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 compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, our 503B outsourcing facility undergoes rigorous FDA inspections and adheres to Current Good Manufacturing Practices (cGMP), ensuring that every batch of medication we produce meets stringent federal requirements for strength, purity, and stability.
The services provided at our location on 2160 W State Road 434 are specifically designed for healthcare providers. We engage in large-scale, batch-level compounding of sterile and non-sterile medications that are distributed for office use by physicians, clinics, hospitals, and other healthcare entities serving patients in our community. The medications produced at our Longwood facility are essential for a wide range of treatments, including hormone replacement therapy, ophthalmology, dermatology, and pain management. By providing these critical medications, we support local healthcare professionals in delivering personalized and effective care to their patients.
Our operational model at 2160 W State Road 434 is built on a foundation of precision and reliability. The compounding processes employed within our facility utilize state-of-the-art technology and equipment to ensure accuracy and sterility. Every step, from ingredient sourcing to final packaging, is meticulously controlled and documented. This allows us to provide healthcare providers at our location with consistent, high-quality medications they can trust. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are dedicated to upholding the integrity of every product that leaves our facility.
For healthcare providers at our location seeking a dependable source for compounded medications, 503B Compounding Pharmacy represents a partner in patient care. We understand the critical need for accessible and reliable medications, and our operations are tailored to meet the specific demands of the medical community we serve directly from 2160 W State Road 434. To learn more about our available formulations or to discuss your specific needs, we encourage you to contact us directly. You can reach our facility 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 operates under Section 503B of the FD&C Act. We comply with Current Good Manufacturing Practices (cGMP) and are subject to regular FDA inspections, ensuring the medications we compound meet the highest federal standards for safety and quality.
Who can order medications from your facility at 2160 W State Road 434?
Our services are provided to healthcare professionals for office use. This includes physicians, surgeons, dermatologists, ophthalmologists, and other licensed practitioners who administer medications within their practice at our location. We do not dispense medications directly to individual patients.
What types of medications does 503B Compounding Pharmacy produce?
At our Longwood facility, we compound a wide array of sterile and non-sterile medications in batches. This includes, but is not limited to, formulations for hormone therapy, pain management, dermatological conditions, and ophthalmic solutions. All products are made following strict cGMP protocols.
How does the quality of a 503B compounded medication differ?
Medications compounded at our FDA-registered outsourcing facility undergo rigorous testing and quality control processes as required by federal law. This provides an additional layer of assurance regarding sterility, potency, and purity compared to medications compounded under traditional pharmacy standards.
How can a healthcare provider at your location place an order?
Healthcare providers can contact our facility directly to discuss their needs and place an order. We can be reached by phone at (407)993-1381. Additional information about our services and available formulations can be found on our website at https://503bcompoundingpharmacy.com/.