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 safe and precise preparation of compounded medications. As a 503B outsourcing facility, we adhere to the highest current good manufacturing practices (cGMP), ensuring that every preparation meets rigorous standards for sterility, potency, and purity. This designation distinguishes our operations from traditional compounding pharmacies, providing a critical service for healthcare providers who require bulk quantities of high-quality medications for their office use.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) that are distributed to healthcare facilities for office use. Our services are essential for physicians, surgeons, dermatologists, and other medical professionals who utilize these medications for procedures and treatments within their practices. The medications prepared at our 2160 W State Road 434, Longwood, FL 32779 location are not intended for individual patient walk-in prescriptions but are instead supplied to licensed practitioners to administer to patients in a clinical setting. This model supports the local medical community by providing a reliable, quality-assured source for essential drugs that may be in shortage or are not commercially available.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to maintain the strictest environmental controls. Our cleanrooms are continuously monitored to ensure they meet ISO Class 7 and 8 standards, which is critical for preventing contamination during the compounding process. Every batch of medication is meticulously prepared by our highly trained technicians and pharmacists, and undergoes extensive testing and validation before it is released. This unwavering commitment to quality and safety is the foundation of our service, providing healthcare professionals with the confidence they need in the medications they use to treat their patients.
503B Compounding Pharmacy plays a vital role in mitigating drug shortages by providing alternative sources for critical medications. When a commercially manufactured drug is unavailable, our facility can often compound a necessary preparation, helping to ensure continuity of care for patients in the local area. We work closely with healthcare providers to understand their specific needs and to develop formulations that meet the exacting requirements of their practices. Our team is committed to supporting the medical community at 2160 W State Road 434, Longwood, FL 32779 with dependable, high-quality compounded medications.
For more information about our services or to discuss your facility's needs, please contact 503B Compounding Pharmacy. You can reach us via our website at or by phone at (407)993-1381. Our team is ready to assist healthcare professionals with their compounding requirements from our location at 2160 W State Road 434, Longwood, FL 32779.
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 complies with strict federal standards for compounding, including current good manufacturing practices (cGMP). This ensures the medications we produce for office use meet the highest levels of quality, sterility, and strength.
2. Can I, as an individual patient, get a prescription filled at 2160 W State Road 434, Longwood, FL 32779?
No. 503B Compounding Pharmacy provides medications in bulk for office use to licensed healthcare practitioners. Individual patient prescriptions are handled by traditional 503A compounding pharmacies. Our services are exclusively for healthcare providers at our 2160 W State Road 434 location.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations (CSPs) in larger quantities. This includes injectables, ophthalmics, and other sterile solutions that are commonly used by physicians and surgeons in clinical and procedural settings.
4. How does ordering work for a healthcare practice?
Healthcare providers can contact 503B Compounding Pharmacy directly at (407)993-1381 to discuss their specific medication needs. Our team will work with your practice to provide the necessary compounded preparations for office use, which can be shipped or made available for pickup at 2160 W State Road 434, Longwood, FL 32779.
5. Why should a practice source medications from your facility instead of a commercial manufacturer?
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a crucial resource during drug shortages, providing a reliable supply of essential medications that may not be available from commercial sources. Our cGMP compliance and rigorous quality control offer an additional layer of safety and assurance for medications used in patient care.