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 compliance in the preparation of compounded medications. We serve healthcare providers and their patients by producing large quantities of sterile and non-sterile compounded preparations that are not available commercially.
As a 503B outsourcing facility, our operations are distinct from traditional compounding pharmacies. We are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, and we undergo regular FDA inspections. This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent standards for potency, purity, and sterility. Our primary mission is to provide healthcare practitioners with reliable access to high-quality compounded medications to support patient-specific treatment plans.
The services provided by 503B Compounding Pharmacy are essential for healthcare providers who require medications in specific strengths, dosage forms, or combinations that are not otherwise available from commercial manufacturers. Our team of highly skilled pharmacists and technicians utilizes state-of-the-art equipment and technology within our facility to compound preparations with precision and consistency. We maintain a robust quality control program, with extensive testing and documentation for every batch we produce.
Healthcare providers can confidently partner with 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 for a dependable supply of essential medications. Our facility is equipped to handle a significant volume of orders, ensuring that practitioners have the medications they need when they need them. We encourage you to learn more about our specific capabilities and current offerings by contacting us directly or visiting our website.
For more information or to discuss your compounding needs, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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. We adhere to current Good Manufacturing Practices (cGMP) and are subject to periodic FDA inspections, ensuring the highest level of quality and safety for our compounded preparations.
Who can place an order with 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for healthcare providers. Orders are placed by physicians, clinicians, and other licensed medical professionals for administration to their patients within their practice settings at 2160 W State Road 434, Longwood, FL 32779.
Can I as a patient pick up my medication directly from your facility?
No. As a 503B outsourcing facility, we distribute compounded preparations to healthcare providers and facilities, not directly to individual patients. Your prescribing healthcare provider will receive the medication from us and then administer it to you as part of your treatment.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding both sterile and non-sterile preparations in larger batch quantities. This includes various dosage forms such as injections, ophthalmics, topicals, and other formulations that are not commercially available.
How do I get more information about your available formulations?
Healthcare providers can obtain a complete list of our current offerings and discuss specific formulation needs by contacting our facility directly. Please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more details.