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 large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to meeting the highest standards of quality, safety, and consistency, providing healthcare providers and patients with medications that are not otherwise commercially available.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals located at and serving 2160 W State Road 434, Longwood, FL 32779 can utilize our services to obtain essential medications for their practice. This allows for efficient patient care, as practitioners can have a ready supply of necessary drugs for procedures, treatments, and prescriptions without the delays associated with traditional compounding.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 adheres to rigorous Current Good Manufacturing Practices (cGMP). This ensures every batch of medication we produce undergoes stringent quality control testing for potency, sterility, and purity. By operating under the 503B framework, we provide an added layer of safety and reliability that goes beyond traditional pharmacy compounding. Healthcare providers can be confident that the medications they administer or dispense from our outsourcing facility meet exacting federal standards.
The medications produced by 503B Compounding Pharmacy are critical for a wide range of medical applications. We compound various formulations, including sterile injectables, ophthalmics, and topicals. These are essential for procedures in clinics and surgical centers associated with 2160 W State Road 434, Longwood, FL 32779. Our work supports local healthcare delivery by ensuring practitioners have access to the specific medications they need, when they need them, all produced under the oversight of the FDA.
503B Compounding Pharmacy is a vital partner for the medical community at 2160 W State Road 434, Longwood, FL 32779. We provide a critical service that bridges the gap between commercial drug manufacturing and individualized patient care at the practice level. For more information about our services or to speak with our team, please contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
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 is registered with and inspected by the U.S. Food and Drug Administration. We compound medications in large batches for office use by healthcare practitioners and must comply with strict federal manufacturing standards known as Current Good Manufacturing Practices (cGMP).
Who can order medications from 503B Compounding Pharmacy?
Our primary clients are healthcare practitioners, including physicians, surgeons, and other medical professionals, who practice at or are associated with 2160 W State Road 434, Longwood, FL 32779. We provide medications for office use to be administered or dispensed within their practice setting.
Does 503B Compounding Pharmacy serve individual patients directly?
No. As an outsourcing facility operating under Section 503B, our business model is focused on supplying healthcare practitioners for office use. Individual patients should receive their compounded medications directly from their prescribing healthcare provider at locations such as 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy produce?
We produce a range of sterile and non-sterile compounded medications in bulk quantities. This includes, but is not limited to, sterile injectables, ophthalmics, and topical formulations that are essential for medical procedures and treatments conducted by practitioners at 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance at a 503B outsourcing facility differ from a traditional compounding pharmacy?
503B Compounding Pharmacy follows Current Good Manufacturing Practices (cGMP), which are the same rigorous quality standards required of major pharmaceutical manufacturers. This includes extensive testing of raw materials, in-process testing, and finished product testing for sterility, potency, and purity, providing a higher level of assurance for medications used at 2160 W State Road 434, Longwood, FL 32779.