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 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, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production that exceed those of traditional compounding pharmacies, providing a critical component of the pharmaceutical supply chain for healthcare providers.
The core function of 503B Compounding Pharmacy is the production of medications that are patient-specific or are in shortage. The facility at 2160 W State Road 434, Longwood, FL 32779, compounds a significant volume of injectable, ophthalmic, and other sterile preparations. These medications are essential for hospitals, surgery centers, clinics, and other healthcare entities that rely on a consistent and reliable source of high-quality compounded preparations. The operation under Section 503B ensures that all products are made in accordance with Current Good Manufacturing Practices (cGMP), which mandates stringent environmental controls, personnel training, and end-product testing for sterility and potency.
For healthcare professionals seeking a trusted partner for their compounding needs, 503B Compounding Pharmacy provides a vital service from its location at 2160 W State Road 434, Longwood, FL 32779. The facility's commitment to compliance and quality offers assurance that the medications provided meet the highest standards of safety and efficacy. By focusing on bulk compounding, 503B Compounding Pharmacy helps mitigate drug shortages and supports the local healthcare infrastructure with essential pharmaceutical products.
To learn more about the services and compliance standards of 503B Compounding Pharmacy, or to inquire about becoming a client, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them directly by phone at (407)993-1381. The team at the Longwood facility is equipped to provide detailed information and support for your organization's specific pharmaceutical compounding requirements.
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 in compliance with Section 503B of the FD&C Act. This registration signifies our adherence to Current Good Manufacturing Practices (cGMP) for the production of compounded medications on a larger scale.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications to healthcare facilities and providers, such as hospitals, clinics, and surgery centers. Medications are not dispensed directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779, but are supplied to the medical professionals who administer them.
What types of medications does 503B Compounding Pharmacy produce?
Our primary focus at our Longwood facility is the compounding of sterile injectable preparations, including IV bags, syringes, and ophthalmic solutions. We specialize in producing these medications, particularly those that are in short supply or are needed in specific formulations not readily available from commercial manufacturers.
How does 503B Compounding Pharmacy ensure the quality of its compounded preparations?
Quality is ensured through strict adherence to cGMP guidelines at our facility on W State Road 434. This includes rigorous environmental monitoring, validated processes, extensive personnel training, and thorough testing of finished products for sterility, potency, and endotoxins before they are released for distribution.
How can a healthcare facility at 2160 W State Road 434, Longwood, FL 32779, place an order?
Healthcare facilities can initiate the process by contacting 503B Compounding Pharmacy directly. For detailed ordering information, formulary availability, and to establish an account, please call our facility at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.