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.
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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality control, undergoing rigorous FDA inspections and producing medications in larger batches for office use by healthcare practitioners. This model ensures that patients at 2160 W State Road 434, Longwood, FL 32779 have access to consistent, high-quality medications when commercially available options are not suitable.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with a reliable source of compounded medications. Physicians, surgeons, veterinarians, and other medical professionals can utilize our services to obtain the specific medications their patients need. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and staffed by highly trained pharmacists and technicians who specialize in compounding. We maintain a robust quality assurance program, including stringent environmental monitoring and sterility testing, to ensure every preparation meets its specified identity, strength, quality, and purity.
503B Compounding Pharmacy provides essential medications that are often on the FDA drug shortage list, helping to mitigate supply chain issues for local practitioners. We compound a range of preparations, including sterile injectables, ophthalmics, and other dosage forms that are not available or are in short supply from conventional manufacturers. By focusing on the specific needs of the medical community at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy serves as a critical partner in patient care, enabling healthcare providers to administer necessary treatments without delay.
For more information about the services provided by 503B Compounding Pharmacy, you can visit our website at or contact us directly by phone at (407)993-1381. Our team is committed to supporting the medical community at 2160 W State Road 434, Longwood, FL 32779 with the highest caliber of compounded pharmaceutical preparations.
FAQ
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 complies with strict federal standards for compounding, including current Good Manufacturing Practices (cGMP). This ensures a higher level of oversight and quality control compared to traditional compounding pharmacies.
2. Can I as an individual patient order medications directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Your physician or healthcare provider at their practice can order the compounded medication we prepare and then administer or dispense it to you as part of your treatment.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
Our facility specializes in compounding sterile preparations, such as injectables, IV bags, and ophthalmic solutions. We focus on producing these medications in batches for healthcare providers to ensure consistency and availability, particularly for drugs that are on shortage or not commercially available.
4. How does a healthcare provider at 2160 W State Road 434 place an order with your facility?
Healthcare providers can establish an account with 503B Compounding Pharmacy by contacting us directly at (407)993-1381. Our team will guide them through the onboarding process and provide information on ordering protocols for our compounded preparations.
5. How does 503B Compounding Pharmacy ensure the quality and sterility of its products?
Our facility at 2160 W State Road 434, Longwood, FL 32779 implements a comprehensive quality assurance program that includes environmental monitoring, personnel training, validated processes, and rigorous end-product testing for sterility and potency, all in compliance with FDA cGMP regulations.