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 operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. As a 503B outsourcing facility, we produce large batches of compounded sterile and non-sterile preparations for physician offices and healthcare facilities without receiving patient-specific prescriptions. Our operations are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, ensuring that every preparation leaving our facility meets exacting standards for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is to provide healthcare providers with access to essential medications that are often in short supply or unavailable from conventional manufacturers. We compound a significant volume of injectable medications, including hormone replacement therapies, vitamins, electrolytes, and other critical sterile preparations. Our state-of-the-art facility in Longwood is designed with controlled environments to prevent contamination, and our processes are continuously validated to ensure product integrity and patient safety. By serving the medical community from our location on W State Road 434, we act as a vital component of the local healthcare infrastructure, enabling practitioners to obtain the necessary medications for their treatment protocols reliably and efficiently.
Healthcare professionals who partner with 503B Compounding Pharmacy benefit from the assurance that comes with FDA-registered sourcing. Our status means we are regularly inspected by the FDA, and we adhere to stringent testing protocols for all components and finished preparations. This level of quality control is a fundamental aspect of our service at 2160 W State Road 434. We provide a dependable alternative to traditional pharmaceutical manufacturers, particularly for medications that have been discontinued or are experiencing national drug shortages. Our team of experienced pharmacists and technicians is dedicated to upholding the principles of cGMP in every batch we compound, ensuring that the healthcare providers we serve can trust the medications they administer.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Orders for our compounded preparations are placed directly by healthcare providers and are delivered from our facility at 2160 W State Road 434. We maintain a professional focus on serving the needs of the medical community, providing consistent quality and reliability in every preparation. For more detailed information about our services or to initiate an account, healthcare providers are encouraged to contact us directly. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website to learn more: https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 and inspected by the U.S. Food and Drug Administration. We operate under Section 503B of the FD&C Act and must comply with strict current Good Manufacturing Practice regulations, which govern the quality and safety of our compounded preparations for healthcare providers.
Who can place an order with 503B Compounding Pharmacy?
Orders are placed by healthcare providers and medical facilities. As a 503B outsourcing facility, we compound medications in bulk for office use and do not accept prescriptions for individual patients. Healthcare professionals can order our preparations for use within their practice at 2160 W State Road 434.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in compounding sterile injectable medications, including but not limited to hormone therapies, vitamin complexes, and other solutions that are often on drug shortage lists or are not commercially available from large-scale manufacturers. All preparations are made at our facility on W State Road 434.
How does 503B Compounding Pharmacy ensure the quality of its compounded preparations?
Our quality assurance is rooted in compliance with FDA cGMP standards. This includes rigorous testing of raw materials, validation of our sterilization processes, environmental monitoring of our cleanrooms, and thorough quality control checks on finished preparations before they are released from our location at 2160 W State Road 434.
How can a healthcare provider get started with 503B Compounding Pharmacy?
Healthcare providers interested in our services can contact us directly to establish an account. We can be reached by phone at (407)993-1381. Additional information about our capabilities and compliance is available on our website at https://503bcompoundingpharmacy.com/.