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. As a 503B outsourcing facility, we produce large batches of compounded sterile and non-sterile preparations for office use by healthcare practitioners, without patient-specific prescriptions. Our operations are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, ensuring that every preparation leaving our facility meets exacting standards for potency, purity, and sterility.
The services provided by 503B Compounding Pharmacy at our Longwood location are distinct from traditional compounding. We supply healthcare providers with essential medications that are often on shortage or unavailable from conventional manufacturers. This enables physicians, surgeons, hospitals, and clinics to have immediate access to critical drugs for their procedures and patient treatments. By working directly with the medical community, 503B Compounding Pharmacy serves as a vital link in the healthcare supply chain, enhancing patient care and supporting the operational needs of local practitioners.
Our state-of-the-art facility at 2160 W State Road 434 is designed to maintain the highest level of environmental control. Our cleanrooms are meticulously monitored to ensure aseptic conditions for the compounding of sterile preparations. Every step of our process, from ingredient sourcing to final packaging, is controlled and documented. This unwavering dedication to quality ensures that healthcare professionals at our location can confidently utilize our products, knowing they are receiving medications produced with precision and accountability.
503B Compounding Pharmacy is dedicated to serving the specific needs of the medical community from our facility in Longwood. We provide a reliable source for essential medications, contributing to the health and well-being of the community. For more information about our services or to discuss your needs, please contact us directly. You can reach us by phone at (407)993-1381 or visit our website to learn more: https://503bcompoundingpharmacy.com/.
FAQ
1. 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 comply with stringent current Good Manufacturing Practice (cGMP) regulations and are subject to regular FDA inspections, ensuring the medications we compound meet the highest standards for safety, quality, and purity.
2. Can I as an individual patient get a prescription filled at 2160 W State Road 434?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. We do not compound patient-specific prescriptions. Your healthcare provider may use medications from our facility during your in-office treatment or procedure, but all orders must be placed by a licensed medical professional.
3. What types of medications does 503B Compounding Pharmacy prepare?
We compound a range of sterile and non-sterile preparations that are often on drug shortage lists or are not commercially available. This includes injectables, ophthalmics, and other formulations essential for hospitals and clinics. Healthcare providers at our location can contact us directly to inquire about specific available preparations.
4. How can a healthcare provider at your location place an order?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. We will provide information on our available preparations and the steps for establishing an account. Please call us at (407)993-1381 to speak with a representative.
5. Why should a medical practice at 2160 W State Road 434 use a 503B outsourcing facility?
Using a 503B outsourcing facility like ours provides assurance of quality and compliance. Our medications are produced under cGMP standards, which are more rigorous than the USP standards applied to traditional pharmacy compounding. This offers healthcare practitioners a reliable and safe source for medications that are critical for patient care but may be unavailable from primary manufacturers.