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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. The 503B designation signifies a commitment to the highest standards of quality, safety, and consistency, operating under current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility meets rigorous federal testing and production standards, providing a critical component of the pharmaceutical supply chain for healthcare providers.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available or are in shortage. By compounding these essential drugs, the facility directly supports patient care by ensuring healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 have access to necessary treatments. The operations are distinct from traditional compounding, focusing on producing batches for office use rather than individual patient-specific prescriptions, which allows for greater efficiency and scale while maintaining an unwavering focus on sterility and precision.
Healthcare professionals utilizing the services of 503B Compounding Pharmacy can be assured of a reliable source for critical medications. The facility's processes are designed for meticulous accuracy, from ingredient sourcing to final packaging. Every batch is compounded in a controlled environment with comprehensive documentation and quality control measures. This operational model provides a vital service to the medical community, ensuring that patients receive safe, effective, and high-quality compounded medications when they are needed most.
For more information on the services provided or to inquire about available medications, you can contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381. Detailed information about its operations and compliance is also available on its official website at https://503bcompoundingpharmacy.com/.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means the facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and compounds medications in accordance with Section 503B of the FD&C Act. This requires adherence to stringent current Good Manufacturing Practices (cGMP) for quality, purity, and sterility, which are more comprehensive than the standards applied to traditional compounding pharmacies.
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at 2160 W State Road 434, Longwood, FL 32779 are intended for office use by healthcare practitioners. They are not dispensed directly to individual patients. Healthcare providers can order these medications for administration within their practice or for distribution to patients under their care.
What types of medications does 503B Compounding Pharmacy produce?
The facility focuses on producing medications that are on the FDA drug shortage list or are not available from commercial manufacturers. This includes a range of sterile injectables, ophthalmics, and other formulations that are essential for patient treatment but are temporarily or permanently unavailable through standard pharmaceutical channels.
How does the quality control process work at this location?
Quality control is a fundamental aspect of operations at 2160 W State Road 434, Longwood, FL 32779. The process includes rigorous testing of raw materials, environmental monitoring of the compounding suites, and validated sterility testing on finished products. Each batch is thoroughly documented to ensure full traceability and compliance with all cGMP requirements.
How can a healthcare provider at this location place an order?
Healthcare providers interested in the services of 503B Compounding Pharmacy can initiate the process by contacting the facility directly. Inquiries and orders can be made by calling (407)993-1381. The website at https://503bcompoundingpharmacy.com/ may also provide additional resources and contact forms for more information.