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 precisely 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. As a 503B outsourcing facility, we produce large batches of sterile and non-sterile compounded drugs for physician offices, hospitals, and healthcare providers without receiving patient-specific prescriptions. Our operations are distinct from traditional compounding pharmacies, focusing on providing practitioners at 2160 W State Road 434, Longwood, FL 32779 with access to a consistent and reliable supply of high-quality medications.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications. This process is conducted under rigorous quality control standards that are inspected and enforced by the FDA. Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and maintained under controlled environmental conditions to ensure the integrity of every preparation. We provide healthcare professionals with essential medications that may be in short supply or unavailable from conventional manufacturers. The services provided by 503B Compounding Pharmacy are integral to supporting the local medical community by ensuring that practitioners have the necessary pharmaceutical tools for patient care.
Our operational model at 2160 W State Road 434, Longwood, FL 32779 is built on a foundation of transparency and regulatory adherence. We are subject to current good manufacturing practice (CGMP) requirements, mandatory FDA inspections, and stringent reporting of adverse events. This level of oversight provides an additional layer of safety and assurance for the healthcare providers we serve. The team at 503B Compounding Pharmacy consists of highly skilled pharmacists, technicians, and quality assurance professionals dedicated to the precise and accurate preparation of medications. For more information about our compliance and services, please contact us directly.
To learn more about the specific compounded preparations available from our facility or to discuss how we can support your practice, we encourage you to reach out. You can contact 503B Compounding Pharmacy at our facility located at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381. Detailed information about our operations and compliance status is also available on our official website at https://503bcompoundingpharmacy.com/.
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 the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This subjects us to federal oversight, including compliance with Current Good Manufacturing Practices (cGMP) and routine FDA inspections, ensuring a high standard of quality and safety for the compounded medications we produce.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications to healthcare practitioners and entities for office use. We do not compound medications based on individual patient prescriptions for the public. Healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 can order compounded preparations from us for administration within their practice.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we compound both sterile and non-sterile medications in larger batches. This often includes preparations that are on drug shortage lists or are otherwise not readily available from standard pharmaceutical manufacturers. The specific medications available can be confirmed by contacting our facility directly.
How does the quality control process work at your facility?
Our quality control process at 2160 W State Road 434, Longwood, FL 32779 is comprehensive and follows strict cGMP protocols. It includes rigorous testing of components, in-process checks, finished preparation testing, environmental monitoring, and extensive documentation to ensure the identity, strength, quality, and purity of all medications we compound.
How can a healthcare provider at this location place an order?
Healthcare providers interested in our services can initiate an order by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, available medications, and any necessary documentation required to process an order from our facility at 2160 W State Road 434, Longwood, FL 32779.