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 at 2160 W State Road 434, Longwood, FL 32779
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 specifically designed and regulated to produce large quantities of compounded sterile and non-sterile medications for healthcare providers. This designation signifies our unwavering commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. We serve a critical role in the healthcare supply chain by providing medications that are often on shortage or unavailable from conventional manufacturers, directly supporting the patient care efforts of local medical practitioners.
The operations at our Longwood location are governed by rigorous Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility is of the highest quality, purity, and potency. Our state-of-the-art cleanrooms, advanced environmental monitoring systems, and validated processes are all dedicated to mitigating risk and preventing contamination. For prescribers and patients at 2160 W State Road 434, Longwood, FL 32779, this translates to a trusted source for essential medications that meet precise specifications.
As a 503B outsourcing facility, our primary function is to compound medications for office use. This means healthcare professionals in the area can obtain compounded preparations to have on hand for immediate administration to patients during procedures or appointments. We provide a vital service by compounding formulations that are not commercially available, such as specific strengths, dosage forms, or allergen-free formulations, thereby enabling personalized treatment plans. Our team of experienced pharmacists and technicians leverages specialized equipment to produce batches of medications, including sterile injectables, ophthalmics, and topicals, with a level of quality control that is integral to our 503B status.
Our location at 2160 W State Road 434, Longwood, FL 32779, is a hub for reliable pharmaceutical compounding. We encourage local healthcare providers to view us as an extension of their practice, a partner in patient care dedicated to safety and compliance. For more information or to discuss your compounding needs, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this pharmacy is a 503B outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779, is registered with the FDA and operates under Section 503B of the FD&C Act. We adhere to stringent Current Good Manufacturing Practices (cGMP) for large-scale compounding, which involves more rigorous quality control and testing standards than a traditional compounding pharmacy.
2. Can I as a patient directly order medications from your 503B facility?
No. As an outsourcing facility, 503B Compounding Pharmacy primarily provides compounded medications for office use by healthcare providers. Your prescriber at their practice will order the medications we compound for administration to you during your visit or procedure.
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, including injectables, ophthalmics, and irrigation solutions, as well as non-sterile preparations. We often compound medications that are currently in shortage or are not available from commercial manufacturers.
4. How does the 503B status ensure the quality and safety of the medications?
Our 503B status requires us to comply with federal cGMP regulations. This includes rigorous testing of ingredients, validated sterilization processes, extensive environmental monitoring of our cleanrooms, and thorough quality assurance testing on finished preparations to ensure safety, sterility, and potency.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can initiate orders by contacting our facility directly. We will work with you to understand your specific needs. You can reach our team for more information by calling (407)993-1381 or visiting our website at .