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 unwavering commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers by producing medications that are patient-specific or in bulk for office use, ensuring that practitioners at 2160 W State Road 434, Longwood, FL 32779 have access to reliable pharmaceutical compounds.
The core function of 503B Compounding Pharmacy is the preparation of medications that are not commercially available. This includes creating formulations without certain allergens like dyes or preservatives, altering the strength or dosage form of a medication to meet specific patient needs, or compounding a drug that is currently on shortage. Our operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under a rigorous quality control system. Every batch of medication is meticulously prepared and tested to ensure sterility, potency, and purity, providing healthcare professionals with the confidence that the medications they administer are of the utmost quality.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians. We adhere to current Good Manufacturing Practices (cGMP), which are the same standards followed by major pharmaceutical manufacturers. This ensures a level of environmental control, testing, and documentation that is integral to patient safety. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with a 503B outsourcing facility like ours means mitigating risk and enhancing patient care with compounded medications they can trust.
503B Compounding Pharmacy provides an essential service for the medical community. We understand that each patient's needs are unique, and commercial medications are not always an option. By working directly with prescribers, we help fulfill these specific requirements from our location at 2160 W State Road 434, Longwood, FL 32779. Our team is dedicated to supporting local healthcare delivery by providing high-quality, compounded pharmaceuticals in a timely and efficient manner.
To learn more about our services or to speak with our team, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/. We are located at 2160 W State Road 434, Longwood, FL 32779 and are committed to serving the specific compounding needs of the healthcare providers at this location.
FAQ
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 complies with strict federal standards under Section 503B of the FD&C Act. We adhere to current Good Manufacturing Practices (cGMP) for higher-level quality control, testing, and reporting compared to a traditional pharmacy.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to licensed healthcare providers for office use or for their specific patients. We do not dispense medications directly to individual patients at our location, 2160 W State Road 434, Longwood, FL 32779, without a prescription from a licensed prescriber.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding both sterile and non-sterile medications in larger batches. This includes medications that are on drug shortage lists, or those that need to be made without certain allergens or in a specific strength or form not available commercially.
4. How does the quality assurance process work at your facility?
At our location, 2160 W State Road 434, Longwood, FL 32779, every compounded batch undergoes rigorous testing for sterility, potency, and endotoxins. Our processes are meticulously documented under our cGMP-quality system to ensure the safety and efficacy of every medication we produce.
5. How can a healthcare provider at this location place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their compounding needs and place an order. We can be reached by phone at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 will guide you through the process.