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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of pharmaceutical quality, exceeding those required of traditional compounding pharmacies. This designation means our processes, testing, and quality control measures are conducted under current Good Manufacturing Practices (cGMP), ensuring that every preparation that leaves our facility is of consistent, predictable, and reproducible quality.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to 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 medication that is currently in shortage. Our work at the Longwood facility is pivotal for hospitals, clinics, and healthcare practitioners who require these tailored pharmaceutical solutions for their patients. We serve as a critical partner in the local healthcare ecosystem, enabling personalized patient care through precision compounding.
Our state-of-the-art facility at 2160 W State Road 434 is designed to support a robust quality assurance program. Every batch of medication is rigorously tested for potency, sterility, and endotoxins to guarantee patient safety and therapeutic efficacy. The environment in which our sterile compounds are produced is meticulously controlled and continuously monitored to prevent contamination. This unwavering commitment to quality and safety is the foundation of our operation and what distinguishes a 503B outsourcing facility from other compounding entities.
Healthcare professionals seeking a reliable source for compounded medications can confidently partner with 503B Compounding Pharmacy. Our team of experienced pharmacists and technicians is dedicated to fulfilling the unique needs of prescribers and their patients. We encourage you to contact us to discuss how our services can support your practice. You can reach us by phone at (407)993-1381 or learn more about our capabilities and compliance on our website at https://503bcompoundingpharmacy.com/.
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 operates under Section 503B of the FD&C Act. This requires us to comply with stringent current Good Manufacturing Practices (cGMP), which include rigorous testing, quality control, and reporting standards for all compounded preparations.
Who can order medications from 503B Compounding Pharmacy?
Our medications are prepared for healthcare providers, including physicians, hospitals, and clinics. A valid prescription from a licensed prescriber is required for all orders. Patients should consult their healthcare provider to determine if a compounded medication from our facility is appropriate for their needs.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in both sterile and non-sterile compounded medications. This includes preparations like sterile injectables, ophthalmics, and other formulations that are made to address specific patient requirements or to help alleviate drug shortages.
How does the quality assurance process work at your facility?
Our quality assurance process at 2160 W State Road 434 is comprehensive. It includes environmental monitoring, validation of all processes and equipment, and rigorous testing of finished drug products for sterility, potency, and purity before they are released, ensuring they meet all specified standards.
How can a healthcare provider at your location place an order?
Healthcare providers can initiate an order by contacting our pharmacy directly at (407)993-1381. Our team will work with you to understand your specific needs and provide information on formulation availability, ordering procedures, and delivery options from our Longwood facility.