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, an FDA-registered 503B outsourcing facility adheres to rigorous current Good Manufacturing Practices (cGMP), ensuring that each batch of medication is produced with unparalleled consistency and purity. We serve healthcare providers and patients at our Longwood location by providing bulk quantities of compounded sterile and non-sterile preparations for office use.
The core mission of 503B Compounding Pharmacy is to provide healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable supply of high-quality compounded medications. Our services are designed to support physicians, surgeons, veterinarians, and other medical professionals by ensuring they have the necessary medications readily available for their patients. By operating as a 503B outsourcing facility, we undertake extensive testing on our ingredients and finished products, providing an additional layer of safety and assurance for the medical community we serve directly from our Longwood facility.
Patients and healthcare providers who utilize the services of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from our unwavering dedication to pharmaceutical excellence. Our state-of-the-art facility is designed to mitigate the risk of contamination and ensure the potency of every preparation. We understand the critical nature of the medications we produce and the importance of their role in patient care. 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.
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 complies with strict federal standards, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet heightened requirements for quality, purity, and strength.
Who can receive medications from 503B Compounding Pharmacy at this location?
Our primary clients are healthcare providers, including physicians, hospitals, and clinics. We provide medications for office use, meaning a practitioner at our location can order and administer these medications to their patients within their practice setting.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we compound a wide range of sterile and non-sterile preparations in larger batches. This includes injectables, ophthalmics, topicals, and other dosage forms that are commonly used in clinical settings.
How does the quality control at a 503B outsourcing facility differ?
Our facility undergoes rigorous testing of active pharmaceutical ingredients and finished drug products. We also adhere to environmental monitoring and stringent sterility testing protocols as mandated by cGMP regulations, providing an extra level of quality assurance for healthcare providers at our location.
How can a healthcare provider at this location place an order?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly. For ordering information and to discuss specific needs, please call our facility at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.