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, located at 2160 W State Road 434, Longwood, FL 32779, is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. We are dedicated to providing high-quality, sterile compounded medications to meet the specific needs of healthcare providers and their patients within the Longwood community. Our facility adheres to stringent quality control standards to ensure the safety and efficacy of every preparation. We specialize in producing bulk, non-patient-specific compounded drugs, offering a reliable source for essential medications. Our commitment is to serve the Longwood area with precision and care, ensuring that healthcare professionals have access to the compounded therapies they require. For inquiries or to learn more about our services, please visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.
Q1: What types of compounded medications does 503B Compounding Pharmacy offer at this Longwood location?
A1: As an FDA-registered 503B outsourcing facility, we specialize in sterile, bulk compounded medications for healthcare providers. Our offerings are designed to meet specific therapeutic needs within the Longwood area.
Q2: Is 503B Compounding Pharmacy accessible to individual patients at 2160 W State Road 434, Longwood, FL 32779?
A2: Our facility operates as a 503B outsourcing facility, meaning we provide compounded medications to licensed healthcare practitioners for office use or administration to their patients. We do not dispense directly to individual patients.
Q3: What makes 503B Compounding Pharmacy different from a traditional retail pharmacy in Longwood?
A3: We are an FDA-registered outsourcing facility, adhering to strict cGMP standards for sterile compounding. This differs from traditional pharmacies that compound patient-specific prescriptions.
Q4: How can a healthcare provider in Longwood place an order with 503B Compounding Pharmacy?
A4: Healthcare providers can learn more about our services and ordering process by visiting our website at https://503bcompoundingpharmacy.com/ or by calling us directly at (407)993-1381.
Q5: What is the significance of being an FDA-registered 503B outsourcing facility for Longwood healthcare providers?
A5: FDA registration under Section 503B signifies that our facility meets rigorous quality and safety standards for sterile compounding, providing a reliable and compliant source of compounded medications for healthcare providers in Longwood.