Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, our 503B status means we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our facility meets stringent federal quality standards for sterility, potency, and purity.
At our location on 2160 W State Road 434, Longwood, FL 32779, we specialize in the large-scale compounding of medications that are typically intended for office use by healthcare practitioners. Our core mission is to provide physicians, surgeons, and other medical professionals with access to a reliable supply of high-quality, compounded sterile preparations (CSPs) and non-sterile preparations. By functioning as an outsourcing facility, we alleviate the compounding burden from individual clinical practices, allowing healthcare providers to focus on patient care with the confidence that their medications are sourced from a trusted, federally regulated entity.
The services provided at 503B Compounding Pharmacy are defined by our operational model. We produce medications in larger batches for which there is a clinical need, and we do so without receiving patient-specific prescriptions. Our portfolio often includes a range of injectables, ophthalmics, and other sterile preparations that are essential for various medical procedures and treatments. All processes within our facility at 2160 W State Road 434, Longwood, FL 32779 are designed to minimize the risk of contamination and ensure the integrity of every product. We maintain a state-of-the-art cleanroom environment and employ advanced analytical testing to verify the identity, strength, and sterility of our compounds.
Engaging with 503B Compounding Pharmacy means partnering with a facility dedicated to unwavering quality and regulatory excellence. Our team of experienced pharmacists and skilled technicians works diligently to support the local medical community by providing essential medications that are critical for patient treatment plans. We understand the profound trust placed in us by healthcare providers and their patients, and we uphold that trust through our relentless dedication to compliance and safety in every vial, syringe, and bottle we produce.
For more information about our services or to discuss how we can support your practice, we encourage you to contact us directly. You can reach our team at (407)993-1381 or visit our website to learn more about our capabilities and compliance standards at https://503bcompoundingpharmacy.com/. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
1. 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 and inspected by the U.S. Food and Drug Administration (FDA) under Section 503B of the FD&C Act. We compound medications in accordance with current Good Manufacturing Practices (cGMP), which are stringent federal regulations for sterility, testing, and quality control that exceed the standards applied to traditional compounding pharmacies.
2. Can I as an individual patient get a prescription filled at your location?
No. 503B Compounding Pharmacy operates as an outsourcing facility that provides medications for office use by healthcare practitioners. We do not accept or compound medications based on individual patient prescriptions. Patients should contact their healthcare provider, who can obtain medications from our facility for administration within their practice at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations (CSPs), which can include injectables, infusions, and ophthalmics. These are produced in larger batches for healthcare providers to have on hand for procedures, treatments, and office-based therapies, ensuring a consistent and reliable supply of critical medications.
4. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers and their authorized staff can place orders directly with our facility by calling (407)993-1381. Our team will guide you through the ordering process, answer any questions about our available preparations, and provide information necessary for procurement and use within your practice.
5. Why should a healthcare provider choose 503B Compounding Pharmacy?
Choosing our facility at 2160 W State Road 434, Longwood, FL 32779 provides assurance of quality and compliance. Our FDA-registered, cGMP-compliant status means every product is rigorously tested for sterility, potency, and purity. This reduces risk for practitioners and provides confidence that the medications used in their practice meet the highest possible safety standards.