Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this compounding pharmacy specializes in the large-scale compounding of sterile medications for healthcare providers. As a 503B outsourcing facility, the pharmacy adheres to rigorous federal standards for quality, safety, and production, ensuring that healthcare facilities in need of bulk compounded preparations receive a reliable and compliant product.
The primary focus of a 503B compounding pharmacy is to support physicians, hospitals, clinics, and other healthcare entities by providing them with medications that are not commercially available or are in shortage. By operating under the stringent requirements of Section 503B, the pharmacy provides an essential service to the medical community, compounding medications without patient-specific prescriptions but rather for office use or in anticipation of patient needs. The team at 503B Compounding Pharmacy is dedicated to maintaining the highest levels of sterility and quality control throughout the compounding process.
For healthcare professionals seeking a trusted source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a commitment to excellence and regulatory compliance. To learn more about their services or to inquire about their products, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean to be a 503B outsourcing facility? A 503B outsourcing facility is an entity registered with the FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration signifies that the facility compounds large volumes of sterile medications for healthcare providers without requiring individual patient prescriptions, adhering to current Good Manufacturing Practices (cGMP) for heightened quality and safety.
Who can receive medications from 503B Compounding Pharmacy? 503B Compounding Pharmacy provides medications to healthcare providers and facilities, such as hospitals, clinics, and physician practices, for office use or administration within their practice. These medications are not dispensed directly to individual patients based on a prescription.
What types of medications does 503B Compounding Pharmacy compound? As an outsourcing facility, 503B Compounding Pharmacy specializes in the compounding of sterile injectable medications. This often includes medications that are on shortage from traditional manufacturers or those that are necessary for specific medical procedures but are not readily available in the commercial market.
How does the quality control process work at your facility? Quality control is paramount. The facility operates under strict cGMP standards, which include rigorous testing of components, in-process monitoring, and thorough sterility testing of finished products. This ensures every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets the highest standards for safety and potency.
How can a healthcare facility place an order? Healthcare facilities interested in the services of 503B Compounding Pharmacy can initiate the process by contacting the facility directly. For more information or to discuss your facility's needs, please visit the website at https://503bcompoundingpharmacy.com/ or call (407)993-1381.