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 compliance in the preparation of compounded medications. We serve healthcare providers and patients by producing large quantities of sterile and non-sterile compounded preparations that are not available commercially. Our operations are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, ensuring that every preparation leaving our facility meets exacting standards for potency, purity, and sterility.
The team at 503B Compounding Pharmacy comprises highly skilled pharmacists and technicians who utilize state-of-the-art technology and equipment within our modern facility at 2160 W State Road 434, Longwood, FL 32779. Our primary focus is on producing medications for office use, which are then distributed to hospitals, clinics, and other healthcare providers for patient administration. This model allows healthcare professionals to access essential medications that are critical for patient care but may be on shortage or unavailable from traditional manufacturers. By operating as a 503B outsourcing facility, we provide a reliable and compliant source for these vital medications, supporting the local healthcare infrastructure.
Patients and prescribers who utilize medications produced at our Longwood location can have absolute confidence in their quality. Every batch is tested and verified to ensure it is free of contaminants and possesses the precise strength and identity as labeled. Our work directly contributes to positive patient outcomes by providing access to necessary medications that are prepared under the most stringent quality controls. For more information about our services or to inquire about our available preparations, please contact us directly. Website: https://503bcompoundingpharmacy.com/ | Phone: (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, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet heightened requirements for safety, quality, and purity.
Who can receive medications from 503B Compounding Pharmacy?
Our preparations are primarily distributed for office use to healthcare providers, such as hospitals, clinics, and physician practices. These providers then administer the medications to their patients. We work directly with medical professionals.
Are the medications compounded at 2160 W State Road 434 tested for quality?
Yes. As an FDA-registered 503B outsourcing facility, we are required to perform rigorous testing on our compounded preparations. This includes testing for sterility, potency, and endotoxins to ensure each batch meets all quality and safety specifications before it is released.
How does a healthcare provider place an order with your facility?
Healthcare providers can contact our facility directly to discuss their needs and place an order. We are available to answer questions and provide information about our available preparations. Please call us at (407)993-1381 to speak with our team.
Can I as a patient pick up a prescription directly from your location?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for office use by healthcare providers. Patients should receive their medications directly from their hospital, clinic, or doctor's office, which sources from our facility at 2160 W State Road 434.