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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production that exceed those of traditional compounding pharmacies, ensuring that healthcare providers at our location have access to the highest quality pharmaceutical preparations.
The core mission of the 503B Compounding Pharmacy at 2160 W State Road 434 is to provide healthcare practitioners with a reliable and compliant source for compounded medications that are not commercially available. This includes producing significant quantities of medications for office use, allowing physicians and clinicians in Longwood to have essential drugs on hand for immediate patient care. The facility's operations are strictly confined to its registered address, focusing its services and distribution on supporting the specific medical community that relies on its consistent output and stringent safety protocols.
By operating as a 503B outsourcing facility, this pharmacy is subject to current Good Manufacturing Practice (cGMP) regulations, mandatory FDA inspections, and stringent quality assurance testing. Every batch of medication produced is rigorously tested for potency, sterility, and endotoxins, providing an unparalleled level of confidence for the medical professionals it serves at 2160 W State Road 434. This commitment to excellence ensures that every preparation leaving the facility meets exacting standards for safety and efficacy.
The team at 503B Compounding Pharmacy comprises highly trained pharmacists, chemists, and technicians who specialize in advanced compounding techniques within a state-of-the-art cleanroom environment. This dedicated staff is focused on the precise and accurate production of medications, including hormone replacement therapies, ophthalmologic preparations, injectable analgesics, and other critical sterile compounds. The facility's work is integral to the local healthcare infrastructure, providing practitioners with the necessary tools to offer comprehensive treatment options to their patients.
For healthcare providers seeking a trusted partner for their compounding needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of quality and reliability. To learn more about its services or to place an order, you can visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that you are a 503B outsourcing facility?
It means our facility at 2160 W State Road 434 is registered with the FDA and operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. We compound large volumes of sterile and non-sterile medications and are subject to federal cGMP standards, routine FDA inspections, and rigorous batch testing, which differentiates us from traditional 503A compounding pharmacies.
Who can order medications from your facility?
Our 503B Compounding Pharmacy provides medications exclusively for healthcare practitioners for office use. We serve physicians, clinicians, and healthcare facilities that require compounded pharmaceutical preparations for their practice at our location. Medications are not dispensed directly to individual patients from our facility.
What types of medications do you compound at your Longwood location?
At our facility on W State Road 434, we specialize in compounding a range of preparations, including sterile injectables, hormone therapy formulations, ophthalmologic solutions, and other medications that are not readily available from commercial manufacturers. All production is confined to our specific address under strict regulatory oversight.
How do I place an order for my practice?
Healthcare providers can place orders by contacting our facility directly at (407)993-1381. Our team will guide you through the ordering process, which is designed for medical professionals requiring compounded medications for use within their practice.
How does your location ensure the quality and sterility of its compounds?
Quality is assured through strict adherence to cGMP regulations. Every batch of medication produced at 2160 W State Road 434 undergoes comprehensive testing in our laboratory for sterility, potency, and endotoxins before it is released, ensuring the highest possible standard for all preparations leaving our facility.