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 standards of pharmaceutical quality, producing medications in larger batches for office use by healthcare practitioners. This model ensures that physicians, surgeons, veterinarians, and other medical professionals in our community have immediate access to critical, high-quality medications for their patients.
The operations at 503B Compounding Pharmacy are distinct from traditional compounding. Our 503B status signifies our registration with the FDA and our commitment to following Current Good Manufacturing Practices (cGMP). This involves rigorous testing of components, stringent environmental monitoring, and validated processes to ensure sterility, potency, and purity in every batch we produce. The medications prepared at our location on W State Road 434 are distributed to local healthcare providers for administration within their practice settings, supporting the medical community in delivering superior patient care.
Our services are exclusively provided from our facility at 2160 W State Road 434, Longwood, FL 32779. We supply a range of sterile compounded preparations, including injectables, ophthalmics, and other dosage forms that are essential for various medical procedures and treatments. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are experts in aseptic processing and quality control. We work directly with healthcare providers to support their specific patient needs with reliable and consistent pharmaceutical products.
For healthcare providers seeking a trusted partner for office-use medications, 503B Compounding Pharmacy at 2160 W State Road 434 is a dedicated resource. We prioritize safety, compliance, and service to the local medical community. To learn more about our available formulations or to discuss your needs, you can contact us directly at our facility. Our website is available at and our phone number is (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. This requires us to comply with more rigorous federal standards, including Current Good Manufacturing Practices (cGMP), for the production of compounded medications intended for office use by healthcare practitioners.
2. Who can purchase medications from 503B Compounding Pharmacy?
Our medications are supplied for office use to licensed healthcare practitioners, including physicians, surgeons, and veterinarians. These medications are administered to patients within the practitioner's care at their practice location. We do not provide medications directly to individual patients from our location at 2160 W State Road 434.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in producing sterile compounded preparations, such as injectable medications, ophthalmic solutions, and other sterile products. These are prepared in batches for healthcare providers to have on hand for procedures and treatments at their practices located near our facility on W State Road 434.
4. How does the quality control process work at your facility?
Quality control is paramount at our location. We adhere to strict cGMP guidelines, which include testing raw materials, conducting environmental monitoring of our cleanrooms, validating our sterilization processes, and performing endotoxin and sterility testing on finished products to ensure every batch meets exacting standards for safety and efficacy.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can contact our facility directly to discuss their needs and place an order. 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 for more information on our services and available formulations.