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 safe and precise preparation of compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of current good manufacturing practices (cGMP), ensuring that every preparation meets rigorous quality and safety protocols for the healthcare providers and patients we serve.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded medications. This is distinct from traditional compounding, as our 503B status means our preparations are created for office use by healthcare practitioners, without the need for patient-specific prescriptions. This allows physicians, surgeons, hospitals, and clinics to have essential medications readily available for immediate administration to patients. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and cleanroom environments to ensure the integrity and sterility of all our preparations.
Our services are integral to supporting the local medical community. Healthcare professionals can rely on 503B Compounding Pharmacy for a consistent supply of high-quality, ready-to-use medications. This includes a range of preparations such as sterile injectables, ophthalmic solutions, and topical formulations. By outsourcing their compounding needs to our 503B facility, medical practices can enhance patient care, improve operational efficiency, and mitigate the risks associated with in-office compounding. We are a pivotal resource for practitioners seeking dependable, cGMP-compliant medications for their practice located at or near 2160 W State Road 434, Longwood, FL 32779.
Quality assurance is the foundation of everything we do at 503B Compounding Pharmacy. Every batch of medication undergoes extensive testing and validation processes to guarantee potency, purity, and sterility. Our commitment to compliance and safety provides peace of mind to the healthcare providers who trust us with their patients' needs. For more information or to discuss your facility's requirements, please contact us directly. We are located at 2160 W State Road 434, Longwood, FL 32779. You can reach us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B. We compound medications in large batches for office use by healthcare practitioners and must comply with strict federal manufacturing standards, including current Good Manufacturing Practices (cGMP).
2. Can I, as an individual patient, get a prescription filled at this location?
No. 503B Compounding Pharmacy provides medications for office use to licensed healthcare practitioners. Individual patients should contact a traditional 503A compounding pharmacy with their patient-specific prescription. Our services are specifically for healthcare providers at or serving 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does this 503B facility typically prepare?
We specialize in preparing sterile injectables, ophthalmic solutions, and other formulations that are commonly used by healthcare providers in clinical settings. All preparations are made in our cGMP-compliant facility located at 2160 W State Road 434, Longwood, FL 32779.
4. How does a medical practice at this location order from your 503B facility?
Healthcare practices can establish an account with our 503B Compounding Pharmacy by contacting us directly. Orders can be placed for delivery or pickup from our facility at 2160 W State Road 434, Longwood, FL 32779. Please call (407)993-1381 to speak with a representative.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing a 503B outsourcing facility like ours ensures that the medications used in a practice are produced under the highest level of FDA oversight and quality control. This reduces risk, ensures consistency, and allows providers to focus on patient care rather than medication preparation.