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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of pharmaceutical quality, producing medications in bulk for healthcare providers to administer to patients within their practice. Our operations are distinct from traditional retail pharmacies, as we supply physician offices, hospitals, and clinics with the essential medications they need to serve their patients effectively and safely.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is the preparation of compounded medications that are not commercially available. This includes creating specific strengths, dosage forms, or formulations that are critical for patient care but are not offered by standard pharmaceutical manufacturers. Our state-of-the-art facility is equipped with advanced technology and staffed by a team of highly trained pharmacists and technicians who are experts in the art and science of pharmaceutical compounding. Every batch of medication is produced under stringent quality control protocols, including rigorous sterility testing and potency verification, to ensure the safety and efficacy of every product that leaves our facility.
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 and the immediate vicinity rely on 503B Compounding Pharmacy for a consistent and reliable supply of high-quality medications. Our services are integral to supporting local medical practices by providing them with the necessary tools to deliver personalized patient treatment. By outsourcing their compounding needs to our FDA-registered facility, healthcare professionals can be confident they are receiving products that meet the most current Good Manufacturing Practice (cGMP) standards. This allows them to focus on patient care while we handle the complex process of pharmaceutical preparation with precision and care.
For healthcare providers seeking a trusted partner for their compounding needs at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy stands as a pillar of quality and reliability. We are committed to supporting the local medical community with our specialized services. To learn more about our available formulations or to discuss your specific needs, please contact our facility directly. You can reach us by phone at (407)993-1381 or visit our website for more detailed information at .
FAQ
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 under Section 503B of the FD&C Act. This requires us to comply with strict current Good Manufacturing Practice (cGMP) regulations, which include rigorous testing for sterility, potency, and purity on all our compounded medications.
Who can purchase medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy supplies medications exclusively to healthcare providers and facilities, such as physician offices, hospitals, and clinics. We do not dispense medications directly to individual patients at our location. Healthcare providers then administer these medications to their patients within their practice.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in the large-scale compounding of both sterile and non-sterile medications that are not commercially available. This includes preparing specific dosages, eliminating non-essential allergens, or creating formulations that are currently in shortage from major manufacturers.
How does a healthcare provider at 2160 W State Road 434 place an order with 503B Compounding Pharmacy?
Healthcare providers can place orders directly with our facility by calling (407)993-1381. Our team will work with you to understand your specific requirements and provide information on available formulations, lead times, and ordering procedures.
Why should a local healthcare provider choose 503B Compounding Pharmacy?
Choosing our facility at 2160 W State Road 434, Longwood, FL 32779 ensures you are receiving medications produced under the highest federal quality standards. As an FDA-registered 503B outsourcing facility, we provide an added layer of safety and assurance through our compliance with cGMP, offering reliability and quality for your patients.