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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our unwavering commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of traditional compounding. We provide healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to a broad range of medications that may be commercially unavailable or in shortage, directly supporting patient care needs.
The core function of 503B Compounding Pharmacy is the production of medications in anticipation of receiving prescriptions, which are then distributed to healthcare practitioners for office use and to pharmacies for dispensing to patients. This model is fundamental to our operations at 2160 W State Road 434, Longwood, FL 32779. Our state-of-the-art facility employs rigorous testing protocols, advanced environmental controls, and a team of highly skilled pharmacists and technicians to ensure every preparation meets precise specifications. This level of quality assurance is a hallmark of the 503B outsourcing facility designation and is central to the service we provide from our location.
Healthcare professionals relying on our services at 2160 W State Road 434, Longwood, FL 32779 can be confident in the integrity of the medications they administer and dispense. Our portfolio includes a significant number of medications that are often on national drug shortage lists, providing a critical and reliable alternative for continuity of care. By operating under the stringent cGMP (current Good Manufacturing Practice) regulations required for 503B outsourcing facilities, we offer a level of oversight and quality control that is essential for patient safety and positive therapeutic outcomes. Our dedicated team at 503B Compounding Pharmacy is focused on serving the specific needs of the medical community from our facility at 2160 W State Road 434, Longwood, FL 32779.
For more information about our available formulations and to understand how our 503B services can support your practice, we encourage you to contact us directly. Our team is available to answer questions and provide detailed product information. You can reach us at (407)993-1381 or visit our website to learn more about our compliance and quality standards at https://503bcompoundingpharmacy.com/. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This designation means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with strict federal standards, including cGMP, for the large-scale production of compounded medications. This ensures a higher level of quality control and consistency compared to traditional pharmacy compounding.
Can I, as a patient, order medications directly from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we provide medications for office use by healthcare practitioners and to pharmacies for dispensing. Patients must receive our medications through their prescribing doctor or a dispensing pharmacy that sources from our location at 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy help with drug shortages?
Our facility at 2160 W State Road 434, Longwood, FL 32779 can compound and supply medications that are on national shortage lists, providing a vital, reliable source for healthcare providers to ensure their patients continue to receive necessary treatments without interruption.
What kind of quality testing is performed on medications at your facility?
At our location on 2160 W State Road 434, Longwood, FL 32779, we perform rigorous sterility testing, endotoxin testing, potency assays, and other analytical testing as required by cGMP standards to verify the identity, strength, quality, and purity of all our compounded preparations.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. Please call our facility at (407)993-1381 to speak with our team or visit https://503bcompoundingpharmacy.com/ for more information on our ordering process.