a healthcare provider place an order with your pharmacy?
Healthcare providers and facilities can place orders by contacting our 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, product availability, and delivery options for our location at 2160 W State Road 434, Longwood, FL 32779.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 ensures the medications you use in your practice are produced under the strict quality and safety standards of cGMP. This provides a higher level of assurance regarding sterility, potency, and purity compared to traditional pharmacy compounding, which is critical for patient safety.