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 at 2160 W State Road 434, Longwood, FL 32779
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 volumes of sterile and non-sterile medications without patient-specific prescriptions. This designation signifies our commitment to the highest standards of quality, safety, and purity, as we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. We serve healthcare providers and facilities by providing them with access to essential medications that may be in shortage or not commercially available.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded medications for office use. This means physicians, surgeons, hospitals, and clinics in need of specific medications for their practice can obtain them directly from our facility at 2160 W State Road 434, Longwood, FL 32779. Our operations are distinct from traditional 503A compounding pharmacies, as we are authorized to compound medications in advance of receiving a prescription and ship them interstate. This model is crucial for ensuring healthcare practitioners have the necessary drugs on hand for immediate patient care, particularly for procedures and treatments where a specific, pre-made formulation is required.
Quality control is the foundation of everything we do at our Longwood location. Our state-of-the-art facility features advanced environmental controls, including ISO-classified cleanrooms for sterile compounding. Every batch of medication we produce undergoes stringent testing and validation processes to ensure sterility, potency, and stability. Our highly trained pharmacists and technicians adhere to exacting protocols to mitigate the risk of contamination and ensure every product that leaves our facility meets its labeled strength, quality, and purity specifications. This unwavering dedication to cGMP standards provides healthcare professionals with confidence in the medications they administer.
We specialize in addressing critical drug shortages, which are a significant challenge for the healthcare system. When a commercially manufactured drug becomes unavailable, 503B Compounding Pharmacy can often step in to compound a necessary alternative, helping to prevent delays in patient treatment. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 and the surrounding medical community can rely on us as a dependable source for these vital medications. Our team works diligently to provide solutions that support continuity of care and positive patient outcomes.
Engaging with our services is designed for healthcare entities. Providers can discuss their specific medication needs with our team to determine if a compounded formulation is appropriate. We provide detailed information on our available products, including formulation data and beyond-use dating. Orders from our facility at 2160 W State Road 434, Longwood, FL 32779 are processed efficiently and delivered directly to the requesting healthcare facility. For more information or to initiate an order, healthcare professionals are encouraged to contact 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 and inspected by the U.S. Food and Drug Administration. We operate under Section 503B of the FD&C Act and must comply with strict current Good Manufacturing Practice (cGMP) regulations, which are the same standards required of major pharmaceutical manufacturers. This ensures a higher level of oversight for sterility, quality, and safety compared to traditional compounding pharmacies.
2. Can I get a prescription filled for myself at your location?
No. 503B Compounding Pharmacy does not compound medications for individual patients based on a personal prescription. We are an outsourcing facility that produces large batches of medications for "office use" by healthcare providers. Individual patients should contact a traditional 503A compounding pharmacy for their personal prescription compounding needs.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds both sterile and non-sterile medications in larger quantities. This often includes injectables, ophthalmics, inhalants, and topical preparations that are on the FDA drug shortage list or are not otherwise available from commercial manufacturers. These are supplied to hospitals, clinics, and physician offices for use in their practice.
4. How can a healthcare facility order from your pharmacy?
Healthcare facilities and licensed practitioners can place orders by contacting 503B Compounding Pharmacy directly. You can initiate an order or inquire about our available formulations by calling us at (407)993-1381 or by visiting our website at . Our team will work with you to fulfill your specific medication requirements.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 provides assurance of quality and compliance. Our adherence to cGMP standards, rigorous testing protocols, and FDA oversight minimizes risk and provides healthcare professionals with confidence in the medications they use for their patients, especially when dealing with drug shortages or needing specific formulations not available on the market.