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. The 503B designation signifies our adherence to the highest standards of pharmaceutical compounding, including current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our pharmacy meets rigorous quality and safety protocols for the healthcare providers and patients we serve.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are not available commercially. This includes creating patient-specific formulations that are prescribed by healthcare providers for individuals with unique medical needs. Our operations at the 2160 W State Road 434 location are designed to support the local medical community by providing access to essential medications that are critical for patient care. The medications compounded at our facility are distributed for office use by healthcare practitioners, ensuring they have the necessary supplies on hand for immediate patient treatment.
As a 503B outsourcing facility, our processes are subject to regular FDA inspections, which provides an additional layer of oversight and assurance beyond traditional compounding. The team at 503B Compounding Pharmacy consists of skilled pharmacists and technicians who utilize state-of-the-art equipment within our controlled environment to ensure product integrity and sterility. Our commitment is to provide healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with reliable access to high-quality compounded medications.
For more information about our services or to speak with our team, please contact us directly. We are available to answer questions from healthcare providers and their staff regarding our compounding capabilities and processes.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
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 compounds medications in accordance with Section 503B of the FD&C Act. This registration requires us to comply with current Good Manufacturing Practices (cGMP) and subjects us to routine FDA inspections to ensure the quality and safety of our compounded preparations.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at our facility are intended for office use by healthcare providers. Patients receive these medications directly from their physician or healthcare professional during treatment at their practice. We work directly with healthcare providers to supply the medications they need for their patients.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy prepares both sterile and non-sterile compounded medications. This includes a range of formulations that are not commercially available, allowing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to access specific medications required for their practice and patient care protocols.
How does a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can place orders by contacting our pharmacy directly. Our team is available to discuss specific compounding needs and process orders to ensure timely delivery to the practice location at 2160 W State Road 434, Longwood, FL 32779.
Why is the 503B designation important for healthcare providers?
The 503B designation provides healthcare providers with assurance that the compounded medications they use are produced under the highest quality standards mandated by federal law. This includes strict controls on ingredient sourcing, testing, environmental conditions, and documentation, which contributes to patient safety and treatment efficacy.