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.
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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality control, current good manufacturing practices (cGMP), and rigorous testing protocols as mandated by federal law. This ensures that every preparation leaving our facility meets precise specifications for strength, purity, and sterility.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. Our services are designed to support the medical community at 2160 W State Road 434, Longwood, FL 32779 by supplying medications that are not commercially available or are in shortage. We compound a significant volume of preparations to ensure that physicians, surgeons, hospitals, and clinics have immediate access to the critical medications their patients need. The operations at our facility are distinct from traditional compounding, focusing on larger-scale production under the oversight of the FDA.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and staffed by a team of highly trained pharmacists and technicians. Every step of the compounding process, from ingredient sourcing to final packaging, is meticulously controlled and documented. This unwavering commitment to cGMP standards provides an additional layer of safety and reliability for the healthcare providers we serve. Patients ultimately benefit from the assurance that the medications administered in a clinical setting originate from a fully compliant and audited 503B outsourcing facility.
503B Compounding Pharmacy is an essential partner for the local medical community. By focusing on the specific needs of practitioners at 2160 W State Road 434, Longwood, FL 32779, we help ensure continuity of care and patient safety. For more information or to discuss your office-use compounding needs, please contact 503B Compounding Pharmacy. You can reach us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
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 are subject to federal oversight, mandatory current good manufacturing practices (cGMP), and routine FDA inspections to ensure the highest quality and safety standards for our compounded preparations.
2. Can I as an individual patient pick up my prescription directly from your facility?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Individual patient prescriptions are typically compounded by a traditional 503A pharmacy. Our preparations are supplied in bulk to physicians, clinics, and hospitals at 2160 W State Road 434, Longwood, FL 32779 for administration to patients within a clinical setting.
3. What kinds of medications does 503B Compounding Pharmacy prepare?
We compound a wide range of sterile and non-sterile medications that are often on drug shortage lists or are not available from commercial manufacturers. This includes sterile injectables, ophthalmics, and other preparations essential for hospitals and clinics serving the community at 2160 W State Road 434, Longwood, FL 32779.
4. How does using a 503B outsourcing facility benefit my practice?
Utilizing our services provides your practice at 2160 W State Road 434, Longwood, FL 32779 with access to high-quality, reliable medications that are in short supply. It ensures compliance with federal regulations for office-use medications and offers the assurance that every product is manufactured under strict cGMP standards, which include rigorous potency and sterility testing.
5. How can I order compounded medications from your facility for my office?
Healthcare practitioners can place orders by contacting 503B Compounding Pharmacy directly. You can reach our team at our facility located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381. Our staff will guide you through the ordering process and answer any specific questions regarding our available preparations.