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 a traditional compounding pharmacy. We serve healthcare providers by producing medications that are patient-specific and often not commercially available, ensuring practitioners at our local address have access to critical pharmaceutical preparations.
The core function of 503B Compounding Pharmacy is the production of medications in anticipation of receiving patient-specific prescriptions. This allows us to supply healthcare professionals with essential drugs that are ready for immediate dispensing. Our operations at 2160 W State Road 434, Longwood, FL 32779 are vital for ensuring a reliable supply of compounded medications, mitigating drug shortages, and providing alternatives when commercially manufactured drugs are discontinued. Our team of highly skilled pharmacists and technicians utilizes state-of-the-art technology and rigorous testing protocols to ensure every preparation meets stringent potency and sterility standards before it is released.
As a 503B outsourcing facility, our primary partners are healthcare providers. We empower local practitioners by providing them with a trusted source for high-quality compounded medications, enabling them to offer personalized treatment options to their patients. The medications produced within our facility at 2160 W State Road 434, Longwood, FL 32779 are distributed to healthcare settings for administration. Our work directly supports the local medical community by enhancing patient care through access to tailored pharmaceutical solutions that address specific clinical needs.
Quality assurance is the foundation of everything we do at 503B Compounding Pharmacy. Our facility adheres to Current Good Manufacturing Practices (cGMP), which are enforced by the FDA. This involves rigorous environmental monitoring, validation of all processes and equipment, and extensive testing of both components and finished products. Every batch compounded at our location on W State Road 434 is subject to these robust quality controls, providing healthcare professionals and their patients with the utmost confidence in the safety and efficacy of the medications they use.
For more information about our services or to speak with our team, we can be reached at (407)993-1381. Detailed information about our capabilities and compliance is available on our website at https://503bcompoundingpharmacy.com/. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
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 and inspected by the FDA. We operate under Section 503B of the FD&C Act and must comply with Current Good Manufacturing Practices (cGMP), which involve rigorous sterility testing, process validation, and environmental monitoring to ensure the highest quality and safety of our compounded medications.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications to healthcare providers and practitioners. Our services are designed to support the local medical community by supplying them with patient-specific medications for office use and administration. Patients should consult their healthcare provider regarding medications compounded at our facility.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile medications in batches. This includes preparations like hormone therapy, sterile injectables, ophthalmics, and other formulations that are often on shortage or are not available from large commercial manufacturers. All production occurs at our location on W State Road 434.
How does 503B Compounding Pharmacy help with drug shortages?
Our facility at 2160 W State Road 434, Longwood, FL 32779 can compound essential medications that are listed on the FDA drug shortage list. This capability provides a critical alternative for healthcare providers when first-line, commercially manufactured treatments are unavailable, helping to ensure continuity of care for patients.
How can a healthcare provider get started with 503B Compounding Pharmacy?
Healthcare providers interested in our services can contact us directly at (407)993-1381 to discuss their specific needs. Our team at our Longwood facility can provide information on our available formulations, ordering process, and compliance documentation. Our website, https://503bcompoundingpharmacy.com/, also serves as a resource for information.