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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality control, purity, and safety, providing medications for healthcare providers to administer to their patients in-office or within other clinical settings.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded drugs that are patient-specific yet not individually identified. This means we compound medications in bulk for office use, allowing physicians, surgeons, and other healthcare professionals at practices and hospitals to have essential medications readily available for immediate administration. Our operations are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures every preparation leaving our facility meets exacting standards for sterility, potency, and stability.
Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by a team of highly skilled pharmacists and technicians. We specialize in sterile compounding, a critical service that requires a controlled environment to prevent microbial contamination. This includes the compounding of injectables, ophthalmics, and other preparations that must be free of harmful microorganisms. Our commitment to quality is unwavering, with every batch undergoing extensive testing and validation before it is released for distribution.
503B Compounding Pharmacy serves an essential role in the healthcare ecosystem by addressing drug shortages and providing medications that are otherwise unavailable from traditional manufacturers. When a commercially available drug is on backorder or discontinued, our facility can often compound a necessary alternative, ensuring patient care is not interrupted. We work directly with healthcare providers, not the general public, to supply these vital medications. 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
1. What does it mean to be a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy is registered with the FDA and operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation requires us to comply with stricter production standards, including current Good Manufacturing Practices (cGMP), and subjects us to regular FDA inspections to ensure the quality, safety, and sterility of the medications we compound for healthcare providers.
2. Can I, as a patient, order medication directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy provides medications exclusively to healthcare professionals for office use. Patients receive our compounded medications through their doctor, surgeon, or other qualified healthcare provider who administers it within their practice or clinical setting located near 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectable medications, including IV bags, ophthalmics, and other preparations that require an aseptic environment. We produce these in batches for healthcare providers to have on hand for procedures and treatments.
4. How does 503B Compounding Pharmacy help with drug shortages?
When commercially manufactured drugs are in short supply or discontinued, 503B Compounding Pharmacy can compound a necessary alternative. This allows medical practices serving the local community to continue providing critical treatments without interruption, ensuring patient care remains consistent.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers and their authorized staff can initiate orders or obtain more information by contacting 503B Compounding Pharmacy directly. Please reach out to us through our website at or call our dedicated phone line at (407)993-1381 to speak with a representative.