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. As a 503B outsourcing facility, we produce large batches of compounded medications for office use, which are then distributed to healthcare practitioners for patient administration within their practice settings. This model is distinct from traditional compounding and is designed for medications that are in significant demand and are not available from commercial manufacturers.
The operations at our Longwood location are conducted under rigorous quality control protocols that meet and often exceed FDA standards. This includes stringent testing of raw materials, meticulous environmental monitoring of our cleanrooms, and comprehensive sterility testing of finished products. The medications produced at 503B Compounding Pharmacy are non-patient-specific, meaning they are not created for an individual patient based on a prescription, but are instead available for healthcare providers to keep in stock for immediate use when the clinical need arises. This ensures that practitioners at local medical offices and clinics have timely access to essential medications.
Our service is dedicated to supporting the local medical community by providing a reliable source of high-quality, compounded sterile preparations. Healthcare providers can confidently utilize our products, knowing they are sourced from an FDA-registered facility that adheres to Current Good Manufacturing Practices (cGMP). The team at our 2160 W State Road 434 facility is comprised of skilled pharmacists and technicians who are experts in their field, dedicated to the science of compounding and the well-being of the patients who ultimately benefit from our work.
For healthcare entities seeking a trusted partner for their office-use medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of quality and reliability. We invite local practitioners to learn more about our processes and product offerings. You can reach us by phone at (407)993-1381 or visit our website for more detailed information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 the U.S. Food and Drug Administration and complies with strict federal standards for compounding, including Current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and consistency for the compounded medications we produce for office use.
Who can order medications from 503B Compounding Pharmacy?
Our medications are produced for office use and are distributed to healthcare practitioners with prescribing authority. Orders are placed by healthcare practices and clinics for administration to patients within their facility at 2160 W State Road 434, Longwood, FL 32779. We do not fulfill prescriptions for individual patients.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in compounding sterile injectable medications that are in high demand but may be on shortage or not commercially available. This includes a range of preparations necessary for clinics and offices in the local area.
How does the quality assurance process work at your facility?
Our quality assurance process at 2160 W State Road 434, Longwood, FL 32779 is comprehensive. It involves validated processes, rigorous testing of components and finished products, and extensive documentation to ensure every batch meets predetermined specifications for identity, strength, quality, and purity.
How can a healthcare practice get started with your services?
Healthcare practices interested in our services can contact us directly to establish an account. We encourage you to call our facility at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ to speak with a representative and learn more about our ordering process and available products.