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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of compounded medications in accordance with the highest standards of quality and safety required for a 503B outsourcing facility.
The primary distinction of a 503B Compounding Pharmacy is its scale and regulatory oversight. Unlike traditional compounding, our operations at the Longwood facility are conducted on a larger scale, and we are subject to rigorous FDA standards, including current Good Manufacturing Practices (cGMP). This ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to medications that are consistently produced and controlled according to quality standards. The medications prepared at 503B Compounding Pharmacy are intended for office use by healthcare practitioners, supporting the medical community in Longwood.
Our services at 2160 W State Road 434, Longwood, FL 32779 are designed to address specific needs that may not be met by commercially available, FDA-approved drugs. This includes creating formulations that are sterile and non-sterile, often in specific strengths or dosage forms required for patient care in the local area. The 503B Compounding Pharmacy provides a critical service by supplying medications that are essential for various medical treatments administered within healthcare settings near our location.
For healthcare professionals and facilities operating at 2160 W State Road 434, Longwood, FL 32779, partnering with an FDA-registered 503B outsourcing facility like ours offers a significant advantage. It provides assurance of quality, reliability, and compliance with federal regulations. The 503B Compounding Pharmacy is committed to supporting the local medical community by ensuring a consistent supply of necessary compounded medications.
To learn more about the services provided by 503B Compounding Pharmacy or to place an order, please contact us directly. We are located at 2160 W State Road 434, Longwood, FL 32779. You can reach us by phone at (407)993-1381 or visit our website for more information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy
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 complies with strict federal regulations, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and consistency for the compounded medications we produce.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides medications for office use by licensed healthcare practitioners. Our services are designed for doctors, clinics, hospitals, and other healthcare providers who administer medications within their practice at our location.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we prepare both sterile and non-sterile compounded medications in various dosage forms. These are typically medications that are not commercially available or are in shortage, tailored to meet the specific needs of healthcare providers serving patients at 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure medication safety and quality?
Our facility at 2160 W State Road 434, Longwood, FL 32779 adheres to rigorous cGMP standards. This involves stringent testing of components, validated processes, environmental monitoring for sterile products, and comprehensive quality control checks throughout the compounding process.
How can a healthcare provider at your location place an order with 503B Compounding Pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. Please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information. Our facility is located at 2160 W State Road 434, Longwood, FL 32779.