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.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under 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 large-scale compounding of sterile and non-sterile medications. This designation signifies our adherence to the most rigorous federal standards for quality control, testing, and production, going beyond the requirements of a traditional compounding pharmacy. We provide these medications for office use by healthcare practitioners, ensuring they have access to necessary drugs for their patients without the burden of in-house compounding.
The core function of 503B Compounding Pharmacy is to supply healthcare providers with high-quality compounded medications. Our location at 2160 W State Road 434, Longwood, FL 32779 is a hub for producing formulations that are often on drug shortage lists or are not commercially available from major pharmaceutical manufacturers. By operating under 503B regulations, we provide an essential service to the medical community, helping to mitigate drug shortages and ensure patient access to critical therapies. Our processes are designed for consistency, sterility, and potency in every batch we compound.
As a 503B outsourcing facility, our operations are subject to ongoing FDA inspections and strict current good manufacturing practices (cGMP). This means every product that leaves our facility at 2160 W State Road 434, Longwood, FL 32779 is produced under a level of scrutiny that ensures its integrity and safety. We invest in advanced analytical testing and environmental monitoring to validate the quality, strength, and purity of our compounded preparations. This commitment to excellence provides healthcare professionals with the confidence that the medications they administer meet the highest possible standards.
The services provided by 503B Compounding Pharmacy are specifically tailored for healthcare providers, including physicians, surgeons, and veterinarians, who require bulk compounded medications for office use. Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a significant volume of medications, which are then distributed to these practitioners. We do not typically dispense medications directly to individual patients upon walk-in request; instead, we serve as a vital link in the healthcare supply chain, supporting local practitioners with reliable access to essential drugs.
For healthcare providers seeking a dependable source for office-use compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a trusted partner. Our compliance with federal 503B standards is our highest priority, ensuring that every preparation is made with precision and care. To learn more about our services or to speak with our team, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this is a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile and non-sterile medications. We operate under strict federal current good manufacturing practices (cGMP) and are subject to regular FDA inspections, ensuring a higher level of regulatory oversight for quality and safety compared to a traditional pharmacy.
2. Can I, as an individual patient, walk into the facility to get a prescription filled?
No. 503B Compounding Pharmacy primarily supplies compounded medications in bulk for office use by healthcare practitioners. Individual patients should have their prescriptions filled at a traditional retail or compounding pharmacy that dispenses directly to the public.
3. What types of medications does this 503B facility compound?
Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a wide array of medications that are often on shortage or are not commercially available. This includes various sterile injectables, ophthalmics, and other preparations needed by healthcare providers in their practice for patient administration.
4. How can a healthcare provider at 2160 W State Road 434 order from you?
Healthcare providers can establish an account with our 503B outsourcing facility to order compounded medications for office use. Please contact our facility directly at (407)993-1381 to speak with a representative about setting up an account and discussing your specific needs.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 ensures the medications you use in your practice are produced under the most stringent federal quality controls. This provides assurance of sterility, potency, and purity, which is critical for patient safety and effective treatment outcomes.