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, including current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures that every preparation leaving our facility is of consistent quality, strength, and purity.
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 supplying medications that are often on shortage or unavailable from conventional manufacturers. This allows physicians, surgeons, and other healthcare providers to have essential medications readily available for their patients without the need for patient-specific prescriptions for each vial or syringe. Our operations are pivotal in supporting local clinical practices by ensuring they have access to the critical medications required for procedures and treatments.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to maintain the utmost environmental control. Our sterile compounding suites are equipped with ISO-classified air quality systems to prevent contamination. Every batch of medication is rigorously tested for sterility, potency, and endotoxin levels by an independent laboratory before it is released for distribution. This meticulous process provides an additional layer of safety and assurance for the healthcare professionals we serve. The 503B Compounding Pharmacy team consists of highly trained pharmacists and technicians who are experts in the science of compounding, ensuring precision in every preparation.
503B Compounding Pharmacy provides a vital service to the healthcare infrastructure at 2160 W State Road 434, Longwood, FL 32779. By focusing on office-use medications, we help streamline the supply chain for practitioners, reduce administrative burdens, and enhance patient care. Our commitment is to reliability, quality, and safety in every compounded preparation we produce. For more information or to discuss your practice's needs, please contact us at our facility. You can reach us via our website at or 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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. We are subject to federal oversight and must comply with current Good Manufacturing Practices (cGMP), which involve rigorous standards for quality control, testing, and reporting.
2. Can I as an individual patient get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy provides medications primarily for office use by healthcare practitioners. We supply medications in bulk to doctors, clinics, and hospitals at 2160 W State Road 434, Longwood, FL 32779. Individual patients should have their prescriptions filled by a traditional 503A compounding pharmacy that compounds based on individual patient prescriptions.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 prepares a wide range of sterile injectable medications, including hormone injections, ophthalmics, and other solutions used in clinical settings. We focus on medications that are often on drug shortage lists or are not commercially available from large-scale manufacturers.
4. How does a healthcare provider at 2160 W State Road 434 order from 503B Compounding Pharmacy?
Healthcare providers can place orders for office-use medications directly with our facility. They can initiate the process by contacting our team via our website at or by calling us at (407)993-1381 to discuss their specific needs and establish an account.
5. How does 503B Compounding Pharmacy ensure the safety of its products?
Safety is paramount. At our location, 2160 W State Road 434, Longwood, FL 32779, we adhere to strict cGMP protocols. This includes environmental monitoring, validated processes, and independent third-party testing of every batch for sterility, potency, and endotoxins before release to ensure the highest quality and safety for patients.