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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practices (cGMP), which ensures every medication we produce meets stringent quality control standards for strength, purity, and stability.
The services provided by 503B Compounding Pharmacy at our Longwood location are specifically designed for healthcare providers. We work directly with physicians, hospitals, and clinics to produce large batches of compounded sterile preparations (CSPs) and non-sterile preparations that are patient-specific or for office use. Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology and maintained under controlled environmental conditions to ensure the integrity of every preparation that leaves our pharmacy.
Our team of highly skilled pharmacists and technicians at the Longwood facility is dedicated to supporting the local medical community by providing reliable access to essential medications that may be in shortage or are not commercially available. By serving as a critical partner to healthcare providers at 2160 W State Road 434, we help ensure that patients receive the necessary medications for their treatment plans. The core of our operation is a unwavering focus on quality assurance and regulatory compliance, providing peace of mind to the practitioners and patients we serve.
For more information about the services available from our specific location, or to discuss how we can support your practice, please contact us directly. We invite you to explore our capabilities and learn more about our compliance standards.
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 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 subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring a higher level of quality control and consistency for the compounded medications we produce.
Who can order medications from 503B Compounding Pharmacy?
Our services are provided to healthcare providers. We supply compounded medications directly to physicians, hospitals, and clinics for their office use or for specific patient prescriptions. Patients should contact their healthcare provider to discuss if a compounded medication from our facility is appropriate for their needs.
What types of medications does the Longwood facility compound?
503B Compounding Pharmacy at 2160 W State Road 434 specializes in compounding both sterile and non-sterile preparations. This includes a focus on medications that are currently in drug shortage or are not available from commercial manufacturers, providing a critical service to the local medical community.
How does the 503B outsourcing model benefit healthcare providers at this location?
Healthcare providers utilizing our services at 2160 W State Road 434 benefit from access to a reliable supply of high-quality compounded medications that adhere to strict federal standards. This allows providers to confidently administer treatments knowing the medications are produced under the cGMP guidelines required of an FDA-registered outsourcing facility.
How can a healthcare provider get started with 503B Compounding Pharmacy?
Healthcare providers interested in our services can contact our facility directly to establish an account and discuss their specific needs. We encourage providers to reach out via our website at https://503bcompoundingpharmacy.com/ or by calling us at (407)993-1381 to speak with a representative.