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 consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, an outsourcing facility like ours is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility meets stringent quality control measures for the healthcare providers and patients we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications that are not available commercially. This means we prepare medications in advance of receiving a prescription, based on the established needs of healthcare providers. Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology, including ISO Class 5 cleanrooms, to ensure the sterility and potency of our preparations. We provide these essential medications to healthcare facilities, clinics, and practitioners, enabling them to better serve their patients with specific needs that cannot be met by mass-produced, commercially available drugs.
Our services are defined by our 503B outsourcing facility status. We specialize in the compounding of injectables, ophthalmics, and other sterile preparations that are critical for patient care. Every batch is tested for sterility, potency, and endotoxins to guarantee patient safety and therapeutic efficacy. The healthcare providers who partner with us at our Longwood facility can be confident in the quality and reliability of the medications they administer. By adhering to the highest level of regulatory compliance, 503B Compounding Pharmacy provides a vital link in the healthcare chain, ensuring access to necessary medications that would otherwise be unavailable.
For more information about our services or to speak with our team, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or call us directly at (407)993-1381. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the local medical community with the highest quality compounded pharmaceuticals.
Frequently Asked Questions
1. 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, mandatory compliance with current Good Manufacturing Practices (cGMP), and routine FDA inspections to ensure the highest standards of quality and safety for all compounded preparations.
2. Who can receive medications from 503B Compounding Pharmacy?
As an outsourcing facility, we provide medications to licensed healthcare providers and facilities. Patients receive our medications through their prescribing physicians, clinics, or hospitals. We do not compound based on individual patient prescriptions directly from the public, but rather supply healthcare professionals who administer or dispense them to their patients.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434 specializes in the large-scale compounding of sterile preparations, including injectables, IV bags, ophthalmics, and other formulations that are not available from commercial pharmaceutical manufacturers. All preparations are made under cGMP conditions in our advanced cleanroom suites.
4. How does the quality control process work at your facility?
Quality control is paramount. Every batch of medication compounded at our Longwood location undergoes rigorous testing, including assays for potency, sterility testing, and endotoxin testing. This extensive quality assurance process is a requirement of our 503B status and ensures every product meets strict specifications before it is released.
5. How can a healthcare provider at your location place an order?
Healthcare providers and facilities can initiate orders by contacting 503B Compounding Pharmacy directly. For detailed information about our available products and ordering process, please call our facility at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ to connect with our team.