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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to our operations at our specific location: 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we adhere to the most rigorous federal standards for quality, safety, and production. Our facility is distinct from traditional compounding pharmacies, as we produce medications on a larger scale without receiving patient-specific prescriptions. This allows us to supply healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with readily available, high-quality compounded medications for office use.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. Our processes are designed to meet the exacting requirements set forth by the FDA for outsourcing facilities. This includes robust quality control protocols, stringent environmental monitoring, and rigorous testing of components and finished drug products. For medical professionals at our location, this means access to a reliable supply of essential medications, such as injectables, ophthalmics, and other formulations that are often in short supply from conventional manufacturers. The assurance of quality and compliance provided by our 503B status is a critical component of the healthcare infrastructure at 2160 W State Road 434, Longwood, FL 32779.
Our services are exclusively tailored for healthcare providers. 503B Compounding Pharmacy supplies medications to physicians, clinics, hospitals, and other healthcare entities for administration to their patients within their practice settings. This model supports efficient patient care by ensuring that practitioners at 2160 W State Road 434, Longwood, FL 32779 have the necessary medications on hand for immediate use during procedures, treatments, or appointments. We do not dispense medications directly to individual patients based on a prescription; instead, we are a wholesale supplier to the medical community, reinforcing our specialized role as an outsourcing facility.
The commitment of 503B Compounding Pharmacy is to uphold the highest standards of pharmaceutical compounding as defined by federal law. Our team of pharmacists and technicians at 2160 W State Road 434, Longwood, FL 32779 is dedicated to precision, sterility, and compliance in every preparation. We provide a vital service by mitigating drug shortages and offering compounded formulations that support the specific needs of local healthcare providers. For more information about our available products and services, healthcare professionals can contact us directly.
Contact 503B Compounding Pharmacy: Website: Phone: (407)993-1381 Address: 2160 W State Road 434, Longwood, FL 32779
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 complies with strict federal current Good Manufacturing Practices (cGMP) for drug production. This ensures a higher level of quality control and oversight compared to traditional pharmacy compounding.
2. Can I, as an individual patient, get a prescription filled at 503B Compounding Pharmacy? No. 503B Compounding Pharmacy operates as a wholesale supplier to healthcare providers. We do not accept or fulfill individual patient prescriptions. Your healthcare provider at their practice can order and administer our medications directly to you during your treatment.
3. What types of medications does 503B Compounding Pharmacy provide? Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a range of sterile and non-sterile medications, often including injectables, ophthalmics, and other formulations that may be on shortage from major manufacturers. The specific drug products are supplied for office use by healthcare providers.
4. How do healthcare providers at this location order from you? Healthcare providers and facilities can contact 503B Compounding Pharmacy directly to establish an account and discuss their medication needs. Our team will provide information on ordering procedures, available products, and delivery options specific to 2160 W State Road 434, Longwood, FL 32779.
5. Why would a healthcare provider choose a 503B outsourcing facility? Healthcare providers choose 503B Compounding Pharmacy for the assurance of FDA-registered quality and compliance. It provides a reliable source for essential medications, helps mitigate drug shortages, and ensures the medications used in their practice meet rigorous federal standards for safety and potency.