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 is an FDA-registered outsourcing facility operating under 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. As a 503B outsourcing facility, we adhere to the most stringent federal quality and safety standards, providing bulk-compounded pharmaceutical products for office use by healthcare practitioners.
The core function of 503B Compounding Pharmacy is to support the medical community by producing medications that are not commercially available or are in shortage. Our operations at the Longwood facility are specifically designed for volume, ensuring that local clinics, hospitals, and healthcare providers have reliable access to essential, high-quality compounded preparations. We operate under current Good Manufacturing Practices (cGMP), which are rigorous FDA-enforced standards that exceed the requirements of traditional compounding pharmacies. This commitment to cGMP ensures every batch of medication we produce is consistently pure, potent, and sterile.
Our services are exclusively tailored for healthcare providers. Physicians, surgeons, veterinarians, and other medical professionals can utilize our 503B compounding services to obtain the specific medications their patients need. This is particularly critical for medications that have been discontinued by large manufacturers or are experiencing national drug shortages. By working directly with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, practitioners can be confident they are sourcing from a facility that prioritizes patient safety through rigorous testing, environmental controls, and quality assurance protocols.
The team at 503B Compounding Pharmacy comprises highly skilled pharmacists, pharmacy technicians, and quality control professionals. Our staff is dedicated to the precise science of compounding, utilizing state-of-the-art equipment and technology within our modern facility. We maintain a robust quality management system that oversees every aspect of production, from sourcing pure active pharmaceutical ingredients (APIs) to final product release. This meticulous process guarantees that every preparation leaving our facility meets its labeled strength, purity, and quality specifications.
Healthcare providers seeking a trusted partner for office-use medications are invited to connect with 503B Compounding Pharmacy. We encourage you to explore our capabilities and learn how our federally regulated compounding services can enhance patient care. For more detailed information about our processes and available formulations, please visit our website or contact our facility directly. We are committed to serving the medical community from our location at 2160 W State Road 434, Longwood, FL 32779.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with Section 503B of the FD&C Act. This requires us to follow current Good Manufacturing Practices (cGMP) for consistent quality, purity, and sterility, and we are subject to regular FDA inspections.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare practitioners, including physicians, surgeons, and veterinarians, for office use. Medications are dispensed to licensed professionals for administration to their patients within their practice setting at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in producing large batches of compounded sterile preparations (CSPs) and non-sterile preparations. This often includes medications that are on shortage or are not available from commercial manufacturers, serving the needs of practitioners from our Longwood location.
How does 503B Compounding Pharmacy ensure medication safety?
Our facility at 2160 W State Road 434, Longwood, FL 32779 implements a comprehensive quality system under cGMP. This includes rigorous testing of components, stringent environmental monitoring, validated sterilization processes, and thorough end-product testing to ensure safety and potency before any batch is released.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can place an order by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the process. You can also find more information on our website at https://503bcompoundingpharmacy.com/.