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 and safety, producing medications in larger batches for healthcare facilities without patient-specific prescriptions. Our core mission is to provide healthcare providers with access to essential medications that are often on shortage or unavailable from conventional manufacturers.
The operations at our Longwood location are governed by rigorous Current Good Manufacturing Practices (cGMP). This ensures every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets precise identity, strength, quality, and purity standards. Our team of highly trained pharmacists and technicians utilizes state-of-the-art equipment within our controlled environment to consistently produce medications that healthcare professionals can trust for their patients. We serve as a critical component of the local healthcare infrastructure, providing a reliable source for compounded medications.
Our services are specifically designed for healthcare facilities and practitioners. The 503B compounding pharmacy model allows us to supply hospitals, clinics, and other healthcare entities with medications they need for their operations. By focusing on batch-level production, we help alleviate drug shortages and provide a consistent supply of vital medications. The entire operation is centralized at our facility on W State Road 434, ensuring all products are created under one roof with meticulous oversight.
Contact 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 for more information. You can reach us via phone at (407)993-1381 or visit our website at . Our team is prepared to assist healthcare providers with their specific medication needs, ensuring they receive the highest quality products from our FDA-registered outsourcing facility.
Frequently Asked Questions
What does it mean to be a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with stricter federal standards, including Current Good Manufacturing Practices (cGMP). This differentiates us from traditional compounding pharmacies and allows us to compound medications in larger batches for office use by healthcare practitioners.
Who can receive medications from your facility?
503B Compounding Pharmacy supplies medications to healthcare facilities and practitioners for office use. We do not dispense medications directly to individual patients at our location on W State Road 434. Healthcare providers can then administer these medications to their patients within their own practice settings.
What types of medications do you compound at your Longwood facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434 compounds a range of sterile and non-sterile medications. This includes preparations often on national drug shortage lists, such as injectables, ophthalmics, and other essential drugs required by hospitals and clinics for patient care.
How do I place an order with your pharmacy?
Healthcare facilities and practitioners can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the ordering process. All operations and order fulfillment are conducted from our location at 2160 W State Road 434, Longwood, FL 32779.
Why should a healthcare provider choose a 503B outsourcing facility?
Choosing our 503B outsourcing facility ensures the medications you use are produced under the highest level of federal oversight and quality control. This provides an added layer of safety and reliability for healthcare providers practicing in and sourcing from the Longwood area, guaranteeing the integrity of the medications administered to patients.