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 safe and precise preparation of compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of current good manufacturing practices (cGMP), ensuring that every preparation is consistent, sterile, and of the utmost quality for the patients and healthcare providers we serve.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) that are distributed to healthcare facilities. Our operations at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding pharmacies, as we produce medications without patient-specific prescriptions, instead providing these essential drugs to hospitals, clinics, and physician offices for office use. This model ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have immediate access to critical medications that may be in short supply or not commercially available.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to maintain a controlled environment. Every step of our process, from ingredient sourcing to final packaging, is rigorously monitored and validated. The medications produced by 503B Compounding Pharmacy are vital for a wide range of medical applications, including anesthesia, pain management, and electrolyte replacement. By operating under the 503B framework, we provide an additional layer of safety and reliability for the medical community.
Healthcare providers seeking a trusted source for high-quality compounded medications can rely on 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. We are committed to supporting the local medical infrastructure by ensuring a consistent supply of essential drugs. For more information about our services or to discuss your facility's needs, please contact us directly. Reach our facility at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or visit our website to learn more: https://503bcompoundingpharmacy.com/.
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 operates under Section 503B of the FD&C Act. This requires us to comply with stringent current good manufacturing practices (cGMP) for the production of compounded drugs, which are subject to FDA oversight regarding production and quality controls.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779?
503B Compounding Pharmacy distributes compounded medications to healthcare facilities and practitioners for "office use." This includes hospitals, surgery centers, and clinics that require bulk quantities of medications for their patients without needing individual patient-specific prescriptions for each vial or preparation.
How does the service at 2160 W State Road 434, Longwood, FL 32779 differ from a traditional compounding pharmacy?
Traditional compounding pharmacies typically compound medications based on individual patient prescriptions. In contrast, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is an outsourcing facility that produces large batches of compounded sterile preparations for healthcare facilities to have on hand for immediate use, operating under federal cGMP standards.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounded sterile preparations. These are typically injectable medications used in clinical settings, such as anesthetic agents, pain management solutions, antibiotics, and nutritional IV preparations, often addressing critical drug shortages.
How can a healthcare facility at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare facilities can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. You can reach our team at (407)993-1381. More information about our processes and available preparations can also be found on our website at https://503bcompoundingpharmacy.com/.