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 specifically designed and regulated to compound large quantities of sterile and non-sterile medications for office use by healthcare practitioners. This designation means we adhere to the highest federal standards for quality control, testing, and production, providing practitioners with a reliable and trusted source for compounded medications to support their patient care protocols.
The core function of 503B Compounding Pharmacy is the anticipatory compounding of medications. Unlike traditional compounding, which is patient-specific, our 503B outsourcing facility prepares batches of medications before receiving individual prescriptions. These medications are then distributed to hospitals, clinics, and healthcare providers' offices located near our facility at 2160 W State Road 434, Longwood, FL 32779, for use within their practice. This model ensures that healthcare professionals have immediate access to critical medications, such as sterile injectables, ophthalmics, and other preparations, which are essential for procedures, emergency kits, and general office stock.
Our operations at 2160 W State Road 434, Longwood, FL 32779 are subject to rigorous FDA oversight, which includes current Good Manufacturing Practices (cGMP). This ensures every product leaving our facility meets stringent standards for potency, purity, and sterility. We employ advanced analytical testing, environmental monitoring, and validated processes to guarantee the integrity and safety of every preparation. For healthcare providers, this translates to unparalleled confidence in the medications they administer to their patients, knowing they are sourced from a fully compliant and audited facility.
Healthcare practitioners seeking a dependable 503B outsourcing partner for their office-use medication needs can rely on our local facility. We provide a vital service to the medical community by compounding preparations that may be commercially unavailable or in shortage. By focusing on the specific requirements of practitioners serving patients from our location, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 acts as a critical component in the local healthcare infrastructure, ensuring access to essential medications.
For more information on our available formulations and distribution protocols, you can visit our website at or contact our facility directly at (407)993-1381. Our team is prepared to assist healthcare providers with their specific compounding requirements.
FAQ
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. We are subject to federal oversight and must comply with Current Good Manufacturing Practices (cGMP), which include rigorous testing and quality control standards far beyond those of a traditional 503A pharmacy.
Can I as an individual patient get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 compounds medications for office use by healthcare practitioners. We do not accept or fulfill prescriptions written for individual patients. Patients should contact their healthcare provider or a traditional compounding pharmacy for personalized prescriptions.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a wide range of sterile and non-sterile medications in bulk for office use. This includes, but is not limited to, sterile injectables, ophthalmics, and other preparations that are routinely used by healthcare practitioners in a clinical setting.
How can a healthcare practitioner order from 503B Compounding Pharmacy?
Healthcare practitioners can order compounded medications for office use from our facility at 2160 W State Road 434, Longwood, FL 32779. For detailed information on our ordering process, available formulations, and distribution, please contact us directly at (407)993-1381.
Why would a healthcare practitioner use a 503B outsourcing facility like yours?
Practitioners use our services at 2160 W State Road 434, Longwood, FL 32779 to source high-quality, FDA-regulated medications for office stock. This is especially critical for medications that are on shortage or are not commercially available from large-scale manufacturers, ensuring they have the necessary supplies for procedures and patient treatments.