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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the identity and operations of our facility at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are held to the highest standards of pharmaceutical compounding, adhering to rigorous Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility is of consistent quality, strength, and purity. Our primary mission is to provide bulk quantities of compounded sterile preparations (CSPs) to healthcare practitioners and facilities, enabling them to better serve their patients with medications that are not commercially available.
The services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding. We do not compound patient-specific prescriptions but instead produce large batches of medications for office use. This model allows physicians, surgeons, hospitals, and clinics in the local area to have immediate access to critical medications for procedures, emergency kits, and general patient care. Our portfolio includes a wide array of sterile preparations, such as injectables, ophthalmics, and irrigations, all compounded in our state-of-the-art cleanroom environment. This facility is meticulously controlled and monitored to ensure an aseptic processing area, which is paramount for patient safety.
Choosing 503B Compounding Pharmacy means partnering with a facility that prioritizes compliance, quality control, and reliability. Every batch of medication is subjected to stringent testing, including sterility testing and endotoxin testing, to verify its safety and efficacy before it is released for distribution. Our team of highly skilled pharmacists and technicians are experts in sterile compounding techniques, utilizing advanced technology and equipment to meet the specific needs of the healthcare providers we serve. We are committed to supporting the local medical community at 2160 W State Road 434, Longwood, FL 32779 by providing a dependable source of high-quality, compounded medications that are essential for modern medical treatments.
For more information about the services offered by 503B Compounding Pharmacy or to discuss your facility's needs, please contact us directly. You can reach our team by visiting our website at https://503bcompoundingpharmacy.com/ or by calling us at (407)993-1381. We are dedicated to upholding the standards expected of an FDA-registered 503B outsourcing facility and are here to serve the healthcare professionals in our community.
Frequently Asked Questions
1. 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 in compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires us to adhere to strict Current Good Manufacturing Practices (cGMP) for the compounding of sterile medications, ensuring the highest levels of quality and safety.
2. Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides compounded medications to healthcare practitioners and facilities, such as hospitals, clinics, and surgical centers. We do not dispense medications directly to individual patients. Healthcare providers at our location can order medications for office use to treat their patients.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations in bulk quantities. This includes a wide range of injectables, ophthalmics, and irrigation solutions that are not available off-the-shelf from commercial pharmaceutical manufacturers.
4. How does 503B Compounding Pharmacy ensure the quality of its compounded preparations?
Quality is assured through rigorous processes mandated by our 503B status. This includes environmental monitoring of our cleanrooms, validation of our sterilization processes, and thorough testing of finished products for sterility and potency before they are released from our facility at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities and practitioners can place an order by contacting 503B Compounding Pharmacy directly. You can reach our team by phone at (407)993-1381 or through the contact information provided on our website at https://503bcompoundingpharmacy.com/.