503B Compounding Pharmacy

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.

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Contact Information

Address:

2160 W State Road 434, Longwood, FL 32779

Phone:

(407)993-1381

Website

https://503bcompoundingpharmacy.com/

Location

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 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. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures that our processes and products meet an exceptional level of consistency and reliability.

The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for healthcare providers. We serve physicians, clinics, hospitals, and other healthcare entities by providing them with essential medications that are not commercially available or are in shortage. By operating from our location at 2160 W State Road 434, Longwood, FL 32779, we are a critical partner to the local medical community, ensuring they have access to vital medications without the need to engage in time-consuming in-house compounding. Our work directly supports healthcare professionals in delivering superior patient care.

Our state-of-the-art facility at 2160 W State Road 434 is designed to maintain the utmost sterility and environmental control. Every step of our operation, from ingredient sourcing to final packaging, is governed by stringent cGMP protocols. This includes extensive testing of components, validated sterilization processes, and robust quality control checks. The medications produced at 503B Compounding Pharmacy are prepared in bulk and are not based on patient-specific prescriptions, which allows us to achieve economies of scale and provide a consistent, reliable supply of high-quality compounded products to the healthcare providers we serve.

Patients who receive medications compounded at our facility can have confidence in their safety and potency. While 503B Compounding Pharmacy does not dispense directly to the public from 2160 W State Road 434, Longwood, FL 32779, our products are integral to the treatments administered by local healthcare providers. We are a foundational component of the healthcare infrastructure, dedicated to upholding the highest pharmaceutical standards for the benefit of the community. For more information about our operations and compliance, or to inquire about our services, please contact us directly.

Website: https://503bcompoundingpharmacy.com/

Phone: (407)993-1381

Frequently Asked Questions

1. What does it mean that 503B Compounding Pharmacy is an outsourcing facility? It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B of the FD&C Act. This subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring the highest level of quality and safety for the compounded medications we produce.

2. Can I, as a patient, pick up a prescription directly from your location? No. 503B Compounding Pharmacy operates as a bulk manufacturer for healthcare facilities. We do not dispense medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779. Your healthcare provider will administer or dispense our products to you as part of your treatment.

3. What kinds of medications does 503B Compounding Pharmacy produce? We specialize in producing compounded sterile preparations (CSPs) in bulk quantities. This often includes medications that are on shortage or are not available from commercial manufacturers. Healthcare providers at facilities in need of these medications can source them from our facility.

4. How does the quality control process work at your facility? Our quality control at 2160 W State Road 434, Longwood, FL 32779 is extensive. It includes rigorous testing of all incoming ingredients, environmental monitoring of our cleanrooms, validated sterilization processes, and thorough testing of finished products to ensure sterility, potency, and purity before they are released for distribution.