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 specifically designed and regulated to produce large volumes of compounded sterile preparations (CSPs) for healthcare practitioners. Unlike a traditional 503A pharmacy, a 503B outsourcing facility provides medications for office use, meaning physicians, surgeons, and other healthcare providers at clinics and hospitals can keep our compounded medications on their shelves to administer to patients without the need for an individual patient-specific prescription. This model is critical for supporting the efficient operations of medical practices located near 2160 W State Road 434, Longwood, FL 32779.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile injectables, including IV bags, syringes, and other parenteral medications. Our processes are governed by Current Good Manufacturing Practices (cGMP), which are the strict quality standards enforced by the FDA for all drug manufacturers. This ensures that every batch of medication we produce at our Longwood facility meets rigorous standards for potency, purity, and sterility. Healthcare professionals who source their medications from our 503B outsourcing facility can have the highest confidence in the quality and consistency of the products they are providing to their patients, knowing they are produced under a level of scrutiny that goes beyond traditional compounding.
By operating as a 503B outsourcing facility, we provide a vital service to the local medical community. We alleviate the compounding burden from individual practices, allowing doctors and nurses to focus on patient care rather than medication preparation. Our location at 2160 W State Road 434, Longwood, FL 32779 is a centralized hub for high-quality, ready-to-use compounded medications. We serve as a reliable partner for physicians, surgical centers, and other healthcare entities that require access to sterile preparations for office use, ensuring they have the necessary medications on hand when needed.
The team at 503B Compounding Pharmacy is comprised of skilled pharmacists, pharmacy technicians, and quality assurance professionals dedicated to upholding the highest standards of pharmaceutical science. Every step of our operation, from ingredient sourcing to final product testing and distribution, is meticulously controlled and documented. Our commitment is to provide healthcare providers with medications they can trust, supporting better patient outcomes and advancing the standard of care for the community served by our facility at 2160 W State Road 434, Longwood, FL 32779.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website to learn more about our compliance and offerings: https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an "outsourcing facility"?
An outsourcing facility is an FDA-registered entity that compounds sterile human drugs in accordance with Section 503B of the FD&C Act. This designation means our facility at 2160 W State Road 434, Longwood, FL 32779 operates under current Good Manufacturing Practices (cGMP) and is subject to FDA oversight, allowing us to compound medications for office use by healthcare practitioners without patient-specific prescriptions.
2. Who can order medications from 503B Compounding Pharmacy?
We provide compounded medications exclusively to healthcare professionals and facilities for office use. This includes physicians, surgeons, dermatologists, veterinarians, and other licensed practitioners who administer medications within their practice located near 2160 W State Road 434, Longwood, FL 32779. We do not dispense medications directly to individual patients.
3. What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in the large-scale production of sterile injectable preparations. This includes IV bags, syringes, and other parenteral medications that are essential for medical procedures, office-based therapies, and surgical support.
4. How does the quality assurance process work at your facility?
Quality is paramount. Our processes at 2160 W State Road 434, Longwood, FL 32779 are governed by strict cGMP standards. This includes rigorous testing of raw materials, environmental monitoring of our cleanrooms, validated sterilization processes, and thorough testing of finished products for sterility, potency, and endotoxins before any batch is released for distribution.
5. How can a healthcare practice near your location start ordering?
Healthcare practices interested in our services can initiate the process by contacting our facility directly. You can call our dedicated line at (407)993-1381 to speak with a representative who can discuss your practice's specific needs, set up an account, and provide information on our ordering procedures and available formulations.