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.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility 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 preparation of compounded sterile preparations (CSPs) for healthcare providers. As a 503B outsourcing facility, we adhere to rigorous federal standards for quality control, sterility testing, and current good manufacturing practices (cGMP). This regulatory framework distinguishes our operations and ensures that healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 receive medications produced under the highest level of pharmaceutical quality and safety oversight.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are typically administered in healthcare settings. Our services are designed to support physicians, surgeons, hospitals, and clinics by providing them with essential medications that may be in short supply or unavailable from traditional manufacturers. The team at our 2160 W State Road 434, Longwood, FL 32779 location consists of highly trained pharmacists and technicians who utilize advanced technology and sterile techniques to compound injectable medications, including IV bags, epidurals, and ophthalmic preparations. Every batch is meticulously prepared and undergoes stringent testing to ensure potency, purity, and sterility before it is released for patient use.
Our facility at 2160 W State Road 434, Longwood, FL 32779 provides a critical service by helping to alleviate drug shortages. When commercial manufacturers have supply interruptions, 503B Compounding Pharmacy can step in to compound necessary medications, ensuring patient care is not disrupted. We maintain a robust quality assurance program that includes environmental monitoring, personnel training, and finished product testing, all compliant with FDA regulations for 503B outsourcing facilities. This commitment to excellence provides healthcare professionals with confidence in the medications they administer to their patients.
503B Compounding Pharmacy is a vital partner for the medical community. We operate by receiving prescriptions or orders from licensed healthcare practitioners. Our location at 2160 W State Road 434, Longwood, FL 32779 is a manufacturing facility focused on wholesale distribution to healthcare entities, not a traditional retail pharmacy for direct patient walk-in services. For more information about our services or to place an order, healthcare providers can contact us directly. Reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website at .
Frequently Asked Questions for 503B Compounding Pharmacy
1. What is a 503B outsourcing facility?
A 503B outsourcing facility is an FDA-registered entity that compounds large volumes of sterile human drugs. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under this designation, which requires compliance with current good manufacturing practices (cGMP) and federal oversight, unlike traditional compounding pharmacies.
2. Who can order medications from your facility?
503B Compounding Pharmacy provides medications to licensed healthcare practitioners and healthcare facilities. This includes hospitals, clinics, surgery centers, and physician offices. We do not dispense medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779.
3. 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 preparations. This includes IV solutions, epidural injections, ophthalmic drops, and other medications typically used in a clinical or surgical setting, particularly those that may be experiencing a national drug shortage.
4. How does the quality assurance process work at your facility?
As an FDA-registered 503B outsourcing facility, we adhere to strict cGMP standards. Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing for sterility, potency, and endotoxins before it is released for distribution to ensure the highest level of patient safety.
5. How can a healthcare provider place an order?
Healthcare providers interested in our services can initiate the process by contacting 503B Compounding Pharmacy directly. You can reach our team at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381. Our website at also provides information for potential clients.