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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. As a 503B outsourcing facility, we adhere to more rigorous federal standards than a traditional 503A compounding pharmacy, providing an elevated level of quality control, testing, and regulatory compliance for the medications we produce.
The core mission of 503B Compounding Pharmacy is to provide healthcare professionals with access to high-quality, compounded medications that are essential for patient care. We serve practitioners by producing medications that are often on shortage, discontinued by manufacturers, or require a specific formulation not available commercially. By operating from our location at 2160 W State Road 434, Longwood, FL 32779, we ensure a reliable supply of critical medications, allowing local practitioners to focus on patient treatment without concerns about drug availability or sterility assurance.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to meet strict Current Good Manufacturing Practices (cGMP). This commitment to excellence is evident in every step of our process, from sourcing high-purity active pharmaceutical ingredients (APIs) to employing advanced compounding technologies and rigorous end-product testing. The medications produced by 503B Compounding Pharmacy are created in a controlled environment with validated processes, ensuring potency, purity, and sterility for every batch.
503B Compounding Pharmacy provides an essential service to the medical community from our facility in Longwood. We empower healthcare providers by giving them more options to treat their patients effectively. For healthcare practitioners seeking a trusted partner for their office-use medication needs, 503B Compounding Pharmacy at 2160 W State Road 434 stands as a pillar of reliability, quality, and service. To learn more about our services or to place an order, please contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an "outsourcing facility"?
An outsourcing facility is an FDA-registered compounding pharmacy that operates under Section 503B of the FD&C Act. This means our facility at 2160 W State Road 434, Longwood, FL 32779 complies with stricter federal standards, including Current Good Manufacturing Practices (cGMP), and undergoes regular FDA inspections to ensure the quality and safety of the medications we compound for office use.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy distributes medications for office use exclusively to healthcare practitioners. We serve physicians, veterinarians, and other qualified healthcare providers who administer medications within their practice located near our facility at 2160 W State Road 434, Longwood, FL 32779. We do not dispense medications directly to individual patients.
What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide range of sterile injectables, ophthalmics, and non-sterile medications. This includes medications that are on national drug shortage lists, have been discontinued by major manufacturers, or require a specific strength or formulation not commercially available.
How does the quality assurance process work at your facility?
Quality is paramount at our location. Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing for potency, sterility, and endotoxins by an independent laboratory before it is released. Our processes are validated, and our facility operates under cGMP to ensure the highest level of quality and consistency in every product we ship.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare practitioners can place orders for compounded medications by contacting 503B Compounding Pharmacy directly. You can reach our team at our facility located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381. You can also visit our website at https://503bcompoundingpharmacy.com/ for more information on our services and to initiate the order process.