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 is precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation is a critical distinction, signifying our commitment to the highest standards of quality, safety, and regulatory oversight. Unlike a traditional compounding pharmacy, our 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP) and is subject to regular FDA inspections. This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets unparalleled standards of sterility, potency, and purity.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific but not otherwise commercially available. We provide these essential pharmaceutical preparations to healthcare providers for office use and for administration to patients within their care. Our operations at 2160 W State Road 434, Longwood, FL 32779 are dedicated to supporting the local medical community by compounding sterile injectables, including IV bags, syringes, and other critical formulations. By operating under Section 503B, we provide practitioners with access to medications that are vital for their practice, all produced under the exacting standards required by the FDA for outsourcing facilities.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by a team of highly skilled pharmacists and technicians. Every process, from ingredient sourcing to final packaging, is meticulously controlled and documented to guarantee the integrity of our compounded preparations. This level of quality control is a fundamental aspect of being a 503B outsourcing facility and is central to our mission. We serve as a reliable partner for healthcare professionals who require bulk, office-use medications that are not available from standard commercial manufacturers, ensuring they can provide the best possible care.
503B Compounding Pharmacy is committed to excellence from our location at 2160 W State Road 434, Longwood, FL 32779. We understand the critical nature of the medications we produce and the trust that healthcare providers place in our facility. Our dedication to compliance, quality, and safety is unwavering. For more detailed information about our services and regulatory status, or to speak with our team, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or contact us directly by phone at (407)993-1381.
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 practices (cGMP) and undergo regular FDA inspections, ensuring the highest levels of quality, sterility, and safety for our compounded preparations.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides compounded medications to healthcare practitioners for "office use" or administration within their practice at 2160 W State Road 434, Longwood, FL 32779. We do not dispense medications directly to individual patients; instead, we supply physicians and clinics with medications they need to treat their patients.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectable medications in larger quantities. This includes IV bags, syringes, and other sterile preparations that are not readily available from commercial manufacturers, providing essential solutions for healthcare providers.
How does the quality control at a 503B outsourcing facility differ?
As a 503B outsourcing facility, our operations at 2160 W State Road 434, Longwood, FL 32779 are governed by cGMP standards. This involves rigorous testing of ingredients, validation of sterilization processes, extensive environmental monitoring of our cleanrooms, and thorough documentation for every batch produced, far exceeding the standards of traditional compounding.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. For more information and to discuss your specific needs, please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ to learn more about our capabilities and compliance.