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 operates as an FDA-registered outsourcing facility in strict compliance with 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 safe and precise preparation of compounded medications. As a 503B outsourcing facility, we adhere to the highest current good manufacturing practices (cGMP) to ensure the quality, purity, and potency of every preparation that leaves our pharmacy. This regulatory framework distinguishes our operations and provides a critical level of assurance for the healthcare providers and patients we serve.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations. These medications are produced in bulk, without patient-specific prescriptions, and are intended for office use by healthcare practitioners. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and environmental controls to support this mission. We serve a vital role in the local healthcare ecosystem by providing practitioners with access to essential medications that may be in shortage, discontinued, or otherwise unavailable from traditional manufacturers.
Our services are integral to supporting medical practices, hospitals, and clinics in the area. By providing a reliable source of high-quality compounded medications, we enable healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to focus on patient care without concerns about drug availability or consistency. Every batch of medication is subjected to rigorous testing and quality control procedures, including sterility testing and endotoxin testing for injectables, to meet the stringent standards required of a 503B outsourcing facility. This commitment to excellence ensures patient safety and therapeutic efficacy.
503B Compounding Pharmacy is committed to upholding the highest standards of pharmaceutical compounding. Our team of experienced pharmacists and technicians at 2160 W State Road 434, Longwood, FL 32779 is dedicated to precision and quality in every step of the process. We operate with transparency and a patient-first mindset, understanding that the medications we produce are a critical component of treatment plans. For more information or to discuss how our services can support your practice, please contact us via our website at or by phone at (407)993-1381.
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 complies with strict federal standards for compounding, known as current good manufacturing practices (cGMP). This ensures a higher level of quality control and oversight compared to traditional compounding pharmacies.
Who can receive medications from 503B Compounding Pharmacy?
Our medications are produced for office use and are distributed to healthcare practitioners and institutions. Patients receive these medications directly from their doctor or clinic, not from our facility at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in preparing large-scale batches of compounded sterile preparations, such as injectables, ophthalmics, and irrigations, as well as non-sterile preparations. These are often medications that are on shortage or not commercially available.
How does 503B Compounding Pharmacy ensure medication safety?
Our location at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced environmental controls, and our processes include rigorous testing, such as sterility and endotoxin testing, for applicable preparations. Our adherence to cGMP standards is fundamental to our commitment to safety.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers and institutions can initiate an order or inquire about our services by contacting 503B Compounding Pharmacy directly through our website at or by calling our main line at (407)993-1381.