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, located at 2160 W State Road 434, Longwood, FL 32779, is dedicated to the sterile and non-sterile compounding of medications. The 503B designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, distinguishing our operations from traditional compounding pharmacies. We serve healthcare providers and patients at our Longwood location by providing bulk quantities of compounded medications for office use, ensuring practitioners have the necessary supplies to treat their patients effectively and without delay.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale production of compounded drugs that are distributed to healthcare facilities for office-based administration. This model supports local clinics and practices by providing them with access to essential medications that may be commercially unavailable or in short supply. By adhering to Current Good Manufacturing Practices (cGMP), our facility ensures every preparation meets rigorous standards for potency, purity, and sterility. The team at our Longwood location is comprised of skilled pharmacists and technicians who utilize advanced technology and meticulous processes to fulfill the specific needs of the medical community we serve directly from our address on State Road 434.
Engaging with 503B Compounding Pharmacy provides healthcare professionals at our local Longwood address with a reliable source for high-quality compounded medications. Our services are designed to integrate seamlessly into clinical practice, offering convenience and assurance. We encourage providers at 2160 W State Road 434 to discuss their specific compounding needs with our pharmacy team. For more detailed information about our services or to initiate an order, please contact us directly. You can reach 503B Compounding Pharmacy by visiting our website at https://503bcompoundingpharmacy.com/ or by calling our dedicated phone line at (407)993-1381.
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 operates under Section 503B of the FD&C Act. This requires us to comply with stringent Current Good Manufacturing Practices (cGMP) for drug production, ensuring a higher level of regulatory oversight for sterility, safety, and quality compared to a traditional compounding pharmacy.
Who can receive medications from your Longwood location?
503B Compounding Pharmacy distributes compounded medications for office use to healthcare providers and facilities. These medications are intended for administration to patients within a clinical setting at our local Longwood address. We do not typically dispense medications directly to individual patients without a provider's involvement.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434 specializes in preparing sterile and non-sterile compounded medications in larger quantities. This includes formulations that are on the FDA drug shortage list or medications that are not commercially available, providing essential options for healthcare providers serving the Longwood community.
How does a healthcare provider at your location place an order?
Healthcare providers can place orders for compounded medications by contacting 503B Compounding Pharmacy directly. Orders for pickup or delivery from our facility at 2160 W State Road 434 can be initiated by calling our main line at (407)993-1381. Our team will guide you through the required documentation and process.
Why should a provider choose 503B Compounding Pharmacy for their office-use medications?
Choosing our facility at 2160 W State Road 434 ensures you are sourcing medications from an FDA-registered outsourcing facility that adheres to the highest manufacturing standards. This provides an added layer of safety and quality assurance for the medications you administer to your patients in Longwood, mitigating risk and ensuring reliability.