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 current good manufacturing practices (cGMP), ensuring that every preparation meets rigorous quality and safety protocols. This designation differentiates us from traditional compounding pharmacies and provides healthcare providers and patients with the assurance of receiving medications produced under the most stringent federal oversight.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are distributed for office use by healthcare practitioners. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and cleanroom environments necessary for producing sterile injectables, ophthalmics, and other complex dosage forms. We provide these medications to clinics, hospitals, and other healthcare providers, enabling them to have essential drugs on hand for immediate patient administration. This service is vital for supporting the local medical community and ensuring patient access to necessary treatments.
Quality control is the foundation of everything we do at 503B Compounding Pharmacy. Every batch of medication prepared at our facility on W State Road 434 undergoes extensive testing and validation processes. Our commitment to cGMP means we maintain meticulous documentation, environmental monitoring, and sterility testing to guarantee the potency, purity, and safety of every preparation that leaves our facility. This unwavering focus on quality provides healthcare professionals with the confidence that the medications they use are reliable and effective for their patients.
Healthcare providers seeking a trusted source for compounded medications can rely on 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. We work directly with medical practices to supply the specific medications they need for their practice. For more detailed information about our services and capabilities, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or contact us directly by phone at (407)993-1381 to speak with a representative.
FAQ
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 current good manufacturing practices (cGMP) for the compounding of medications, which includes rigorous testing, sterility assurance, and quality control measures that exceed traditional pharmacy standards.
Can I as an individual patient pick up my prescription directly from your location?
No. 503B Compounding Pharmacy primarily distributes compounded medications for office use to licensed healthcare practitioners and facilities. Individual patients should obtain their compounded medications through their healthcare provider's office or a traditional 503A compounding pharmacy that handles individual patient prescriptions.
What types of medications does 503B Compounding Pharmacy prepare?
At our facility on W State Road 434, we specialize in compounding sterile preparations, including injectables, infusions, and ophthalmics. These are prepared in larger batches for healthcare providers to have on hand for administering to patients in a clinical setting.
How can a healthcare provider at a local clinic order from 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, available medications, and delivery options to the practice location.
Why should a healthcare provider choose 503B Compounding Pharmacy for their office-use medications?
Choosing our facility at 2160 W State Road 434, Longwood, FL 32779 ensures that the medications are produced under the highest level of federal oversight and quality control. Our adherence to cGMP provides an added layer of safety and reliability for medications used in patient care, mitigating risk for both the practitioner and their patients.