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 precisely 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 adheres to rigorous federal current Good Manufacturing Practices (cGMP), ensuring every preparation meets stringent quality control standards for strength, sterility, and purity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for healthcare providers. We provide these essential medications to physician offices, hospitals, clinics, and other healthcare entities that serve patients at our location. By operating as a 503B outsourcing facility, we provide a critical service to the local medical community at 2160 W State Road 434, Longwood, FL 32779, ensuring they have reliable access to high-quality medications that may be commercially unavailable or in shortage.
Our services are defined by our regulatory status. We specialize in the non-patient-specific, anticipatory compounding of a broad range of sterile preparations. This includes intravenous (IV) bags, injectables, ophthalmics, and other complex formulations. The medications produced within our facility are created in larger batches under a prescription order from a licensed practitioner, but they are not made for an individual patient identified before compounding begins. This model allows for greater efficiency and readiness for the healthcare providers we serve at our Longwood location.
Quality and safety are the cornerstones of our operation at 2160 W State Road 434. Our state-of-the-art facility features advanced environmental controls, including ISO-classified cleanrooms, to prevent contamination. Every batch of medication undergoes extensive testing and validation processes to guarantee potency and sterility. This unwavering commitment to cGMP standards provides healthcare professionals at our location with the confidence that the medications they administer are of the highest possible quality and reliability.
503B Compounding Pharmacy is dedicated to supporting the local healthcare infrastructure. We understand the critical need for a dependable supply of essential medications. Our team of highly skilled pharmacists and technicians works diligently to meet this need for the medical community operating at and around 2160 W State Road 434, Longwood, FL 32779. 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
1. 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 operates under Section 503B of the FD&C Act. This requires us to comply with strict federal current Good Manufacturing Practices (cGMP) for the production of compounded medications, which includes rigorous testing, sterility assurance, and quality control standards that exceed those of traditional pharmacies.
2. Can I, as an individual patient, get a prescription filled directly at 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we provide compounded medications to healthcare providers and facilities, not directly to individual patients. Your physician or healthcare provider at our location would order the necessary medication from us to administer to you within their practice or clinic setting.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434 specializes in compounding sterile preparations (CSPs) in large batches. This includes intravenous (IV) fluids, hormone injections, antibiotic injections, ophthalmic drops, and other injectable medications that are often used in clinical settings by healthcare professionals.
4. How does 503B Compounding Pharmacy ensure the quality of its compounded medications?
We ensure quality through strict adherence to cGMP guidelines. This involves environmental monitoring of our ISO-classified cleanrooms, validated sterilization processes, and comprehensive testing of raw materials and finished products for potency, sterility, and endotoxins. Every batch is produced and verified under these rigorous protocols at our Longwood facility.
5. How can a healthcare provider at 2160 W State Road 434 place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate an order or inquire about our services by contacting our facility directly. We encourage you to visit our website at https://503bcompoundingpharmacy.com/ for more detailed information or to call our dedicated line at (407)993-1381 to speak with a representative about your specific needs.