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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets our facility apart, signifying our adherence to the highest standards of pharmaceutical compounding. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is purpose-built to produce large volumes of compounded sterile preparations (CSPs) and non-sterile preparations for healthcare providers. Our mission is to provide a reliable, high-quality source of medications that are not commercially available, directly serving the patient care needs of practitioners in our community.
The 503B outsourcing facility model is defined by rigorous federal oversight. Unlike traditional 503A compounding pharmacies, our operation is subject to current Good Manufacturing Practices (cGMP), which are the same stringent quality standards required of major pharmaceutical manufacturers. This involves extensive environmental monitoring, validated sterilization processes, robust quality control testing, and thorough documentation for every batch we produce. For prescribers at 2160 W State Road 434, Longwood, FL 32779, this means an unparalleled level of confidence in the potency, purity, and sterility of the medications they administer to their patients.
Our core service at 2160 W State Road 434, Longwood, FL 32779 is the large-scale compounding of medications for office use. This allows healthcare practitioners in our immediate area to maintain an inventory of essential, often critical, medications that are on shortage or are not produced by commercial pharmaceutical companies. We compound a significant volume of injectable medications, including hormone replacement therapy (HRT), peptides, vitamins, and other therapeutic solutions. These are supplied in multi-dose vials or ready-to-administer syringes, providing convenience and efficiency for medical practices.
In addition to sterile preparations, our 503B Compounding Pharmacy also produces non-sterile compounded medications. This includes topical creams, gels, ointments, and transdermal formulations that are prepared in batches under strict quality control protocols. All processes at our facility, from ingredient sourcing to final packaging, are designed to ensure batch-to-batch consistency and compliance with all federal regulations. Patients and providers at 2160 W State Road 434, Longwood, FL 32779 benefit from our commitment to safety and quality in every prescription we compound.
Engagement with the local medical community is a priority for our facility. We provide essential support to healthcare providers by offering a dependable solution for drug shortages and patient-specific needs that cannot be met by mass-produced drugs. Our team of licensed pharmacists and trained technicians is dedicated to the science of compounding, ensuring that every product that leaves our facility at 2160 W State Road 434, Longwood, FL 32779 meets its labeled strength and purity specifications. For more information or to inquire about our services, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with current Good Manufacturing Practices (cGMP). This federal oversight ensures we meet the highest standards for quality, sterility, and strength in our large-scale compounded medications, which are primarily for office use by healthcare providers.
2. Can I as a patient get a prescription filled directly at 2160 W State Road 434?
503B Compounding Pharmacy primarily serves healthcare practitioners by providing medications for office use. Patients typically receive medications that we have compounded directly from their provider's office during treatment. Patients should discuss their specific medication needs with their healthcare provider, who can determine if our compounded preparations are appropriate.
3. What types of medications does this 503B facility compound?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding both sterile and non-sterile preparations in large batches. This includes injectable medications like hormones, peptides, and vitamins, as well as topical formulations such as creams and gels. All are produced for healthcare providers to use within their practice.
4. How does the quality control at a 503B facility differ from a regular pharmacy?
As a 503B outsourcing facility, we operate under strict cGMP guidelines mandated by the FDA. This involves rigorous environmental monitoring, validated sterilization processes, ingredient testing, and thorough documentation for every batch. This level of quality control is more extensive than that of a traditional compounding pharmacy, focusing on large-scale batch consistency and safety.
5. How can a healthcare provider at this location start ordering from your 503B facility?
Healthcare providers interested in our services can contact our facility directly to establish an account. We encourage providers at 2160 W State Road 434, Longwood, FL 32779 to reach out to our pharmacy team to discuss their specific needs, review our available formulations, and understand our ordering process. Please contact us at or (407)993-1381 to speak with a representative.