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, undergoing rigorous FDA inspections and producing medications in larger batches for office use by healthcare practitioners.
The core function of 503B Compounding Pharmacy is to provide physicians, surgeons, veterinarians, and other healthcare providers with access to high-quality, compounded medications for their patients. Our location at 2160 W State Road 434, Longwood, FL 32779 is a hub for producing these essential pharmaceutical preparations. We compound a significant volume of medications, which are then available for practitioners to keep in their offices for immediate administration, ensuring timely and effective patient care.
Our services at 2160 W State Road 434, Longwood, FL 32779 are defined by our regulatory status. The 503B compounding process involves stringent environmental quality controls, validated processes, and extensive testing to ensure sterility, potency, and purity. This level of oversight provides an additional layer of safety and reliability for the medical community we serve directly from our Longwood facility. We are equipped to handle complex compounding needs, including IV bags, injectables, ophthalmics, and other dosage forms required for clinical use.
Healthcare professionals can rely on 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 for a consistent supply of critical medications. Our operations are designed to support local clinics, hospitals, and practices by alleviating the burden of in-office compounding, allowing medical staff to focus on patient care. We work closely with providers to understand their specific needs and deliver compounded preparations that meet exact specifications.
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 . Our team at 2160 W State Road 434, Longwood, FL 32779 is committed to supporting the local medical community with exceptional service and FDA-registered compounded medications.
FAQ
1. What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. This designation requires us to follow current Good Manufacturing Practices (cGMP), undergo regular FDA inspections, and produce compounded medications for office use by healthcare practitioners.
2. Can I as an individual patient pick up my prescription at your location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides medications exclusively for office use by licensed healthcare practitioners. Individual patient prescriptions are typically compounded by traditional 503A pharmacies. Patients should receive their medications directly from their doctor's office or clinic.
3. What types of medications do you compound at your Longwood facility?
At our facility on W State Road 434, we compound a wide range of sterile and non-sterile preparations, including intravenous (IV) injections, ophthalmics, and other injectable medications. These are prepared in batches for healthcare providers to have on hand for procedures and treatments.
4. How can a healthcare provider place an order with your pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly at (407)993-1381 to establish an account and place orders. Our team at 2160 W State Road 434, Longwood, FL 32779 will work with you to fulfill your specific compounding requirements.
5. Why should a practice source medications from a 503B facility like yours?
Sourcing from our 503B facility ensures the medications are produced under the highest level of federal quality and safety standards. This provides practitioners at local clinics and hospitals with confidence in the sterility, potency, and purity of the compounded medications they use on patients.