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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical distinction in the pharmacy sector, signifying adherence to the highest standards of quality, safety, and production. Unlike traditional compounding, a 503B outsourcing facility is subject to rigorous current Good Manufacturing Practice (cGMP) regulations, mandatory FDA inspections, and stringent reporting requirements for adverse events. This ensures that every preparation leaving the facility meets exacting specifications for potency, purity, and sterility.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are defined by this 503B status. The facility specializes in the large-scale compounding of medications, producing batches for office use by healthcare practitioners. This model is essential for clinics, hospitals, surgical centers, and veterinary practices that require a reliable, bulk supply of high-quality compounded preparations. By centralizing production in an FDA-registered facility, 503B Compounding Pharmacy provides practitioners with a trusted source for medications that are consistently formulated and rigorously tested, thereby enhancing patient safety and practice efficiency.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, engaging with a 503B outsourcing facility offers significant advantages. It mitigates the risks associated with in-office compounding or sourcing from less regulated entities, ensuring full compliance with federal law. The team at 503B Compounding Pharmacy comprises skilled pharmacists and technicians who utilize advanced technology and controlled environments to compound a range of preparations. Their work is dedicated to supporting the local medical community with a dependable and compliant source of essential medications, all produced within the regulated environment of their Longwood facility.
Communication with the healthcare providers they serve is a cornerstone of their operation at 2160 W State Road 434, Longwood, FL 32779. The pharmacy is committed to facilitating easy access for orders and inquiries. Providers can initiate contact or place orders through the official website at https://503bcompoundingpharmacy.com/ or by calling the facility directly at (407)993-1381. The focus remains exclusively on delivering the specific services of an FDA-registered 503B outsourcing facility to the medical community from this specific location.
Frequently Asked Questions
What does it mean that this is a 503B outsourcing facility at 2160 W State Road 434?
It means this facility is registered with the FDA under Section 503B and operates as an outsourcing facility. This registration requires compliance with stricter production standards, known as cGMP, and subjects the facility to federal oversight and inspection to ensure the quality and safety of compounded medications produced for office use.
Who can receive medications from 503B Compounding Pharmacy at this location?
Medications compounded at 2160 W State Road 434, Longwood, FL 32779 are intended for office use by licensed healthcare practitioners. This includes physicians, veterinarians, and other qualified providers who then administer or dispense these medications to their patients within their practice setting.
Can I as an individual patient pick up a prescription at your Longwood facility?
No. As a 503B outsourcing facility, our operations are focused on supplying other healthcare providers, not individual patients. Individual patient prescriptions are typically handled by traditional 503A compounding pharmacies. Our service is dedicated to supporting practitioners from our location on W State Road 434.
How do I place an order as a healthcare provider?
Healthcare providers can place orders for compounded medications by contacting 503B Compounding Pharmacy directly. You may initiate the process by calling (407)993-1381 or by visiting the official website at https://503bcompoundingpharmacy.com/ to discuss your practice's specific needs.
Why should a practice at this location use a 503B outsourcing facility?
Utilizing a 503B outsourcing facility like ours ensures that the medications you use in your practice are produced under the highest federally mandated quality controls. This reduces risk, ensures compliance, and provides confidence in the sterility, potency, and purity of the preparations you administer to your patients.