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 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. We serve healthcare providers and patients by producing large quantities of sterile and non-sterile compounded preparations that are not available commercially or are in shortage.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under rigorous quality control protocols. Our state-of-the-art facility is designed to meet and exceed the current good manufacturing practices (cGMP) mandated for 503B outsourcing facilities. This ensures that every preparation leaving our pharmacy is of the highest quality, purity, and potency. We provide healthcare practitioners with a reliable source for essential medications, supporting patient care in the local community.
503B Compounding Pharmacy specializes in the large-scale production of compounded medications. Our services are distinct from traditional compounding pharmacies, as we function as an outsourcing facility supplying healthcare facilities and providers. The medications prepared at our location on 2160 W State Road 434 are distributed for office use, enabling healthcare providers to have the necessary treatments on hand for their patients. Our work supports the local medical community by addressing critical drug shortages and providing access to vital medications.
Our team at 2160 W State Road 434, Longwood, FL 32779 is comprised of skilled pharmacists and technicians dedicated to the science of compounding. We utilize advanced technology and stringent testing methods to ensure the integrity of every batch. The primary focus of 503B Compounding Pharmacy is to uphold the trust placed in us by the healthcare providers we serve, ensuring they receive consistent, high-quality, and safe compounded preparations for their practice needs.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website for detailed information at https://503bcompoundingpharmacy.com/. Our facility welcomes inquiries from healthcare professionals regarding our available preparations and compliance standards.
Frequently Asked Questions
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 stricter current good manufacturing practices (cGMP) for the large-scale production of compounded medications, ensuring a higher level of quality and safety control compared to traditional compounding.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy supplies compounded medications to healthcare providers and facilities for office use. These medications are not dispensed directly to individual patients at our location but are provided to licensed practitioners for administration or dispensing within their professional practice.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 prepares a range of sterile and non-sterile compounded medications. This includes formulations that are on the FDA drug shortage list or are medically necessary but not commercially available. All preparations are made in larger batches under cGMP standards.
How does 503B Compounding Pharmacy ensure medication quality and safety?
We ensure quality and safety through strict adherence to cGMP guidelines. This involves rigorous testing of components, validated processes, environmental monitoring, and thorough documentation for every batch produced at our location. Our compliance with these federal standards is a core function of our operation.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can contact our facility directly to discuss their needs and place an order. We can be reached by phone at (407)993-1381. Our team will provide information on available preparations, ordering procedures, and compliance documentation from our location at 2160 W State Road 434, Longwood, FL 32779.