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 is an FDA-registered outsourcing facility operating under 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 large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, providing healthcare providers with access to medications that are not commercially available. Our operations are distinct from traditional compounding pharmacies, as we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations and regular facility inspections.
The primary function of 503B Compounding Pharmacy is to supply compounded medications for office use. This means we provide medications directly to physicians, hospitals, clinics, and healthcare facilities for administration to their patients within their practice setting. Healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 can rely on our 503B outsourcing facility for a consistent supply of high-quality, compounded preparations. We do not typically dispense medications directly to individual patients upon their personal prescription; instead, we support the local medical community by being a trusted, compliant source for their compounding needs.
Our services at the Longwood location are defined by our regulatory status. We compound medications in anticipation of receiving prescriptions, which allows for quicker fulfillment of orders from area healthcare providers. The medications produced at our 503B outsourcing facility are essential for many medical procedures, office-based treatments, and emergency kits. By operating under Section 503B, we ensure that every product leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent federal standards for potency, purity, and sterility where applicable.
For healthcare providers seeking a dependable 503B outsourcing facility partner, 503B Compounding Pharmacy offers a critical service. We encourage local medical practices to contact us to discuss their specific office-use medication requirements. You can reach our facility at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or visit our website at . Our team is committed to supporting the healthcare community with the reliable service and quality medications expected from an FDA-registered 503B outsourcing facility.
Frequently Asked Questions for 503B Compounding Pharmacy
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 Federal Food, Drug, and Cosmetic Act. This subjects us to federal oversight, compliance with current Good Manufacturing Practices (cGMP), and routine FDA inspections, ensuring the medications we compound meet the highest standards for safety and quality.
2. Can I, as an individual patient, get a prescription filled directly at 2160 W State Road 434, Longwood, FL 32779?
No. 503B Compounding Pharmacy primarily supplies compounded medications for office use to healthcare providers, not directly to individual patients. Your physician or healthcare provider would order the necessary medication from our 503B outsourcing facility and then administer it to you within their practice located at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does the 503B outsourcing facility in Longwood compound?
Our 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 compounds a range of sterile and non-sterile medications in larger batches for office use. This includes preparations used in clinics, hospitals, and medical offices for procedures, injections, and other treatments that require medications not readily available from commercial manufacturers.
4. How do healthcare providers at 2160 W State Road 434, Longwood, FL 32779 order from your 503B outsourcing facility?
Healthcare providers and their authorized staff can place orders for compounded medications by contacting 503B Compounding Pharmacy directly. They can reach our facility at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381 or through our website at . Our team will assist with setting up an account and processing orders for office-use medications.
5. Why should a healthcare provider choose 503B Compounding Pharmacy for their compounding needs?
Healthcare providers choosing our 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 benefit from our commitment to compliance with strict federal quality standards. We provide the assurance that comes with FDA registration and cGMP compliance, which is essential for medications used in a professional healthcare setting. We are a local resource dedicated to supporting the medical community.