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, quality, and purity.
At our Longwood location, we specialize in the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. Our core service is the production of medications in bulk for physicians, clinics, hospitals, and other healthcare providers serving patients at 2160 W State Road 434, Longwood, FL 32779. This model allows healthcare professionals to have essential, often difficult-to-find medications readily available for their patients without the burden of in-house compounding. We provide a critical supply chain solution, particularly during drug shortages, by producing high-quality alternatives to commercially available drugs that may be on backorder or discontinued.
The operational focus of 503B Compounding Pharmacy is on consistency and reliability. By producing medications in larger batches, we achieve a level of standardization and testing that is vital for patient safety. Each batch is thoroughly tested for sterility, potency, and endotoxin levels before it is released, providing unparalleled assurance to the medical community we serve directly from our facility on W State Road 434. Our team of highly trained pharmacists and technicians utilizes state-of-the-art equipment and cleanroom technology to maintain the integrity of every preparation.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with our 503B outsourcing facility means accessing a dependable source of compounded medications that are essential for patient care. We encourage local practitioners to learn more about how our services can support their practice. You can reach us by phone at (407)993-1381 or visit our website to discover more about our capabilities and compliance at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility?
It means our pharmacy is registered with the FDA and operates under Section 503B of the FD&C Act. We are subject to strict federal standards, including Current Good Manufacturing Practices (cGMP), and routine FDA inspections. This ensures the medications we produce at our Longwood location undergo rigorous testing for quality, sterility, and strength.
2. Who can order medications from your facility at 2160 W State Road 434?
Our services are designed for healthcare practitioners. We provide compounded medications for office use to physicians, surgeons, dermatologists, veterinarians, and other licensed healthcare providers whose practices are located at 2160 W State Road 434, Longwood, FL 32779.
3. Do you provide compounded medications directly to individual patients?
No, as a 503B outsourcing facility, we distribute our compounded medications for office use to healthcare practitioners. Individual patients receive their medications directly from their prescribing doctor or clinic at the time of their appointment or procedure.
4. How does your service benefit local healthcare practices?
We provide a reliable source of high-quality, batch-tested medications, which is especially critical during national drug shortages. This allows practices at 2160 W State Road 434 to ensure they have the necessary medications on hand for treatments and procedures without the need for their own in-house compounding.
5. How can a practice at this location place an order?
Healthcare practices can contact us directly to establish an account and place orders. Please call our facility at (407)993-1381 to speak with a representative. You can also find more information on our website at https://503bcompoundingpharmacy.com/.