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 the highest standards of quality, safety, and consistency, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers and patients by providing access to essential medications that are not commercially available, ensuring those at 2160 W State Road 434, Longwood, FL 32779 receive the specific care they need.
The core function of 503B Compounding Pharmacy is the production of medications in anticipation of receiving patient-specific prescriptions. This allows us to supply healthcare facilities with vital drugs that may be on shortage or are not manufactured by pharmaceutical companies. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced technology and rigorous testing protocols to ensure every preparation meets stringent potency, sterility, and purity standards. Our processes are designed for efficiency and reliability, providing a critical link in the healthcare supply chain for the local medical community.
Patients and providers visiting or servicing 2160 W State Road 434, Longwood, FL 32779 benefit from our specialized capabilities. We compound a significant volume of medications, which are then distributed to hospitals, clinics, and physician offices. This model ensures that when a healthcare provider needs a specific compounded medication for a patient, it can be readily available without delay. Our work supports personalized treatment plans and helps address critical drug shortages, contributing directly to positive patient outcomes for the community we serve from our location.
Quality assurance is the foundation of everything we do at 503B Compounding Pharmacy. Our facility undergoes regular and rigorous inspections by the FDA to maintain our registered outsourcing facility status. Every batch of medication is tested to verify its identity, strength, quality, and purity. This unwavering commitment to compliance and safety provides peace of mind to every healthcare provider and patient who relies on medications from our location at 2160 W State Road 434, Longwood, FL 32779. We are a trusted partner in health, dedicated to upholding the highest pharmaceutical standards.
For more information about our services or to speak with our team, we encourage you to contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our compliance and processes at https://503bcompoundingpharmacy.com/. Our facility at 2160 W State Road 434, Longwood, FL 32779 is proud to serve the local healthcare infrastructure with quality and dedication.
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 for compounding medications in large batches for healthcare providers, beyond state-level pharmacy regulations.
2. Can I pick up my personal prescription directly from your facility at 2160 W State Road 434?
No. As a 503B outsourcing facility, we primarily compound large batches of medications which are then distributed to hospitals, clinics, and physician offices. Patients receive their medications through their healthcare provider, not via direct pickup from our location.
3. How does your pharmacy at 2160 W State Road 434 address drug shortages?
Our facility compounds medications that are currently on the FDA's drug shortage list or are not available from commercial manufacturers. This provides a reliable source of essential medications for healthcare providers serving patients in need.
4. What quality controls are in place at your Longwood location?
Our facility at 2160 W State Road 434, Longwood, FL 32779 adheres to rigorous FDA-mandated testing for sterility, potency, and purity. We undergo regular FDA inspections to ensure all processes meet the highest standards for patient safety.
5. Who should I contact to inquire about your compounded medications?
Healthcare providers can contact us directly at (407)993-1381 to discuss their needs. Patients should speak with their doctor to determine if a medication compounded at our facility is appropriate for their treatment.