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 at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to producing compounded medications that adhere to the highest standards of quality, safety, and sterility. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations and regular facility inspections. This ensures that every batch of medication produced for healthcare providers is consistent, reliable, and of pharmaceutical grade.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications for office use. This means healthcare practitioners at medical offices, hospitals, clinics, and surgical centers can order essential medications directly from the facility at 2160 W State Road 434, Longwood, FL 32779. These medications are not intended for individual patient dispensing with a prescription but are instead used by providers within their practice for treatments such as injections, infusions, and topical applications. This model provides practitioners with a trusted, convenient, and compliant source for critical drugs, allowing them to focus on patient care.
By operating from its specific location, 503B Compounding Pharmacy serves as a vital local resource for the medical community. The facility specializes in the compounding of sterile preparations, a process that requires a controlled environment with strict protocols to eliminate microbial contamination. This includes the production of injectables, ophthalmics, and other sterile solutions. The team of highly trained pharmacists and technicians utilizes state-of-the-art equipment within the Longwood facility to ensure every product meets exacting specifications. The focus remains on providing healthcare professionals with access to medications that may be in short supply, discontinued, or necessary for specific clinical protocols.
For healthcare providers seeking a dependable partner for their medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 offers a streamlined process. Orders can be placed, and inquiries can be made by contacting the facility directly at (407)993-1381 or by visiting their official website at https://503bcompoundingpharmacy.com/. The dedicated staff is available to discuss specific requirements, provide documentation, and ensure a seamless experience from order to delivery, reinforcing their role as a cornerstone of the local healthcare infrastructure.
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 operates in compliance with Section 503B of the FD&C Act. This subjects us to federal oversight, mandatory compliance with current Good Manufacturing Practices (cGMP), and routine FDA inspections to ensure the quality, safety, and sterility of our compounded medications for office use.
2. As a healthcare provider, how do I order medications from your Longwood location?
Healthcare providers can place orders for office-use medications directly with our facility. Please contact our team at (407)993-1381 to establish an account and discuss your specific needs. Our staff will guide you through the ordering process to ensure you receive the required compounded preparations.
3. Can individual patients get prescriptions filled at 2160 W State Road 434?
No. 503B Compounding Pharmacy operates as an outsourcing facility that compounds medications in large batches for office use by healthcare providers. We do not dispense medications directly to individual patients based on a prescription. Patients should work with their healthcare provider or a traditional compounding pharmacy for individual prescriptions.
4. What types of sterile compounds do you produce at your facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a range of sterile preparations. This includes injectable medications, ophthalmic solutions, and other sterile drugs intended for use by healthcare professionals within their practice settings.
5. How can I get more information about your services and compliance?
For detailed information about our compounding services, quality controls, and compliance documentation, please visit our website at https://503bcompoundingpharmacy.com/ or call us directly at (407)993-1381. Our team is available to answer questions and provide the necessary information to healthcare providers.