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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. We are located at 2160 W State Road 434, Longwood, FL 32779, providing essential pharmaceutical compounding services from this specific facility. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing compounded medications in large batches for office use by healthcare practitioners. Our operations are distinct from traditional compounding pharmacies, as we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations.
The primary function of 503B Compounding Pharmacy at 2160 W State Road 434 is to supply healthcare providers with high-quality, sterile and non-sterile compounded preparations. These medications are not dispensed directly to individual patients from our location but are instead distributed for use in clinical settings. Physicians, surgeons, veterinarians, and other healthcare professionals can rely on our facility for a consistent and reliable source of compounded drugs that are essential for patient treatment plans. Our work supports the local medical community by ensuring they have access to necessary medications that may be commercially unavailable or in short supply.
Our state-of-the-art facility at 2160 W State Road 434 is designed to meet stringent regulatory requirements. We utilize advanced technology and controlled environments to ensure every preparation meets exacting standards for potency, purity, and sterility. The team at 503B Compounding Pharmacy consists of highly skilled pharmacists and technicians who are experts in the science of compounding. We are committed to excellence in every batch we produce, providing healthcare practitioners with the confidence that the medications they use are safe, effective, and of the highest quality.
503B Compounding Pharmacy serves a critical role in the healthcare ecosystem from our location in Longwood. By focusing on large-scale compounding, we help alleviate drug shortages and provide access to vital medications that are not otherwise available from commercial manufacturers. Healthcare providers who utilize our services can be assured of our commitment to compliance, quality, and safety in every aspect of our operation at 2160 W State Road 434.
For more information, please visit our website at or contact us by phone at (407)993-1381.
Frequently Asked Questions
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 in compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This subjects us to federal oversight and strict current Good Manufacturing Practice (cGMP) regulations, ensuring the highest standards for the medications we compound.
2. Can I, as a patient, pick up my prescription directly from your location at 2160 W State Road 434?
No. 503B Compounding Pharmacy does not typically dispense medications directly to individual patients. Our facility compounds medications in large batches for office use by healthcare practitioners. Your healthcare provider will administer or dispense the medication to you from their practice location.
3. What types of medications does 503B Compounding Pharmacy produce at its Longwood facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434 compounds a wide range of sterile and non-sterile preparations. This includes injectables, ophthalmics, and other dosage forms that are supplied to hospitals, clinics, and medical offices for use in treating their patients.
4. How does a healthcare provider at a local practice order from your facility?
Healthcare providers can establish an account with 503B Compounding Pharmacy by contacting us directly. Orders from our facility at 2160 W State Road 434 can be placed by phone at (407)993-1381. We work directly with medical practices to supply the compounded medications they require.
5. Why would a healthcare provider choose 503B Compounding Pharmacy over other compounders?
Healthcare providers choose our facility at 2160 W State Road 434 because of our commitment to quality and compliance as an FDA-registered 503B outsourcing facility. Our adherence to cGMP standards provides an added layer of safety and assurance for the medications used in their practice, especially for office-use products.