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 large-scale compounding of sterile and non-sterile medications. This designation differentiates us from traditional 503A compounding pharmacies, as we adhere to the FDA's Current Good Manufacturing Practices (cGMP), which are the same rigorous standards followed by conventional drug manufacturers. This ensures an unparalleled level of quality control, sterility assurance, and consistency in every batch of medication we produce for the healthcare providers and patients we serve at our Longwood location.
The core mission of 503B Compounding Pharmacy is to provide healthcare practitioners with access to high-quality, compounded medications that are often in short supply or unavailable from standard pharmaceutical manufacturers. By operating from our facility on W State Road 434, we are positioned to reliably supply hospitals, surgery centers, clinics, and other healthcare entities with the essential medications they require for patient care. Our processes are designed for efficiency and scale, allowing us to compound medications in larger batches while maintaining meticulous documentation and quality testing throughout every step of production.
Our services at 2160 W State Road 434 are fundamentally focused on being a bulk manufacturer for healthcare institutions. This includes the compounding of various preparations such as sterile injectables, intravenous bags, ophthalmics, and other dosage forms that are critical in clinical settings. Every product that leaves our facility is the result of a stringent quality assurance protocol, which includes validated sterility testing, endotoxin testing, and potency verification. For healthcare providers at our local address, this means they can confidently administer our medications, knowing they meet the highest possible safety and quality standards set forth by the FDA.
Engaging with 503B Compounding Pharmacy is a straightforward process for medical professionals. Orders are placed directly through our facility, and our team manages the logistics from production to delivery. We prioritize clear communication and reliable service for all our clients at 2160 W State Road 434. To learn more about our available formulations or to initiate an order, we encourage you to contact us directly. You can reach our team by phone at (407)993-1381 or visit our website for more detailed information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 strict federal standards known as Current Good Manufacturing Practices (cGMP). This registration signifies we undergo regular FDA inspections and adhere to higher-level quality control protocols for the medications we compound.
Who can purchase medications from 503B Compounding Pharmacy at this location?
Our services are designed for healthcare entities. We supply medications to hospitals, ambulatory surgery centers, clinics, and other healthcare providers. Medications are prescribed by practitioners and administered within their professional practice settings at our local address.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in compounding large batches of sterile preparations, including injectables, IV nutritionals, and ophthalmics, as well as non-sterile medications. Our focus is on drugs that are on the FDA’s drug shortage list or are not otherwise available from traditional manufacturers for the healthcare providers we serve.
How does the quality assurance process work at your facility?
Every batch of medication compounded at our location on W State Road 434 undergoes rigorous testing before it is released. This includes testing for sterility, potency, and endotoxins. Our quality control laboratory and procedures are designed to meet cGMP standards, ensuring the safety and efficacy of all products.
How do I place an order with 503B Compounding Pharmacy?
Healthcare providers and institutions can place orders directly through our facility. For ordering information, a list of available products, and to discuss your specific needs, please contact our team directly at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.