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 a commitment to producing compounded medications that adhere to the highest standards of quality, safety, and sterility. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to current Good Manufacturing Practices (cGMP) and undergoes regular FDA inspections. This rigorous regulatory framework ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can confidently source medications for their patients.
The primary function of 503B Compounding Pharmacy is the large-scale compounding of sterile preparations. This includes a wide array of essential medications such as intravenous (IV) bags, hormone injections, ophthalmic solutions, and other injectable drugs. These preparations are produced in bulk for office use by healthcare practitioners, ensuring that patients at 2160 W State Road 434, Longwood, FL 32779 have access to necessary treatments that may be commercially unavailable or in short supply. By operating under Section 503B, our pharmacy can provide these critical medications without requiring patient-specific prescriptions for the initial compounding batch, thereby enhancing efficiency for local medical practices.
Quality control is the cornerstone of operations at 503B Compounding Pharmacy. Every process, from ingredient sourcing to final product release, is meticulously documented and validated. Our facility at 2160 W State Road 434, Longwood, FL 32779 employs advanced environmental monitoring, rigorous testing protocols, and sterile compounding techniques to ensure each preparation meets exacting specifications. This unwavering focus on quality mitigates risk and provides assurance to the medical community that the medications they administer are safe, potent, and pure.
503B Compounding Pharmacy serves as a vital component of the healthcare infrastructure for practitioners at 2160 W State Road 434, Longwood, FL 32779. We provide a reliable alternative during drug shortages, which can disrupt patient care. Furthermore, we compound medications that are no longer available from large-scale manufacturers, ensuring continuity of treatment. The services of a 503B outsourcing facility are essential for hospitals, clinics, and surgical centers that require ready-to-administer sterile preparations for their patients.
The team at 503B Compounding Pharmacy comprises highly trained pharmacists, technicians, and quality assurance professionals dedicated to upholding the principles of cGMP. Our commitment is to support the local medical community by providing a consistent and dependable supply of high-quality compounded medications. For more information or to inquire about our services, please contact 503B Compounding Pharmacy 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 at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What is a 503B outsourcing facility?
A 503B outsourcing facility is an FDA-registered entity that compounds large volumes of sterile medications in accordance with current Good Manufacturing Practices (cGMP). 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under this federal designation, which involves stricter regulatory oversight compared to traditional compounding pharmacies.
Who can order from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Orders are typically placed by hospitals, clinics, and other healthcare facilities at 2160 W State Road 434, Longwood, FL 32779. We do not compound medications based on individual patient prescriptions for direct dispensing to the public.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in sterile compounded preparations, including intravenous (IV) solutions, injectable medications, and ophthalmic drops. These are produced for healthcare providers serving patients at 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure medication safety?
Safety is ensured through adherence to cGMP standards, which include rigorous testing of components, validated sterile compounding processes, environmental monitoring, and comprehensive quality control checks at our facility located at 2160 W State Road 434, Longwood, FL 32779.
How can a healthcare provider place an order?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can initiate an order by contacting 503B Compounding Pharmacy directly. Please call (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more detailed ordering information.