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. This designation is central to the operations at our specific location: 2160 W State Road 434, Longwood, FL 32779. As a 503B Compounding Pharmacy, we are distinguished from traditional compounding pharmacies by the scale of our production and the rigorous federal standards we adhere to. Our primary function is the large-scale compounding of sterile medications, which are then distributed to healthcare providers for administration to their patients within clinical settings. The facility at 2160 W State Road 434 is designed and maintained to meet the exacting requirements for sterile drug production, ensuring the highest levels of quality and safety for every preparation.
The core mission of 503B Compounding Pharmacy is to provide healthcare practitioners with access to critical medications that may be in short supply or not commercially available. By operating as a 503B outsourcing facility, we help mitigate drug shortages, offering a reliable source for essential injectable medications. The processes at our Longwood location are governed by Current Good Manufacturing Practices (cGMP), which far exceed the standards applied to traditional pharmacy compounding. This involves extensive environmental monitoring, rigorous testing of components and finished products, and a comprehensive quality assurance program. Every step, from sourcing ingredients to final packaging, is meticulously controlled and documented at our facility on W State Road 434.
For healthcare providers and clinics, partnering with 503B Compounding Pharmacy at 2160 W State Road 434 ensures they receive medications produced under the highest regulatory oversight. Our services are tailored to support the operational needs of medical practices by providing bulk quantities of sterile compounded preparations. It is important to note that 503B Compounding Pharmacy does not typically dispense medications directly to individual patients from this location; instead, we serve as a vital link in the healthcare supply chain, supplying physicians and hospitals with the necessary tools for patient care. Our commitment is to uphold the integrity of every dose that leaves our facility, contributing to positive patient outcomes.
Prospective clients and healthcare partners are encouraged to learn more about our specific capabilities and compliance status. Detailed information about our services and quality commitments can be found on our website. To discuss your facility's specific needs or to initiate an order, please contact 503B Compounding Pharmacy directly. We are located at 2160 W State Road 434, Longwood, FL 32779. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, operates under Section 503B of the FD&C Act. This registration signifies that our facility complies with stringent federal standards, including Current Good Manufacturing Practices (cGMP), for the large-scale production of sterile compounded medications for healthcare providers.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy supplies compounded medications exclusively to healthcare practitioners and facilities for office use. Medications are not typically dispensed directly to individual patients at our location on W State Road 434. Patients receive these medications through their healthcare provider in a clinical setting.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in compounding sterile injectable medications. This often includes preparations that are on drug shortage lists or are not available from conventional manufacturers, providing a critical supply for clinics and hospitals served from our Longwood location.
How does the quality control process work at your facility?
Our facility at 2160 W State Road 434 adheres to rigorous cGMP standards. This involves extensive testing of raw materials, stringent environmental controls in our cleanrooms, and quality testing on finished products to ensure every batch meets predefined specifications for sterility, potency, and purity before distribution.
How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities interested in our services should contact 503B Compounding Pharmacy directly to discuss their needs. You can reach our team at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information on ordering and becoming a client. All operations are conducted from our location at 2160 W State Road 434, Longwood, FL 32779.