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, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility meets stringent quality control benchmarks for the healthcare providers and patients we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. Our operations are designed to provide healthcare practitioners with access to essential drugs that may be in shortage, discontinued, or otherwise unavailable for their patients. By producing these medications in bulk, we achieve a level of consistency, reliability, and quality control that is essential for patient safety. The medications prepared at our facility on W State Road 434 are distributed to healthcare settings for office use, ensuring practitioners have the necessary treatments on hand for immediate patient care.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology and environmental controls necessary for cGMP-compliant manufacturing. Our processes are meticulously validated, and our highly trained staff undergoes continuous education to uphold the strict protocols required for an FDA-registered outsourcing facility. We maintain a robust quality assurance program that oversees every aspect of production, from ingredient sourcing and testing to final product sterility testing and release. This unwavering focus on quality guarantees that every preparation is pure, potent, and precisely formulated.
503B Compounding Pharmacy provides a critical service to the local medical community by helping to alleviate drug shortages. When commercially manufactured drugs are not available, our facility can step in to compound these vital medications, preventing interruptions in patient treatment plans. Healthcare providers can confidently source these preparations from our location, knowing they are receiving a product manufactured under the highest regulatory standards. We serve as a reliable partner to practitioners, ensuring they have consistent access to the compounded medications their practice requires.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website to learn more about our compliance and capabilities at https://503bcompoundingpharmacy.com/. Our facility is dedicated to supporting healthcare delivery from our location at 2160 W State Road 434, Longwood, FL 32779.
FAQ
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 operates under Section 503B of the FD&C Act. We are subject to federal oversight, including compliance with current Good Manufacturing Practices (cGMP) and routine FDA inspections, ensuring the highest level of quality and safety for our compounded preparations.
Can I as an individual patient pick up my prescription directly from your location?
No. As a 503B outsourcing facility, we compound medications in larger batches for "office use" by healthcare practitioners. Individual patient prescriptions are typically compounded by traditional 503A pharmacies. Healthcare providers order from us to have medications available in their offices for administration to patients.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility on W State Road 434 specializes in compounding sterile injectables, ophthalmics, and other preparations that are often on national drug shortage lists or are no longer available from large commercial manufacturers. We provide these in bulk to healthcare practices.
How does a healthcare provider at a local practice place an order with your facility?
Healthcare providers can contact our facility directly to discuss their needs and place an order. They can reach our team by calling (407)993-1381. Our staff will guide them through the ordering process specific to our 503B outsourcing services.
Why should a healthcare provider choose 503B Compounding Pharmacy for their office-use medications?
Choosing our facility ensures that the medications are produced under the strictest cGMP standards required by the FDA. This provides an unparalleled level of quality, consistency, and sterility assurance for medications used in a clinical setting, directly supporting patient safety and care standards.