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 is located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are distinct from traditional compounding pharmacies. We engage in the large-scale, non-patient-specific compounding of sterile and non-sterile medications. These medications are then distributed to healthcare providers and facilities for office use, ensuring they have the necessary drugs on hand for immediate patient needs. Our operations are subject to rigorous FDA standards, including current good manufacturing practices (cGMP), which provides an additional layer of safety and quality assurance for the medications we compound.
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides healthcare practitioners with a reliable source for high-quality compounded medications. Our services are designed to support local clinics, hospitals, surgical centers, and other healthcare providers by supplying them with essential drugs that may be in shortage or are not commercially available. By operating as a 503B outsourcing facility, we help ensure patient safety and improve access to critical medications. Our team of experienced pharmacists and technicians utilizes state-of-the-art technology and adheres to the highest standards of quality control throughout the entire compounding process.
For healthcare providers seeking a trusted 503B outsourcing facility, we are your local partner at 2160 W State Road 434, Longwood, FL 32779. We encourage you to contact us to discuss your specific needs. You can reach us by phone at (407)993-1381 or visit our website at . Our team is dedicated to supporting the local medical community with consistent, high-quality compounded pharmaceutical products.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and compounds medications on a larger scale without requiring patient-specific prescriptions. We operate under stricter federal regulations, including cGMP, to ensure the highest quality and safety standards for the medications we supply to healthcare providers.
2. Can I, as an individual patient, get a prescription filled at your location?
No. As a 503B outsourcing facility, we do not compound medications for individual patients based on a prescription. Our services are exclusively for healthcare providers and facilities at 2160 W State Road 434, Longwood, FL 32779 who order medications for office use to treat their patients.
3. What types of medications does your 503B facility compound?
Our 503B Compounding Pharmacy compounds a range of sterile and non-sterile medications, often focusing on drugs that are currently in shortage or are not available from commercial manufacturers. Healthcare providers can contact us at (407)993-1381 to inquire about our current product list and availability.
4. How do I, as a healthcare provider, place an order with your facility?
Healthcare providers and facilities can place orders by contacting our facility directly at 2160 W State Road 434, Longwood, FL 32779. You can reach our team by phone at (407)993-1381 to discuss your needs, place an order, or request more information about our compounding services.
5. Why should a healthcare provider choose your 503B facility?
Choosing our 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 ensures you receive medications produced under federally mandated cGMP standards. This provides an elevated level of quality control, sterility assurance, and consistency, which is crucial for patient safety and effective treatment outcomes.