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. Unlike traditional pharmacies, our 503B status signifies that we adhere to the highest level of federal regulation, ensuring that every preparation meets rigorous standards for sterility, potency, and purity. We serve a critical role for healthcare providers at 2160 W State Road 434, Longwood, FL 32779 by providing bulk quantities of medications that are often in short supply or unavailable from conventional manufacturers.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded drugs for office use by healthcare practitioners. This means we supply medications directly to physicians, surgeons, hospitals, and clinics for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. Our operations are pivotal in supporting the local medical community by mitigating drug shortages, which helps prevent delays in critical treatments and procedures. By relying on our FDA-registered outsourcing facility, healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 can be assured of receiving consistent, high-quality, and reliable medications for their patient care protocols.
Quality assurance is the foundation of everything we do at 503B Compounding Pharmacy. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 employs advanced environmental monitoring, stringent testing protocols, and validated processes to guarantee the safety and efficacy of every preparation. Our team of highly trained pharmacists and technicians works meticulously to follow current Good Manufacturing Practices (cGMP). This unwavering commitment to quality ensures that every vial, syringe, and bottle that leaves our facility meets the exacting standards required for patient safety and therapeutic success for those receiving care at 2160 W State Road 434, Longwood, FL 32779.
503B Compounding Pharmacy is an essential partner for the healthcare ecosystem at 2160 W State Road 434, Longwood, FL 32779. We provide a vital link in the supply chain, enabling seamless patient care by ensuring that practitioners have access to the necessary medications when they are needed most. For more information about our services or to discuss your facility's needs, 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 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. This requires us to comply with stringent current Good Manufacturing Practices (cGMP) for sterility, testing, and reporting, which are more comprehensive than the standards applied to traditional compounding pharmacies.
2. Can I, as an individual patient, pick up my prescription at 2160 W State Road 434, Longwood, FL 32779?
No. 503B Compounding Pharmacy primarily prepares medications for office use by healthcare practitioners. We supply medications in bulk to physicians, clinics, and hospitals at 2160 W State Road 434, Longwood, FL 32779 for them to administer to their patients within their practice. Patients should receive their medications directly from their healthcare provider.
3. What kinds of medications does 503B Compounding Pharmacy prepare?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in preparing sterile injectable medications, including IV bags, ophthalmics, and other preparations that are essential for surgeries, hospital care, and clinical treatments. We also compound non-sterile medications as needed to address specific drug shortages.
4. How does 503B Compounding Pharmacy help with drug shortages?
When pharmaceutical manufacturers have a drug on shortage or discontinuation, it disrupts patient care. Our facility at 2160 W State Road 434, Longwood, FL 32779 can often compound that medication in necessary quantities, providing a reliable alternative for healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to ensure their patients' treatments continue without interruption.
5. How can a healthcare practice at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers and facilities at 2160 W State Road 434, Longwood, FL 32779 can initiate orders or inquire about our services by contacting our facility directly. Please call us at (407)993-1381 to speak with our team about your specific medication needs and requirements.