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: Your FDA-Registered Outsourcing Facility in Longwood
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility, a designation defined under Section 503B of the Federal Food, Drug, and Cosmetic Act. This specific regulatory status is central to our operations at our facility located at 2160 W State Road 434, Longwood, FL 32779. It signifies our commitment to adhering to the highest standards of pharmaceutical compounding, which includes rigorous testing for potency, sterility, and purity, far exceeding the standards required of traditional compounding pharmacies. Our primary mission is to provide healthcare providers and patients at our location with access to high-quality, compounded medications that are often unavailable through conventional commercial channels.
The distinction of being a 503B outsourcing facility means we are permitted to compound medications in larger volumes without patient-specific prescriptions. These medications are then distributed to healthcare providers for office use, allowing physicians, surgeons, and other medical professionals practicing in and around our Longwood facility to have essential medications readily on hand. This is critical for treatments administered in-clinic, for emergency kits, and for stocking hospital and surgical center shelves with vital drugs that are in short supply or have been discontinued by large-scale manufacturers.
Our state-of-the-art facility at 2160 W State Road 434 is designed to maintain the strict environmental controls and sterile conditions mandated by the FDA. Our team of skilled pharmacists and technicians utilizes advanced technology and evidence-based practices to ensure every preparation meets exacting specifications. We specialize in a range of sterile compounded preparations, including hormone replacement therapy (HRT), ophthalmics, injectables, and other complex formulations required by the local medical community. By focusing on these specific services from our Longwood location, we directly support the continuity of care for patients in our immediate area.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with 503B Compounding Pharmacy means gaining a reliable source for compounded medications that are produced under a framework of unparalleled quality assurance. We encourage you to reach out to our team to discuss your specific needs and how our services can integrate into your practice to better serve your patients. You can contact us directly at (407)993-1381 or visit our website to learn more: https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with Current Good Manufacturing Practices (cGMP). This registration under Section 503B signifies we operate under stricter federal regulations for sterility, testing, and quality control compared to traditional 503A compounding pharmacies.
2. As a patient at 2160 W State Road 434, can I order medication directly from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we provide compounded medications for office use by healthcare providers. Your physician or healthcare provider at this location can order and stock medications from us to administer to you directly in their practice. Patients do not order directly from our facility.
3. What types of compounded medications does 503B Compounding Pharmacy provide for local healthcare providers?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in sterile compounded preparations. This includes medications like hormone replacement therapy (HRT), ophthalmics, injectables, and other formulations that are often on drug shortage lists or are not commercially available for healthcare providers to use.
4. How does the quality assurance at a 503B outsourcing facility benefit patients at this location?
The enhanced quality controls, including mandatory sterility and potency testing on every batch of medication, provide an added layer of safety and reliability. For patients receiving treatment at 2160 W State Road 434, this means the compounded medications administered by their provider are held to the highest manufacturing standards.
5. How can a healthcare provider at this address start ordering from 503B Compounding Pharmacy?
Healthcare providers can initiate the process by contacting our pharmacy directly at (407)993-1381. Our team will guide them through the set-up process, discuss their specific medication needs for their practice at 2160 W State Road 434, and provide all necessary documentation and support.