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 is an FDA-registered outsourcing facility operating under 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 produce large volumes of compounded sterile and non-sterile medications for healthcare providers. This designation means we adhere to the highest federal standards for quality control, sterility assurance, and production practices, providing a critical service for the local medical community.
Unlike traditional compounding pharmacies, our 503B outsourcing facility status requires us to follow Current Good Manufacturing Practices (cGMP). This rigorous framework ensures every medication prepared at our Longwood location meets stringent specifications for identity, strength, quality, and purity. We provide these medications to healthcare practitioners for office use and for administration to patients within their care, serving as a vital link in the local healthcare supply chain at 2160 W State Road 434, Longwood, FL 32779.
The core function of 503B Compounding Pharmacy is the large-scale production of medications that are often on shortage or are not commercially available. Our team of skilled pharmacists and technicians utilizes advanced technology and controlled environments to compound a range of preparations. This includes sterile injectables, ophthalmics, and other dosage forms that are essential for hospitals, clinics, and surgical centers that rely on our facility for a consistent and reliable supply of critical drugs.
Our operations at 2160 W State Road 434, Longwood, FL 32779, are integral to supporting the local healthcare infrastructure. By providing bulk, office-use medications, we enable area physicians and surgeons to focus on patient care without the concerns of drug shortages or the complexities of in-house compounding. We are committed to upholding the trust placed in us by the medical professionals we serve, ensuring that every product that leaves our facility is of the utmost quality and safety.
For healthcare providers seeking a dependable source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, stands as a partner in patient care. We invite local medical practices to contact us to discuss their specific needs. 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 facility is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779, is registered with the FDA and operates under Section 503B of the FD&C Act. We are held to Current Good Manufacturing Practice (cGMP) standards, which are more rigorous than the standards applied to traditional compounding pharmacies, ensuring a higher level of quality control and sterility assurance for the medications we produce.
2. Can I, as an individual patient, pick up a prescription directly from your location?
No. 503B Compounding Pharmacy provides medications primarily for "office use" by healthcare providers. This means we supply medications in bulk to hospitals, clinics, and physician offices at 2160 W State Road 434, Longwood, FL 32779, where a healthcare professional will then administer them to you. We do not typically dispense medications directly to individual patients.
3. What types of medications does your facility in Longwood compound?
Our FDA-registered outsourcing facility at 2160 W State Road 434 specializes in producing large volumes of compounded sterile preparations. This includes sterile injectables, IV bags, ophthalmics, and other medications that are essential for surgical and clinical settings. We focus on drugs that are currently in shortage or are not available from commercial manufacturers.
4. How does a local healthcare provider place an order with your pharmacy?
Healthcare providers and facilities can place orders for office-use medications directly with our facility. To initiate an order or to discuss your specific needs, please contact our team at 2160 W State Road 434, Longwood, FL 32779, by calling (407)993-1381. Our staff will guide you through the ordering process.
5. Why should a medical practice choose your 503B facility over other suppliers?
Choosing our facility at 2160 W State Road 434, Longwood, FL 32779, ensures you are receiving medications produced under the strictest federal cGMP standards. This offers a greater assurance of quality, purity, and sterility. We provide a reliable local source for medications that may be on national shortage, helping to ensure continuity of care for your patients.