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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are held to the highest standards of pharmaceutical compounding, adhering to rigorous Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility meets strict quality and safety protocols for identity, strength, quality, and purity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and, in certain cases, non-sterile preparations. These preparations are not commercially available and are produced for office use by healthcare practitioners. Our services are provided directly to practitioners and healthcare facilities, not to individual patients at the retail level. The medications we compound are essential for a wide range of medical treatments and procedures, including office-administered injections, IV therapies, and topical applications used in clinical settings.
By operating under Section 503B, our pharmacy provides a critical service to the medical community at 2160 W State Road 434, Longwood, FL 32779. Healthcare providers can confidently utilize our preparations, knowing they are sourced from an FDA-registered and inspected facility that prioritizes patient safety above all else. Our dedicated team of pharmacists and technicians utilizes state-of-the-art technology and cleanroom environments to ensure the integrity of every preparation.
For healthcare providers seeking a reliable source for high-quality, office-use medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a trusted partner. We are committed to supporting the local medical community with consistent, dependable, and safe compounded pharmaceutical products. For more information, please visit our website at or contact us directly by phone at (407)993-1381.
FAQ
1. What does it mean that this is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under strict federal regulations known as Current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and oversight for the sterile and non-sterile preparations we compound for healthcare practitioners.
2. Can I, as a patient, pick up a prescription directly from this location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. We do not dispense medications directly to individual patients. Your healthcare provider will administer any preparations compounded at our facility within their practice.
3. What types of medications does 503B Compounding Pharmacy produce?
We produce a wide array of compounded sterile preparations, including injectables, IV bags, and ophthalmics, as well as certain non-sterile preparations. These are medications that are not otherwise commercially available and are essential for various medical treatments provided by local practitioners.
4. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate orders and discuss their specific compounding needs by contacting our facility directly at (407)993-1381. Our team will provide all necessary information regarding ordering procedures and product availability.
5. Why should a practitioner choose a 503B outsourcing facility?
Choosing a 503B outsourcing facility like ours ensures that the compounded medications used in your practice are produced under the most stringent quality and safety standards mandated by the FDA. This mitigates risk and provides assurance for both the practitioner and the patient.