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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, an FDA-registered 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), providing an elevated level of assurance for the medications we produce. We serve healthcare providers and their patients from our specific location, ensuring access to vital medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. Our operations at 2160 W State Road 434 are designed to support the needs of healthcare professionals by providing bulk quantities of compounded preparations. This allows clinics, hospitals, and other healthcare entities in the area to obtain essential medications without the burden of in-house compounding. Our processes are meticulously controlled and monitored, from the sourcing of pure, high-quality active pharmaceutical ingredients (APIs) to the final packaging and labeling. Every batch is subjected to stringent testing to ensure potency, purity, and sterility, guaranteeing that healthcare providers at our location receive only the most reliable pharmaceutical products.
Patients and practitioners who utilize the services of 503B Compounding Pharmacy at 2160 W State Road 434 benefit from our specialized capabilities. We provide medications that are often on shortage or discontinued by large manufacturers, helping to prevent interruptions in critical patient care. Our facility is equipped with state-of-the-art technology and staffed by experienced pharmacists and technicians dedicated to the science of compounding. We operate with a patient-first philosophy, understanding that the medications we produce directly impact health outcomes. For healthcare providers seeking a trusted partner for compounded medications, our location serves as a vital resource.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical professionals at our location. Prescriptions or orders for compounded medications are managed with efficiency and precision. Our team is available to consult on specific patient needs or formulary requirements. We encourage healthcare providers to reach out to discuss how our services can support their practice and enhance patient care. The dedicated team at our Longwood facility is ready to assist with any inquiries.
For comprehensive information about our compliance, services, and processes, we invite you to visit our website at https://503bcompoundingpharmacy.com/. To speak directly with a member of our professional staff regarding an order or a specific patient need, please call us at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This requires us to comply with stringent current good manufacturing practices (cGMP) for higher standards of quality control, testing, and reporting compared to a traditional 503A pharmacy.
2. Who can order medications from 503B Compounding Pharmacy?
We provide medications primarily to healthcare providers and facilities, not directly to individual patients. Practitioners and institutions can order compounded medications from our location at 2160 W State Road 434 for administration or dispensing to their patients.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434 specializes in compounding sterile injectables, ophthalmics, and other preparations in larger batch quantities. We focus on medications that are on drug shortage lists or are otherwise not available from conventional manufacturers.
4. How does the ordering process work for providers at your location?
Healthcare providers can initiate an order by contacting our facility directly at (407)993-1381. Our team will work with you to process the prescription order, which is then compounded, tested for quality assurance, and prepared for pickup or delivery from our address on W State Road 434.
5. How can I verify the quality and safety of the compounded medications?
As a 503B outsourcing facility, we are subject to FDA inspection and must meet cGMP standards. Specific information about our quality control processes, testing protocols, and compliance can be discussed by calling our pharmacy at (407)993-1381 or reviewed on our website.