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 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. This designation signifies our commitment to adhering to the most rigorous federal standards for quality, safety, and production. Unlike traditional compounding, our 503B status means our processes, testing, and facility are subject to current Good Manufacturing Practices (cGMP), providing an additional layer of assurance for the medications we prepare.
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 our location on W State Road 434, enabling physicians, surgeons, veterinarians, and other healthcare providers to obtain the specific medications their patients need without the burden of in-office compounding. Our products are prepared in advance and held in inventory, allowing for immediate dispensing to meet patient needs efficiently and reliably.
Our services at the Longwood facility are critical for providing medications that are often on shortage or are not commercially available from major pharmaceutical manufacturers. We compound a significant volume of sterile injectables, ophthalmics, and other dosage forms that are essential for hospital, clinic, and office-based procedures. By operating under Section 503B, we ensure these vital medications are produced with the highest level of quality control, including stringent sterility testing, stability studies, and endotoxin testing, providing practitioners and their patients with confidence in the medications they use.
Healthcare providers seeking a reliable source for high-quality compounded medications can partner with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. We provide a critical service to the local medical community by ensuring access to essential drugs that support a wide range of treatments and procedures. For more information on our available formulations or to discuss your office use needs, please contact us directly.
Website: | Phone: (407)993-1381
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 complies with Section 503B of the Federal Food, Drug, and Cosmetic Act. We operate under current Good Manufacturing Practices (cGMP), which are the strict federal standards for drug manufacturing that ensure identity, strength, quality, and purity.
2. Can I, as an individual patient, pick up a prescription directly from your location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. We supply compounded medications in bulk to physicians, clinics, and hospitals. Individual patients receive their medications directly from their healthcare provider, who dispenses from their stock obtained from our facility.
3. What types of medications does 503B Compounding Pharmacy typically produce?
Our facility on W State Road 434 specializes in producing large batches of medications that are often on shortage or not commercially available. This includes a significant volume of sterile preparations like injectables, IV bags, and ophthalmics, as well as non-sterile compounds, which are supplied to healthcare providers for use in their practice.
4. How does the quality control at a 503B outsourcing facility differ from a traditional pharmacy?
As a 503B outsourcing facility, our processes are governed by cGMP regulations. This requires rigorous testing of raw materials, in-process testing, and finished product testing for sterility, endotoxins, potency, and stability. This level of testing and quality assurance exceeds the standards required of traditional compounding pharmacies, providing a higher level of safety and consistency for bulk compounded medications.
5. How can a healthcare provider at a local clinic order from your facility?
Healthcare providers and institutions can contact 503B Compounding Pharmacy directly to establish an account and discuss their specific medication needs. Our team will work with you to provide the necessary compounded medications for your practice. Reach out to us via our website at or by phone at (407)993-1381 for more information.