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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of sterile and non-sterile compounded medications. This designation signifies our commitment to the highest standards of quality, safety, and compliance, operating under the rigorous current Good Manufacturing Practices (cGMP). We serve healthcare providers and their patients by providing access to medications that are not commercially available or are in shortage, ensuring critical therapeutic needs are met.
The operations at our Longwood location are central to our mission. Our state-of-the-art facility is designed to control for environmental contaminants, ensuring the integrity of every preparation. Our highly trained pharmacists and technicians utilize advanced technology and precise processes to compound a wide array of pharmaceutical preparations. This includes intravenous (IV) bags, hormone replacement therapies, ophthalmics, and other essential medications. Every batch is meticulously prepared and undergoes stringent quality control testing to verify potency, sterility, and purity before it is released, providing assurance to the medical community we serve.
503B Compounding Pharmacy provides its services exclusively from our facility at 2160 W State Road 434, Longwood, FL 32779. We work directly with physicians, hospitals, and clinics, providing them with the high-quality compounded medications necessary for patient care. Our role as a 503B outsourcing facility means we can compound medications in larger volumes for office use, allowing healthcare practitioners to have essential drugs on hand for immediate patient needs. Our team is dedicated to supporting the local medical community with reliable service and consistent product quality.
Engaging with 503B Compounding Pharmacy is a streamlined process for healthcare providers. Orders are managed through our secure systems, and our team is available to provide support and information. We encourage medical professionals to reach out to discuss their specific compounding requirements. You can learn more about our services and capabilities by visiting our website at https://503bcompoundingpharmacy.com/ or by calling our facility directly at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is ready to assist you.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and regulated under Section 503B of the FD&C Act. We adhere to stricter current Good Manufacturing Practices (cGMP) and are subject to FDA inspection, which provides a higher level of oversight compared to traditional compounding pharmacies.
Who can place an order with 503B Compounding Pharmacy at this location?
We provide compounded medications exclusively to licensed healthcare practitioners for office use or for their patients. Orders are placed by physicians, hospitals, clinics, and other healthcare providers. Patients must work through their prescribing provider to access our medications from 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in preparing sterile compounded medications, including IV injections, ophthalmics, and other formulations that are on drug shortage lists or are not available from commercial manufacturers, all produced under cGMP standards.
How does the quality control process work at your facility?
Quality control is paramount at our location. Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing for sterility, potency, and endotoxins before it is released. This ensures every preparation meets the strict specifications required for patient safety and therapeutic effectiveness.
How can a healthcare provider get started or learn more about your services?
Healthcare providers interested in our services can contact us directly to discuss their needs. The best way to initiate contact is by calling our facility at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more detailed information about our capabilities and processes at 2160 W State Road 434, Longwood, FL 32779.