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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest current good manufacturing practices (cGMP), providing a critical level of safety, quality, and consistency for the medications we prepare. We serve healthcare providers and patients by producing medications that are not commercially available, ensuring those at our specific location have access to essential treatments.
The core function of 503B Compounding Pharmacy is to support the medical community. We provide bulk compounded medications to healthcare facilities and practitioners for office use, meaning these preparations are administered to patients within the practitioner's care. Our operations at 2160 W State Road 434, Longwood, FL 32779 are integral to the local healthcare infrastructure, ensuring that physicians, hospitals, and clinics have a reliable, quality-conscious source for patient-specific needs. We compound a significant volume of medications, which allows for greater efficiency and accessibility for the medical professionals we serve directly.
Quality and safety are the foundational principles of everything we do at our Longwood facility. As a 503B outsourcing facility, our processes are subject to rigorous FDA oversight and regular inspections. This includes stringent testing of components, in-process materials, and finished drug products. Our environment is meticulously controlled, with sterile compounding performed in ISO-classified cleanrooms by highly trained personnel. This unwavering commitment to cGMP standards at our location on W State Road 434 ensures that every preparation leaving our pharmacy meets exacting specifications for potency, purity, and stability.
503B Compounding Pharmacy provides a vital service by compounding medications that are on the FDA’s drug shortage list or are otherwise unavailable from traditional manufacturers. This capability is crucial for preventing interruptions in patient care for the local community. Healthcare providers at our location can depend on us to compound essential injectables, ophthalmics, and other formulations when there is a market shortage, helping to ensure their patients continue to receive the therapies they need without delay.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical professionals. Orders from practitioners for office use are placed directly with our facility. We encourage healthcare providers at our location to connect with us to discuss their specific compounding needs. You can learn more about our capabilities and services by visiting our website at https://503bcompoundingpharmacy.com/ or by calling our facility directly at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is ready to provide support and information.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and compounds medications in accordance with strict federal standards known as current good manufacturing practices (cGMP). This provides an additional layer of quality and safety oversight compared to traditional compounding.
2. Can I, as a patient, order medication directly from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we provide compounded medications for office use by healthcare providers. Your physician or healthcare facility at our location would order the medication from us to have on hand for administering to you during appointments or procedures.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide range of sterile preparations, including injectables, infusions, and ophthalmics, that are not available from commercial manufacturers or are listed on the FDA drug shortage list.
4. How does a healthcare provider at your location place an order?
Healthcare practitioners can place orders for office-use compounded medications by contacting our pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, available formulations, and delivery.
5. Why would a healthcare provider choose 503B Compounding Pharmacy?
Providers choose our facility at 2160 W State Road 434, Longwood, FL 32779 for our commitment to cGMP quality, our reliability in providing medications during shortages, and our role as a trusted partner in patient care, ensuring access to essential medications that are not otherwise available.