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, current good manufacturing practices (cGMP), and rigorous testing protocols mandated by federal law. This ensures that every preparation leaving our pharmacy meets stringent specifications for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. We serve the medical community at 2160 W State Road 434, Longwood, FL 32779 by producing preparations that are not commercially available or are in shortage. Our services enable physicians, surgeons, dermatologists, and other healthcare providers to have immediate access to critical medications for their patients without the need for a patient-specific prescription for each vial or tube. This model supports efficient clinic and surgical center operations by ensuring a ready supply of essential drugs.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology for sterile compounding, including ISO-classified cleanrooms. Our highly trained staff of pharmacists and technicians are experts in aseptic technique and quality assurance. Every batch of medication is compounded under controlled environmental conditions and undergoes thorough testing to verify sterility and potency before it is released. This unwavering commitment to quality and safety is the foundation of our operation as a trusted 503B outsourcing facility.
503B Compounding Pharmacy provides healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for a wide range of preparations. We encourage medical practices to contact us to discuss their specific office-use compounding needs. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website at . Our team is ready to provide information and support to the local healthcare community.
Frequently Asked Questions
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 stringent federal standards for production, testing, and quality control, which are more comprehensive than those applied to traditional compounding pharmacies.
Who can order medications from 503B Compounding Pharmacy?
Our medications are prepared for office use and are distributed to licensed healthcare practitioners for administration within their practice. We provide medications to physicians and healthcare providers at 2160 W State Road 434, Longwood, FL 32779 for use in their clinics, surgical centers, and other medical offices.
Can individual patients pick up prescriptions directly from your location?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for healthcare facilities. We do not dispense medications directly to individual patients based on a personal prescription. Patients should receive their medications directly from their healthcare provider at the point of care.
What kinds of medications does 503B Compounding Pharmacy prepare?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 prepares a broad range of sterile and non-sterile compounded medications, including injectables, ophthalmics, topicals, and other formulations that are often on drug shortage lists or are not available from commercial manufacturers.
How do I, as a healthcare provider, place an order?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly to establish an account. You can reach us at our facility located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381 or by visiting our website at . Our team will guide you through the ordering process.